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FDA 510(k)

AUSTENAL CONDENSING INSTRUMENT

K-Number: K865025 · 1987-02-19

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

Device Summary

AUSTENAL CONDENSING INSTRUMENT 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 K865025. The device is classified under product code EKG. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AUSTENAL CONDENSING INSTRUMENT?

AUSTENAL CONDENSING INSTRUMENT 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 K865025.

When did AUSTENAL CONDENSING INSTRUMENT receive FDA 510(k) clearance?

AUSTENAL CONDENSING INSTRUMENT received FDA 510(k) clearance on 1987-02-19, under 510(k) number K865025.

Who is the listed applicant for AUSTENAL CONDENSING INSTRUMENT?

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 CONDENSING INSTRUMENT?

The FDA product code for AUSTENAL CONDENSING INSTRUMENT is EKG.

Related Clinical Trials

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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

View all 19 devices →

Related Devices (Code: EKG)

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.

K843901ISOSTATIC CONDENSERShofu Dental Corp.K823322DENTAL INSTRUMENTS - PLUGGERSMiltex, 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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