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FDA 510(k)

RHODIA HYDROPHILIC DENTAL IMPRESSION MATERIAL

K-Number: K013140 · 2001-10-10

ApplicantRhodia, Inc.
Decision Date2001-10-10
Product CodeELW
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

RHODIA HYDROPHILIC DENTAL IMPRESSION MATERIAL is the device name listed in this FDA 510(k) record. The listed applicant is Rhodia, Inc.. It received FDA 510(k) clearance on 2001-10-10 under 510(k) number K013140. 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 RHODIA HYDROPHILIC DENTAL IMPRESSION MATERIAL?

RHODIA HYDROPHILIC DENTAL IMPRESSION MATERIAL is a medical device that received FDA 510(k) clearance on 2001-10-10. The listed applicant is Rhodia, Inc.. The 510(k) number is K013140.

When did RHODIA HYDROPHILIC DENTAL IMPRESSION MATERIAL receive FDA 510(k) clearance?

RHODIA HYDROPHILIC DENTAL IMPRESSION MATERIAL received FDA 510(k) clearance on 2001-10-10, under 510(k) number K013140.

Who is the listed applicant for RHODIA HYDROPHILIC DENTAL IMPRESSION MATERIAL?

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

What is the FDA product code for RHODIA HYDROPHILIC DENTAL IMPRESSION MATERIAL?

The FDA product code for RHODIA HYDROPHILIC DENTAL IMPRESSION MATERIAL is ELW.

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Other records listing Rhodia, 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.

K013859RHODIA BITE REGISTRATION MATERIALK013129RHODIA DENTAL PUTTY IMPRESSION MATERIAL

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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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