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FDA 510(k)

T3 Pro Implants– ZimVie Packaging System

K-Number: K251660 · 2025-06-27

ApplicantBiomet 3i, LLC
Decision Date2025-06-27
Product CodeDZE
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

T3 Pro Implants– ZimVie Packaging System 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 2025-06-27 under 510(k) number K251660. 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– ZimVie Packaging System?

T3 Pro Implants– ZimVie Packaging System is a medical device that received FDA 510(k) clearance on 2025-06-27. The listed applicant is Biomet 3i, LLC. The 510(k) number is K251660.

When did T3 Pro Implants– ZimVie Packaging System receive FDA 510(k) clearance?

T3 Pro Implants– ZimVie Packaging System received FDA 510(k) clearance on 2025-06-27, under 510(k) number K251660.

Who is the listed applicant for T3 Pro Implants– ZimVie Packaging System?

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– ZimVie Packaging System?

The FDA product code for T3 Pro Implants– ZimVie Packaging System is DZE.

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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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