Atlas FDA

Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account

Angelus Industria DE Produtos Odontologicos S/A · Predicate Candidate Screening

5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.

281 daysmedian FDA review time
345 days90th percentile
5clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K201222Bio-C Repair Ion+Angelus Industria DE Produtos Odontologicos S/A2021-02-112810
K190537BIO-C Sealer Ion+Angelus Industria DE Produtos Odontologicos S/A2019-12-122830
K180199BIO-C TEMPAngelus Industria DE Produtos Odontologicos S/A2019-01-043450
K180185BIO-C REPAIRAngelus Industria DE Produtos Odontologicos S/A2018-08-312200
K172701BIO-C SEALERAngelus Industria DE Produtos Odontologicos S/A2018-01-041190

Methodology

Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.

Prepared with Atlas

Predicate research, review-time statistics and recall monitoring for 510(k) teams: atlasbyauro.com/fda