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FDA 510(k)

AUSTENAL ACUSOFT SOFT LINER

K-Number: K862557 · 1987-02-19

ApplicantAustenal Dental, Inc.
Decision Date1987-02-19
Product CodeEBI
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

AUSTENAL ACUSOFT SOFT LINER 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 1987-02-19 under 510(k) number K862557. The device is classified under product code EBI. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AUSTENAL ACUSOFT SOFT LINER?

AUSTENAL ACUSOFT SOFT LINER is a medical device that received FDA 510(k) clearance on 1987-02-19. The listed applicant is Austenal Dental, Inc.. The 510(k) number is K862557.

When did AUSTENAL ACUSOFT SOFT LINER receive FDA 510(k) clearance?

AUSTENAL ACUSOFT SOFT LINER received FDA 510(k) clearance on 1987-02-19, under 510(k) number K862557.

Who is the listed applicant for AUSTENAL ACUSOFT SOFT LINER?

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 ACUSOFT SOFT LINER?

The FDA product code for AUSTENAL ACUSOFT SOFT LINER is EBI.

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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: EBI)

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.

K261802Glidewell™ Denture Base ResinPrismatik Dentalcraft, Inc.K261626UltraPrint Flexible Denture UVGuangzhou Heygears IMC., Inc.K262681NanoCeram Resin3BFAB TEKNOLOJI A.S.K262300Denture Base Resin V2Formlabs Ohio, Inc.K261474DENTCA Tru FlexibleDentca, Inc.K260569DB 4000 High Impact Denture BaseCarbon, Inc.

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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