Cleared Traditional

VERA PD SOLDER

K972632 · Aalba Dent, Inc. · Dental
Aug 1997
Decision
32d
Days
Class 2
Risk

About This 510(k) Submission

K972632 is an FDA 510(k) clearance for the VERA PD 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, 32 days after receiving the submission on July 14, 1997. This device falls under the Dental review panel. Regulated under 21 CFR 872.3060.

Submission Details

510(k) Number K972632 FDA.gov
FDA Decision Cleared SESE
Date Received July 14, 1997
Decision Date August 15, 1997
Days to Decision 32 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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