Cleared Traditional

K030951 - TESCERAFLO A2, MODEL T-21012P (FDA 510(k) Clearance)

Also includes:

TESCERAFLO A2 OPAQUE, MODEL T-210120P

K030951 · Bisco, Inc. · Dental device

Jun 2003

Decision

72d

Days

Class 2

Risk

K030951 is an FDA 510(k) clearance for the TESCERAFLO A2, MODEL T-21012P. This device is classified as a Material, Tooth Shade, Resin (Class II - Special Controls, product code EBF).

Submitted by Bisco, Inc. (Schaumburg, US). The FDA issued a Cleared decision on June 6, 2003, 72 days after receiving the submission on March 26, 2003.

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

Submission Details

510(k) Number	K030951 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	March 26, 2003
Decision Date	June 06, 2003
Days to Decision	72 days
Submission Type	Traditional
Review Panel	Dental (DE)
Summary	Summary PDF