Cleared Traditional

STABIDENT LOCAL ANESTHESIA SYSTEM

K910446 · Fairfax Dental, Inc. · Dental

Jun 1991

Decision

140d

Days

Class 1

Risk

About This 510(k) Submission

K910446 is an FDA 510(k) clearance for the STABIDENT LOCAL ANESTHESIA SYSTEM, a Needle, Dental (Class I — General Controls, product code DZM), submitted by Fairfax Dental, Inc. (Miami, US). The FDA issued a Cleared decision on June 3, 1991, 140 days after receiving the submission on January 14, 1991. This device falls under the Dental review panel. Regulated under 21 CFR 872.4730.

Submission Details

510(k) Number	K910446 FDA.gov
FDA Decision	Cleared SESE
Date Received	January 14, 1991
Decision Date	June 03, 1991
Days to Decision	140 days
Submission Type	Traditional
Review Panel	Dental (DE)
Summary	—