Cleared Traditional

AUROFILM NP

K003387 · Metalor Dental USA Corp. · Dental
Jan 2001
Decision
70d
Days
Class 2
Risk

About This 510(k) Submission

K003387 is an FDA 510(k) clearance for the AUROFILM NP, a Alloy, Metal, Base (Class II — Special Controls, product code EJH), submitted by Metalor Dental USA Corp. (North Attleborough, US). The FDA issued a Cleared decision on January 9, 2001, 70 days after receiving the submission on October 31, 2000. This device falls under the Dental review panel. Regulated under 21 CFR 872.3710.

Submission Details

510(k) Number K003387 FDA.gov
FDA Decision Cleared SESE
Date Received October 31, 2000
Decision Date January 09, 2001
Days to Decision 70 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Statement

Device Classification

Product Code EJH — Alloy, Metal, Base
Device Class Class II — Special Controls
CFR Regulation 21 CFR 872.3710