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FDA 510(k)

CHROMOPRINT CHROMATIC ALGINATE IMPRESSION MATERIAL

K-Number: K964323 · 1996-12-16

ApplicantFen Dental Mfg., Inc.
Decision Date1996-12-16
Product CodeELW
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

CHROMOPRINT CHROMATIC ALGINATE IMPRESSION MATERIAL is the device name listed in this FDA 510(k) record. The listed applicant is Fen Dental Mfg., Inc.. It received FDA 510(k) clearance on 1996-12-16 under 510(k) number K964323. 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 CHROMOPRINT CHROMATIC ALGINATE IMPRESSION MATERIAL?

CHROMOPRINT CHROMATIC ALGINATE IMPRESSION MATERIAL is a medical device that received FDA 510(k) clearance on 1996-12-16. The listed applicant is Fen Dental Mfg., Inc.. The 510(k) number is K964323.

When did CHROMOPRINT CHROMATIC ALGINATE IMPRESSION MATERIAL receive FDA 510(k) clearance?

CHROMOPRINT CHROMATIC ALGINATE IMPRESSION MATERIAL received FDA 510(k) clearance on 1996-12-16, under 510(k) number K964323.

Who is the listed applicant for CHROMOPRINT CHROMATIC ALGINATE IMPRESSION MATERIAL?

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

What is the FDA product code for CHROMOPRINT CHROMATIC ALGINATE IMPRESSION MATERIAL?

The FDA product code for CHROMOPRINT CHROMATIC ALGINATE IMPRESSION MATERIAL is ELW.

Related Clinical Trials

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.

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Other records listing Fen Dental Mfg., 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.

K951465SUNLITE 1275K942430AGALLOY, DISALLOY, EPSILON AND LAMBDA

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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