KOJ · Class II · 21 CFR 872.6080

FDA Product Code KOJ: Airbrush

Leading manufacturers include Deldent , Ltd., Kreativ, Inc. and Kis Products.

48
Total
48
Cleared
202d
Avg days
1984
Since
Growing category - 1 submissions in the last 2 years vs 0 in the prior period
Review times improving: avg 1d recently vs 206d historically

FDA 510(k) Cleared Airbrush Devices (Product Code KOJ)

48 devices
1–24 of 48
Cleared May 09, 2025
turbodent touch
K251425
Mectron S.P.A.
Dental · 1d
Cleared Feb 16, 2007
BETA-POWDER
K063236
Brainbase Corporation
Dental · 114d
Cleared Nov 23, 2004
RONDOFLEX PLUS 360
K042872
Kavo America Corporation
Dental · 36d
Cleared Jan 15, 2004
PROSMILE AIR POLISHER AND PROPHYLAXIS POWDER
K033675
Sirona Dental Systems GmbH
Dental · 52d
Cleared Jan 09, 2004
PREPAIR
K033215
Danville Materials, Inc.
Dental · 98d
Cleared Oct 09, 2003
VELOPEX AQUACUT FLUID ABRASION UNIT
K024105
Velopex International, Inc.
Dental · 300d
Cleared Apr 15, 2003
GROMAN PREPMASTER
K030292
Groman, Inc.
Dental · 77d
Cleared Aug 01, 2002
CLINPRO PROPHY POWDER
K021450
3M Espe AG Dental Products
Dental · 87d
Cleared Mar 15, 2002
NEW PROPHY POWDER
K014188
Dentsply Intl.
Dental · 84d
Cleared Feb 19, 2002
JETPOLISHER
K014249
Deldent , Ltd.
Dental · 55d
Cleared Feb 19, 2002
JETSTREAM
K014252
Deldent , Ltd.
Dental · 55d
Cleared Jan 29, 2002
JETSONIC 2000
K014245
Deldent , Ltd.
Dental · 34d
Cleared Jan 10, 2002
MINIBLASTER
K013969
Deldent , Ltd.
Dental · 38d
Cleared Aug 06, 2001
DISPO ETCH
K984380
Kis Products
Dental · 972d
Cleared Aug 06, 2001
DISPODRILL
K993124
Kis Products
Dental · 686d
Cleared Aug 06, 2001
DISPOPROPHY
K993182
Kis Products
Dental · 683d
Cleared May 10, 2001
DENTO-PREP PARTICLE MICROBLASTER
K010816
Ronvig A/S
Dental · 52d
Cleared Nov 28, 2000
KAVO CORUND HANDPIECE 2013
K002708
Kavo America
Dental · 90d
Cleared Jun 15, 2000
MACH 7
K990060
Kreativ, Inc.
Dental · 524d
Cleared Jun 08, 2000
AIRDENT II CS
K001313
Air Technologies, Inc.
Dental · 43d
Cleared May 04, 2000
SIMPLEX AIRBRATOR (SAB-7)
K980672
Irt Management Corp.
Dental · 804d
Cleared Sep 29, 1999
S.S. WHITE TECHNOLOGIES, MODELS 6500-D,6500-E, AND 6500-F
K984415
S.S. White Technologies, Inc.
Dental · 293d
Cleared Aug 11, 1999
JETSONIC 2000
K990545
Sds Dental, Inc.
Dental · 170d
Cleared Sep 24, 1998
AIR TECHNIQUES' AIRDENT II
K981564
Air Techniques, Inc.
Dental · 146d

About Product Code KOJ - Regulatory Context

510(k) Submission Activity

48 total 510(k) submissions under product code KOJ since 1984, with 48 receiving FDA clearance (average review time: 202 days).

Submission volume has increased in recent years - 1 submissions in the last 24 months compared to 0 in the prior period - suggesting growing market activity in this device classification.

FDA 510(k) Review Time - KOJ Product Code

Recent submissions under KOJ have taken an average of 1 days to reach a decision - down from 206 days historically, suggesting improved FDA processing for this classification.

KOJ devices are reviewed by the Dental panel. Browse all Dental devices →