Certain BellaTek Express and BellaTek Flex Abutments
K-Number: K183138 · 2019-07-02
ApplicantBiomet 3i
Decision Date2019-07-02
Product CodeNHA
Advisory CommitteeDE
DecisionSubstantially Equivalent
Device Summary
Certain BellaTek Express and BellaTek Flex Abutments is a medical device manufactured by Biomet 3i. It received FDA 510(k) clearance on 2019-07-02 under approval number K183138. The device is classified under product code NHA. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Certain BellaTek Express and BellaTek Flex Abutments?
Certain BellaTek Express and BellaTek Flex Abutments is a medical device that received FDA 510(k) clearance on 2019-07-02. It is manufactured by Biomet 3i. The 510(k) number is K183138.
When was Certain BellaTek Express and BellaTek Flex Abutments approved by the FDA?
Certain BellaTek Express and BellaTek Flex Abutments received FDA 510(k) clearance on 2019-07-02, under approval number K183138.
What company makes Certain BellaTek Express and BellaTek Flex Abutments?
Certain BellaTek Express and BellaTek Flex Abutments is manufactured by Biomet 3i.
What is the FDA product code for Certain BellaTek Express and BellaTek Flex Abutments?
The FDA product code for Certain BellaTek Express and BellaTek Flex Abutments is NHA.
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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.