Dentsply Sirona: FDA 510(k) clearances across all its applicant names

FDA lists 541 510(k) clearances, 1 PMA and 0 De Novo decision across the 14 applicant names Caduvo groups under Dentsply Sirona, first 1976, latest 2026. Median 510(k) review time across these names: 67 days. Since 2017 the median was 130 days, against 137 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 14 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 130 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 137 days.

Top product codes

Plus 89 more product codes.

Review panels

• Dental (474)
• Radiology (31)
• General Hospital (8)
• Orthopedic (6)
• General and Plastic Surgery (5)
• Gastroenterology and Urology (4)
• Anesthesiology (3)
• Ophthalmic (3)
• Neurology (2)

Most recent Dentsply Sirona 510(k) clearances

531 earlier clearances. See the full list in Caduvo.

PMA and De Novo decisions

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.

Dentsply and Sirona merged in 2016. L.D. Caulk and Maillefer are long-standing Dentsply units; Astra Tech dental acquired 2011. Left out: Gendex (dental imaging sold to Danaher 1996) and Astra Tech (Dentsply bought only the dental part in 2011; the Astra Tech name also covers urology products).

Sources

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

Frequently asked questions

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

FDA lists 541 510(k) clearances, 1 PMA and 0 De Novo decision across the 14 applicant names Caduvo groups under Dentsply Sirona, first 1976, latest 2026. FDA records each applicant name separately; Caduvo adds up the names listed on this page.

Which FDA applicant names does Dentsply Sirona file under?

The names with the most 510(k) clearances in this group are Dentsply Intl. (291); Dentsply Sirona (88); Dentsply International, Inc. (59); Sirona Dental Systems GmbH (42); L.D. Caulk Co. (20). The full list of 14 names is on this page.

How long does FDA take to clear Dentsply Sirona 510(k)s?

The median time from FDA receipt to decision across 510(k)s cleared under these names is 67 days. Since 2017 the median was 130 days, against 137 days for all cleared 510(k)s in the same product codes.

Does the Dentsply Sirona 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 541 Dentsply Sirona clearances with predicates and recalls
• Run predicate analysis for product code EIH, Dentsply Sirona'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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