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FDA 510(k)

Thommen Implant System

K-Number: K171795 · 2017-09-29

ApplicantThommen Medical AG
Decision Date2017-09-29
Product CodeDZE
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

Thommen Implant System is the device name listed in this FDA 510(k) record. The listed applicant is Thommen Medical AG. It received FDA 510(k) clearance on 2017-09-29 under 510(k) number K171795. 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 Thommen Implant System?

Thommen Implant System is a medical device that received FDA 510(k) clearance on 2017-09-29. The listed applicant is Thommen Medical AG. The 510(k) number is K171795.

When did Thommen Implant System receive FDA 510(k) clearance?

Thommen Implant System received FDA 510(k) clearance on 2017-09-29, under 510(k) number K171795.

Who is the listed applicant for Thommen Implant System?

The FDA 510(k) record lists Thommen Medical AG as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Thommen Implant System?

The FDA product code for Thommen Implant System is DZE.

Other records listing Thommen Medical 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.

K160244VARIOuniteK151984Thommen Milling Abutment for CAD/CAM

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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