Cleared Traditional

VS11 SF

K951271 · Metalor Dental USA Corp. · Dental
Jun 1995
Decision
93d
Days
Class 2
Risk

About This 510(k) Submission

K951271 is an FDA 510(k) clearance for the VS11 SF, 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 22, 1995, 93 days after receiving the submission on March 21, 1995. This device falls under the Dental review panel. Regulated under 21 CFR 872.3060.

Submission Details

510(k) Number K951271 FDA.gov
FDA Decision Cleared SESE
Date Received March 21, 1995
Decision Date June 22, 1995
Days to Decision 93 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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