Cleared Traditional

BLUWHITE DIAMOND DENTAL BURS MODIFIED

K120037 · Beavers Dental, Div. Sybron Canada, Ltd. · Dental

Apr 2012

Decision

106d

Days

Class 1

Risk

About This 510(k) Submission

K120037 is an FDA 510(k) clearance for the BLUWHITE DIAMOND DENTAL BURS MODIFIED, a Instrument, Diamond, Dental (Class I — General Controls, product code DZP), submitted by Beavers Dental, Div. Sybron Canada, Ltd. (Orange, US). The FDA issued a Cleared decision on April 20, 2012, 106 days after receiving the submission on January 5, 2012. This device falls under the Dental review panel. Regulated under 21 CFR 872.4535.

Submission Details

510(k) Number	K120037 FDA.gov
FDA Decision	Cleared SESE
Date Received	January 05, 2012
Decision Date	April 20, 2012
Days to Decision	106 days
Submission Type	Traditional
Review Panel	Dental (DE)
Summary	Summary PDF