Cleared Traditional

K934247 - BISCO UNIVERSAL HYBRID COMPOSITE (FDA 510(k) Clearance)

K934247 · Bisco, Inc. · Dental device

Nov 1993

Decision

91d

Days

Class 2

Risk

K934247 is an FDA 510(k) clearance for the BISCO UNIVERSAL HYBRID 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 November 29, 1993, 91 days after receiving the submission on August 30, 1993.

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

Submission Details

510(k) Number	K934247 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	August 30, 1993
Decision Date	November 29, 1993
Days to Decision	91 days
Submission Type	Traditional
Review Panel	Dental (DE)
Summary	Statement