Bio-C Repair Ion+
K-Number: K201222 · 2021-02-11
Decision Date2021-02-11
Product CodeKIF
Advisory CommitteeDE
DecisionSubstantially Equivalent
Device Summary
Bio-C Repair Ion+ is a medical device manufactured by Angelus Industria DE Produtos Odontologicos S/A. It received FDA 510(k) clearance on 2021-02-11 under approval number K201222. 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 Repair Ion+?
Bio-C Repair Ion+ is a medical device that received FDA 510(k) clearance on 2021-02-11. It is manufactured by Angelus Industria DE Produtos Odontologicos S/A. The 510(k) number is K201222.
When was Bio-C Repair Ion+ approved by the FDA?
Bio-C Repair Ion+ received FDA 510(k) clearance on 2021-02-11, under approval number K201222.
What company makes Bio-C Repair Ion+?
Bio-C Repair Ion+ is manufactured by Angelus Industria DE Produtos Odontologicos S/A.
What is the FDA product code for Bio-C Repair Ion+?
The FDA product code for Bio-C Repair Ion+ is KIF.
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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.