Cleared Traditional

K003317 - RENEW LS-1 (FDA 510(k) Clearance)

K003317 · Bisco, Inc. · Dental device

Nov 2000

Decision

28d

Days

Class 2

Risk

K003317 is an FDA 510(k) clearance for the RENEW LS-1. 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 21, 2000, 28 days after receiving the submission on October 24, 2000.

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

Submission Details

510(k) Number	K003317 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	October 24, 2000
Decision Date	November 21, 2000
Days to Decision	28 days
Submission Type	Traditional
Review Panel	Dental (DE)
Summary	Summary PDF