Cleared Special

RONDOFLEX PLUS 360

K042872 · Kavo America Corporation · Dental
Nov 2004
Decision
36d
Days
Class 2
Risk

About This 510(k) Submission

K042872 is an FDA 510(k) clearance for the RONDOFLEX PLUS 360, a Airbrush (Class II — Special Controls, product code KOJ), submitted by Kavo America Corporation (Deer Field, US). The FDA issued a Cleared decision on November 23, 2004, 36 days after receiving the submission on October 18, 2004. This device falls under the Dental review panel. Regulated under 21 CFR 872.6080.

Submission Details

510(k) Number K042872 FDA.gov
FDA Decision Cleared 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

Device Classification

Product Code KOJ — Airbrush
Device Class Class II — Special Controls
CFR Regulation 21 CFR 872.6080