Cleared Special

BISCEM TRANSLUCENT, MODEL D-45011; BISCEM OPAQUE, MODEL D-45012

K082449 · Bisco, Inc. · Dental

Sep 2008

Decision

31d

Days

Class 2

Risk

About This 510(k) Submission

K082449 is an FDA 510(k) clearance for the BISCEM TRANSLUCENT, MODEL D-45011; BISCEM OPAQUE, MODEL D-45012, a Cement, Dental (Class II — Special Controls, product code EMA), submitted by Bisco, Inc. (Schaumburg, US). The FDA issued a Cleared decision on September 25, 2008, 31 days after receiving the submission on August 25, 2008. This device falls under the Dental review panel. Regulated under 21 CFR 872.3275.

Submission Details

510(k) Number	K082449 FDA.gov
FDA Decision	Cleared SESE
Date Received	August 25, 2008
Decision Date	September 25, 2008
Days to Decision	31 days
Submission Type	Special
Review Panel	Dental (DE)
Summary	Summary PDF