BIO-C TEMP
K-Number: K180199 · 2019-01-04
Decision Date2019-01-04
Product CodeKIF
Advisory CommitteeDE
DecisionSubstantially Equivalent
Device Summary
BIO-C TEMP is a medical device manufactured by Angelus Industria DE Produtos Odontologicos S/A. It received FDA 510(k) clearance on 2019-01-04 under approval number K180199. 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 TEMP?
BIO-C TEMP is a medical device that received FDA 510(k) clearance on 2019-01-04. It is manufactured by Angelus Industria DE Produtos Odontologicos S/A. The 510(k) number is K180199.
When was BIO-C TEMP approved by the FDA?
BIO-C TEMP received FDA 510(k) clearance on 2019-01-04, under approval number K180199.
What company makes BIO-C TEMP?
BIO-C TEMP is manufactured by Angelus Industria DE Produtos Odontologicos S/A.
What is the FDA product code for BIO-C TEMP?
The FDA product code for BIO-C TEMP is KIF.
Other Devices by Angelus Industria DE Produtos Odontologicos S/A
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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.