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510(k) K981564

AIR TECHNIQUES' AIRDENT II by Air Techniques, Inc. — Product Code KOJ

K981564 is an FDA 510(k) premarket notification submitted by Air Techniques, Inc. for the device "AIR TECHNIQUES' AIRDENT II". The FDA issued a decision of Substantially Equivalent on September 24, 1998. The device falls under product code KOJ (Airbrush), a Class II device regulated under 21 CFR 872.6080. Air Techniques, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 24, 1998
Date Received
May 1, 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 Air Techniques, Inc.

  • K191623 — ScanX Touch/ScanX Duo Touch (August 21, 2019)
  • K190949 — ScanX Barrier Envelopes (July 26, 2019)
  • K101289 — SCANX D5000 SERIES SCANNER MODEL: D5000-F, D5000-FB, D5000-FVB, D5000-Q, D5000-Q (August 3, 2010)
  • K090169 — SPECTRA FLUORESCENCE CARIES DETECTION DEVICE (August 18, 2009)
  • K052271 — RINSENDO (May 26, 2006)
  • K050693 — ACCENT (May 26, 2005)
  • K042397 — SCANX 14 (October 5, 2004)
  • K042266 — ACCLAIM (August 31, 2004)
  • K031198 — SCANX 10 (June 20, 2003)
  • K024285 — A/T X-RAY 70 (April 16, 2003)

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