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FDA 510(k)

AUSTENAL DENTAL COMPOSITE RESIN

K-Number: K854957 · 1986-01-30

ApplicantAustenal Dental, Inc.
Decision Date1986-01-30
Product CodeEBD
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

AUSTENAL DENTAL COMPOSITE RESIN 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 1986-01-30 under 510(k) number K854957. The device is classified under product code EBD. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AUSTENAL DENTAL COMPOSITE RESIN?

AUSTENAL DENTAL COMPOSITE RESIN is a medical device that received FDA 510(k) clearance on 1986-01-30. The listed applicant is Austenal Dental, Inc.. The 510(k) number is K854957.

When did AUSTENAL DENTAL COMPOSITE RESIN receive FDA 510(k) clearance?

AUSTENAL DENTAL COMPOSITE RESIN received FDA 510(k) clearance on 1986-01-30, under 510(k) number K854957.

Who is the listed applicant for AUSTENAL DENTAL COMPOSITE RESIN?

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 DENTAL COMPOSITE RESIN?

The FDA product code for AUSTENAL DENTAL COMPOSITE RESIN is EBD.

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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: EBD)

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.

K254091GLOSSY COAT (15ML)YAMAHACHI DENTAL MFG., Co.K250804ID LIGHT CURE SYSTEMId Korea Co., Ltd.K240735visio.lign color, visio.lign shieldBredent GmbH & Co. KGK223365RODIN Palette Naturalizing KitBelport Company, Inc., Gingi-PakK211854VITA Akzent LCVita Zahnfabrik GmbH H Rauter & COK162408Nano Varnish, Plaquit, Lightpaint on SurfaceDreve Dentamid GmbH

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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