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FDA 510(k)

AUSTENAL HYCO ALGINATE IMPRESSION MATERIAL

K-Number: K860911 · 1986-03-26

ApplicantAustenal Dental, Inc.
Decision Date1986-03-26
Product CodeELW
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

AUSTENAL HYCO ALGINATE IMPRESSION MATERIAL is the device name listed in this FDA 510(k) record. The listed applicant is Austenal Dental, Inc.. It received FDA 510(k) clearance on 1986-03-26 under 510(k) number K860911. 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 AUSTENAL HYCO ALGINATE IMPRESSION MATERIAL?

AUSTENAL HYCO ALGINATE IMPRESSION MATERIAL is a medical device that received FDA 510(k) clearance on 1986-03-26. The listed applicant is Austenal Dental, Inc.. The 510(k) number is K860911.

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

AUSTENAL HYCO ALGINATE IMPRESSION MATERIAL received FDA 510(k) clearance on 1986-03-26, under 510(k) number K860911.

Who is the listed applicant for AUSTENAL HYCO ALGINATE IMPRESSION MATERIAL?

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

What is the FDA product code for AUSTENAL HYCO ALGINATE IMPRESSION MATERIAL?

The FDA product code for AUSTENAL HYCO ALGINATE IMPRESSION MATERIAL is ELW.

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Other records listing Austenal Dental, 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.

K890713OVERDENTURE - STUD ATTACHMENTK883799BASE, DENTURE, RELINING, REPAIRING, REBASING,RESINK880875VITALLIUM EQUIPOISE ALLOYK871849LIGHT CURE DENTURE GLAZEK872746VITALLIUM WIREK863630AUSTENAL ACUPAC 20 DENTURE BASE MATERIAL

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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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