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FDA 510(k)

PLASTALGIN AND PLASTALGIN ORTHO

K-Number: K032708 · 2003-11-20

ApplicantSeptodont
Decision Date2003-11-20
Product CodeELW
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

PLASTALGIN AND PLASTALGIN ORTHO is the device name listed in this FDA 510(k) record. The listed applicant is Septodont. It received FDA 510(k) clearance on 2003-11-20 under 510(k) number K032708. 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 PLASTALGIN AND PLASTALGIN ORTHO?

PLASTALGIN AND PLASTALGIN ORTHO is a medical device that received FDA 510(k) clearance on 2003-11-20. The listed applicant is Septodont. The 510(k) number is K032708.

When did PLASTALGIN AND PLASTALGIN ORTHO receive FDA 510(k) clearance?

PLASTALGIN AND PLASTALGIN ORTHO received FDA 510(k) clearance on 2003-11-20, under 510(k) number K032708.

Who is the listed applicant for PLASTALGIN AND PLASTALGIN ORTHO?

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

What is the FDA product code for PLASTALGIN AND PLASTALGIN ORTHO?

The FDA product code for PLASTALGIN AND PLASTALGIN ORTHO is ELW.

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Other records listing Septodont as applicant

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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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