Cleared Traditional

DUNHALL/OMNII INTERNATIONAL ROTARY DIAMOND BURS

K940908 · Dunhall Pharmaceuticals, Inc. · Dental

Aug 1994

Decision

186d

Days

Class 1

Risk

About This 510(k) Submission

K940908 is an FDA 510(k) clearance for the DUNHALL/OMNII INTERNATIONAL ROTARY DIAMOND BURS, a Instrument, Diamond, Dental (Class I — General Controls, product code DZP), submitted by Dunhall Pharmaceuticals, Inc. (Gravette, US). The FDA issued a Cleared decision on August 29, 1994, 186 days after receiving the submission on February 24, 1994. This device falls under the Dental review panel. Regulated under 21 CFR 872.4535.

Submission Details

510(k) Number	K940908 FDA.gov
FDA Decision	Cleared SESE
Date Received	February 24, 1994
Decision Date	August 29, 1994
Days to Decision	186 days
Submission Type	Traditional
Review Panel	Dental (DE)
Summary	Statement