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510(k) K063236

BETA-POWDER by Brainbase Corporation — Product Code KOJ

K063236 is an FDA 510(k) premarket notification submitted by Brainbase Corporation for the device "BETA-POWDER". The FDA issued a decision of Substantially Equivalent on February 16, 2007. The device falls under product code KOJ (Airbrush), a Class II device regulated under 21 CFR 872.6080. Brainbase Corporation has at least 2 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 16, 2007
Date Received
October 25, 2006
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 Brainbase Corporation

  • K083372 — ARROWBONE-A, ARROWBONE-B (December 8, 2009)
  • K052254 — MYTIS ARROW XXXX (June 1, 2006)

Other clearances for product code KOJ

  • K251425 — turbodent touch (May 9, 2025)
  • 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)
  • K014249 — JETPOLISHER (February 19, 2002)

FDA data resources