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FDA 510(k)

G-C FIT-CHECKER IMPRESSION MATERIAL

K-Number: K812679 · 1981-10-06

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

Device Summary

G-C FIT-CHECKER 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 K812679. 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 G-C FIT-CHECKER IMPRESSION MATERIAL?

G-C FIT-CHECKER 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 K812679.

When did G-C FIT-CHECKER IMPRESSION MATERIAL receive FDA 510(k) clearance?

G-C FIT-CHECKER IMPRESSION MATERIAL received FDA 510(k) clearance on 1981-10-06, under 510(k) number K812679.

Who is the listed applicant for G-C FIT-CHECKER 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 G-C FIT-CHECKER IMPRESSION MATERIAL?

The FDA product code for G-C FIT-CHECKER 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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