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FDA 510(k)

ELITE MONOPHASE

K-Number: K022653 · 2002-10-28

ApplicantZhermack S.P.A.
Decision Date2002-10-28
Product CodeELW
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

ELITE MONOPHASE is the device name listed in this FDA 510(k) record. The listed applicant is Zhermack S.P.A.. It received FDA 510(k) clearance on 2002-10-28 under 510(k) number K022653. 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 ELITE MONOPHASE?

ELITE MONOPHASE is a medical device that received FDA 510(k) clearance on 2002-10-28. The listed applicant is Zhermack S.P.A.. The 510(k) number is K022653.

When did ELITE MONOPHASE receive FDA 510(k) clearance?

ELITE MONOPHASE received FDA 510(k) clearance on 2002-10-28, under 510(k) number K022653.

Who is the listed applicant for ELITE MONOPHASE?

The FDA 510(k) record lists Zhermack S.P.A. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ELITE MONOPHASE?

The FDA product code for ELITE MONOPHASE is ELW.

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Other records listing Zhermack S.P.A. 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.

K083739HYDRORISE AND HYDROSYSTEMK081084COLORISE RIGIDK080130OCCLUFAST CADK073005ELITE GLASSK070677COLORISEK070700FREEALGIN

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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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