AUROFILM 2000— 510(k) K973372

Substantially Equivalent

Metalor Dental USA Corp.

FDA 510(k) clearance K973372 for AUROFILM 2000, Substantially Equivalent on 1997-11-26. Applicant: Metalor Dental USA Corp.. Device class: 2.

Clearance details

Applicant: Metalor Dental USA Corp.
Product code: Code EJT
Device class: Class 2
Regulation: 21 CFR 872.3060
Advisory panel: Dental
Date received: 1997-09-08
Decision date: 1997-11-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: North Attleborough, MA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code EJT

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