Cleared Traditional

BOND-1 C & B

K013543 · Jeneric/Pentron, Inc. · Dental
Feb 2002
Decision
128d
Days
Class 2
Risk

About This 510(k) Submission

K013543 is an FDA 510(k) clearance for the BOND-1 C & B, 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 February 22, 2002, 128 days after receiving the submission on October 17, 2001. This device falls under the Dental review panel. Regulated under 21 CFR 872.3200.

Submission Details

510(k) Number K013543 FDA.gov
FDA Decision Cleared SESE
Date Received October 17, 2001
Decision Date February 22, 2002
Days to Decision 128 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