Cleared Traditional

ASEPTIC DENTAL TECH. TOTAL TREATMENT SYSTEM

K914562 · Aseptic Dental Technologies, Inc. · Dental

Mar 1992

Decision

146d

Days

Class 1

Risk

About This 510(k) Submission

K914562 is an FDA 510(k) clearance for the ASEPTIC DENTAL TECH. TOTAL TREATMENT SYSTEM, a Needle, Dental (Class I — General Controls, product code DZM), submitted by Aseptic Dental Technologies, Inc. (Arlington Heights, US). The FDA issued a Cleared decision on March 9, 1992, 146 days after receiving the submission on October 15, 1991. This device falls under the Dental review panel. Regulated under 21 CFR 872.4730.

Submission Details

510(k) Number	K914562 FDA.gov
FDA Decision	Cleared SESE
Date Received	October 15, 1991
Decision Date	March 09, 1992
Days to Decision	146 days
Submission Type	Traditional
Review Panel	Dental (DE)
Summary	Summary PDF