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510(k) K980216

KREATIV MACH 5, MACH 5 PLUS, MACH M, MACH 6 by Kreativ, Inc. — Product Code KOJ

K980216 is an FDA 510(k) premarket notification submitted by Kreativ, Inc. for the device "KREATIV MACH 5, MACH 5 PLUS, MACH M, MACH 6". The FDA issued a decision of Substantially Equivalent on June 16, 1998. The device falls under product code KOJ (Airbrush), a Class II device regulated under 21 CFR 872.6080. Kreativ, Inc. has at least 4 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 16, 1998
Date Received
January 21, 1998
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 Kreativ, Inc.

  • K990060 — MACH 7 (June 15, 2000)
  • K983227 — POWER BLOCK (December 11, 1998)
  • K962376 — KREATIV KURING LIGHT SYSTEM (March 21, 1997)
  • K940776 — KREATIV MODEL KV-1 (December 21, 1994)

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