Cleared Traditional

DENTIN CONDITIONING AND ADHESIVE SYSTEM (BOND-1)

K013542 · Jeneric/Pentron, Inc. · Dental

Feb 2002

Decision

120d

Days

Class 2

Risk

About This 510(k) Submission

K013542 is an FDA 510(k) clearance for the DENTIN CONDITIONING AND ADHESIVE SYSTEM (BOND-1), 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 14, 2002, 120 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	K013542 FDA.gov
FDA Decision	Cleared SESE
Date Received	October 17, 2001
Decision Date	February 14, 2002
Days to Decision	120 days
Submission Type	Traditional
Review Panel	Dental (DE)
Summary	Summary PDF