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FDA 510(k)

EXAFLEX IMPRESSION MATERIAL

K-Number: K812406 · 1981-10-06

ApplicantG-C Intl. Corp.
Decision Date1981-10-06
Product CodeELW
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

EXAFLEX IMPRESSION MATERIAL is the device name listed in this FDA 510(k) record. The listed applicant is G-C Intl. Corp.. It received FDA 510(k) clearance on 1981-10-06 under 510(k) number K812406. 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 EXAFLEX IMPRESSION MATERIAL?

EXAFLEX IMPRESSION MATERIAL is a medical device that received FDA 510(k) clearance on 1981-10-06. The listed applicant is G-C Intl. Corp.. The 510(k) number is K812406.

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

EXAFLEX IMPRESSION MATERIAL received FDA 510(k) clearance on 1981-10-06, under 510(k) number K812406.

Who is the listed applicant for EXAFLEX IMPRESSION MATERIAL?

The FDA 510(k) record lists G-C Intl. Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for EXAFLEX IMPRESSION MATERIAL?

The FDA product code for EXAFLEX IMPRESSION MATERIAL is ELW.

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Other records listing G-C Intl. Corp. as applicant

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K913175MIRACLE MIX CAPS GLASS IONOMER CEMENT INCAPSULESK913884FUJI II LCK901999FUJI LINING CEMENT LIGHT CUREK902531EXAPHASE, SINGLE PHASE IMPRESSION MATERIALK896883GC CERVICAL CEMENTK895976TOOTH SHADE RESIN

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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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