Cleared Traditional

VS 1A

K933563 · Metalor Dental USA Corp. · Dental
Oct 1993
Decision
90d
Days
Class 2
Risk

About This 510(k) Submission

K933563 is an FDA 510(k) clearance for the VS 1A, 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 October 20, 1993, 90 days after receiving the submission on July 22, 1993. This device falls under the Dental review panel. Regulated under 21 CFR 872.3060.

Submission Details

510(k) Number K933563 FDA.gov
FDA Decision Cleared SESE
Date Received July 22, 1993
Decision Date October 20, 1993
Days to Decision 90 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