Cleared Traditional

OPULENT 76 AND 83

K945723 · Aalba Dent, Inc. · Dental
Dec 1994
Decision
38d
Days
Class 2
Risk

About This 510(k) Submission

K945723 is an FDA 510(k) clearance for the OPULENT 76 AND 83, a Alloy, Gold-based Noble Metal (Class II — Special Controls, product code EJT), submitted by Aalba Dent, Inc. (Fairfield, US). The FDA issued a Cleared decision on December 29, 1994, 38 days after receiving the submission on November 21, 1994. This device falls under the Dental review panel. Regulated under 21 CFR 872.3060.

Submission Details

510(k) Number K945723 FDA.gov
FDA Decision Cleared SESE
Date Received November 21, 1994
Decision Date December 29, 1994
Days to Decision 38 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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