Cleared Traditional

K910446 - STABIDENT LOCAL ANESTHESIA SYSTEM

K910446 is an FDA 510(k) clearance for STABIDENT LOCAL ANESTHESIA SYSTEM, manufactured by Fairfax Dental, Inc.. The device is a Class 1 Dental device with product code DZM cleared through the Traditional 510(k) pathway after a 140-day FDA review.

K910446 · Fairfax Dental, Inc. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 1991
Decision
140d
Days
Class 1
Risk

K910446 is an FDA 510(k) clearance for the STABIDENT LOCAL ANESTHESIA SYSTEM. Classified as Needle, Dental (product code DZM), Class I - General Controls.

Submitted by Fairfax Dental, Inc. (Miami, US). The FDA issued a Cleared decision on June 3, 1991 after a review of 140 days - within the typical 510(k) review window.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.4730 - the FDA dental device regulatory framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Dental review framework, consistent with the majority of Class II 510(k) submissions.

View all Fairfax Dental, Inc. devices

FDA 510(k) Submission Details - K910446

510(k) Number K910446 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 14, 1991
Decision Date June 03, 1991
Days to Decision 140 days
Submission Type Traditional
Review Panel Dental (DE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
13d slower than avg
Panel avg: 127d · This submission: 140d
Pathway characteristics
Predicate-based equivalence.

DZM Device Classification - Class 1, General Controls

Product Code DZM Needle, Dental
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 872.4730
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - DZM Needle, Dental

All 8
Devices cleared under the same product code (DZM) and FDA review panel - the closest regulatory comparables to K910446.
X-TIP INTRAOSSEOUS PERFORATOR
K990511 · Schiff & Co. · Apr 1999
JENKER NEEDLE STICK PROTECTOR
K920758 · Dentsply Intl. · Apr 1992
SAFETY PLUS DENTAL INJECTION NEEDLE
K913573 · Specialites Septodont · Nov 1991
DENTAL NEEDLE (CARTRIDGE TYPE)
K870921 · Churchill Corp. · Apr 1987
TERUMO DENTAL NEEDLES
K864970 · Terumo Medical Corp. · Mar 1987
EXEL DENTAL NEEDLE
K861150 · Exel Intl. · Apr 1986