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FDA 510(k)

CHROMACLONE COLOR CHANGING ALGINATE IMPRESS MATERIALS

K-Number: K940860 · 1994-05-27

ApplicantUltradent Products, Inc.
Decision Date1994-05-27
Product CodeELW
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

CHROMACLONE COLOR CHANGING ALGINATE IMPRESS MATERIALS is the device name listed in this FDA 510(k) record. The listed applicant is Ultradent Products, Inc.. It received FDA 510(k) clearance on 1994-05-27 under 510(k) number K940860. 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 CHROMACLONE COLOR CHANGING ALGINATE IMPRESS MATERIALS?

CHROMACLONE COLOR CHANGING ALGINATE IMPRESS MATERIALS is a medical device that received FDA 510(k) clearance on 1994-05-27. The listed applicant is Ultradent Products, Inc.. The 510(k) number is K940860.

When did CHROMACLONE COLOR CHANGING ALGINATE IMPRESS MATERIALS receive FDA 510(k) clearance?

CHROMACLONE COLOR CHANGING ALGINATE IMPRESS MATERIALS received FDA 510(k) clearance on 1994-05-27, under 510(k) number K940860.

Who is the listed applicant for CHROMACLONE COLOR CHANGING ALGINATE IMPRESS MATERIALS?

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

What is the FDA product code for CHROMACLONE COLOR CHANGING ALGINATE IMPRESS MATERIALS?

The FDA product code for CHROMACLONE COLOR CHANGING ALGINATE IMPRESS MATERIALS is ELW.

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Related Devices (Code: ELW)

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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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