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FDA 510(k)

PERMADYNE POLYETHER RUBBER IMPRESSION

K-Number: K800031 · 1980-02-05

ApplicantEspe Dental Products
Decision Date1980-02-05
Product CodeELW
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

PERMADYNE POLYETHER RUBBER IMPRESSION is the device name listed in this FDA 510(k) record. The listed applicant is Espe Dental Products. It received FDA 510(k) clearance on 1980-02-05 under 510(k) number K800031. 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 PERMADYNE POLYETHER RUBBER IMPRESSION?

PERMADYNE POLYETHER RUBBER IMPRESSION is a medical device that received FDA 510(k) clearance on 1980-02-05. The listed applicant is Espe Dental Products. The 510(k) number is K800031.

When did PERMADYNE POLYETHER RUBBER IMPRESSION receive FDA 510(k) clearance?

PERMADYNE POLYETHER RUBBER IMPRESSION received FDA 510(k) clearance on 1980-02-05, under 510(k) number K800031.

Who is the listed applicant for PERMADYNE POLYETHER RUBBER IMPRESSION?

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

What is the FDA product code for PERMADYNE POLYETHER RUBBER IMPRESSION?

The FDA product code for PERMADYNE POLYETHER RUBBER IMPRESSION is ELW.

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Other records listing Espe Dental Products 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.

K810950VISIO-SEALK802819KETAC-CEM IN REF. TO K802048K802049NIMETIC-DISPERSK771901CAPMIXK771889UNIOLITEK771120IMPREFLEX ALGINATE IMPRESSION MATERIAL

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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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