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FDA 510(k)

DURABOND NON-PRECIOUS CERAMIC ALLOY

K-Number: K010069 · 2001-02-15

ApplicantMatech, Inc.
Decision Date2001-02-15
Product CodeEJH
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

DURABOND NON-PRECIOUS CERAMIC ALLOY is the device name listed in this FDA 510(k) record. The listed applicant is Matech, Inc.. It received FDA 510(k) clearance on 2001-02-15 under 510(k) number K010069. 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 DURABOND NON-PRECIOUS CERAMIC ALLOY?

DURABOND NON-PRECIOUS CERAMIC ALLOY is a medical device that received FDA 510(k) clearance on 2001-02-15. The listed applicant is Matech, Inc.. The 510(k) number is K010069.

When did DURABOND NON-PRECIOUS CERAMIC ALLOY receive FDA 510(k) clearance?

DURABOND NON-PRECIOUS CERAMIC ALLOY received FDA 510(k) clearance on 2001-02-15, under 510(k) number K010069.

Who is the listed applicant for DURABOND NON-PRECIOUS CERAMIC ALLOY?

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

What is the FDA product code for DURABOND NON-PRECIOUS CERAMIC ALLOY?

The FDA product code for DURABOND NON-PRECIOUS CERAMIC ALLOY is EJH.

Related Clinical Trials

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.

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Other records listing Matech, 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.

K993572CERADIUM V NON-PRECIOUS CERAMIC ALLOYK992881HI BOND NON-PRECIOUS CERAMIC ALLOYK992705CERADIUM NON-PRECIOUS CERAMIC ALLOYK974894KROMATICA COLOR CHANGING ALGINATEK925746REPLICA

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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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