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510(k) K974488

AIRPREP SYSTEM - MODEL 9001 by Asi Medical, Inc. — Product Code KOJ

K974488 is an FDA 510(k) premarket notification submitted by Asi Medical, Inc. for the device "AIRPREP SYSTEM - MODEL 9001". The FDA issued a decision of Substantially Equivalent on May 26, 1998. The device falls under product code KOJ (Airbrush), a Class II device regulated under 21 CFR 872.6080. Asi Medical, Inc. has at least 4 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 26, 1998
Date Received
November 26, 1997
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 Asi Medical, Inc.

  • K123139 — ADVANCED ENDODONTIC SYSTEM- DESIGNER SERIES (March 28, 2013)
  • K110481 — TRITON SELF CONTAINED DENTAL SYSTEM, TRITON SELF CONTAINED DENTAL SYSTEM, WITH C (April 5, 2012)
  • K974487 — SEAC ADVANCED DENTAL SYSTEM - MODEL 2001,2010 OR MODEL 2020 (February 18, 1998)
  • K932873 — SEAC MOBILE UNIT BY ASI MEDICAL (March 7, 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