Cleared Traditional

K915668 - BISCO CAVITY CLEANSER (FDA 510(k) Clearance)

K915668 · Bisco, Inc. · Dental device

Apr 1992

Decision

125d

Days

Class 2

Risk

K915668 is an FDA 510(k) clearance for the BISCO CAVITY CLEANSER. This device is classified as a Material, Tooth Shade, Resin (Class II - Special Controls, product code EBF).

Submitted by Bisco, Inc. (Itasca, US). The FDA issued a Cleared decision on April 21, 1992, 125 days after receiving the submission on December 18, 1991.

This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.3690.

Submission Details

510(k) Number	K915668 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	December 18, 1991
Decision Date	April 21, 1992
Days to Decision	125 days
Submission Type	Traditional
Review Panel	Dental (DE)
Summary	Statement