Cleared Traditional

AUROFLUID M, ALLOY NO. 5315

K993475 · Metalor Dental USA Corp. · Dental
Dec 1999
Decision
56d
Days
Class 2
Risk

About This 510(k) Submission

K993475 is an FDA 510(k) clearance for the AUROFLUID M, ALLOY NO. 5315, a Alloy, Other Noble Metal (Class II — Special Controls, product code EJS), submitted by Metalor Dental USA Corp. (North Attleborough, US). The FDA issued a Cleared decision on December 9, 1999, 56 days after receiving the submission on October 14, 1999. This device falls under the Dental review panel. Regulated under 21 CFR 872.3060.

Submission Details

510(k) Number K993475 FDA.gov
FDA Decision Cleared SESE
Date Received October 14, 1999
Decision Date December 09, 1999
Days to Decision 56 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Statement

Device Classification

Product Code EJS — Alloy, Other Noble Metal
Device Class Class II — Special Controls
CFR Regulation 21 CFR 872.3060