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FDA 510(k)

SUMMAR NON-PRECIOUS, CERAMIC ALLOY

K-Number: K811013 · 1981-06-26

ApplicantShofu Dental Corp.
Decision Date1981-06-26
Product CodeEJH
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

SUMMAR NON-PRECIOUS, CERAMIC ALLOY is the device name listed in this FDA 510(k) record. The listed applicant is Shofu Dental Corp.. It received FDA 510(k) clearance on 1981-06-26 under 510(k) number K811013. 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 SUMMAR NON-PRECIOUS, CERAMIC ALLOY?

SUMMAR NON-PRECIOUS, CERAMIC ALLOY is a medical device that received FDA 510(k) clearance on 1981-06-26. The listed applicant is Shofu Dental Corp.. The 510(k) number is K811013.

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

SUMMAR NON-PRECIOUS, CERAMIC ALLOY received FDA 510(k) clearance on 1981-06-26, under 510(k) number K811013.

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

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

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

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

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Other records listing Shofu Dental Corp. 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.

K111855HY-BOND RESIGLASSK110252BEAUTIBOND MULTI PR PLUSK110235BEAUTIBOND MULTIK101603BEAUTIFIL FLOW PLUSK101621LITE ARTK093559VINTAGE MP

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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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