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FDA 510(k)

COLTENE PRESSURE SPOT INDICATOR

K-Number: K811667 · 1981-07-15

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

Device Summary

COLTENE PRESSURE SPOT INDICATOR 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 K811667. 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 PRESSURE SPOT INDICATOR?

COLTENE PRESSURE SPOT INDICATOR 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 K811667.

When did COLTENE PRESSURE SPOT INDICATOR receive FDA 510(k) clearance?

COLTENE PRESSURE SPOT INDICATOR received FDA 510(k) clearance on 1981-07-15, under 510(k) number K811667.

Who is the listed applicant for COLTENE PRESSURE SPOT INDICATOR?

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 PRESSURE SPOT INDICATOR?

The FDA product code for COLTENE PRESSURE SPOT INDICATOR 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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