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FDA 510(k)

T3 Pro Implants

K-Number: K213672 · 2022-03-28

ApplicantBiomet 3i, LLC
Decision Date2022-03-28
Product CodeDZE
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

T3 Pro Implants is the device name listed in this FDA 510(k) record. The listed applicant is Biomet 3i, LLC. It received FDA 510(k) clearance on 2022-03-28 under 510(k) number K213672. 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 T3 Pro Implants?

T3 Pro Implants is a medical device that received FDA 510(k) clearance on 2022-03-28. The listed applicant is Biomet 3i, LLC. The 510(k) number is K213672.

When did T3 Pro Implants receive FDA 510(k) clearance?

T3 Pro Implants received FDA 510(k) clearance on 2022-03-28, under 510(k) number K213672.

Who is the listed applicant for T3 Pro Implants?

The FDA 510(k) record lists Biomet 3i, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for T3 Pro Implants?

The FDA product code for T3 Pro Implants is DZE.

Other records listing Biomet 3i, LLC as applicant

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Related Devices (Code: DZE)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K251188UNIQA® Dental Implants SystemUniqa Dental, Ltd.K251232MegaGen Zygoma Dental Implant SystemMegagen Implant Co., Ltd.K250806Dental Implant SystemA.B. Dental Devices , Ltd.K260006INOSS SystemInosys, Inc.K252731Promimic ZrP Surface Dental Implant; Promimic ZrP + HAnano Surface Dental ImplantPromimic ABK252031Adin Long Dental Implant SystemAdin Dental Implant Systems , 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.

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