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FDA 510(k)

CRYSTALLOY-P

K-Number: K810594 · 1981-03-24

ApplicantShofu Dental Corp.
Decision Date1981-03-24
Product CodeEJH
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

CRYSTALLOY-P 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 1981-03-24 under 510(k) number K810594. 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 CRYSTALLOY-P?

CRYSTALLOY-P is a medical device that received FDA 510(k) clearance on 1981-03-24. The listed applicant is Shofu Dental Corp.. The 510(k) number is K810594.

When did CRYSTALLOY-P receive FDA 510(k) clearance?

CRYSTALLOY-P received FDA 510(k) clearance on 1981-03-24, under 510(k) number K810594.

Who is the listed applicant for CRYSTALLOY-P?

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 CRYSTALLOY-P?

The FDA product code for CRYSTALLOY-P 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.

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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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