Envista (Nobel Biocare, Ormco, Kerr): FDA 510(k) clearances across all its applicant names

FDA lists 437 510(k) clearances, 0 PMA and 0 De Novo decisions across the 17 applicant names Caduvo groups under Envista (Nobel Biocare, Ormco, Kerr), first 1978, latest 2026. Median 510(k) review time across these names: 81 days. Since 2017 the median was 149 days, against 149 days for all cleared 510(k)s in the same product codes. Groups are curated by Caduvo from public sources listed below; FDA does not group applicants. Counts include filings made before an acquisition, and can include older filings by a business that was later sold when FDA records them under the same applicant name; see the notes on this page.

510(k) clearances per year

The 17 FDA applicant names in this group

Review time against the same product codes

Since 2017, 510(k)s cleared under these names took a median 149 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 149 days.

Top product codes

Plus 51 more product codes.

Review panels

• Dental (415)
• General Hospital (10)
• Radiology (10)
• Ear, Nose and Throat (1)
• General and Plastic Surgery (1)

Most recent Envista (Nobel Biocare, Ormco, Kerr) 510(k) clearances

427 earlier clearances. See the full list in Caduvo.

Recalls

198 product recalls in 80 recall events under these names; 3 initiated in the last five years.

Recalling firms are matched to the applicant names above by name only, so recalls filed under other names are not counted. A recall count says nothing about how safe one company's devices are compared with another's.

How this group is built

Groups are curated by Caduvo from public sources listed below; FDA does not group applicants. Counts include filings made before an acquisition, and can include older filings by a business that was later sold when FDA records them under the same applicant name; see the notes on this page.

Envista was spun off from Danaher in 2019 with Danaher's dental businesses: Sybron Dental Specialties (Kerr, Ormco; acquired by Danaher 2006), Nobel Biocare (2014), Implant Direct (2011). Includes filings made before each acquisition. Left out: KaVo (sold to Planmeca 2022), the 1970s–80s SYBRON corporate name (also lab businesses).

Sources

• https://en.wikipedia.org/wiki/Envista
• https://en.wikipedia.org/wiki/Nobel_Biocare
• https://en.wikipedia.org/wiki/Sybron_Dental_Specialties

Frequently asked questions

How many FDA 510(k) clearances are listed across Envista (Nobel Biocare, Ormco, Kerr)'s applicant names?

FDA lists 437 510(k) clearances, 0 PMA and 0 De Novo decisions across the 17 applicant names Caduvo groups under Envista (Nobel Biocare, Ormco, Kerr), first 1978, latest 2026. FDA records each applicant name separately; Caduvo adds up the names listed on this page.

Which FDA applicant names does Envista (Nobel Biocare, Ormco, Kerr) file under?

The names with the most 510(k) clearances in this group are Sybron Dental Specialties, Inc. (121); Nobel Biocare AB (94); Ormco Corp. (46); Kerr Corporation (41); Kerr Corporation (Danbury) (32). The full list of 17 names is on this page.

How long does FDA take to clear Envista (Nobel Biocare, Ormco, Kerr) 510(k)s?

The median time from FDA receipt to decision across 510(k)s cleared under these names is 81 days. Since 2017 the median was 149 days, against 149 days for all cleared 510(k)s in the same product codes.

Does the Envista (Nobel Biocare, Ormco, Kerr) count include acquired companies?

Yes. A group includes filings an acquired business made under its own name, including before the acquisition. Businesses that were sold are left out, and names whose ownership is unclear are not included. FDA does not group applicants; the sources for each grouping are listed on this page.

Next steps

• See all 437 Envista (Nobel Biocare, Ormco, Kerr) clearances with predicates and recalls
• Run predicate analysis for product code DZE, Envista (Nobel Biocare, Ormco, Kerr)'s most frequent

Data from openFDA (510(k), PMA, De Novo, device recalls). Applicant names are matched exactly, with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this grouping or data.

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