Cleared Traditional

K014249 - JETPOLISHER

K014249 is an FDA 510(k) clearance for JETPOLISHER, manufactured by Deldent , Ltd.. The device is a Class 2 Dental device with product code KOJ cleared through the Traditional 510(k) pathway after a 55-day FDA review.

K014249 · Deldent , Ltd. · Dental device
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Feb 2002
Decision
55d
Days
Class 2
Risk

K014249 is an FDA 510(k) clearance for the JETPOLISHER. Classified as Airbrush (product code KOJ), Class II - Special Controls.

Submitted by Deldent , Ltd. (Petach Tikvah, IL). The FDA issued a Cleared decision on February 19, 2002 after a review of 55 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Deldent , Ltd. devices

FDA 510(k) Submission Details - K014249

510(k) Number K014249 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 26, 2001
Decision Date February 19, 2002
Days to Decision 55 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
72d faster than avg
Panel avg: 127d · This submission: 55d
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.

Regulatory Peers - KOJ Airbrush

All 28
Devices cleared under the same product code (KOJ) and FDA review panel - the closest regulatory comparables to K014249.
PROSMILE AIR POLISHER AND PROPHYLAXIS POWDER
K033675 · Sirona Dental Systems GmbH · Jan 2004
CLINPRO PROPHY POWDER
K021450 · 3M Espe AG Dental Products · Aug 2002
NEW PROPHY POWDER
K014188 · Dentsply Intl. · Mar 2002
DISPO ETCH
K984380 · Kis Products · Aug 2001
DISPODRILL
K993124 · Kis Products · Aug 2001
DISPOPROPHY
K993182 · Kis Products · Aug 2001