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FDA 510(k)

IMPRESSIX, COLORCHANGE ALGINATE

K-Number: K062400 · 2006-11-16

ApplicantCavex Holland BV
Decision Date2006-11-16
Product CodeELW
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

IMPRESSIX, COLORCHANGE ALGINATE is the device name listed in this FDA 510(k) record. The listed applicant is Cavex Holland BV. It received FDA 510(k) clearance on 2006-11-16 under 510(k) number K062400. 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 IMPRESSIX, COLORCHANGE ALGINATE?

IMPRESSIX, COLORCHANGE ALGINATE is a medical device that received FDA 510(k) clearance on 2006-11-16. The listed applicant is Cavex Holland BV. The 510(k) number is K062400.

When did IMPRESSIX, COLORCHANGE ALGINATE receive FDA 510(k) clearance?

IMPRESSIX, COLORCHANGE ALGINATE received FDA 510(k) clearance on 2006-11-16, under 510(k) number K062400.

Who is the listed applicant for IMPRESSIX, COLORCHANGE ALGINATE?

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

What is the FDA product code for IMPRESSIX, COLORCHANGE ALGINATE?

The FDA product code for IMPRESSIX, COLORCHANGE ALGINATE is ELW.

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Other records listing Cavex Holland BV 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.

K073539PROVISA CEMK072245EMULATE ADVANCEDK061267SIMULATE, COLOR CHANGE ALGINATEK052455IMPRESSIXK051207CAVEX ORTHOTRACEK042806QUADRANT UNIT-1-BOND

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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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