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FDA 510(k)

COLTENE COLTEX/COLTOFLAX

K-Number: K811666 · 1981-07-15

ApplicantColtene, Inc.
Decision Date1981-07-15
Product CodeELW
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

COLTENE COLTEX/COLTOFLAX is the device name listed in this FDA 510(k) record. The listed applicant is Coltene, Inc.. It received FDA 510(k) clearance on 1981-07-15 under 510(k) number K811666. 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 COLTENE COLTEX/COLTOFLAX?

COLTENE COLTEX/COLTOFLAX is a medical device that received FDA 510(k) clearance on 1981-07-15. The listed applicant is Coltene, Inc.. The 510(k) number is K811666.

When did COLTENE COLTEX/COLTOFLAX receive FDA 510(k) clearance?

COLTENE COLTEX/COLTOFLAX received FDA 510(k) clearance on 1981-07-15, under 510(k) number K811666.

Who is the listed applicant for COLTENE COLTEX/COLTOFLAX?

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

What is the FDA product code for COLTENE COLTEX/COLTOFLAX?

The FDA product code for COLTENE COLTEX/COLTOFLAX is ELW.

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Other records listing Coltene, Inc. 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.

K902392COLTOSOL TEMPORARY ENDODONTIC FILLING MATERIALK882800COLTENE PRESIDENT JET REGULAR BODYK873671COLTENE PRESIDENT JET IMPRESSION MATERIALS SYSTEMK870266COLTENE BRILLIANT D.I. DIRECT INLAY SYSTEMK870047COLTENE RAPIDK863998COLTENE JET-MIXER

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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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