Browse hierarchy: [Dental (DE)](/submissions/DE) → [Subpart G — Miscellaneous Devices](/submissions/DE/subpart-g%E2%80%94miscellaneous-devices) → [21 CFR 872.6080](/submissions/DE/subpart-g%E2%80%94miscellaneous-devices/872.6080) → KOJ — Airbrush # KOJ · Airbrush _Dental · 21 CFR 872.6080 · Class 2_ **Canonical URL:** https://fda.innolitics.com/submissions/DE/subpart-g%E2%80%94miscellaneous-devices/KOJ ## Overview - **Product Code:** KOJ - **Device Name:** Airbrush - **Regulation:** [21 CFR 872.6080](/submissions/DE/subpart-g%E2%80%94miscellaneous-devices/872.6080) - **Device Class:** 2 - **Review Panel:** [Dental](/submissions/DE) - **3rd-party reviewable:** yes ## Identification An airbrush is an AC-powered device intended for use in conjunction with articulation paper. The device uses air-driven particles to roughen the surfaces of dental restorations. Uneven areas of the restorations are then identified by use of articulation paper. ## Classification Rationale Class II. The special control for this device is International Electrotechnical Commission's IEC 60601-1-AM2 (1995-03), Amendment 2, “Medical Electrical Equipment—Part 1: General Requirements for Safety.” ## Special Controls The special control for this device is International Electrotechnical Commission's IEC 60601-1-AM2 (1995-03), Amendment 2, “Medical Electrical Equipment—Part 1: General Requirements for Safety.” ## Recent Cleared Devices (20 of 48) Showing 20 most recent of 48 cleared devices. | Record | Device Name | Applicant | Decision Date | Decision | | --- | --- | --- | --- | --- | | [K251425](https://fda.innolitics.com/submissions/DE/subpart-g%E2%80%94miscellaneous-devices/KOJ/K251425.md) | turbodent touch | Mectron S.P.A. | May 9, 2025 | SESE | | [K063236](https://fda.innolitics.com/submissions/DE/subpart-g%E2%80%94miscellaneous-devices/KOJ/K063236.md) | BETA-POWDER | Brainbase Corporation | Feb 16, 2007 | SESE | | [K042872](https://fda.innolitics.com/submissions/DE/subpart-g%E2%80%94miscellaneous-devices/KOJ/K042872.md) | RONDOFLEX PLUS 360 | Kavo America Corporation | Nov 23, 2004 | SESE | | [K033675](https://fda.innolitics.com/submissions/DE/subpart-g%E2%80%94miscellaneous-devices/KOJ/K033675.md) | PROSMILE AIR POLISHER AND PROPHYLAXIS POWDER | Sirona Dental Systems GmbH | Jan 15, 2004 | SESE | | [K033215](https://fda.innolitics.com/submissions/DE/subpart-g%E2%80%94miscellaneous-devices/KOJ/K033215.md) | PREPAIR | Danville Materials, Inc. | Jan 9, 2004 | SESE | | [K024105](https://fda.innolitics.com/submissions/DE/subpart-g%E2%80%94miscellaneous-devices/KOJ/K024105.md) | VELOPEX AQUACUT FLUID ABRASION UNIT | Velopex International, Inc. | Oct 9, 2003 | SESE | | [K030292](https://fda.innolitics.com/submissions/DE/subpart-g%E2%80%94miscellaneous-devices/KOJ/K030292.md) | GROMAN PREPMASTER | Groman, Inc. | Apr 15, 2003 | SESE | | [K021450](https://fda.innolitics.com/submissions/DE/subpart-g%E2%80%94miscellaneous-devices/KOJ/K021450.md) | CLINPRO PROPHY POWDER | 3M Espe AG Dental Products | Aug 1, 2002 | SESE | | [K014188](https://fda.innolitics.com/submissions/DE/subpart-g%E2%80%94miscellaneous-devices/KOJ/K014188.md) | NEW PROPHY POWDER | Dentsply Intl. | Mar 15, 2002 | SESE | | [K014252](https://fda.innolitics.com/submissions/DE/subpart-g%E2%80%94miscellaneous-devices/KOJ/K014252.md) | JETSTREAM | Deldent , Ltd. | Feb 19, 2002 | SESE | | [K014249](https://fda.innolitics.com/submissions/DE/subpart-g%E2%80%94miscellaneous-devices/KOJ/K014249.md) | JETPOLISHER | Deldent , Ltd. | Feb 19, 2002 | SESE | | [K014245](https://fda.innolitics.com/submissions/DE/subpart-g%E2%80%94miscellaneous-devices/KOJ/K014245.md) | JETSONIC 2000 | Deldent , Ltd. | Jan 29, 2002 | SESE | | [K013969](https://fda.innolitics.com/submissions/DE/subpart-g%E2%80%94miscellaneous-devices/KOJ/K013969.md) | MINIBLASTER | Deldent , Ltd. | Jan 10, 2002 | SESE | | [K993182](https://fda.innolitics.com/submissions/DE/subpart-g%E2%80%94miscellaneous-devices/KOJ/K993182.md) | DISPOPROPHY | Kis Products | Aug 6, 2001 | SESE | | [K993124](https://fda.innolitics.com/submissions/DE/subpart-g%E2%80%94miscellaneous-devices/KOJ/K993124.md) | DISPODRILL | Kis Products | Aug 6, 2001 | SESE | | [K984380](https://fda.innolitics.com/submissions/DE/subpart-g%E2%80%94miscellaneous-devices/KOJ/K984380.md) | DISPO ETCH | Kis Products | Aug 6, 2001 | SESE | | [K010816](https://fda.innolitics.com/submissions/DE/subpart-g%E2%80%94miscellaneous-devices/KOJ/K010816.md) | DENTO-PREP PARTICLE MICROBLASTER | Ronvig A/S | May 10, 2001 | SESE | | [K002708](https://fda.innolitics.com/submissions/DE/subpart-g%E2%80%94miscellaneous-devices/KOJ/K002708.md) | KAVO CORUND HANDPIECE 2013 | Kavo America | Nov 28, 2000 | SESE | | [K990060](https://fda.innolitics.com/submissions/DE/subpart-g%E2%80%94miscellaneous-devices/KOJ/K990060.md) | MACH 7 | Kreativ, Inc. | Jun 15, 2000 | SESE | | [K001313](https://fda.innolitics.com/submissions/DE/subpart-g%E2%80%94miscellaneous-devices/KOJ/K001313.md) | AIRDENT II CS | Air Technologies, Inc. | Jun 8, 2000 | SESE | ## Top Applicants - Deldent , Ltd. — 4 clearances - Kis Products — 3 clearances - Kreativ, Inc. — 3 clearances - Danville Engineering, Inc. — 2 clearances - Young Dental Manufacturing Co. 1, LLC — 2 clearances --- **Source:** [https://fda.innolitics.com/submissions/DE/subpart-g%E2%80%94miscellaneous-devices/KOJ](https://fda.innolitics.com/submissions/DE/subpart-g%E2%80%94miscellaneous-devices/KOJ) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. 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