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FDA 510(k)

PROOF ALGINATE IMPRESSION MATERIAL

K-Number: K854855 · 1986-01-30

ApplicantSybron Corp.
Decision Date1986-01-30
Product CodeELW
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

PROOF ALGINATE IMPRESSION MATERIAL is the device name listed in this FDA 510(k) record. The listed applicant is Sybron Corp.. It received FDA 510(k) clearance on 1986-01-30 under 510(k) number K854855. 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 PROOF ALGINATE IMPRESSION MATERIAL?

PROOF ALGINATE IMPRESSION MATERIAL is a medical device that received FDA 510(k) clearance on 1986-01-30. The listed applicant is Sybron Corp.. The 510(k) number is K854855.

When did PROOF ALGINATE IMPRESSION MATERIAL receive FDA 510(k) clearance?

PROOF ALGINATE IMPRESSION MATERIAL received FDA 510(k) clearance on 1986-01-30, under 510(k) number K854855.

Who is the listed applicant for PROOF ALGINATE IMPRESSION MATERIAL?

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

What is the FDA product code for PROOF ALGINATE IMPRESSION MATERIAL?

The FDA product code for PROOF ALGINATE IMPRESSION MATERIAL is ELW.

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Other records listing Sybron Corp. as applicant

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K862284SEALITEK844092DIAGNOSTIC MICROSOPCE SLIDESK842132TYCOS SELF-CHECK/DIGITAL FEVER THERMOK841910KERR SEALAPEX ROOT CANAL SEALERK841732LIEBEL-FLARSHEIM AFC 1000 X-RAY FILMK840407KERR RESIN BONDED BRIDGE CEMENT

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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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