Cleared Traditional

ANEST-EZE DENTAL DRILL RA#2

K896149 · Signature One Products, Inc. · Dental

Jan 1990

Decision

88d

Days

Class 1

Risk

About This 510(k) Submission

K896149 is an FDA 510(k) clearance for the ANEST-EZE DENTAL DRILL RA#2, a Drill, Dental, Intraoral (Class I — General Controls, product code DZA), submitted by Signature One Products, Inc. (Boca Raton, US). The FDA issued a Cleared decision on January 19, 1990, 88 days after receiving the submission on October 23, 1989. This device falls under the Dental review panel. Regulated under 21 CFR 872.4130.

Submission Details

510(k) Number	K896149 FDA.gov
FDA Decision	Cleared SESE
Date Received	October 23, 1989
Decision Date	January 19, 1990
Days to Decision	88 days
Submission Type	Traditional
Review Panel	Dental (DE)
Summary	—