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FDA 510(k)

OVERDENTURE - STUD ATTACHMENT

K-Number: K890713 · 1989-07-14

ApplicantAustenal Dental, Inc.
Decision Date1989-07-14
Product CodeDZE
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

OVERDENTURE - STUD ATTACHMENT 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 1989-07-14 under 510(k) number K890713. The device is classified under product code DZE. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the OVERDENTURE - STUD ATTACHMENT?

OVERDENTURE - STUD ATTACHMENT is a medical device that received FDA 510(k) clearance on 1989-07-14. The listed applicant is Austenal Dental, Inc.. The 510(k) number is K890713.

When did OVERDENTURE - STUD ATTACHMENT receive FDA 510(k) clearance?

OVERDENTURE - STUD ATTACHMENT received FDA 510(k) clearance on 1989-07-14, under 510(k) number K890713.

Who is the listed applicant for OVERDENTURE - STUD ATTACHMENT?

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 OVERDENTURE - STUD ATTACHMENT?

The FDA product code for OVERDENTURE - STUD ATTACHMENT is DZE.

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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.

K883799BASE, DENTURE, RELINING, REPAIRING, REBASING,RESINK880875VITALLIUM EQUIPOISE ALLOYK871849LIGHT CURE DENTURE GLAZEK872746VITALLIUM WIREK863630AUSTENAL ACUPAC 20 DENTURE BASE MATERIALK862557AUSTENAL ACUSOFT SOFT LINER

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Related Devices (Code: DZE)

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.

K261392TriActive Dental Implant SystemParagon Implant Mfg., LLCK260463ZEROS Dental Implant SystemZeros Co., Ltd.K251188UNIQA® Dental Implants SystemUniqa Dental, Ltd.K251232MegaGen Zygoma Dental Implant SystemMegagen Implant Co., Ltd.K250806Dental Implant SystemA.B. Dental Devices , Ltd.K260006INOSS SystemInosys, 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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