Cleared Traditional

STABIDENT LOCAL ANESTHESIA SYSTEM (K910446) - FDA 510(k) Clearance

Class I Dental device.

K910446 · Fairfax Dental, Inc. · Dental device
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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

Submission Details

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.

Device Classification

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.