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FDA 510(k)

IMPREGUM PENTA DUOSOFT

K-Number: K994193 · 2000-01-28

ApplicantEspe Dental AG
Decision Date2000-01-28
Product CodeELW
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

IMPREGUM PENTA DUOSOFT is the device name listed in this FDA 510(k) record. The listed applicant is Espe Dental AG. It received FDA 510(k) clearance on 2000-01-28 under 510(k) number K994193. 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 IMPREGUM PENTA DUOSOFT?

IMPREGUM PENTA DUOSOFT is a medical device that received FDA 510(k) clearance on 2000-01-28. The listed applicant is Espe Dental AG. The 510(k) number is K994193.

When did IMPREGUM PENTA DUOSOFT receive FDA 510(k) clearance?

IMPREGUM PENTA DUOSOFT received FDA 510(k) clearance on 2000-01-28, under 510(k) number K994193.

Who is the listed applicant for IMPREGUM PENTA DUOSOFT?

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

What is the FDA product code for IMPREGUM PENTA DUOSOFT?

The FDA product code for IMPREGUM PENTA DUOSOFT is ELW.

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Other records listing Espe Dental AG 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.

K011394LAVA FRAME, LAVA FRAME SHADE, LAVA CERAMK011154ELIPAR FREELIGHTK002793KETAC CEM UK002364PROTEMP HK001494MODIFICATION TO PROMPT L-POPK000595DIMENSION PENTA L

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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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