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FDA 510(k)

MULTIPLE (ADDITION SILICONE IMPRESSION MATERIAL)

K-Number: K041229 · 2004-06-17

ApplicantCosmedent, Inc.
Decision Date2004-06-17
Product CodeELW
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

MULTIPLE (ADDITION SILICONE IMPRESSION MATERIAL) is the device name listed in this FDA 510(k) record. The listed applicant is Cosmedent, Inc.. It received FDA 510(k) clearance on 2004-06-17 under 510(k) number K041229. 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 MULTIPLE (ADDITION SILICONE IMPRESSION MATERIAL)?

MULTIPLE (ADDITION SILICONE IMPRESSION MATERIAL) is a medical device that received FDA 510(k) clearance on 2004-06-17. The listed applicant is Cosmedent, Inc.. The 510(k) number is K041229.

When did MULTIPLE (ADDITION SILICONE IMPRESSION MATERIAL) receive FDA 510(k) clearance?

MULTIPLE (ADDITION SILICONE IMPRESSION MATERIAL) received FDA 510(k) clearance on 2004-06-17, under 510(k) number K041229.

Who is the listed applicant for MULTIPLE (ADDITION SILICONE IMPRESSION MATERIAL)?

The FDA 510(k) record lists Cosmedent, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MULTIPLE (ADDITION SILICONE IMPRESSION MATERIAL)?

The FDA product code for MULTIPLE (ADDITION SILICONE IMPRESSION MATERIAL) is ELW.

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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

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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