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FDA 510(k)

IMPREGUM GARANT L DUOSOFT

K-Number: K994190 · 2000-01-27

ApplicantEspe Dental AG
Decision Date2000-01-27
Product CodeELW
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

IMPREGUM GARANT L 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 2000-01-27 under 510(k) number K994190. 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 GARANT L DUOSOFT?

IMPREGUM GARANT L DUOSOFT is a medical device that received FDA 510(k) clearance on 2000-01-27. The listed applicant is Espe Dental AG. The 510(k) number is K994190.

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

IMPREGUM GARANT L DUOSOFT received FDA 510(k) clearance on 2000-01-27, under 510(k) number K994190.

Who is the listed applicant for IMPREGUM GARANT L 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 GARANT L DUOSOFT?

The FDA product code for IMPREGUM GARANT L 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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