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FDA 510(k)

FIRST IMPRESSION WITH CHLORHEXIDINE

K-Number: K894281 · 1989-09-26

ApplicantCoe Laboratories, Inc.
Decision Date1989-09-26
Product CodeELW
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

FIRST IMPRESSION WITH CHLORHEXIDINE is the device name listed in this FDA 510(k) record. The listed applicant is Coe Laboratories, Inc.. It received FDA 510(k) clearance on 1989-09-26 under 510(k) number K894281. 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 FIRST IMPRESSION WITH CHLORHEXIDINE?

FIRST IMPRESSION WITH CHLORHEXIDINE is a medical device that received FDA 510(k) clearance on 1989-09-26. The listed applicant is Coe Laboratories, Inc.. The 510(k) number is K894281.

When did FIRST IMPRESSION WITH CHLORHEXIDINE receive FDA 510(k) clearance?

FIRST IMPRESSION WITH CHLORHEXIDINE received FDA 510(k) clearance on 1989-09-26, under 510(k) number K894281.

Who is the listed applicant for FIRST IMPRESSION WITH CHLORHEXIDINE?

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

What is the FDA product code for FIRST IMPRESSION WITH CHLORHEXIDINE?

The FDA product code for FIRST IMPRESSION WITH CHLORHEXIDINE is ELW.

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Other records listing Coe Laboratories, 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.

K903292ACCUFLEX/ACCUMIX VINYL POLY IMPRESSION MATERIALSK894282FIRST IMPRESSION TMK891140OCCLU-SEAL(TM) VISIBLE LIGHT-CURED FISSURE SEALANTK885010TRIPTON(TM) VISIBLE LIGHT-CURED UNIV. BONDINGK881422COE PAK AUTO MIX, REGULAR OR HARD SETK881091OMNISIL, VINYL POLYSILOXANE IMPRESSION MATERIAL

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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

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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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