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FDA 510(k), K172701, BIO-C SEALER
FDA 510(k), K172701, BIO-C SEALER
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510(K) Number: K172701
Device Name: BIO-C SEALER
Manufacturer: Paulo Sergio Calixto de Oliveira
Device Classification Name: Resin, Root Canal Filling
Regulation Number: KIF
Classification Product Code: 09/07/2017
Date Received: 01/04/2018
Decision Date: Substantially Equivalent (SESE)
Regulation Medical Specialty: Dental
Device Name: BIO-C SEALER
Manufacturer: Paulo Sergio Calixto de Oliveira
Device Classification Name: Resin, Root Canal Filling
Regulation Number: KIF
Classification Product Code: 09/07/2017
Date Received: 01/04/2018
Decision Date: Substantially Equivalent (SESE)
Regulation Medical Specialty: Dental
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- Status: Pending Fast-Track Request
- Delivery: Approximately 1 to 2 weeks
NOTE: This document is not currently in our library. Upon purchase, we will request the document from the FDA FOIA office. Learn more about Fast-Track Requests here.
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