Cleared Traditional

K862384 - SCHEIN AP-1 AIR POLISHING UNIT

K862384 is an FDA 510(k) clearance for SCHEIN AP-1 AIR POLISHING UNIT, manufactured by Henry Schein, Inc.. The device is a Class 2 Dental device with product code KOJ cleared through the Traditional 510(k) pathway after a 136-day FDA review.

K862384 · Henry Schein, Inc. · Dental device
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Nov 1986
Decision
136d
Days
Class 2
Risk

K862384 is an FDA 510(k) clearance for the SCHEIN AP-1 AIR POLISHING UNIT. Classified as Airbrush (product code KOJ), Class II - Special Controls.

Submitted by Henry Schein, Inc. (Port Washington, US). The FDA issued a Cleared decision on November 7, 1986 after a review of 136 days - within the typical 510(k) review window.

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 Henry Schein, Inc. devices

FDA 510(k) Submission Details - K862384

510(k) Number K862384 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 24, 1986
Decision Date November 07, 1986
Days to Decision 136 days
Submission Type Traditional
Review Panel Dental (DE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
9d slower than avg
Panel avg: 127d · This submission: 136d
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.