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FDA 510(k)

BONASIL A+ IMPRESSION MATERIALS

K-Number: K102836 · 2011-01-13

ApplicantDmp, Ltd.
Decision Date2011-01-13
Product CodeELW
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

BONASIL A+ IMPRESSION MATERIALS is the device name listed in this FDA 510(k) record. The listed applicant is Dmp, Ltd.. It received FDA 510(k) clearance on 2011-01-13 under 510(k) number K102836. 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 BONASIL A+ IMPRESSION MATERIALS?

BONASIL A+ IMPRESSION MATERIALS is a medical device that received FDA 510(k) clearance on 2011-01-13. The listed applicant is Dmp, Ltd.. The 510(k) number is K102836.

When did BONASIL A+ IMPRESSION MATERIALS receive FDA 510(k) clearance?

BONASIL A+ IMPRESSION MATERIALS received FDA 510(k) clearance on 2011-01-13, under 510(k) number K102836.

Who is the listed applicant for BONASIL A+ IMPRESSION MATERIALS?

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

What is the FDA product code for BONASIL A+ IMPRESSION MATERIALS?

The FDA product code for BONASIL A+ IMPRESSION MATERIALS is ELW.

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Other records listing Dmp, Ltd. 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.

K121915BRIGHT RESTORATIVE MATERIALSK102252DMP PIT & FISSURE SEALANTK102255DMP ETCHING GELK102254DMP SINGLE BONDINGK102257NANOCERAM- BRIGHT

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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