Cleared Traditional

MICROHYBRID 11

K022971 · Ab Ardent · Dental
Nov 2002
Decision
80d
Days
Class 2
Risk

About This 510(k) Submission

K022971 is an FDA 510(k) clearance for the MICROHYBRID 11, 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 25, 2002, 80 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 K022971 FDA.gov
FDA Decision Cleared SESE
Date Received September 06, 2002
Decision Date November 25, 2002
Days to Decision 80 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