Atlas FDA

KOJ

48 FDA 510(k) clearances · Product code

141 daysmedian time to decision
683 days90th percentile
48clearances measured

FDA profile

Official device name
Airbrush
Device class
Class II (moderate risk)
Regulation
21 CFR 872.6080
Medical specialty
Dental
Flags
Third-party review eligible
Adverse events (MAUDE)
1996: 1 · 2009: 3
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free

RecordFirmDate
turbodent touch (K251425)Mectron S.P.A.2025-05-09
BETA-POWDER (K063236)Brainbase Corporation2007-02-16
RONDOFLEX PLUS 360 (K042872)Kavo America Corporation2004-11-23
PROSMILE AIR POLISHER AND PROPHYLAXIS POWDER (K033675)Sirona Dental Systems GmbH2004-01-15
PREPAIR (K033215)Danville Materials, Inc.2004-01-09
VELOPEX AQUACUT FLUID ABRASION UNIT (K024105)Velopex International, Inc.2003-10-09
GROMAN PREPMASTER (K030292)Groman, Inc.2003-04-15
CLINPRO PROPHY POWDER (K021450)3M Espe AG Dental Products2002-08-01
NEW PROPHY POWDER (K014188)Dentsply Intl.2002-03-15
JETPOLISHER (K014249)Deldent , Ltd.2002-02-19
JETSTREAM (K014252)Deldent , Ltd.2002-02-19
JETSONIC 2000 (K014245)Deldent , Ltd.2002-01-29
MINIBLASTER (K013969)Deldent , Ltd.2002-01-10
DISPO ETCH (K984380)Kis Products2001-08-06
DISPOPROPHY (K993182)Kis Products2001-08-06
DISPODRILL (K993124)Kis Products2001-08-06
DENTO-PREP PARTICLE MICROBLASTER (K010816)Ronvig A/S2001-05-10
KAVO CORUND HANDPIECE 2013 (K002708)Kavo America2000-11-28
MACH 7 (K990060)Kreativ, Inc.2000-06-15
AIRDENT II CS (K001313)Air Technologies, Inc.2000-06-08
SIMPLEX AIRBRATOR (SAB-7) (K980672)Irt Management Corp.2000-05-04
S.S. WHITE TECHNOLOGIES, MODELS 6500-D,6500-E, AND 6500-F (K984415)S.S. White Technologies, Inc.1999-09-29
JETSONIC 2000 (K990545)Sds Dental, Inc.1999-08-11
AIR TECHNIQUES' AIRDENT II (K981564)Air Techniques, Inc.1998-09-24
PREPTECH(TM) 200 CAVITY PREPARATION SYSTEM (K974655)Prep Technology Corp.1998-07-09
KREATIV MACH 5, MACH 5 PLUS, MACH M, MACH 6 (K980216)Kreativ, Inc.1998-06-16
AIRPREP SYSTEM - MODEL 9001 (K974488)Asi Medical, Inc.1998-05-26
ULTRA-BLASTER (K980726)Ultradent Products, Inc.1998-05-12
AEROETCHER (K973679)Parkell, Inc.1998-03-10
MICROETCHER AP (K970589)Danville Engineering, Inc.1997-09-17
MICROJET CAVITY PREPARATION SYSTEM (K964755)Midwest Dental Products Corp.1997-09-11
ACCU-PREP (K970484)Bisco, Inc.1997-07-01
SIMPLEX AIRBRATOR (K970249)Simplex Medical Systems, Inc.1997-05-07
ABRADENT MICRO ABRASIVE SANDBLASTER MODEL DV-1 (K964145)Crystal Mark, Inc.1996-12-31
MICADENT (K964059)Hampton Research1996-12-19
OPTIBLAST INTRAORAL SANDBLASTER (K955573)Buffalo Dental Mfg. Co., Inc.1996-05-03
JETSTREAM CAVITY PREPARATION SYSTEM (K955050)Dove Systems, Inc.1996-03-07
SANDBLASTER (K931845)Mirage Dental Systems1995-03-01
KREATIV MODEL KV-1 (K940776)Kreativ, Inc.1994-12-21
MICROPREP CAVITY PREPERATION SYSTEM (K932997)Sunrise Technologies, Inc.1994-04-25
MODEL 2000 DENTAL AIR ABRASIVE SYSTEM (K921748)Texas Airsonics, Inc.1992-11-25
YOUNG PROPHY SYSTEM, PS UNIT (K903284)Young Dental Manufacturing Co. 1, LLC1990-12-17
MICROETCHER (K902836)Danville Engineering, Inc.1990-11-20
JETPOLISHER(TM) (K875340)Young Dental Manufacturing Co. 1, LLC1988-06-10
D-23 DENTURE ADHESIVE (K871980)Solar Dental Co., Inc.1987-06-05
SCHEIN AP-1 AIR POLISHING UNIT (K862384)Henry Schein, Inc.1986-11-07
SATLEC PROPHY UNIT PU 3055 (K852521)Spelna, Inc.1985-07-31
FIBER HEMOFILTERS FH55-FH77 & 88 (K840720)Gambro, Inc.1984-04-24

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Every clearance here is in the API, with alerts when new ones post.