Cleared Traditional

K080687 - SMARTBURS
(FDA 510(k) Clearance)

K080687 · S.S. White Burs, Inc. · Dental device

Jun 2008

Decision

101d

Days

Class 1

Risk

K080687 is an FDA 510(k) clearance for the SMARTBURS. This device is classified as a Bur, Dental (Class I - General Controls, product code EJL).

Submitted by S.S. White Burs, Inc. (Lakewood, US). The FDA issued a Cleared decision on June 20, 2008, 101 days after receiving the submission on March 11, 2008.

This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.3240.

Submission Details

510(k) Number	K080687 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	March 11, 2008
Decision Date	June 20, 2008
Days to Decision	101 days
Submission Type	Traditional
Review Panel	Dental (DE)
Summary	Statement