Cleared Traditional

ARGI-SATIN OR OPTI0-STAR

K965216 · Argen Precious Metals, Inc. · Dental
Feb 1997
Decision
59d
Days
Class 2
Risk

About This 510(k) Submission

K965216 is an FDA 510(k) clearance for the ARGI-SATIN OR OPTI0-STAR, a Teeth, Porcelain (Class II — Special Controls, product code ELL), submitted by Argen Precious Metals, Inc. (San Diego, US). The FDA issued a Cleared decision on February 27, 1997, 59 days after receiving the submission on December 30, 1996. This device falls under the Dental review panel. Regulated under 21 CFR 872.3920.

Submission Details

510(k) Number K965216 FDA.gov
FDA Decision Cleared SESE
Date Received December 30, 1996
Decision Date February 27, 1997
Days to Decision 59 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Statement

Device Classification

Product Code ELL — Teeth, Porcelain
Device Class Class II — Special Controls
CFR Regulation 21 CFR 872.3920

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