Cleared Traditional

K934596 - BISCO DUO LINK D/C LUTING COMPOSITE (FDA 510(k) Clearance)

K934596 · Bisco, Inc. · Dental device

Jan 1994

Decision

124d

Days

Class 2

Risk

K934596 is an FDA 510(k) clearance for the BISCO DUO LINK D/C LUTING COMPOSITE. This device is classified as a Agent, Tooth Bonding, Resin (Class II - Special Controls, product code KLE).

Submitted by Bisco, Inc. (Itasca, US). The FDA issued a Cleared decision on January 26, 1994, 124 days after receiving the submission on September 24, 1993.

This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.3200.

Submission Details

510(k) Number	K934596 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	September 24, 1993
Decision Date	January 26, 1994
Days to Decision	124 days
Submission Type	Traditional
Review Panel	Dental (DE)
Summary	Statement