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FDA 510(k)

ULTRACAST

K-Number: K862499 · 1986-08-18

ApplicantUltratek
Decision Date1986-08-18
Product CodeEJH
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

ULTRACAST is the device name listed in this FDA 510(k) record. The listed applicant is Ultratek. It received FDA 510(k) clearance on 1986-08-18 under 510(k) number K862499. 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 ULTRACAST?

ULTRACAST is a medical device that received FDA 510(k) clearance on 1986-08-18. The listed applicant is Ultratek. The 510(k) number is K862499.

When did ULTRACAST receive FDA 510(k) clearance?

ULTRACAST received FDA 510(k) clearance on 1986-08-18, under 510(k) number K862499.

Who is the listed applicant for ULTRACAST?

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

What is the FDA product code for ULTRACAST?

The FDA product code for ULTRACAST is EJH.

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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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