Cleared Traditional

SEAL BLOCK PRO (NOT FINALIZED), SEAL BLOCK OTC (NOT FINALIZED)

K123653 · Bisco, Inc. · Dental

Jun 2013

Decision

188d

Days

Class 2

Risk

About This 510(k) Submission

K123653 is an FDA 510(k) clearance for the SEAL BLOCK PRO (NOT FINALIZED), SEAL BLOCK OTC (NOT FINALIZED), a Varnish, Cavity (Class II — Special Controls, product code LBH), submitted by Bisco, Inc. (Schaumburg, US). The FDA issued a Cleared decision on June 3, 2013, 188 days after receiving the submission on November 27, 2012. This device falls under the Dental review panel. Regulated under 21 CFR 872.3260.

Submission Details

510(k) Number	K123653 FDA.gov
FDA Decision	Cleared SESE
Date Received	November 27, 2012
Decision Date	June 03, 2013
Days to Decision	188 days
Submission Type	Traditional
Review Panel	Dental (DE)
Summary	Summary PDF