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FDA 510(k)

POLYSIL (VINYL POLYSILOXAN IMPRESSION MATERIAL)

K-Number: K945142 · 1995-01-11

ApplicantScican
Decision Date1995-01-11
Product CodeELW
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

POLYSIL (VINYL POLYSILOXAN IMPRESSION MATERIAL) is the device name listed in this FDA 510(k) record. The listed applicant is Scican. It received FDA 510(k) clearance on 1995-01-11 under 510(k) number K945142. 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 POLYSIL (VINYL POLYSILOXAN IMPRESSION MATERIAL)?

POLYSIL (VINYL POLYSILOXAN IMPRESSION MATERIAL) is a medical device that received FDA 510(k) clearance on 1995-01-11. The listed applicant is Scican. The 510(k) number is K945142.

When did POLYSIL (VINYL POLYSILOXAN IMPRESSION MATERIAL) receive FDA 510(k) clearance?

POLYSIL (VINYL POLYSILOXAN IMPRESSION MATERIAL) received FDA 510(k) clearance on 1995-01-11, under 510(k) number K945142.

Who is the listed applicant for POLYSIL (VINYL POLYSILOXAN IMPRESSION MATERIAL)?

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

What is the FDA product code for POLYSIL (VINYL POLYSILOXAN IMPRESSION MATERIAL)?

The FDA product code for POLYSIL (VINYL POLYSILOXAN IMPRESSION MATERIAL) is ELW.

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Other records listing Scican 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.

K062418K-SPRAY, MODEL 085-2715K021064QUANTIM 16 AUTOCLAVEK983679STATIM 5000 CASSETTE AUTOCLAVEK964691TCB TEMPORARY CROWN AND BRIDGE MATERIALK962179STAT IM 5000 CASSETTE AUTOCLAVEK944036STERIMASTER AUTOCLAVE

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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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