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510(k) K014245

JETSONIC 2000 by Deldent , Ltd. — Product Code KOJ

K014245 is an FDA 510(k) premarket notification submitted by Deldent , Ltd. for the device "JETSONIC 2000". The FDA issued a decision of Substantially Equivalent on January 29, 2002. The device falls under product code KOJ (Airbrush), a Class II device regulated under 21 CFR 872.6080. Deldent , Ltd. has at least 5 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 29, 2002
Date Received
December 26, 2001
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 Deldent , Ltd.

  • K014252 — JETSTREAM (February 19, 2002)
  • K014249 — JETPOLISHER (February 19, 2002)
  • K014238 — DELSONIC 2000 (January 24, 2002)
  • K013969 — MINIBLASTER (January 10, 2002)
  • K011179 — DELDENT ULTRASONIC INSERTS (June 5, 2001)

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