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FDA 510(k)

AUSTRY ALLOY(DENTAL BAKE-ON ALLOY)

K-Number: K800994 · 1980-05-02

ApplicantHowmedica Corp.
Decision Date1980-05-02
Product CodeEJS
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

AUSTRY ALLOY(DENTAL BAKE-ON ALLOY) is the device name listed in this FDA 510(k) record. The listed applicant is Howmedica Corp.. It received FDA 510(k) clearance on 1980-05-02 under 510(k) number K800994. The device is classified under product code EJS. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AUSTRY ALLOY(DENTAL BAKE-ON ALLOY)?

AUSTRY ALLOY(DENTAL BAKE-ON ALLOY) is a medical device that received FDA 510(k) clearance on 1980-05-02. The listed applicant is Howmedica Corp.. The 510(k) number is K800994.

When did AUSTRY ALLOY(DENTAL BAKE-ON ALLOY) receive FDA 510(k) clearance?

AUSTRY ALLOY(DENTAL BAKE-ON ALLOY) received FDA 510(k) clearance on 1980-05-02, under 510(k) number K800994.

Who is the listed applicant for AUSTRY ALLOY(DENTAL BAKE-ON ALLOY)?

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

What is the FDA product code for AUSTRY ALLOY(DENTAL BAKE-ON ALLOY)?

The FDA product code for AUSTRY ALLOY(DENTAL BAKE-ON ALLOY) is EJS.

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Other records listing Howmedica Corp. as applicant

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K983528MICRO DYNAMIC MESHK983404TYPE 3 FEMORAL COMPONENTSK980926DURATION II ACETABULAR COMPONENTS-ETHYLENE OXIDE STERILIZATIONK980925DURATION II TIBIAL INSERTS-ETHYLENE OXIDE STERILIZATIONK980626DURATION II ACETABULAR COMPONENTS-GAS PLASMA STERILIZATIONK980632DURATION II TIBIAL INSERTS - GAS PLASMA STERILIZATION

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Related Devices (Code: EJS)

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.

K041433BRIGHT GOLD XHIvoclar Vivadent, Inc.K040436SIMIDUR SUPERIORWieland Dental + Technik GmbH & Co. KGK022252STERNGOLD 1, MODEL 1127781SterngoldK022469ECO E4Wieland Dental + Technik GmbH & Co. KGK021367STERNGOLD 66, MODEL #1180230SterngoldK020195SIMIDUR S1SWieland Dental + Technik GmbH & Co. KG

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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