FDA · official record K190537Substantially Equivalent

BIO-C Sealer Ion+

Name: BIO-C Sealer Ion+ — FDA K190537
Creator: Angelus Industria DE Produtos Odontologicos S/A
Keywords: BIO-C Sealer Ion+, BIO-C Sealer Ion+, K190537, KIF, FDA

United StatesKIFAngelus Industria DE Produtos Odontologicos S/A

Verified

Official record identity

FDA application number: K190537
Decision date: December 12, 2019
Published decision: Substantially Equivalent

Classification

Product code: KIF

Published parties

Applicant: Angelus Industria DE Produtos Odontologicos S/A

Additional source fields

Decision code: SESE
Published decision: Substantially Equivalent
Submission type: Abbreviated
Received date: 2019-03-04
Review panel: Dental
Current product-code class (harmonized): 2
Current product-code regulation (harmonized): 872.3820

About this record

This record preserves an application published in the FDA 510(k) bulk export, including the DEN entries FDA includes in that export. Historical decisions do not establish current marketing status. Product-code harmonization is separate from the original application; joined establishment identifiers are not assigned to the applicant. The complete official export is checked daily and raw evidence is retained.