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FDA 510(k)

TOUAREG CloseFit™ UNP 2.75mmD

K-Number: K153111 · 2016-05-06

ApplicantAdin Dental Implants Systems , Ltd.
Decision Date2016-05-06
Product CodeDZE
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

TOUAREG CloseFit™ UNP 2.75mmD is the device name listed in this FDA 510(k) record. The listed applicant is Adin Dental Implants Systems , Ltd.. It received FDA 510(k) clearance on 2016-05-06 under 510(k) number K153111. 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 TOUAREG CloseFit™ UNP 2.75mmD?

TOUAREG CloseFit™ UNP 2.75mmD is a medical device that received FDA 510(k) clearance on 2016-05-06. The listed applicant is Adin Dental Implants Systems , Ltd.. The 510(k) number is K153111.

When did TOUAREG CloseFit™ UNP 2.75mmD receive FDA 510(k) clearance?

TOUAREG CloseFit™ UNP 2.75mmD received FDA 510(k) clearance on 2016-05-06, under 510(k) number K153111.

Who is the listed applicant for TOUAREG CloseFit™ UNP 2.75mmD?

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

What is the FDA product code for TOUAREG CloseFit™ UNP 2.75mmD?

The FDA product code for TOUAREG CloseFit™ UNP 2.75mmD is DZE.

Other records listing Adin Dental Implants 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.

K212775Adin Short 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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