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510(k) K002708

KAVO CORUND HANDPIECE 2013 by Kavo America — Product Code KOJ

K002708 is an FDA 510(k) premarket notification submitted by Kavo America for the device "KAVO CORUND HANDPIECE 2013". The FDA issued a decision of Substantially Equivalent on November 28, 2000. The device falls under product code KOJ (Airbrush), a Class II device regulated under 21 CFR 872.6080. Kavo America has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 28, 2000
Date Received
August 30, 2000
Clearance Type
Traditional
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

  • K073074 — KEY LASER III 1243 US WITH DETECT (July 10, 2008)
  • K072262 — GENTLERAY 980 DIODE LASER SYSTEM (October 26, 2007)
  • K063624 — KAVO EVEREST C-TEMP (February 8, 2007)
  • K051909 — DIAGNODENT (October 21, 2005)
  • K030146 — KAVO KEY LASER 1242 AND KAVO KEY LASER 1243+ (August 3, 2005)
  • K050019 — IN EXAM INTRAORAL DENTAL X-RAY SYSTEM (January 31, 2005)
  • K032081 — KAVO EVEREST ZS-BLANK MODELS, 42, 20, AND 60 (July 24, 2003)
  • K031868 — PROPHYPEARLS (July 9, 2003)
  • K030607 — KAVO EVEREST G-BLANK, KAVO EVEREST G-CERAM, COATING CERAMIC LF-3-PFM, GLAZE AND (May 2, 2003)
  • K024214 — KAVO EVEREST TITANBLANK (March 12, 2003)

Other clearances for product code KOJ

  • K251425 — turbodent touch (May 9, 2025)
  • K063236 — BETA-POWDER (February 16, 2007)
  • K042872 — RONDOFLEX PLUS 360 (November 23, 2004)
  • 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)

FDA data resources