AUROFILM NP— 510(k) K003387

Substantially Equivalent

Metalor Dental USA Corp.

FDA 510(k) clearance K003387 for AUROFILM NP, Substantially Equivalent on 2001-01-09. Applicant: Metalor Dental USA Corp.. Device class: 2.

Clearance details

Applicant: Metalor Dental USA Corp.
Product code: Code EJH
Device class: Class 2
Regulation: 21 CFR 872.3710
Advisory panel: Dental
Date received: 2000-10-31
Decision date: 2001-01-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: North Attleborough, MA, US

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.