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FDA 510(k)

DENTURE PLASTIC TEETH

K-Number: K924526 · 1992-11-04

ApplicantAustenal, Inc.
Decision Date1992-11-04
Product CodeELM
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

DENTURE PLASTIC TEETH is the device name listed in this FDA 510(k) record. The listed applicant is Austenal, Inc.. It received FDA 510(k) clearance on 1992-11-04 under 510(k) number K924526. The device is classified under product code ELM. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DENTURE PLASTIC TEETH?

DENTURE PLASTIC TEETH is a medical device that received FDA 510(k) clearance on 1992-11-04. The listed applicant is Austenal, Inc.. The 510(k) number is K924526.

When did DENTURE PLASTIC TEETH receive FDA 510(k) clearance?

DENTURE PLASTIC TEETH received FDA 510(k) clearance on 1992-11-04, under 510(k) number K924526.

Who is the listed applicant for DENTURE PLASTIC TEETH?

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

What is the FDA product code for DENTURE PLASTIC TEETH?

The FDA product code for DENTURE PLASTIC TEETH is ELM.

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Other records listing Austenal, 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.

K011674DC - CRISTALK001799DC-TELLK001815DC ZIRKONK001798DC TITANK970522MYERSON'S ECONOMY DENTURE BASE MATERIALK970205VITALLIUM 2000 ALLOY; VITALLIUM 2000 PLUS ALLOY; COBALT CHROME CASTING ALLOY

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Related Devices (Code: ELM)

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.

K122955DENTAVIT, MONARCH, ACROTONE, SENATOR, DENTORIUMWright Health Group , Ltd.K122925NEW STETIC ARTIFICIAL TEETHNew SteticK122852PHYSIOSTAR NFCCandulor USA, Inc.K121749VERACIAShofu Dental CorporationK120404MERZ DENTAL GMBH ARTEGRAL HD PREFORMED PLASTIC DENTURE TEETHMerz Dental GmbHK120736SR PHONARES IIIvoclar Vivadent, AG

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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