Cleared Special

K042872 - RONDOFLEX PLUS 360

K042872 is an FDA 510(k) clearance for RONDOFLEX PLUS 360, manufactured by Kavo America Corporation. The device is a Class 2 Dental device with product code KOJ cleared through the Special 510(k) pathway after a 36-day FDA review.

K042872 · Kavo America Corporation · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 2004
Decision
36d
Days
Class 2
Risk

K042872 is an FDA 510(k) clearance for the RONDOFLEX PLUS 360. Classified as Airbrush (product code KOJ), Class II - Special Controls.

Submitted by Kavo America Corporation (Deer Field, US). The FDA issued a Cleared decision on November 23, 2004 after a review of 36 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Kavo America Corporation devices

FDA 510(k) Submission Details - K042872

510(k) Number K042872 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 18, 2004
Decision Date November 23, 2004
Days to Decision 36 days
Submission Type Special
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
91d faster than avg
Panel avg: 127d · This submission: 36d
Pathway characteristics
Modification to existing cleared device.

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 K042872.
turbodent touch
K251425 · Mectron S.P.A. · May 2025
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