Product Code: KOJ FDA class 2 21 CFR 872.6080

Airbrush

Dental

A Dental Airbrush is a device used in dentistry to deliver a fine, precise stream of air, water, or abrasive particles to the tooth surface for purposes including stain removal, surface preparation, minimally invasive caries removal, and application of dental materials. It is classified as FDA Class 2, indicating moderate risk requiring 510(k) premarket clearance. The product code is KOJ and the applicable regulation is 21 CFR 872.6080 in the Dental specialty. This device is eligible for third-party review.

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510(k)s

FEI Numbers

Registration Numbers

Unique Applicants

Years Active

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Basic Information

Product Code: KOJ
Device Class: FDA class 2
Regulation Number: 872.6080
Medical Specialty: Dental
Review Panel: DE
Submission Type: 1

Device Characteristics

✗

GMP Exempt

✗

Implant

✗

Life Sustain/Support

✓

Third Party

—

Summary Malfunction Reporting

510(k) Clearance History

Related 510(k) Clearances

This FDA classification is associated with 48 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K251425	turbodent touch	May 09, 2025	Substantially Equivalent	Mectron S.P.A.
K063236	BETA-POWDER	Feb 16, 2007	Substantially Equivalent	Brainbase Corporation
K042872	RONDOFLEX PLUS 360	Nov 23, 2004	Substantially Equivalent	Kavo America Corporation
K033675	PROSMILE AIR POLISHER AND PROPHYLAXIS POWDER	Jan 15, 2004	Substantially Equivalent	Sirona Dental Systems GmbH
K033215	PREPAIR	Jan 09, 2004	Substantially Equivalent	Danville Materials, Inc.
K024105	VELOPEX AQUACUT FLUID ABRASION UNIT	Oct 09, 2003	Substantially Equivalent	Velopex International, Inc.
K030292	GROMAN PREPMASTER	Apr 15, 2003	Substantially Equivalent	Groman, Inc.
K021450	CLINPRO PROPHY POWDER	Aug 01, 2002	Substantially Equivalent	3M Espe AG Dental Products
K014188	NEW PROPHY POWDER	Mar 15, 2002	Substantially Equivalent	Dentsply Intl.
K014252	JETSTREAM	Feb 19, 2002	Substantially Equivalent	Deldent , Ltd.
K014249	JETPOLISHER	Feb 19, 2002	Substantially Equivalent	Deldent , Ltd.
K014245	JETSONIC 2000	Jan 29, 2002	Substantially Equivalent	Deldent , Ltd.
K013969	MINIBLASTER	Jan 10, 2002	Substantially Equivalent	Deldent , Ltd.
K993182	DISPOPROPHY	Aug 06, 2001	Substantially Equivalent	Kis Products
K993124	DISPODRILL	Aug 06, 2001	Substantially Equivalent	Kis Products
K984380	DISPO ETCH	Aug 06, 2001	Substantially Equivalent	Kis Products
K010816	DENTO-PREP PARTICLE MICROBLASTER	May 10, 2001	Substantially Equivalent	Ronvig A/S
K002708	KAVO CORUND HANDPIECE 2013	Nov 28, 2000	Substantially Equivalent	Kavo America
K990060	MACH 7	Jun 15, 2000	Substantially Equivalent	Kreativ, Inc.
K001313	AIRDENT II CS	Jun 08, 2000	Substantially Equivalent	Air Technologies, Inc.
K980672	SIMPLEX AIRBRATOR (SAB-7)	May 04, 2000	Substantially Equivalent	Irt Management Corp.
K984415	S.S. WHITE TECHNOLOGIES, MODELS 6500-D,6500-E, AND 6500-F	Sep 29, 1999	Substantially Equivalent	S.S. White Technologies, Inc.
K990545	JETSONIC 2000	Aug 11, 1999	Substantially Equivalent	Sds Dental, Inc.
K981564	AIR TECHNIQUES' AIRDENT II	Sep 24, 1998	Substantially Equivalent	Air Techniques, Inc.
K974655	PREPTECH(TM) 200 CAVITY PREPARATION SYSTEM	Jul 09, 1998	Substantially Equivalent	Prep Technology Corp.
K980216	KREATIV MACH 5, MACH 5 PLUS, MACH M, MACH 6	Jun 16, 1998	Substantially Equivalent	Kreativ, Inc.
K974488	AIRPREP SYSTEM - MODEL 9001	May 26, 1998	Substantially Equivalent	Asi Medical, Inc.
K980726	ULTRA-BLASTER	May 12, 1998	Substantially Equivalent	Ultradent Products, Inc.
K973679	AEROETCHER	Mar 10, 1998	Substantially Equivalent	Parkell, Inc.
K970589	MICROETCHER AP	Sep 17, 1997	Substantially Equivalent	Danville Engineering, Inc.
K964755	MICROJET CAVITY PREPARATION SYSTEM	Sep 11, 1997	Substantially Equivalent	Midwest Dental Products Corp.
K970484	ACCU-PREP	Jul 01, 1997	Substantially Equivalent	Bisco, Inc.
K970249	SIMPLEX AIRBRATOR	May 07, 1997	Substantially Equivalent	Simplex Medical Systems, Inc.
K964145	ABRADENT MICRO ABRASIVE SANDBLASTER MODEL DV-1	Dec 31, 1996	Substantially Equivalent	Crystal Mark, Inc.
K964059	MICADENT	Dec 19, 1996	Substantially Equivalent	Hampton Research
K955573	OPTIBLAST INTRAORAL SANDBLASTER	May 03, 1996	Substantially Equivalent	Buffalo Dental Mfg. Co., Inc.
K955050	JETSTREAM CAVITY PREPARATION SYSTEM	Mar 07, 1996	Substantially Equivalent	Dove Systems, Inc.
K931845	SANDBLASTER	Mar 01, 1995	Substantially Equivalent	Mirage Dental Systems
K940776	KREATIV MODEL KV-1	Dec 21, 1994	Substantially Equivalent	Kreativ, Inc.
K932997	MICROPREP CAVITY PREPERATION SYSTEM	Apr 25, 1994	Substantially Equivalent	Sunrise Technologies, Inc.
K921748	MODEL 2000 DENTAL AIR ABRASIVE SYSTEM	Nov 25, 1992	Substantially Equivalent	Texas Airsonics, Inc.
K903284	YOUNG PROPHY SYSTEM, PS UNIT	Dec 17, 1990	Substantially Equivalent	Young Dental Manufacturing Co. 1, LLC
K902836	MICROETCHER	Nov 20, 1990	Substantially Equivalent	Danville Engineering, Inc.
K875340	JETPOLISHER(TM)	Jun 10, 1988	Substantially Equivalent	Young Dental Manufacturing Co. 1, LLC
K871980	D-23 DENTURE ADHESIVE	Jun 05, 1987	Substantially Equivalent	Solar Dental Co., Inc.
K862384	SCHEIN AP-1 AIR POLISHING UNIT	Nov 07, 1986	Substantially Equivalent	Henry Schein, Inc.
K852521	SATLEC PROPHY UNIT PU 3055	Jul 31, 1985	Substantially Equivalent	Spelna, Inc.
K840720	FIBER HEMOFILTERS FH55-FH77 & 88	Apr 24, 1984	Substantially Equivalent	Gambro, Inc.