Cleared Traditional

AALBA GOLD SOLDER

K972532 · Aalba Dent, Inc. · Dental
Aug 1997
Decision
39d
Days
Class 2
Risk

About This 510(k) Submission

K972532 is an FDA 510(k) clearance for the AALBA GOLD SOLDER, 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 August 15, 1997, 39 days after receiving the submission on July 7, 1997. This device falls under the Dental review panel. Regulated under 21 CFR 872.3060.

Submission Details

510(k) Number K972532 FDA.gov
FDA Decision Cleared SESE
Date Received July 07, 1997
Decision Date August 15, 1997
Days to Decision 39 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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