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510(k) K001313

AIRDENT II CS by Air Technologies, Inc. — Product Code KOJ

K001313 is an FDA 510(k) premarket notification submitted by Air Technologies, Inc. for the device "AIRDENT II CS". The FDA issued a decision of Substantially Equivalent on June 8, 2000. The device falls under product code KOJ (Airbrush), a Class II device regulated under 21 CFR 872.6080.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 8, 2000
Date Received
April 26, 2000
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

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  • 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