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FDA 510(k)

TOUAREG CLOSEFIT DENTAL IMPANT SYSTEM

K-Number: K112585 · 2012-05-24

ApplicantAdin Dental Implants System, Ltd.
Decision Date2012-05-24
Product CodeDZE
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

TOUAREG CLOSEFIT DENTAL IMPANT SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Adin Dental Implants System, Ltd.. It received FDA 510(k) clearance on 2012-05-24 under 510(k) number K112585. 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 DENTAL IMPANT SYSTEM?

TOUAREG CLOSEFIT DENTAL IMPANT SYSTEM is a medical device that received FDA 510(k) clearance on 2012-05-24. The listed applicant is Adin Dental Implants System, Ltd.. The 510(k) number is K112585.

When did TOUAREG CLOSEFIT DENTAL IMPANT SYSTEM receive FDA 510(k) clearance?

TOUAREG CLOSEFIT DENTAL IMPANT SYSTEM received FDA 510(k) clearance on 2012-05-24, under 510(k) number K112585.

Who is the listed applicant for TOUAREG CLOSEFIT DENTAL IMPANT SYSTEM?

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

What is the FDA product code for TOUAREG CLOSEFIT DENTAL IMPANT SYSTEM?

The FDA product code for TOUAREG CLOSEFIT DENTAL IMPANT 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.

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Other records listing Adin Dental Implants System, 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.

K081751ADIN DENTAL IMPLANTS SYSTEM

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.

K261392TriActive Dental Implant SystemParagon Implant Mfg., LLCK260463ZEROS Dental Implant SystemZeros Co., Ltd.K251188UNIQA® Dental Implants SystemUniqa Dental, Ltd.K251232MegaGen Zygoma Dental Implant SystemMegagen Implant Co., Ltd.K250806Dental Implant SystemA.B. Dental Devices , Ltd.K260006INOSS SystemInosys, Inc.

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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