Cleared Traditional

K930405 - BISCO D/C CORE COMPOSITE (FDA 510(k) Clearance)

K930405 · Bisco, Inc. · Dental device

Aug 1993

Decision

210d

Days

Class 2

Risk

K930405 is an FDA 510(k) clearance for the BISCO D/C CORE COMPOSITE. 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 August 24, 1993, 210 days after receiving the submission on January 26, 1993.

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

Submission Details

510(k) Number	K930405 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	January 26, 1993
Decision Date	August 24, 1993
Days to Decision	210 days
Submission Type	Traditional
Review Panel	Dental (DE)
Summary	Statement