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Envista (NVST) Gets FDA 510 (k) Approval for N1 Implant System

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Envista Holdings Corporation (NVST - Free Report) recently announced the receipt of the FDA 510 (k) clearance for the Nobel Biocare N1 implant system. With a biologically-driven design of components and advanced treatment protocols, the new system represents a significant step in patient-centric dental implant solutions.

Envista is a holding entity of more than 30 trusted dental brands, including KaVo, Kerr, Nobel Biocare and Ormco, among others.

It is worth mentioning that the demand for high-quality patient-centric solutions is higher than ever these days, and the Nobel Biocare N1 system allows clinicians to set a new standard in customizing, digitizing and democratizing the implant treatment experience they can provide patients.

More on Nobel Biocare N1 Implant System

Beyond an implant, N1 is a wide-ranging system of dedicated instruments, prosthetic components and surgical protocols. The system comes with new features, including an implant designed for immediate placement and predictable insertion torques, a trioval conical connection for the abutment to slide into place, and an emergence profile intended for soft tissue maintenance.

The Nobel Biocare N1 system includes the novel feature of the OsseoShaper an instrument that redefines site preparation and is set to reshape implantology with optimized workflows, greater patient comfort and quick treatment times. This allows to deliver enhanced patient comfort and has shown to preserve vital bones in pre-clinical studies.

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Further, fully embracing the new Mucointegration concept, the system also features the Xeal and TiUltra surface treatments, with specially customized surface chemistry and topography to optimize tissue integration at every level. Furthermore, Nobel Biocare N1 is expected to be integrated into the digital workflow with the DTX Studio suite, giving dental professionals more opportunities to provide patients with shorter time to teeth.

Industry Prospects

Per a report by Grand View Research, the global dental implant market size was valued at $3.60 billion in 2020 and is expected to expand at a CAGR of 11.0% by 2028. Increasing applications of dental implants in various therapeutic areas and increasing demand for prosthetics are the major factors driving the market.

Recent Developments

In December 2021, Envista entered into a definitive agreement to acquire Carestream Dental's Intra-Oral Scanner business for $600 million. The acquisition is in line with Envista's long-term strategy to focus on the fastest-growing segments of the dental market and to develop differentiated solutions via the digitalization of dental workflows.

During the November earnings update, Envista noted that the company is witnessing solid demand across the dental market. Geographically, North America and Western Europe's core sales growth was 8.2% and 9.1% in third-quarter 2021, respectively, as business conditions continue to improve compared to the third quarter of 2020. The company’s emerging markets, including China, grew over 15% in the third quarter. In China, the company continues to witness solid growth in both strategically important implant business as well as its orthodontic solutions.

Price Performance

Shares of the company have gained 38% in a year against the industry's decline of 4.8%.

Zacks Rank and Key Picks

Envista currently carries a Zacks Rank #4 (Sell). You can see the complete list of today's Zacks #1 Rank (Strong Buy) stocks here.

Few better-ranked stocks in the broader medical space that investors can consider include Thermo Fisher Scientific Inc. (TMO - Free Report) , McKesson Corporation (MCK - Free Report) and NextGen Healthcare, Inc. (NXGN - Free Report) .

Thermo Fisher’s earnings surpassed estimates in each of the trailing four quarters, the average surprise being 9.02%. The company currently carries a Zacks Rank of 2 (Buy).

Thermo Fisher’s long-term earnings growth rate is estimated at 14%. The company’s earnings yield of 3.7% compares favorably with the industry’s (3.6%).

McKesson’s earnings beat estimates in each of the trailing four quarters, the average surprise being 19.9%. The company currently carries a Zacks Rank #2.

McKesson’s long-term earnings growth rate is estimated at 8.9%. The company’s earnings yield of 9.9% compares favorably with the industry’s 3.2%.

NextGen Healthcare’s earnings surpassed estimates in each of the trailing four quarters, the average surprise being 16%. The company currently carries a Zacks Rank of 2.

NextGen Healthcare’s long-term earnings growth rate is estimated at 8.5%. The company’s earnings yield of 5.9% compares favorably with the industry’s (4.1%).