Cleared Traditional

DUOLINK II

K101787 · Bisco, Inc. · Dental
Oct 2010
Decision
105d
Days
Class 2
Risk

About This 510(k) Submission

K101787 is an FDA 510(k) clearance for the DUOLINK II, 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 review panel. Regulated under 21 CFR 872.3275.

Submission Details

510(k) Number K101787 FDA.gov
FDA Decision Cleared 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

Device Classification

Product Code EMA — Cement, Dental
Device Class Class II — Special Controls
CFR Regulation 21 CFR 872.3275