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FDA 510(k)

TRI-matrix Implant Line

K-Number: K203660 · 2021-12-21

ApplicantTri Dental Implants Int. AG
Decision Date2021-12-21
Product CodeDZE
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

TRI-matrix Implant Line is the device name listed in this FDA 510(k) record. The listed applicant is Tri Dental Implants Int. AG. It received FDA 510(k) clearance on 2021-12-21 under 510(k) number K203660. 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 TRI-matrix Implant Line?

TRI-matrix Implant Line is a medical device that received FDA 510(k) clearance on 2021-12-21. The listed applicant is Tri Dental Implants Int. AG. The 510(k) number is K203660.

When did TRI-matrix Implant Line receive FDA 510(k) clearance?

TRI-matrix Implant Line received FDA 510(k) clearance on 2021-12-21, under 510(k) number K203660.

Who is the listed applicant for TRI-matrix Implant Line?

The FDA 510(k) record lists Tri Dental Implants Int. AG as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for TRI-matrix Implant Line?

The FDA product code for TRI-matrix Implant Line is DZE.

Other records listing Tri Dental Implants Int. AG as applicant

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.

K242661TRI-matrix® X-Force Implants

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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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