Cleared Traditional

DENTAL DIAMOND DRILLS

K923757 · Alpha Industrializacao DE Metais Ltda. · Dental

Mar 1993

Decision

231d

Days

Class 1

Risk

About This 510(k) Submission

K923757 is an FDA 510(k) clearance for the DENTAL DIAMOND DRILLS, a Instrument, Diamond, Dental (Class I — General Controls, product code DZP), submitted by Alpha Industrializacao DE Metais Ltda. (Taboso De Serra Brazil, BR). The FDA issued a Cleared decision on March 16, 1993, 231 days after receiving the submission on July 28, 1992. This device falls under the Dental review panel. Regulated under 21 CFR 872.4535.

Submission Details

510(k) Number	K923757 FDA.gov
FDA Decision	Cleared SESE
Date Received	July 28, 1992
Decision Date	March 16, 1993
Days to Decision	231 days
Submission Type	Traditional
Review Panel	Dental (DE)
Summary	Statement