Cleared Traditional

VS1 PLUS

K952499 · Metalor Dental USA Corp. · Dental
Jun 1995
Decision
17d
Days
Class 2
Risk

About This 510(k) Submission

K952499 is an FDA 510(k) clearance for the VS1 PLUS, a Alloy, Gold-based Noble Metal (Class II — Special Controls, product code EJT), submitted by Metalor Dental USA Corp. (Rockville Centre, US). The FDA issued a Cleared decision on June 16, 1995, 17 days after receiving the submission on May 30, 1995. This device falls under the Dental review panel. Regulated under 21 CFR 872.3060.

Submission Details

510(k) Number K952499 FDA.gov
FDA Decision Cleared SESE
Date Received May 30, 1995
Decision Date June 16, 1995
Days to Decision 17 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Statement

Device Classification

Product Code EJT — Alloy, Gold-based Noble Metal
Device Class Class II — Special Controls
CFR Regulation 21 CFR 872.3060

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