Preparations for the 40th International Dental Show from March 14th to 18th, 2023 in Cologne, Germany, are in full swing. For Dentsply Sirona, this event is all about being "United for better dentistry”—for more connectivity, collaboration, and partnership to advance dentistry. To this end, the company will be presenting interactive events, exciting digital experiences, and live demonstrations at its exceptional exhibition space in Hall 11.2.

Dentsply Sirona will focus on digital dentistry, sustainability, and how the industry can advance oral health globally by being “United for better dentistry.” The exhibition space will be constructed using wooden floors and reused materials wherever possible, and attendees are invited to use digital tools to engage with materials and information. The exhibition booth also includes an area that focuses on sustainability. All IDS attendees are invited to express their commitment to more sustainable dentistry by signing a green leaf and sticking it onto the Sustainability Commitment Wall.

Dentsply Sirona will also showcase DS Core, an innovation that transforms dentistry and helps users to concentrate on what matters most, the patient. It is an open, cloud-based platform that seamlessly connects various Dentsply Sirona devices, including CEREC Primemill, Primescan, Primescan Connect, Primeprint, and even Axeos. Data generated from the platform is securely collected and stored in a database that can be accessed from anywhere and anytime while being GPDR and HIPAA compliant.

Dentsply Sirona’s latest innovations in digital dentistry

Visitors to the booth will be able to experience Dentsply Sirona’s cutting-edge solutions, products, and latest innovations firsthand.

▪ Primescan Connect is the new laptop version of the Primescan intraoral scanner, which is making its first international appearance at IDS. Attendees will be able to experience how this new scanner embodies the guiding principle of Dentsply Sirona’s digital universe - to simplify dentistry. Primescan Connect, powered by DS Core, provides an efficient, easy-to-learn way of generating high-quality digital impressions.

▪ Primeprint Solution, the highly automated and integrated 3D printing unit, makes it easy and fast to produce surgical guides, bite splints, temporary restorations, working models and much more will also be on show first time publicly at IDS.

▪ The OmniTaper EV Implant System: A proven surface technology and intuitive and secure procedures optimize the Implants treatment process, resulting in increased efficiency for clinicians and improved care for patients.

▪ The new SmartLite Pro Endo Activator is an efficient solution for activating root canal irrigation with a significant advantage over passive irrigation. The activation of the irrigation fluid produces a canal surface with more opened dentinal tubules. This improves obturation of the lateral and accessory canals. It also extends the modular system of the SmartLite Pro curing light.

▪ Axeos represents a 2D/3D X-ray system for practices with a broad treatment spectrum. The device offers sharp panoramic X-rays, has different volumes and offers further 3D applications - covering a wide spectrum of dental indications, making it ideal for specialists in particular.

▪ Axano* treatment center features intuitive workflows and smart controls that make treatment more efficient, reliable, hygienic, and ergonomic. Axano allows dentists to concentrate fully on their profession and patients.

▪ Finally, there is the opportunity to get to know the SureSmile Clear Aligner System in more detail and the complete offering as well as a seamless workflow for clinicians and patients.

High-quality education and peer exchange

Dentsply Sirona’s exhibition space for IDS 2023 will also include live demonstrations across different workflows, including all 3D printing indications that can be implemented with Primeprint Solution. Close to 50 experts from practices and laboratories will be available at the Dentsply Sirona booth to answer questions and engage in discussions with visitors.

Another highlight will be the “DS Talks” panel discussions, which will address two topics rapidly shaping the dental industry and the world: Digitalization and Sustainability. "Dentsply Sirona continues to focus on innovation and clinical education with a commitment to doing so in a sustainable manner and enabling our customers to practice dentistry with sustainability in mind,” said Simon Campion, President and CEO of Dentsply Sirona. “We look forward to showcasing these commitments during IDS 2023 and invite all attendees to join us and unite for better dentistry to improve both oral health and the health of our planet.”

Dentsply Sirona at the IDS: Hall 11.2

More information on the program and registration for educational trainings can be found here:

https://www.dentsplysirona.com/en/lp/ids-2023.html

WATCH DS TALKS

From March 14, the live streams of DS Talks can be found under https://www.dentsplysirona.com/en/company/newsroom/ids.html

*Pending 510(k), not available for sale within the United States.

Julie Charlestein, CEO of Premier Dental, has made the Wall Street Journal Best Seller List with her recently released book, "How to Lead Your Family Business." The book discusses Charlestein's experience as the fourth-generation leader of her family's industry-leading business and the strategies she has developed to navigate working with and for family, reshape generations-old company cultures, earn the respect of colleagues, and more. 

On Thursday, March 2, at 7:00 pm ET, the Facial Pain Association will host the webinar "Can You Spot The Difference? Real Stories From My Chair About Neuropathic Facial Pain." The informative presentation by Donald Nixdorf, DDS, MS, will discuss how neuropathic pain and trigeminal neuralgia (TN) are related to dentistry. Nixdorf will cover the important similarities and differences between TN and dental pain and the symptoms to look out for so you and your team can quickly identify it. He will also reveal the top 3 'mimics' of trigeminal neuralgia dental practices see on a regular basis and what to do after you suspect your patient has trigeminal neuralgia or neuropathic pain. Bring your questions to the live Q&A session at the end of the presentation.

Webinar details

Speaker: Donald Nixdorf, DDS, MS

Thursday, March 2 at 7pm ET

Register at - https://us02web.zoom.us/webinar/register/4716764854498/WN_nCdCQ0e3TQKBuLEy3vhiFA

Move will uplift voices of dental therapists in fight to expand access to equitable care

Recognizing that uplifting the voices and experiences of dental therapists is a crucial step toward growing the profession and improving access to equitable and effective oral health care, the National Partnership for Dental Therapy (NPDT) today announced the addition of a new co-chair, the American Dental Therapy Association (ADTA).

The ADTA joins Community Catalyst, the National Indian Health Board, and the National Coalition of Dentists for Health Equity as co-chairs of the partnership, which was formed in 2019. The NPDT has guided the continued growth of dental therapy across the country—dental therapists are now authorized to work in 13 states, while over a dozen other states and Tribal governments are in the process of exploring authorization of the profession.

“Decades of evidence has shown that dental therapists are experts at providing high-quality, affordable oral health care while addressing critical gaps in access,” said Sarah Chagnon, president of the ADTA. “Every state and jurisdiction in the country should be able to license, educate, and employ dental therapists to be members of the dental team. We’re proud to join with the NPDT and ensure that more Americans—especially those from traditionally underserved areas—get the care they need.”

Dental therapists can work in a variety of settings, but they are specifically trained to extend routine care into areas where dental care is lacking, including schools, nursing homes, and rural and low-income communities. Because their employment cost is one-third to one-half the amount of a dentist, hiring dental therapists has proven to be a cost-effective way for a range of dental care settings to treat more low-income and uninsured patients with the same budget.

“Improving the dental care system and building a more representative workforce requires input and leadership from a diverse array of stakeholders,” said Tera Bianchi, director of partner engagement at Community Catalyst. “The ADTA is a passionate advocate for dental therapists and the patients they serve, and a leader in the fight for oral health care equity. We’re thrilled to welcome them to the team.”

The momentum for dental therapy continues to grow. In 2022, Colorado became the 13th state to allow dental therapists to practice in at least some settings and Skagit Valley College in Washington opened as the fifth dental therapy program in the U.S. Last August, a report from a federal advisory committee called on Congress and the U.S. Department of Health and Human Services to fund additional dental therapy training programs, scholarships and repayment programs, and longitudinal tracking mechanisms to help the profession grow and support vulnerable communities. 

The economical solution for the fabrication of in-house restorations in the dental practice.

At the CDS Midwinter Meeting in Chicago, vhf camfacture AG has launched a highly innovative machine for wet and dry machining of blocks. This machine will boost dig­itization and enable many practices to easily and economically enter same-day den­tistry, from which dentists and patients will benefit alike. The E4 offers its users maxi­mum freedom: it can be easily combined with the preferred intraoral scanner and the materials suitable for the respective patient case. The E4 is the ideal complement for the practice workflow and impresses with perfectly manufactured dental restorations made of materials ranging from PMMA to glass ceramics.

Simplicity was the focus of development for the E4, just as it was for the E5 mill for discs launched a good two weeks earlier. Together, they are part of the new EASE Class from vhf. After all, every dentist should be able to enter same-day dentistry in shortest time with any intraoral scanner and the E4. Simplicity manifests itself in the E4 in several ways: its freedom from compressed air, its low weight of only 28 kg, and its compact housing, which requires only slightly more floor space than an A3 sheet of paper. This means it can be installed any­where. The machine is operated intuitively via the provided DENTALCAM software – with­out any additional licensing costs.

In terms of material and indication diversity, the E4 is a true all-rounder. As standard, it is equipped to wet grind blocks made of glass ceramics or composites with ceramic content. Thanks to PUREWATER Technology, no grinding additives are required – which means trou­ble-free disposal and lower running costs. With a few simple steps, the range of indications for the E4 can be significantly expanded by using an optional dry tank instead of the liquid tank. In this way, materials such as zirconia, PMMA and other composites can also be dry milled. The ability to process blocks up to 45 mm in length is particularly helpful here.

Dry milling reveals another major innovation: here too, the E4 operates completely without compressed air – it therefore requires neither an external connection for compressed air nor a built-in compressor. This is not only another sustainability aspect of the E4, it also saves further costs and allows much greater freedom in the placement of the machine. This free­dom from compressed air is made possible by vhf’s patent-pending AIRTOOL. The turbine blades of this tool generate a strong air flow due to the high speeds of the high-frequency spindle, which keeps the workpiece free of chips and dust.

Dr. Nicolas Rohde, Chief Strategy Officer at vhf camfacture AG, sums up the balancing act that had to be mastered in the design of the E4: “With more than 30 years of experience in mechanical engineering, it was a matter of course for us not only to design the E4 to be light, compact and easy to operate, but also to build it entirely without compromise from high-quality industrial components. This is where reliability meets precision, and we give every dentist the opportunity to produce lab-quality dental restorations in their own prac­tice.”

The world premiere of the E4 took place on February 23, 2023 at 7 pm CET at the CDS Midwinter Meeting in Chicago. From February 24, it can also be seen in Chicago at the LMT Lab Day, and from March 14 at the IDS in Cologne. More information about the E4 can be found on the dedicated microsite at ease.vhf.com/e4

Cayster Inc., a developer of software and solutions for digital dentistry, announced a strategic collaboration with Ivoclar Inc. and its VivaScan intraoral scanning technology. The collaboration marks a new era in digital dentistry and intraoral scanning experience and will enable dentists, laboratories, trainers and mentors to seamlessly collaborate in real-time.

"We are thrilled to be bringing our groundbreaking technology to Ivoclar, a company that is a leader in so many facets of digital dentistry," said Dr. Gary Kaye, Chairman and Co-founder Cayster Inc.

Cayster's innovative software and digital dentistry ecosystem eliminates inefficiencies by integrating disparate technologies and provides dental offices and dental laboratories with an end-to-end solution that enhances clinical, operational, and financial outcomes.

"Our approach to technology is to build an intuitive user experience that connects directly with what users want to accomplish by leveraging Cayster's deep expertise in AI, UX and distributed systems … " said Adi Narayan, CEO and co-founder Cayster Inc.

Cayster's robust all-in-one digital platform significantly reduces remakes, improves turn-around- times and minimizes chairside adjustments and connects seamlessly with financial and business intelligence platforms.

"This is a transformative step in advancing dentistry", says Chris Holden , President, Ivoclar Inc. - North America. "This collaboration leverages Ivoclar's digital workflow and dental expertise jointly with Cayster's technology application producing an amazing user experience while delivering an elevated standard of patient care." 

View a video about the collaboration here or learn more at www.cayster.com.

The National Denturist Association, USA has announced that it is now accepting proposals for clinics to be offered at the 12th World Symposium on Denturism to be hosted in partnership with the International Federation of Denturists.

Clinic submissions can be for keynotes, general sessions, hands-on workshops and break out sessions.

Topics might cover:

· Denture anatomy & materials

· Impressions & casts

· Occlusion

· Denture design and fabrication

· Clinical procedures

· Patient Management

· Office Management and Marketing

Share your expertise and passions with over 200 attendees from around the world!

Deadline to apply: March 31, 2023

Apply with the 2023 Call for Clinics Submission Form.

For more information contact Shelly Joines, CMP at sjoines@executiveoffice.org or 850-205-5634 or visit the website.

Companies Participate in Q&A Discussion at Cal-Lab, Featuring Keynote Presentation by Stanley M. Bergman, and Offer Product Demonstrations, Panel Discussion, and Peer to Peer Education at LMT LAB DAY

Henry Schein, Inc., and its dental laboratory business, Zahn Dental, kicked off a host of events taking place concurrent to the Chicago Dental Society Midwinter Meeting that demonstrate the Companies’ depth of commitment to the laboratory business.

Henry Schein and Zahn Dental attended Cal-Lab held at the Westin Michigan Avenue, and LMT LAB DAY at the Hyatt Regency Chicago as part of a broader effort to deepen relationships with dental laboratories and help support customers’ digital adoption journey.

Attended by the nation’s most prominent laboratory companies, Cal-Lab featured a keynote presentation from Stanley M. Bergman, Chairman of the Board and Chief Executive Officer of Henry Schein. Mr. Bergman addressed growth drivers of implants, increasing investment in dental technology, clinical digital workflows, the future of 3D printing, and striking a balance between technology and the human touch. Joining Mr. Bergman at the Cal-Lab session were the following industry leaders, who participated in a question-and answer-discussion after the presentation: Mark Greenstein, Chief Growth Officer of Heartland Dental; Jeff Stronk, Board Chair of Cal-Lab; René Willi, CEO of Henry Schein’s Global Oral Reconstruction Group; and David Kochman, Henry Schein’s Chief Corporate Affairs Officer. The session was moderated by Mark Palmer, Vice President and General Manager of Zahn Dental.

“We are excited to be back in Chicago to participate in the Cal-Lab meeting and to support dental lab leaders by providing solutions technicians can rely on to help enhance digital workflows,” said Mr. Bergman. “Henry Schein and Zahn Dental are committed to delivering products and services that help foster the adoption of digital solutions in dentistry, specifically among lab technicians. While keeping our pulse on the emerging trends that are on the horizon, we can help advance the valuable role that labs play in dentistry.”

Concurrently, LMT LAB DAY, featuring Zahn Dental, offered two days of CE education to more than 1,000 registered lab technicians, and more than 8,000 square feet of hands-on product demonstrations in Ballrooms E and F of the Hyatt Regency Chicago. Laboratory owners and technicians heard from Zahn’s trusted advisors about implementing new strategies and solutions to create an enhanced, integrated digital workflow, and demonstrate products, such as Myerson’s TRUJETX3™, a 3D printer for one-piece digital dentures and a Henry Schein exclusive made in the United States. In addition to hands-on product demos, nearly 20 educational opportunities were offered by Zahn Dental on topics including digital dentures, patient acceptance, 3D printing, and digital workflows. For a complete list of courses, click here.

“Our team of trusted advisors at Zahn Dental is excited to meet with laboratory owners and technicians, helping to demonstrate the critically important and reliable solutions available to support their digital adoption journey,” said Rita Acquafredda, President, Global Dental Lab & Prosthetic Solutions, Zahn Dental. “Recognizing that the health of the global dental services market is being driven by increased investment in technology, we look forward to exploring these solutions, and more, to meet labs’ unique needs.”

After a full day discussing the current, and future, state of dental laboratories, and digital solutions that can help accelerate the digitization of dental labs, Zahn, together with sponsors DESS and Myerson, hosted a cocktail hour at 5:00 – 6:00 p.m. at the Zahn ballroom on Friday, February 24.

On Saturday, February 25, from 10:30 – 11:30 a.m. CT, Zahn presented a panel discussion, “Build & Grow Your Removable Department with Key Opinion Leaders on Today's 3D Denture Printing Processes,” featuring Zahn Dental's panel of experts who discussed current trends in 3D printed options. Panelists included Chris Kabot, Vice President, Technology, Research & Development at Affordable Dentures and Implants (Morrisville, NC); Kent Kohli, CDT, Owner at Precision Dental Designs, Inc. (Anchorage, AK); Jessica Love, CDT, Owner at Capture Dental Arts (Draper, UT); Dennis Urban, CDT, Director of Operations and Clinical Education at MicroDental (Stony Brook, NY); and Susan van Kinsbergen, CDT, Vice President at Myerson LLC, (Parker, CO). Moderated by Fran Parathyras, RDH, Zahn Dental (Long Island, NY), the panel covered how to drive adoption of the latest digital denture solutions in equipment, materials and workflows as well as how to implement these processes for profitability, and to enhance engagement among dental providers.

For more information, visit www.zahndental.com/Chicago2023, or call (800) 496-9500.

Dentsply Sirona today announced that Richard Rosenzweig has been appointed Senior Vice President (SVP), Corporate Development, General Counsel and Secretary, effective February 27, 2023. In this role he also takes on responsibility for Compliance, Corporate Development and Strategy and becomes a member of the Management Team reporting to the CEO.

Richard Rosenzweig is a strategic and business-minded Executive with both commercial and enterprise focus, diverse leadership experience and a 25-year history advising global health care companies. Mr. Rosenzweig joins from AngioDynamics where he led the legal department (including compliance) and served as Secretary to the Board as Senior Vice President, General Counsel & Secretary.

Simon Campion, Chief Executive Officer of Dentsply Sirona, said, “We are pleased to have Richard with his diverse leadership experience and a 25-year track record in healthcare join us. As a strong, collaborative leader with seasoned skills in building teams and setting and executing strategies, he will strengthen our Management Team during a phase of organizational changes. Richard adds valuable additional experience with his record of delivering excellent results, including in complex strategic initiatives, transactions and disputes. He also brings critical in-depth governance & compliance expertise.”

Richard Rosenzweig said, “It’s an honor to join Dentsply Sirona as a leading healthcare company and global leader in the dental industry. I share the same values and I am convinced that with the strong team, operational excellence, and a strong focus on accountability we can unlock the full potential of Dentsply Sirona globally. I look forward to partnering with the Management Team on the important mission to transform dentistry to improve oral health globally.”

About Richard Rosenzweig

Most recently, Richard Rosenzweig served as Senior Vice President, General Counsel & Secretary at AngioDynamics where he led the legal department including compliance and served as Secretary to the Board for this publicly traded medical device company. Previously, he held several roles during his more than ten years at C. R. Bard Inc., including serving as Vice President, Law & Assistant Secretary, and being a Member of the Corporate Management Committee. Other previous experiences include General Counsel roles at other public companies and a leading role at Johnson & Johnson. He is a member of the Director’s Leadership Council at Rutgers Biomedical and Health Sciences and has served as a member of the Rutgers Cancer Institute of New Jersey Director’s Leadership Counsel for 15 years. Richard earned his law degree from Boston University School of Law and holds a Bachelor of Arts, Psychology, from Brandeis University.

▪ Einstein Pro XL delivers precision DLP® printing of dental and orthodontic models, temporary and permanent restorations, and other dental and medical devices in the largest build volume in its price category¹

▪ With high-speed 3D printing enabled by proprietary HyperPrint™ technology, Einstein Pro XL can print more than 330 crowns in about 30 minutes or 30 full arch dental models in about an hour

▪ This ROI powerhouse retails for less than $40,000, without a long-term lease commitment

▪ Einstein Pro XL is capable of printing a wide range of dental resins for models, night guards, and more. However, it’s the only high-volume printer qualified to print Flexcera™ Smile Ultra+, an FDA 510(k) cleared Class II material for strong, beautiful, and permanent dental restorations, including veneers, crowns, bridges, and dentures

▪ Based on 20+ years of R&D from industry leaders in 3D printing technologies, the Einstein Pro XL features cutting-edge upgrades, such as a 4K UHD projector and NanoFit 385, a custom wavelength for a more efficient cure that requires less postprocessing

▪ Einstein Pro XL, which will be on display Feb. 23-25 at LMT Lab Day in Chicago and March 14-18 at the International Dental Show in Cologne, Germany, is available for purchase today

Desktop Health — the trusted production-grade medical 3D printing brand of Desktop Metal, Inc. (NYSE: DM) — today announced global availability of the Einstein Pro XL, an affordable, high-accuracy, high-throughput 3D printer ideal for dental labs, orthodontists, and other medical device manufacturers.

The Einstein Pro XL is a DLP-based polymer printing system that uses a 4K ultra high-definition projector to deliver precision printing of 45 micron in X and Y across a large build area of 9.8 x 5.5 x 6.5 in (249.1 x 140.1 x 165.1 mm). This high-speed printer features proprietary Hyperprint™ technology that turbocharges print times with strategically applied heat and a closed-loop sensing system, in addition to other enhancements.

The Einstein Pro XL retails for $39,999, without a long-term lease commitment. This new model joins the popular entry-level Einstein desktop printer, which launched in 2022, as a complete set of printers for dental and medical professionals.

“The Einstein Pro XL stands alone as a premium, production-grade DLP system in the sub-$40,000 dental lab market,” said Ric Fulop, Founder and CEO of Desktop Metal. “Built on a trusted DLP architecture, the Einstein Pro XL is loaded with upgrades that make it an ROI powerhouse for productivity-oriented labs serving the most demanding dental professionals and patients.

“While Einstein Pro XL can 3D print a wide range of resins for dental models and other devices such as bite guards, it’s the only large-volume printer on the market capable of printing our popular and proprietary Flexcera material for exceptionally strong temporary and permanent restorations. We’re delighted to offer this highly anticipated new system to the global market.”

"I have been printing in-office since 2014, and ever since we started printing with the Einstein Pro XL 3D printer, we have been able to double our production in fewer prints while satisfying our standard of high accuracy models,” said Dr. Ed Lin, co-owner of Orthodontic Specialists of Green Bay, which has its own in-house orthodontic lab. “We are very excited about the high throughput and reliable precision of this new printer from Desktop Health.”

An Affordable Workhorse

To meet the demanding uptime requirements of dental and orthodontic labs, the Einstein Pro XL has been tested in hundreds of hours of printing internally and externally with users worldwide. While final throughput may vary based on specific case sizes, testing of multiple Einstein Pro XL systems across multiple builds demonstrates the high productivity of the system:

Dental & Orthodontic Model Print Times

▪ 30 full arch models in 68 minutes

▪ 46 crown & bridge models in 61 minutes

Prosthetics & Appliances Print Times

▪ 52 night guards in 186 minutes

▪ 14 monolithic dentures in 79 minutes

▪ 18 denture bases in 130 minutes

▪ 15 full arch denture teeth in 35 minutes

▪ 330 temporaries or crowns in 32 minutes

Premium Materials

The Einstein Pro XL is qualified to 3D print Desktop Health’s most popular dental materials.

The full family of Flexcera materials — including Flexcera Base, Flexcera Smile and Flexcera Smile Ultra+² — is qualified on the Einstein Pro XL to print temporary and permanent restorations. An FDA 510(k) cleared Class II material, Flexcera Smile Ultra+ prints strong and beautiful temporary and permanent dental restorations, including veneers, crowns, bridges, and dentures.

Model materials, such as longtime favorite E-Model Light and Model Z for speed, can produce accurate full arch models quickly for the final creation of thermoformed orthodontic aligners or fitting of crowns, bridges and more.

What’s more, SmileGuard™ for bite splints, night guards, and mouth guards, as well as E-Tray are also qualified for use on the Einstein Pro XL. E-Guard and E-Guide, already approved for use on the Einstein desktop printer, are expected to be qualified on the Einstein Pro XL by the end of June.

The Benefits of DLP Printing

The Einstein Pro XL is a DLP printing system, a form of 3D printing photopolymers that originated in 2002 with the EnvisionTEC Perfactory series, the base platform for the Einstein Pro XL.

DLP delivers both speed and quality by harnessing the power of a high-definition projector to rapidly flash and cure one layer of resin at a time using a theater-quality DLP chip. Because projectors expose light in pixels, the brightness of each pixel can be controlled individually. That allows for curing of each pixel to different depths or volumetric pixels, also known as voxels. The ability to control each voxel dramatically improves the accuracy and surface quality of 3D printed parts, especially when paired with custom optics and specific light wavelengths.

The Einstein Pro XL features a 4K UHD projector powered by an industrial DLP chip below the print vat. Dual linear slides for the moving build plate ensure a high accuracy print across the entire print bed by maintaining a parallel build environment. Depending on the material being processed, layer thicknesses down to 25 micron can be achieved. Custom optics and NanoFit 385, a custom wavelength for superior curing, are just some of the upgrades offered in this new system. Desktop Metal acquired EnvisionTEC and its DLP technology in 2021.

To learn more about 3D printing with DLP technology on the Einstein Pro XL, visit https://health.desktopmetal.com/3d-printers/einstein-pro-xl/.

1 The Einstein Pro XL is offered in the sub-$40,000 price category.

2 Flexcera Smile Ultra+ is an FDA 510(k) cleared Class II material and is still awaiting final regulatory approval in the EU.