Cleared Traditional

HIGH SILVER CONVENTIONAL

K020452 · Ab Ardent · Dental
May 2002
Decision
85d
Days
Class 2
Risk

About This 510(k) Submission

K020452 is an FDA 510(k) clearance for the HIGH SILVER CONVENTIONAL, a Alloy, Amalgam (Class II — Special Controls, product code EJJ), submitted by Ab Ardent (Tonawanda, US). The FDA issued a Cleared decision on May 7, 2002, 85 days after receiving the submission on February 11, 2002. This device falls under the Dental review panel. Regulated under 21 CFR 872.3070.

Submission Details

510(k) Number K020452 FDA.gov
FDA Decision Cleared SESE
Date Received February 11, 2002
Decision Date May 07, 2002
Days to Decision 85 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Statement

Device Classification

Product Code EJJ — Alloy, Amalgam
Device Class Class II — Special Controls
CFR Regulation 21 CFR 872.3070