Cleared Traditional

K921748 - MODEL 2000 DENTAL AIR ABRASIVE SYSTEM

K921748 is an FDA 510(k) clearance for MODEL 2000 DENTAL AIR ABRASIVE SYSTEM, manufactured by Texas Airsonics, Inc.. The device is a Class 2 Dental device with product code KOJ cleared through the Traditional 510(k) pathway after a 226-day FDA review.

K921748 · Texas Airsonics, Inc. · Dental device
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Nov 1992
Decision
226d
Days
Class 2
Risk

K921748 is an FDA 510(k) clearance for the MODEL 2000 DENTAL AIR ABRASIVE SYSTEM. Classified as Airbrush (product code KOJ), Class II - Special Controls.

Submitted by Texas Airsonics, Inc. (North Attleboro, US). The FDA issued a Cleared decision on November 25, 1992 after a review of 226 days - an extended review cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.6080 - 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 Texas Airsonics, Inc. devices

FDA 510(k) Submission Details - K921748

510(k) Number K921748 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 13, 1992
Decision Date November 25, 1992
Days to Decision 226 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
99d slower than avg
Panel avg: 127d · This submission: 226d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KOJ Device Classification - Class 2, Special Controls

Product Code KOJ Airbrush
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.6080
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Dental devices follow this clearance model.