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FDA 510(k)

HYDROGUM

K-Number: K935898 · 1995-08-22

ApplicantZhermack Dental Production
Decision Date1995-08-22
Product CodeELW
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

HYDROGUM is the device name listed in this FDA 510(k) record. The listed applicant is Zhermack Dental Production. It received FDA 510(k) clearance on 1995-08-22 under 510(k) number K935898. 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 HYDROGUM?

HYDROGUM is a medical device that received FDA 510(k) clearance on 1995-08-22. The listed applicant is Zhermack Dental Production. The 510(k) number is K935898.

When did HYDROGUM receive FDA 510(k) clearance?

HYDROGUM received FDA 510(k) clearance on 1995-08-22, under 510(k) number K935898.

Who is the listed applicant for HYDROGUM?

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

What is the FDA product code for HYDROGUM?

The FDA product code for HYDROGUM is ELW.

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Other records listing Zhermack Dental Production 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.

K935892INDURENT GELK935890ZETAPLUS (PUTTY)K935896THIXOFLEXK935885ELITE FAST PUTTY SOFTK935889OCCLUFASTK935884ELITE PUTTY SOFT

View all 11 devices →

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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