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FDA 510(k)

POLY SILOXANE IMPRESSION MATERIAL

K-Number: K053014 · 2005-11-15

ApplicantClinician'S Choice Dental Products, Inc.
Decision Date2005-11-15
Product CodeELW
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

POLY SILOXANE IMPRESSION MATERIAL 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 2005-11-15 under 510(k) number K053014. 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 POLY SILOXANE IMPRESSION MATERIAL?

POLY SILOXANE IMPRESSION MATERIAL is a medical device that received FDA 510(k) clearance on 2005-11-15. The listed applicant is Clinician'S Choice Dental Products, Inc.. The 510(k) number is K053014.

When did POLY SILOXANE IMPRESSION MATERIAL receive FDA 510(k) clearance?

POLY SILOXANE IMPRESSION MATERIAL received FDA 510(k) clearance on 2005-11-15, under 510(k) number K053014.

Who is the listed applicant for POLY SILOXANE IMPRESSION MATERIAL?

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 POLY SILOXANE IMPRESSION MATERIAL?

The FDA product code for POLY SILOXANE IMPRESSION MATERIAL 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.

K081017TEMPLATE AND COUNTER-FIT

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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