Cleared Traditional

MICROHYBRID 12

K022974 · Ab Ardent · Dental
Nov 2002
Decision
77d
Days
Class 2
Risk

About This 510(k) Submission

K022974 is an FDA 510(k) clearance for the MICROHYBRID 12, a Material, Tooth Shade, Resin (Class II — Special Controls, product code EBF), submitted by Ab Ardent (Tonawanda, US). The FDA issued a Cleared decision on November 22, 2002, 77 days after receiving the submission on September 6, 2002. This device falls under the Dental review panel. Regulated under 21 CFR 872.3690.

Submission Details

510(k) Number K022974 FDA.gov
FDA Decision Cleared SESE
Date Received September 06, 2002
Decision Date November 22, 2002
Days to Decision 77 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Statement

Device Classification

Product Code EBF — Material, Tooth Shade, Resin
Device Class Class II — Special Controls
CFR Regulation 21 CFR 872.3690