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FDA 510(k)

TEMPLATE AND COUNTER-FIT

K-Number: K081017 · 2008-08-04

ApplicantClinician'S Choice Dental Products, Inc.
Decision Date2008-08-04
Product CodeELW
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

TEMPLATE AND COUNTER-FIT is the device name listed in this FDA 510(k) record. The listed applicant is Clinician'S Choice Dental Products, Inc.. It received FDA 510(k) clearance on 2008-08-04 under 510(k) number K081017. The device is classified under product code ELW. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TEMPLATE AND COUNTER-FIT?

TEMPLATE AND COUNTER-FIT is a medical device that received FDA 510(k) clearance on 2008-08-04. The listed applicant is Clinician'S Choice Dental Products, Inc.. The 510(k) number is K081017.

When did TEMPLATE AND COUNTER-FIT receive FDA 510(k) clearance?

TEMPLATE AND COUNTER-FIT received FDA 510(k) clearance on 2008-08-04, under 510(k) number K081017.

Who is the listed applicant for TEMPLATE AND COUNTER-FIT?

The FDA 510(k) record lists Clinician'S Choice Dental Products, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for TEMPLATE AND COUNTER-FIT?

The FDA product code for TEMPLATE AND COUNTER-FIT is ELW.

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Other records listing Clinician'S Choice Dental Products, Inc. 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.

K053014POLY SILOXANE IMPRESSION MATERIAL

Related Devices (Code: ELW)

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.

K254152Dia-X Sil Light BodyDiaDent Group InternationalK254142Dia-X Sil Heavy BodyDiaDent Group InternationalK254112Dia-X Sil BiteDiaDent Group InternationalK253501Hydro Print Premium Fast Set - 454g (1lb) (052037); Hydro Print Premium Regular Set - 454g (1lb) (052327); Chroma Print Premium Fast Set - 454g (1lb) (052457); Chroma Print Premium Regular Set - 454g (1lb) (051460); Perfil Pro - 454g (1lb) (056213); Perfil Pro+ - 454g (1lb) (056121); Perfil Pro Chroma - 454g (1lb) (056122); Hydro Print Premium Fast Set - Multi Pack (056205); Hydro Print Premium Regular Set - Multi Pack (056208); Hydro Print Premium Fast Set - 9,07Kg (20lb) (056204);Vigodent Indústria E Comercio LtdaK250969JET BITE; JET BLUE BITE FAST; JET BLUE BITE SUPERFASTDent4you AGK241924Elastic Impression MaterialBeijing Okvd Biological Technology , 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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