Cleared Traditional

All-Bond Universal w/BAC (not finalized)

K161051 · Bisco, Inc. · Dental

Sep 2016

Decision

148d

Days

Class 2

Risk

About This 510(k) Submission

K161051 is an FDA 510(k) clearance for the All-Bond Universal w/BAC (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 September 9, 2016, 148 days after receiving the submission on April 14, 2016. This device falls under the Dental review panel. Regulated under 21 CFR 872.3200.

Submission Details

510(k) Number	K161051 FDA.gov
FDA Decision	Cleared SESE
Date Received	April 14, 2016
Decision Date	September 09, 2016
Days to Decision	148 days
Submission Type	Traditional
Review Panel	Dental (DE)
Summary	Summary PDF