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FDA 510(k)

AUROFILM NP

K-Number: K003387 · 2001-01-09

ApplicantMetalor Dental USA Corp.
Decision Date2001-01-09
Product CodeEJH
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

AUROFILM NP is the device name listed in this FDA 510(k) record. The listed applicant is Metalor Dental USA Corp.. It received FDA 510(k) clearance on 2001-01-09 under 510(k) number K003387. 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 AUROFILM NP?

AUROFILM NP is a medical device that received FDA 510(k) clearance on 2001-01-09. The listed applicant is Metalor Dental USA Corp.. The 510(k) number is K003387.

When did AUROFILM NP receive FDA 510(k) clearance?

AUROFILM NP received FDA 510(k) clearance on 2001-01-09, under 510(k) number K003387.

Who is the listed applicant for AUROFILM NP?

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

What is the FDA product code for AUROFILM NP?

The FDA product code for AUROFILM NP is EJH.

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Other records listing Metalor Dental USA 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.

K993475AUROFLUID M, ALLOY NO. 5315K993506PAGALINOR 4 , ALLOY NO. 5440K993505V-DELTA SPECIAL, ALLOY NO. 5154K993507V-SUPRAGOLD, ALLOY NO. 5024K993508V-SUPRA PLUS, ALLOY NO. 5025K993474DELTAPAL, ALLOY NO. 5161

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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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