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FDA 510(k)

GENIE ULTRA HYDROPHILIC IMPRESSION MATERIAL

K-Number: K030414 · 2003-04-09

ApplicantSultan Chemists, Inc.
Decision Date2003-04-09
Product CodeELW
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

GENIE ULTRA HYDROPHILIC IMPRESSION MATERIAL is the device name listed in this FDA 510(k) record. The listed applicant is Sultan Chemists, Inc.. It received FDA 510(k) clearance on 2003-04-09 under 510(k) number K030414. 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 GENIE ULTRA HYDROPHILIC IMPRESSION MATERIAL?

GENIE ULTRA HYDROPHILIC IMPRESSION MATERIAL is a medical device that received FDA 510(k) clearance on 2003-04-09. The listed applicant is Sultan Chemists, Inc.. The 510(k) number is K030414.

When did GENIE ULTRA HYDROPHILIC IMPRESSION MATERIAL receive FDA 510(k) clearance?

GENIE ULTRA HYDROPHILIC IMPRESSION MATERIAL received FDA 510(k) clearance on 2003-04-09, under 510(k) number K030414.

Who is the listed applicant for GENIE ULTRA HYDROPHILIC IMPRESSION MATERIAL?

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

What is the FDA product code for GENIE ULTRA HYDROPHILIC IMPRESSION MATERIAL?

The FDA product code for GENIE ULTRA HYDROPHILIC IMPRESSION MATERIAL is ELW.

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Other records listing Sultan Chemists, Inc. 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.

K052699VERSA-LINK PORCELAIN BONDING SYSTEMK052409SILGIMIX ALGINATE REPLACEMENT IMPRESSION MATERIALK043054GENIE MAGIC MIX ULTRA HYDROPHILIC IMPRESSION MATERIALK020612SULTAN SPOROX TEST VIAL, MODEL 75195K002843SULTAN SENSITEMP RESIN TEMPORARY CEMENT, MODEL 70010K991509PRO-PORTION CLEANER/DISINFECTANT

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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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