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FDA 510(k)

OMNISIL, VINYL POLYSILOXANE IMPRESSION MATERIAL

K-Number: K881091 · 1988-06-28

ApplicantCoe Laboratories, Inc.
Decision Date1988-06-28
Product CodeELW
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

OMNISIL, VINYL POLYSILOXANE IMPRESSION MATERIAL is the device name listed in this FDA 510(k) record. The listed applicant is Coe Laboratories, Inc.. It received FDA 510(k) clearance on 1988-06-28 under 510(k) number K881091. 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 OMNISIL, VINYL POLYSILOXANE IMPRESSION MATERIAL?

OMNISIL, VINYL POLYSILOXANE IMPRESSION MATERIAL is a medical device that received FDA 510(k) clearance on 1988-06-28. The listed applicant is Coe Laboratories, Inc.. The 510(k) number is K881091.

When did OMNISIL, VINYL POLYSILOXANE IMPRESSION MATERIAL receive FDA 510(k) clearance?

OMNISIL, VINYL POLYSILOXANE IMPRESSION MATERIAL received FDA 510(k) clearance on 1988-06-28, under 510(k) number K881091.

Who is the listed applicant for OMNISIL, VINYL POLYSILOXANE IMPRESSION MATERIAL?

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

What is the FDA product code for OMNISIL, VINYL POLYSILOXANE IMPRESSION MATERIAL?

The FDA product code for OMNISIL, VINYL POLYSILOXANE IMPRESSION MATERIAL is ELW.

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Other records listing Coe Laboratories, 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.

K903292ACCUFLEX/ACCUMIX VINYL POLY IMPRESSION MATERIALSK894282FIRST IMPRESSION TMK894281FIRST IMPRESSION WITH CHLORHEXIDINEK891140OCCLU-SEAL(TM) VISIBLE LIGHT-CURED FISSURE SEALANTK885010TRIPTON(TM) VISIBLE LIGHT-CURED UNIV. BONDINGK881422COE PAK AUTO MIX, REGULAR OR HARD SET

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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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