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FDA 510(k)

Dental Implant System

K-Number: K250806 · 2026-06-18

ApplicantA.B. Dental Devices , Ltd.
Decision Date2026-06-18
Product CodeDZE
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

Dental Implant System is the device name listed in this FDA 510(k) record. The listed applicant is A.B. Dental Devices , Ltd.. It received FDA 510(k) clearance on 2026-06-18 under 510(k) number K250806. 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 Dental Implant System?

Dental Implant System is a medical device that received FDA 510(k) clearance on 2026-06-18. The listed applicant is A.B. Dental Devices , Ltd.. The 510(k) number is K250806.

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

Dental Implant System received FDA 510(k) clearance on 2026-06-18, under 510(k) number K250806.

Who is the listed applicant for Dental Implant System?

The FDA 510(k) record lists A.B. Dental Devices , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Dental Implant System?

The FDA product code for Dental Implant System is DZE.

Related Clinical Trials

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.

NCT03917927A Clinical Study of the Eztetic Dental Implant SystemCOMPLETEDNCT04237545A Clinical Study of the T3 Short Dental Implant SystemCOMPLETEDNCT05062863An Observational Clinical Study of the T3 Dental Implant SystemCOMPLETEDNCT05498662An Observational Study of the T3 Pro Dental Implant SystemACTIVE_NOT_RECRUITINGNCT06571812A Clinical Study of the TSX Dental Implant System (Xpresso)RECRUITING

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.K260006INOSS SystemInosys, Inc.K252731Promimic ZrP Surface Dental Implant; Promimic ZrP + HAnano Surface Dental ImplantPromimic ABK252031Adin Long Dental Implant SystemAdin Dental Implant Systems , Ltd.K253334ZENEX Implant System_Short (R-System)Izenimplant Co., 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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