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FDA 510(k)

SEPTOSIL SILICONE FOR PRECISION IMPRESSION

K-Number: K851388 · 1985-05-29

ApplicantSpecialites Septodont
Decision Date1985-05-29
Product CodeELW
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

SEPTOSIL SILICONE FOR PRECISION IMPRESSION is the device name listed in this FDA 510(k) record. The listed applicant is Specialites Septodont. It received FDA 510(k) clearance on 1985-05-29 under 510(k) number K851388. 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 SEPTOSIL SILICONE FOR PRECISION IMPRESSION?

SEPTOSIL SILICONE FOR PRECISION IMPRESSION is a medical device that received FDA 510(k) clearance on 1985-05-29. The listed applicant is Specialites Septodont. The 510(k) number is K851388.

When did SEPTOSIL SILICONE FOR PRECISION IMPRESSION receive FDA 510(k) clearance?

SEPTOSIL SILICONE FOR PRECISION IMPRESSION received FDA 510(k) clearance on 1985-05-29, under 510(k) number K851388.

Who is the listed applicant for SEPTOSIL SILICONE FOR PRECISION IMPRESSION?

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

What is the FDA product code for SEPTOSIL SILICONE FOR PRECISION IMPRESSION?

The FDA product code for SEPTOSIL SILICONE FOR PRECISION IMPRESSION is ELW.

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Other records listing Specialites Septodont 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.

K012427PHARMAETHYL LOCAL PULP AND VITALITY TESTING AGENTK010415ISODANK982773QUICKSET LIQUID AND POWDERK982671SECURALLOYK980633ENDOSOLV EK920692SEPTOCALCINE ULTRA

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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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