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FDA 510(k)

MOUSSE, POLYVINYL SILOXANE IMPRESSION MATERIAL

K-Number: K905032 · 1991-03-15

ApplicantParkell
Decision Date1991-03-15
Product CodeELW
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

MOUSSE, POLYVINYL SILOXANE IMPRESSION MATERIAL is the device name listed in this FDA 510(k) record. The listed applicant is Parkell. It received FDA 510(k) clearance on 1991-03-15 under 510(k) number K905032. 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 MOUSSE, POLYVINYL SILOXANE IMPRESSION MATERIAL?

MOUSSE, POLYVINYL SILOXANE IMPRESSION MATERIAL is a medical device that received FDA 510(k) clearance on 1991-03-15. The listed applicant is Parkell. The 510(k) number is K905032.

When did MOUSSE, POLYVINYL SILOXANE IMPRESSION MATERIAL receive FDA 510(k) clearance?

MOUSSE, POLYVINYL SILOXANE IMPRESSION MATERIAL received FDA 510(k) clearance on 1991-03-15, under 510(k) number K905032.

Who is the listed applicant for MOUSSE, POLYVINYL SILOXANE IMPRESSION MATERIAL?

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

What is the FDA product code for MOUSSE, POLYVINYL SILOXANE IMPRESSION MATERIAL?

The FDA product code for MOUSSE, POLYVINYL SILOXANE IMPRESSION MATERIAL is ELW.

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Other records listing Parkell 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.

K923867METAFILK900303CONNECTK896719PRIMER-P ADHESIVE AGENTK895750HEMA-PRIMERK892003ABRAKADABRA - DENTAL ADHESIVE SYSTEMK884918PORCELAIN ETCHING GEL AND ETCHING GEL BARRIER

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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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