Cleared Traditional

ALL-BOND UNIVERSAL SC (NOT FINALIZED)

K131734 · Bisco, Inc. · Dental

Apr 2014

Decision

302d

Days

Class 2

Risk

About This 510(k) Submission

K131734 is an FDA 510(k) clearance for the ALL-BOND UNIVERSAL SC (NOT FINALIZED), a Agent, Tooth Bonding, Resin (Class II — Special Controls, product code KLE), submitted by Bisco, Inc. (Schaumburg, US). The FDA issued a Cleared decision on April 11, 2014, 302 days after receiving the submission on June 13, 2013. This device falls under the Dental review panel. Regulated under 21 CFR 872.3200.

Submission Details

510(k) Number	K131734 FDA.gov
FDA Decision	Cleared SESE
Date Received	June 13, 2013
Decision Date	April 11, 2014
Days to Decision	302 days
Submission Type	Traditional
Review Panel	Dental (DE)
Summary	Summary PDF