Cleared Traditional

K964931 - WHITE CORE (FDA 510(k) Clearance)

K964931 · Bisco, Inc. · Dental device

Feb 1997

Decision

62d

Days

Class 2

Risk

K964931 is an FDA 510(k) clearance for the WHITE CORE. 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 February 10, 1997, 62 days after receiving the submission on December 10, 1996.

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

Submission Details

510(k) Number	K964931 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	December 10, 1996
Decision Date	February 10, 1997
Days to Decision	62 days
Submission Type	Traditional
Review Panel	Dental (DE)
Summary	Statement