Cleared Traditional

K875339 - JETPOLISHER AIRPOLISHING POWDER (FDA 510(k) Clearance)

Class I Dental device.

K875339 · Young Dental Manufacturing Co. 1, LLC · Dental device
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Apr 1988
Decision
110d
Days
Class 1
Risk

K875339 is an FDA 510(k) clearance for the JETPOLISHER AIRPOLISHING POWDER. Classified as Agent, Polishing, Abrasive, Oral Cavity (product code EJR), Class I - General Controls.

Submitted by Young Dental Manufacturing Co. 1, LLC (Maryland Heights, US). The FDA issued a Cleared decision on April 18, 1988 after a review of 110 days - within the typical 510(k) review window.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.6030 - 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 Young Dental Manufacturing Co. 1, LLC devices

Submission Details

510(k) Number K875339 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 30, 1987
Decision Date April 18, 1988
Days to Decision 110 days
Submission Type Traditional
Review Panel Dental (DE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
17d faster than avg
Panel avg: 127d · This submission: 110d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code EJR Agent, Polishing, Abrasive, Oral Cavity
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 872.6030
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.