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FDA 510(k)

A-SP ALLOY (SILVER-PALLADIUM CROWN & BRIDGE ALLOY)

K-Number: K864826 · 1987-02-10

ApplicantAustenal Dental, Inc.
Decision Date1987-02-10
Product CodeEJH
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

A-SP ALLOY (SILVER-PALLADIUM CROWN & BRIDGE ALLOY) 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 1987-02-10 under 510(k) number K864826. The device is classified under product code EJH. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the A-SP ALLOY (SILVER-PALLADIUM CROWN & BRIDGE ALLOY)?

A-SP ALLOY (SILVER-PALLADIUM CROWN & BRIDGE ALLOY) is a medical device that received FDA 510(k) clearance on 1987-02-10. The listed applicant is Austenal Dental, Inc.. The 510(k) number is K864826.

When did A-SP ALLOY (SILVER-PALLADIUM CROWN & BRIDGE ALLOY) receive FDA 510(k) clearance?

A-SP ALLOY (SILVER-PALLADIUM CROWN & BRIDGE ALLOY) received FDA 510(k) clearance on 1987-02-10, under 510(k) number K864826.

Who is the listed applicant for A-SP ALLOY (SILVER-PALLADIUM CROWN & BRIDGE ALLOY)?

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 A-SP ALLOY (SILVER-PALLADIUM CROWN & BRIDGE ALLOY)?

The FDA product code for A-SP ALLOY (SILVER-PALLADIUM CROWN & BRIDGE ALLOY) is EJH.

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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: EJH)

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.

K123929BEGOPAL+Bego Bremer Goldschlaegerei Wilh. Herbst GmbH & COK040180CONTINUM VAalba Dent, Inc.K040179CONTINUMAalba Dent, Inc.K033356VERASOFT ESAalba Dent, Inc.K033045DREAM BOND, DREAMCAST CHROME, DREAMCAST V, DREAM FLEXICAST, DREAM LITHECASTAmerican Green Dent. Mfg, Inc.K032136WIROBOND CBego U.S.A.

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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