Cleared Traditional

QUEST 2 AND 20

K945910 · Aalba Dent, Inc. · Dental
Dec 1994
Decision
27d
Days
Class 2
Risk

About This 510(k) Submission

K945910 is an FDA 510(k) clearance for the QUEST 2 AND 20, 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, 27 days after receiving the submission on December 2, 1994. This device falls under the Dental review panel. Regulated under 21 CFR 872.3060.

Submission Details

510(k) Number K945910 FDA.gov
FDA Decision Cleared SESE
Date Received December 02, 1994
Decision Date December 29, 1994
Days to Decision 27 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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