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FDA 510(k)

ISO FUNCTIONAL

K-Number: K022430 · 2002-10-18

ApplicantGC America, Inc.
Decision Date2002-10-18
Product CodeELW
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

ISO FUNCTIONAL is the device name listed in this FDA 510(k) record. The listed applicant is GC America, Inc.. It received FDA 510(k) clearance on 2002-10-18 under 510(k) number K022430. 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 ISO FUNCTIONAL?

ISO FUNCTIONAL is a medical device that received FDA 510(k) clearance on 2002-10-18. The listed applicant is GC America, Inc.. The 510(k) number is K022430.

When did ISO FUNCTIONAL receive FDA 510(k) clearance?

ISO FUNCTIONAL received FDA 510(k) clearance on 2002-10-18, under 510(k) number K022430.

Who is the listed applicant for ISO FUNCTIONAL?

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

What is the FDA product code for ISO FUNCTIONAL?

The FDA product code for ISO FUNCTIONAL is ELW.

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Other records listing GC America, Inc. as applicant

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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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