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FDA 510(k)

MODIFICATION TO:REGISTRADO X-TRA

K-Number: K051535 · 2005-06-28

ApplicantVoco GmbH
Decision Date2005-06-28
Product CodeELW
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

MODIFICATION TO:REGISTRADO X-TRA is the device name listed in this FDA 510(k) record. The listed applicant is Voco GmbH. It received FDA 510(k) clearance on 2005-06-28 under 510(k) number K051535. 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 MODIFICATION TO:REGISTRADO X-TRA?

MODIFICATION TO:REGISTRADO X-TRA is a medical device that received FDA 510(k) clearance on 2005-06-28. The listed applicant is Voco GmbH. The 510(k) number is K051535.

When did MODIFICATION TO:REGISTRADO X-TRA receive FDA 510(k) clearance?

MODIFICATION TO:REGISTRADO X-TRA received FDA 510(k) clearance on 2005-06-28, under 510(k) number K051535.

Who is the listed applicant for MODIFICATION TO:REGISTRADO X-TRA?

The FDA 510(k) record lists Voco GmbH as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MODIFICATION TO:REGISTRADO X-TRA?

The FDA product code for MODIFICATION TO:REGISTRADO X-TRA is ELW.

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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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