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FDA 510(k)

BIO-C Sealer Ion+

K-Number: K190537 · 2019-12-12

ApplicantAngelus Industria DE Produtos Odontologicos S/A
Decision Date2019-12-12
Product CodeKIF
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

BIO-C Sealer Ion+ is a medical device manufactured by Angelus Industria DE Produtos Odontologicos S/A. It received FDA 510(k) clearance on 2019-12-12 under approval number K190537. The device is classified under product code KIF. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BIO-C Sealer Ion+?

BIO-C Sealer Ion+ is a medical device that received FDA 510(k) clearance on 2019-12-12. It is manufactured by Angelus Industria DE Produtos Odontologicos S/A. The 510(k) number is K190537.

When was BIO-C Sealer Ion+ approved by the FDA?

BIO-C Sealer Ion+ received FDA 510(k) clearance on 2019-12-12, under approval number K190537.

What company makes BIO-C Sealer Ion+?

BIO-C Sealer Ion+ is manufactured by Angelus Industria DE Produtos Odontologicos S/A.

What is the FDA product code for BIO-C Sealer Ion+?

The FDA product code for BIO-C Sealer Ion+ is KIF.

Other Devices by Angelus Industria DE Produtos Odontologicos S/A

K180185BIO-C REPAIR K172701BIO-C SEALER K180199BIO-C TEMP K201222Bio-C Repair Ion+

Related Devices (Code: KIF)

K161239MTA2.2 MATERIALAvalon Biomed, Inc. K151047MTA Repair HPAngelus Industria DE Productos Odontologicos K153067Tubli-Seal, Tubli-Seal EWT,Tubli-Seal Xpress, Tubli-Seal EWT XpressSybron Dental Specialties K152956Pulp Canal Sealer, Pulp Canal Sealer EWTSybron Dental Specialties K152959Sealapex tubes, Sealapex bulk package, Sealapex Xpress dual-barrel syringesSybron Dental Specialties K170950Well-Root STVericom Co., Ltd.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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