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FDA 510(k)

R-SI-LINE METAL-BITE

K-Number: K010926 · 2001-04-12

ApplicantR-Dental Dentalerzeugnisse GmbH
Decision Date2001-04-12
Product CodeELW
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

R-SI-LINE METAL-BITE is the device name listed in this FDA 510(k) record. The listed applicant is R-Dental Dentalerzeugnisse GmbH. It received FDA 510(k) clearance on 2001-04-12 under 510(k) number K010926. 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 R-SI-LINE METAL-BITE?

R-SI-LINE METAL-BITE is a medical device that received FDA 510(k) clearance on 2001-04-12. The listed applicant is R-Dental Dentalerzeugnisse GmbH. The 510(k) number is K010926.

When did R-SI-LINE METAL-BITE receive FDA 510(k) clearance?

R-SI-LINE METAL-BITE received FDA 510(k) clearance on 2001-04-12, under 510(k) number K010926.

Who is the listed applicant for R-SI-LINE METAL-BITE?

The FDA 510(k) record lists R-Dental Dentalerzeugnisse GmbH as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for R-SI-LINE METAL-BITE?

The FDA product code for R-SI-LINE METAL-BITE is ELW.

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Other records listing R-Dental Dentalerzeugnisse GmbH 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.

K001414KWIKKMODEL

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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