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FDA 510(k)

76 ELW BITE CHECKER SILICONE

K-Number: K851469 · 1985-05-01

ApplicantG-C Intl. Corp.
Decision Date1985-05-01
Product CodeELW
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

76 ELW BITE CHECKER SILICONE 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 1985-05-01 under 510(k) number K851469. 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 76 ELW BITE CHECKER SILICONE?

76 ELW BITE CHECKER SILICONE is a medical device that received FDA 510(k) clearance on 1985-05-01. The listed applicant is G-C Intl. Corp.. The 510(k) number is K851469.

When did 76 ELW BITE CHECKER SILICONE receive FDA 510(k) clearance?

76 ELW BITE CHECKER SILICONE received FDA 510(k) clearance on 1985-05-01, under 510(k) number K851469.

Who is the listed applicant for 76 ELW BITE CHECKER SILICONE?

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 76 ELW BITE CHECKER SILICONE?

The FDA product code for 76 ELW BITE CHECKER SILICONE 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)

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

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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