Cleared Traditional

K923842 - BISCO UNIVERSAL BOND-3 (FDA 510(k) Clearance)

K923842 · Bisco, Inc. · Dental device

Sep 1992

Decision

60d

Days

Class 2

Risk

K923842 is an FDA 510(k) clearance for the BISCO UNIVERSAL BOND-3. This device is classified as a Agent, Tooth Bonding, Resin (Class II - Special Controls, product code KLE).

Submitted by Bisco, Inc. (Itasca, US). The FDA issued a Cleared decision on September 29, 1992, 60 days after receiving the submission on July 31, 1992.

This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.3200.

Submission Details

510(k) Number	K923842 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	July 31, 1992
Decision Date	September 29, 1992
Days to Decision	60 days
Submission Type	Traditional
Review Panel	Dental (DE)
Summary	Statement