Cleared Traditional

K875339 - JETPOLISHER AIRPOLISHING POWDER

K875339 is an FDA 510(k) clearance for JETPOLISHER AIRPOLISHING POWDER, manufactured by Young Dental Manufacturing Co. 1, LLC. The device is a Class 1 Dental device with product code EJR cleared through the Traditional 510(k) pathway after a 110-day FDA review.

K875339 · Young Dental Manufacturing Co. 1, LLC · Dental device
Download Printable Device Report (PDF)
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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

FDA 510(k) Submission Details - K875339

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.

EJR Device Classification - Class 1, General Controls

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.

Regulatory Peers - EJR Agent, Polishing, Abrasive, Oral Cavity

All 30
Devices cleared under the same product code (EJR) and FDA review panel - the closest regulatory comparables to K875339.
PULPDENT OIL FREE SURFACE PREPARATION PASTE
K901052 · Pulpdent Corp. · Apr 1990
KEN'S PROPHY GEL - REGULAR
K896661 · Pulpdent Corp. · Feb 1990
ENAMEL MICROABRASION COMPOUND
K891536 · Premier Dental Products Co. · Jun 1989
DIAMOND-LUSTER DENTAL POLISHING PASTE
K873686 · Scientific Pharmaceuticals, Inc. · Nov 1987
ABRASIVE DISC - POLISHING WHEEL
K872251 · Dentsply Intl. · Jul 1987
JOHNSON & JOHNSON STAINING REMOVING COMPOUND
K864226 · Johnson & Johnson Professionals, Inc. · May 1987