Logos are each company's own site icon, matched by name through Wikidata.Company names and logos identify the companies in public FDA and registry records and do not imply endorsement.
Medical device makerLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field. in United StatesLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field.. FDA records under 5 spellings of its name, each linked to the record.
As of Nov 15, 2026, FDA's public records list Dentsply Sirona and its 31 subsidiaries with 430 510(k) clearances, 12 device recalls, 8 drug applications and 4 AI-enabled devices. The most recent is a 510(k) clearance dated Oct 30, 2026: DS Core Detect.
Group recordsLabelled by a language model (which subsidiaries belong to the group) from the firm's FDA names. It is not an FDA field.: 454, 32 entities
510(k) clearances: 430
Device recalls: 12
Drug applications: 8
AI-enabled devices: 4
Records by Year
Drug approvals, 510(k) clearances, recalls and letters, 2017 to 2026 to date, Dentsply Sirona and its 31 subsidiaries
How to read this
A hatched bar is a year that is not over, so its count covers only part of the year.
142017Records14
1020182018Records10vs 2017−4
102019Records10vs 2018+0
1620202020Records16vs 2019+6
52021Records5vs 2020−11
820222022Records8vs 2021+3
52023Records5vs 2022−3
1120242024Records11vs 2023+6
172025Records17vs 2024+6
1020262026 to dateRecords10
Latest Records
Newest first across sources; each opens the record
Spellings are joined only when they reduce to the same name, or a reviewed source names the same company. Sharing an FDA establishment number (FEI) is not enough: contract sites make products for many firms. Facts marked AI were labelled by a language model from the firm's FDA names; everything else comes from FDA or Wikidata.How this page is built
