Cleared Traditional

K924151 - BISCO D/C RESINOMER (FDA 510(k) Clearance)

K924151 · Bisco, Inc. · Dental device

Dec 1992

Decision

132d

Days

Class 2

Risk

K924151 is an FDA 510(k) clearance for the BISCO D/C RESINOMER. 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 December 28, 1992, 132 days after receiving the submission on August 18, 1992.

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

Submission Details

510(k) Number	K924151 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	August 18, 1992
Decision Date	December 28, 1992
Days to Decision	132 days
Submission Type	Traditional
Review Panel	Dental (DE)
Summary	Statement