BIO-C Sealer Ion+— 510(k) K190537

Name: FDA 510(k) clearance K190537
Creator: U.S. Food and Drug Administration
Published: 2019-12-12

Substantially Equivalent

Angelus Industria DE Produtos Odontologicos S/A

FDA 510(k) clearance K190537 for BIO-C Sealer Ion+, Substantially Equivalent on 2019-12-12. Applicant: Angelus Industria DE Produtos Odontologicos S/A. Device class: 2.

Clearance details

Applicant: Angelus Industria DE Produtos Odontologicos S/A
Product code: Code KIF
Device class: Class 2
Regulation: 21 CFR 872.3820
Advisory panel: Dental
Date received: 2019-03-04
Decision date: 2019-12-12
Decision: Substantially Equivalent
Clearance type: Abbreviated
Location: Londrina, BR

Download summary PDF View on FDA.gov ↗

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