Straumann Group: FDA 510(k) clearances across all its applicant names

FDA lists 227 510(k) clearances, 0 PMA and 0 De Novo decisions across the 13 applicant names Caduvo groups under Straumann Group, first 1990, latest 2026. Median 510(k) review time across these names: 128 days. Since 2017 the median was 170 days, against 158 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 13 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 170 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 158 days.

Top product codes

Plus 14 more product codes.

Review panels

• Dental (211)
• General Hospital (14)
• Radiology (1)
• General and Plastic Surgery (1)

Most recent Straumann Group 510(k) clearances

217 earlier clearances. See the full list in Caduvo.

Recalls

48 product recalls in 34 recall events under these names; 16 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.

Straumann entity names plus Neodent (filed as JJGC Indústria e Comércio de Materiais Dentários; full control 2015), ClearCorrect (2017), Anthogyr (2019), Dental Wings (2017). Includes filings made before each acquisition.

Sources

• https://en.wikipedia.org/wiki/Straumann

Frequently asked questions

How many FDA 510(k) clearances are listed across Straumann Group's applicant names?

FDA lists 227 510(k) clearances, 0 PMA and 0 De Novo decisions across the 13 applicant names Caduvo groups under Straumann Group, first 1990, latest 2026. FDA records each applicant name separately; Caduvo adds up the names listed on this page.

Which FDA applicant names does Straumann Group file under?

The names with the most 510(k) clearances in this group are Institut Straumann AG (90); Straumann USA (66); Jjgc Industria E Comercio DE Materiais Dentarios S.A. (28); Jjgc Industria E Comercio DE Materiais Dentarios S (11); Anthogyr (10). The full list of 13 names is on this page.

How long does FDA take to clear Straumann Group 510(k)s?

The median time from FDA receipt to decision across 510(k)s cleared under these names is 128 days. Since 2017 the median was 170 days, against 158 days for all cleared 510(k)s in the same product codes.

Does the Straumann Group 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 227 Straumann Group clearances with predicates and recalls
• Run predicate analysis for product code NHA, Straumann Group'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.

All parent companies · FDA device companies by applicant name · FDA product code lookup