Cleared Traditional

K032597 - BISCEM GI (FDA 510(k) Clearance)

K032597 · Bisco, Inc. · Dental device

Nov 2003

Decision

74d

Days

Class 2

Risk

K032597 is an FDA 510(k) clearance for the BISCEM GI. This device is classified as a Cement, Dental (Class II - Special Controls, product code EMA).

Submitted by Bisco, Inc. (Schaumburg, US). The FDA issued a Cleared decision on November 4, 2003, 74 days after receiving the submission on August 22, 2003.

This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.3275.

Submission Details

510(k) Number	K032597 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	August 22, 2003
Decision Date	November 04, 2003
Days to Decision	74 days
Submission Type	Traditional
Review Panel	Dental (DE)
Summary	Summary PDF