Home / 510(k) Clearances / K042872

510(k) K042872

RONDOFLEX PLUS 360 by Kavo America Corporation — Product Code KOJ

K042872 is an FDA 510(k) premarket notification submitted by Kavo America Corporation for the device "RONDOFLEX PLUS 360". The FDA issued a decision of Substantially Equivalent on November 23, 2004. The device falls under product code KOJ (Airbrush), a Class II device regulated under 21 CFR 872.6080. Kavo America Corporation has at least 3 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 23, 2004
Date Received
October 18, 2004
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Airbrush
Device Class
Class II
Regulation Number
872.6080
Review Panel
DE
Submission Type

Other clearances by Kavo America Corporation

  • K042394 — DIAGNODENT PERIO TIP (ACCESSORY) (August 2, 2005)
  • K050744 — KAVO ERGOCOM/ERGOCAM (April 21, 2005)
  • K033221 — KAVO EVEREST ZH-BLANK (October 28, 2003)

Other clearances for product code KOJ

  • K251425 — turbodent touch (May 9, 2025)
  • K063236 — BETA-POWDER (February 16, 2007)
  • K033675 — PROSMILE AIR POLISHER AND PROPHYLAXIS POWDER (January 15, 2004)
  • K033215 — PREPAIR (January 9, 2004)
  • K024105 — VELOPEX AQUACUT FLUID ABRASION UNIT (October 9, 2003)
  • K030292 — GROMAN PREPMASTER (April 15, 2003)
  • K021450 — CLINPRO PROPHY POWDER (August 1, 2002)
  • K014188 — NEW PROPHY POWDER (March 15, 2002)
  • K014252 — JETSTREAM (February 19, 2002)
  • K014249 — JETPOLISHER (February 19, 2002)

FDA data resources