Cleared Traditional

K014188 - NEW PROPHY POWDER

K014188 is an FDA 510(k) clearance for NEW PROPHY POWDER, manufactured by Dentsply Intl.. The device is a Class 2 Dental device with product code KOJ cleared through the Traditional 510(k) pathway after a 84-day FDA review.

K014188 · Dentsply Intl. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2002
Decision
84d
Days
Class 2
Risk

K014188 is an FDA 510(k) clearance for the NEW PROPHY POWDER. Classified as Airbrush (product code KOJ), Class II - Special Controls.

Submitted by Dentsply Intl. (York, US). The FDA issued a Cleared decision on March 15, 2002 after a review of 84 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 Dentsply Intl. devices

FDA 510(k) Submission Details - K014188

510(k) Number K014188 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 21, 2001
Decision Date March 15, 2002
Days to Decision 84 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
43d faster than avg
Panel avg: 127d · This submission: 84d
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 29
Devices cleared under the same product code (KOJ) and FDA review panel - the closest regulatory comparables to K014188.
RONDOFLEX PLUS 360
K042872 · Kavo America Corporation · Nov 2004
PROSMILE AIR POLISHER AND PROPHYLAXIS POWDER
K033675 · Sirona Dental Systems GmbH · Jan 2004
CLINPRO PROPHY POWDER
K021450 · 3M Espe AG Dental Products · Aug 2002
DISPO ETCH
K984380 · Kis Products · Aug 2001
DISPODRILL
K993124 · Kis Products · Aug 2001
DISPOPROPHY
K993182 · Kis Products · Aug 2001