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510(k) K014249

JETPOLISHER by Deldent , Ltd. — Product Code KOJ

K014249 is an FDA 510(k) premarket notification submitted by Deldent , Ltd. for the device "JETPOLISHER". The FDA issued a decision of Substantially Equivalent on February 19, 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
February 19, 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)
  • K014245 — JETSONIC 2000 (January 29, 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