Cleared Traditional

K940030 - BISCO COMPOSITE (FDA 510(k) Clearance)

K940030 · Bisco, Inc. · Dental device

Feb 1994

Decision

32d

Days

Class 2

Risk

K940030 is an FDA 510(k) clearance for the BISCO COMPOSITE. This device is classified as a Cement, Dental (Class II - Special Controls, product code EMA).

Submitted by Bisco, Inc. (Itasca, US). The FDA issued a Cleared decision on February 4, 1994, 32 days after receiving the submission on January 3, 1994.

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

Submission Details

510(k) Number	K940030 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	January 03, 1994
Decision Date	February 04, 1994
Days to Decision	32 days
Submission Type	Traditional
Review Panel	Dental (DE)
Summary	Statement