Cleared Traditional

BOND-3 ADHESIVE

K020499 · Jeneric/Pentron, Inc. · Dental
Apr 2002
Decision
67d
Days
Class 2
Risk

About This 510(k) Submission

K020499 is an FDA 510(k) clearance for the BOND-3 ADHESIVE, a Agent, Tooth Bonding, Resin (Class II — Special Controls, product code KLE), submitted by Jeneric/Pentron, Inc. (Wallingford, US). The FDA issued a Cleared decision on April 22, 2002, 67 days after receiving the submission on February 14, 2002. This device falls under the Dental review panel. Regulated under 21 CFR 872.3200.

Submission Details

510(k) Number K020499 FDA.gov
FDA Decision Cleared SESE
Date Received February 14, 2002
Decision Date April 22, 2002
Days to Decision 67 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF

Device Classification

Product Code KLE — Agent, Tooth Bonding, Resin
Device Class Class II — Special Controls
CFR Regulation 21 CFR 872.3200