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FDA 510(k)

P10 SPECIAL

K-Number: K993344 · 1999-11-15

ApplicantNorth American Alloys, Inc.
Decision Date1999-11-15
Product CodeEJH
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

P10 SPECIAL is the device name listed in this FDA 510(k) record. The listed applicant is North American Alloys, Inc.. It received FDA 510(k) clearance on 1999-11-15 under 510(k) number K993344. 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 P10 SPECIAL?

P10 SPECIAL is a medical device that received FDA 510(k) clearance on 1999-11-15. The listed applicant is North American Alloys, Inc.. The 510(k) number is K993344.

When did P10 SPECIAL receive FDA 510(k) clearance?

P10 SPECIAL received FDA 510(k) clearance on 1999-11-15, under 510(k) number K993344.

Who is the listed applicant for P10 SPECIAL?

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

What is the FDA product code for P10 SPECIAL?

The FDA product code for P10 SPECIAL 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 North American Alloys, 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.

K873661CHROME-COBALT BASE DENTAL ALLOYK862930PERFECT ONEK853845ALLOY BK853498PERFECT 10

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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