FDA 510(k)

TSX Implants

K-Number: K220978 · 2022-09-14

Decision Date2022-09-14

Product CodeDZE

Advisory CommitteeDE

DecisionSubstantially Equivalent

Device Summary

TSX Implants is a medical device manufactured by Biomet 3i, LLC. It received FDA 510(k) clearance on 2022-09-14 under approval number K220978. The device is classified under product code DZE. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TSX Implants?

TSX Implants is a medical device that received FDA 510(k) clearance on 2022-09-14. It is manufactured by Biomet 3i, LLC. The 510(k) number is K220978.

When was TSX Implants approved by the FDA?

TSX Implants received FDA 510(k) clearance on 2022-09-14, under approval number K220978.

What company makes TSX Implants?

TSX Implants is manufactured by Biomet 3i, LLC.

What is the FDA product code for TSX Implants?

The FDA product code for TSX Implants is DZE.

Other Devices by Biomet 3i, LLC

K192522TSV BellaTek Express and BellaTek Flex Abutments K212730BellaTek Encode Emergence Healing Abutments K213672T3 Pro Implants K241753Immediate Molar Implants K241032BellaTek Bars K251660T3 Pro Implants ZimVie Packaging System

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Related Devices (Code: DZE)

K160475Ritter Dental Implant SystemRitter Implants GmbH & Co. KG K161244s-Clean OneQ-SL Narrow Implant SystemDentis Co., Ltd. K163043Zeramex P6 Dental Implant SystemDentalpoint AG K161497Dental Implants and AbutmentsDitron Precision, Ltd. K153332ETIII SA Fixture System (O3.2mm)Hiossen, Inc. K151970KJ Mini Implant SystemKj Meditech 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.