Home Systems biology Nobel Biocare Receives 510 (k) FDA Clearance for the Nobel Biocare N1 ™ Implant System

Nobel Biocare Receives 510 (k) FDA Clearance for the Nobel Biocare N1 ™ Implant System



BREA, California, Dec. 27 2021 / PRNewswire / – Envista Holdings Corporation (NYSE: NVST) (“Envista”) today announced that the United States Food and Drug Administration (FDA) has cleared the Nobel Biocare N1 â„¢ Implant System. Benefiting from a biological design of cutting-edge components and treatment protocols, the N1 â„¢ implant system represents a significant advance in patient-centered implant solutions.

More than an implant, N1 is a complete system of instruments, prosthetic components and dedicated surgical protocols. New system features include an implant designed for immediate placement and predictable insertion torques, a tri-oval taper connection for the abutment to slide into place, and an emergence profile designed for soft tissue retention.

Innovative site preparation for greater patient comfort

The Nobel Biocare N1 ™ System includes the new functionality of the OsseoShaper ™, an instrument that redefines site preparation and is designed to reshape implantology with optimized workflows, greater patient comfort and treatment times faster. By gently “shaping” the osteotomy at low speed and without irrigation, the OsseoShaper ™ reduces noise and vibration compared to conventional drilling protocols. This improves patient comfort and has been shown in preclinical studies to preserve vital bone.

Embrace surface chemistry and digital workflows

Fully embracing the new Mucointegration â„¢ concept, the Nobel Biocare N1 â„¢ features Xeal â„¢ and TiUltra â„¢ surface treatments. With their specially adapted surface chemistry and topography, TiUltra Implants and Xeal Abutments can benefit from this design to optimize tissue integration at all levels. Nobel Biocare N1 â„¢ will be further integrated into the digital workflow with the DTX Studio â„¢ suite, giving dental professionals more opportunities to give patients a shorter lead time to the teeth.

Amir Aghdaei, CEO of Envista, said: “For more than 50 years, Nobel Biocare has been a pioneering force behind implantology. The demand for high-quality, patient-centric solutions is higher than ever, and the Nobel Biocare N1 â„¢ System enables clinicians to set a new standard in personalizing, digitizing and democratizing the implant treatment experience. ‘they can provide to patients. “

Patrik Eriksson, President Nobel Biocare, explained: “Drilling protocols have hardly changed over the past 50 years. However, the OsseoShaper â„¢ offers a whole new approach designed for patient comfort, a streamlined workflow and better predictability; while respecting the biology to achieve rapid osseointegration. We are excited to partner with clinicians to bring the N1 System to patients based in the United States. “

About Nobel Biocare

Nobel Biocare is a world leader in the field of innovative dental implant restorations. The company’s portfolio offers solutions ranging from single tooth to fully edentulous indications with dental implant systems (including key brands NobelActive® and NobelParallel â„¢ and the ceramic implant NobelPearl â„¢ *) a comprehensive range of individualized prostheses precision and CAD / CAM systems (NobelProcera®), digital solutions for treatment planning and guided surgery (NobelClinician® suite and DTX Studio â„¢) as well as biomaterials. Nobel Biocare supports its clients through all phases of professional development, providing them with world-class training and education as well as practice support and patient information material. The company is headquartered at Zurich, Switzerland. Production takes place at five sites located United States, Sweden, and Germany. Products and services are available in more than 80 countries through subsidiaries and distributors.

* Distributed by Nobel Biocare. Manufactured by Dentalpoint AG

About Envista

Envista is a global family of more than 30 trusted dental brands including KaVo, Kerr, Nobel Biocare and Ormco, united by a common goal: partnering with professionals to improve lives. Envista helps its customers provide the best possible patient care through cutting-edge dental consumables, solutions, technologies and services. Our comprehensive portfolio, comprising dental implants and treatment options, orthodontics and digital imaging technologies, covers approximately 90% of dentists’ clinical needs for the diagnosis, treatment and prevention of dental conditions as well as the improving the aesthetics of the human smile. With a foundation made up of the proven Envista Business System (EBS) methodology, an experienced management team and a strong culture based on continuous improvement, commitment to innovation and a deep customer focus, Envista is well equipped to meet the end-to-end needs of dental professionals around the world. Envista is one of the world’s largest dental product companies, with significant market positions in some of the most attractive segments of the dental product industry. For more information, please visit www.envistaco.com.

Forward-looking statements

Certain statements contained in this press release are “forward-looking” statements within the meaning of federal securities laws. There are a number of important factors which could cause actual results, developments and business decisions to differ materially from those suggested or indicated by these forward-looking statements, and you should not place undue reliance on such forward-looking statements. These factors include, among others, the impact of the COVID-19 pandemic, including new variants of the virus, the pace of recovery in the markets in which we operate, US and global economic conditions, markets served by us and the financial markets, the impact of our debt securities on our operations and liquidity, developments and uncertainties in trade policies and regulations, contractions or growth rates and the cyclicality of the markets we service, inventory fluctuations of our distributors and customers, loss of a distributor, our relationships with and performance of our distribution partners, competition, our ability to successfully develop and market new products and services, potential for inappropriate conduct by our employees, agents or business partners, our compliance with applicable laws and regulations (including relating to medical devices and the healthcare industry), the results of our clinical trials and their perceptions, the penalties associated with any off-label marketing of our products, changes made to our products which require new authorizations or authorizations marketing, our ability to effectively manage cost reductions and other changes in the healthcare industry, our ability to identify and successfully complete acquisitions and investment strategies, our ability to integrate the businesses we acquire and to obtain the expected benefits of these acquisitions, the contingent liabilities related to acquisitions, investments and divestitures, material restrictions and / or potential liability based on the tax implications of transactions with Danaher, security breaches or other disruptions to our IT systems or violations of the laws on r data confidentiality, our ability to adequately protect our intellectual property, the impact of our restructuring activities on our growth capacity, exchange rate risks, changes in tax laws applicable to multinational companies, litigation and other contingent liabilities, including intellectual property and environmental, health and safety issues, risks associated with product, service or software defects, risks associated with the manufacture of products, product costs and surcharges, our ability to adjust purchasing and manufacturing capacity to reflect market conditions, reliance on single or limited sources of supply, the impact of regulation on demand for our products and services, labor, international economic, political, legal, compliance and trade factors, and related disruptions to war, terrorism, widespread protests and civil unrest, natural disasters, public health problems and other events. Additional information regarding factors that could cause actual results to differ materially from these forward-looking statements can be found in our filings with the SEC, including our annual report on Form 10-K for fiscal 2020 and our quarterly reports on form. 10-Q. These forward-looking statements speak only as of the date of this press release and, except to the extent required by applicable law, we assume no obligation to update or revise any forward-looking statements, whether as of the following new information, events and developments or other.

Stephen keller
Investor Relations
Envista Holding Company
200, boul. S. Kraemer, building E
Brea, California 92821
Telephone: (714) 817-7000
Fax: (714) 817-5450

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