Cleared Traditional

PLATINUM FOIL PLATINUM MILING WAFER

K914627 · Metalor Dental USA Corp. · Dental
Nov 1991
Decision
28d
Days
Class 2
Risk

About This 510(k) Submission

K914627 is an FDA 510(k) clearance for the PLATINUM FOIL PLATINUM MILING WAFER, a Alloy, Other Noble Metal (Class II — Special Controls, product code EJS), submitted by Metalor Dental USA Corp. (Rockville Centre, US). The FDA issued a Cleared decision on November 13, 1991, 28 days after receiving the submission on October 16, 1991. This device falls under the Dental review panel. Regulated under 21 CFR 872.3060.

Submission Details

510(k) Number K914627 FDA.gov
FDA Decision Cleared SESE
Date Received October 16, 1991
Decision Date November 13, 1991
Days to Decision 28 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