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FDA 510(k)

PERFECT 10

K-Number: K853498 · 1985-09-27

ApplicantNorth American Alloys, Inc.
Decision Date1985-09-27
Product CodeEJH
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

PERFECT 10 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 1985-09-27 under 510(k) number K853498. 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 PERFECT 10?

PERFECT 10 is a medical device that received FDA 510(k) clearance on 1985-09-27. The listed applicant is North American Alloys, Inc.. The 510(k) number is K853498.

When did PERFECT 10 receive FDA 510(k) clearance?

PERFECT 10 received FDA 510(k) clearance on 1985-09-27, under 510(k) number K853498.

Who is the listed applicant for PERFECT 10?

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 PERFECT 10?

The FDA product code for PERFECT 10 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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

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.

K993344P10 SPECIALK873661CHROME-COBALT BASE DENTAL ALLOYK862930PERFECT ONEK853845ALLOY B

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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