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FDA 510(k)

UniFit Dental Implant System

K-Number: K223714 · 2023-12-29

ApplicantAdin Dental Implant Systems , Ltd.
Decision Date2023-12-29
Product CodeDZE
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

UniFit Dental Implant System is the device name listed in this FDA 510(k) record. The listed applicant is Adin Dental Implant Systems , Ltd.. It received FDA 510(k) clearance on 2023-12-29 under 510(k) number K223714. 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 UniFit Dental Implant System?

UniFit Dental Implant System is a medical device that received FDA 510(k) clearance on 2023-12-29. The listed applicant is Adin Dental Implant Systems , Ltd.. The 510(k) number is K223714.

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

UniFit Dental Implant System received FDA 510(k) clearance on 2023-12-29, under 510(k) number K223714.

Who is the listed applicant for UniFit Dental Implant System?

The FDA 510(k) record lists Adin Dental Implant Systems , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for UniFit Dental Implant System?

The FDA product code for UniFit Dental Implant System is DZE.

Other records listing Adin Dental Implant Systems , Ltd. 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.

K252031Adin Long Dental Implant SystemK250178Adin Customized Abutments

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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