TSV BellaTek Express and BellaTek Flex Abutments
K-Number: K192522 · 2019-12-09
ApplicantBiomet 3i, LLC
Decision Date2019-12-09
Product CodeNHA
Advisory CommitteeDE
DecisionSubstantially Equivalent
Device Summary
TSV BellaTek Express and BellaTek Flex Abutments is a medical device manufactured by Biomet 3i, LLC. It received FDA 510(k) clearance on 2019-12-09 under approval number K192522. 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 TSV BellaTek Express and BellaTek Flex Abutments?
TSV BellaTek Express and BellaTek Flex Abutments is a medical device that received FDA 510(k) clearance on 2019-12-09. It is manufactured by Biomet 3i, LLC. The 510(k) number is K192522.
When was TSV BellaTek Express and BellaTek Flex Abutments approved by the FDA?
TSV BellaTek Express and BellaTek Flex Abutments received FDA 510(k) clearance on 2019-12-09, under approval number K192522.
What company makes TSV BellaTek Express and BellaTek Flex Abutments?
TSV BellaTek Express and BellaTek Flex Abutments is manufactured by Biomet 3i, LLC.
What is the FDA product code for TSV BellaTek Express and BellaTek Flex Abutments?
The FDA product code for TSV 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.