Cleared Traditional

K101787 - DUOLINK II (FDA 510(k) Clearance)

K101787 · Bisco, Inc. · Dental device

Oct 2010

Decision

105d

Days

Class 2

Risk

K101787 is an FDA 510(k) clearance for the DUOLINK II. This device is classified as a Cement, Dental (Class II - Special Controls, product code EMA).

Submitted by Bisco, Inc. (Schaumburg, US). The FDA issued a Cleared decision on October 8, 2010, 105 days after receiving the submission on June 25, 2010.

This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.3275.

Submission Details

510(k) Number	K101787 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	June 25, 2010
Decision Date	October 08, 2010
Days to Decision	105 days
Submission Type	Traditional
Review Panel	Dental (DE)
Summary	Summary PDF