Cleared Special

K042872 - RONDOFLEX PLUS 360 (FDA 510(k) Clearance)

Class II Dental device cleared through the Special 510(k) pathway - typically does not require clinical trials.

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

Submission Details

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.

Device Classification

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.