Cleared Traditional

K003361 - RENEW LS-2 (FDA 510(k) Clearance)

K003361 · Bisco, Inc. · Dental device

Nov 2000

Decision

32d

Days

Class 2

Risk

K003361 is an FDA 510(k) clearance for the RENEW LS-2. 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 November 28, 2000, 32 days after receiving the submission on October 27, 2000.

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

Submission Details

510(k) Number	K003361 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	October 27, 2000
Decision Date	November 28, 2000
Days to Decision	32 days
Submission Type	Traditional
Review Panel	Dental (DE)
Summary	Summary PDF