Young Prophy System, PS Unit
FDA 510(k) K903284 · Young Dental Manufacturing Co. 1, LLC
510(k) numberK903284
Submission
- Device name
- Young Prophy System, PS Unit
- Applicant
- Young Dental Manufacturing Co. 1, LLC
Earth City, MO, US - Received
- July 22, 1990
- Decision date
- December 17, 1990
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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| K251425 | turbodent touchKOJ · Traditional | Mectron S.P.A. | 05/09/2025SE |
| K063236 | Beta-PowderKOJ · Traditional | Brainbase Corporation | 02/16/2007SE |
| K042872 | Rondoflex Plus 360KOJ · Special | Kavo America Corporation | 11/23/2004SE |
| K033675 | Prosmile Air Polisher and Prophylaxis PowderKOJ · Traditional | Sirona Dental Systems GmbH | 01/15/2004SE |
| K033215 | PrepairKOJ · Traditional | Danville Materials, Inc. | 01/09/2004SE |
| K024105 | Velopex Aquacut Fluid Abrasion UnitKOJ · Traditional | Velopex International, Inc. | 10/09/2003SE |
| K030292 | Groman PrepmasterKOJ · Traditional | Groman, Inc. | 04/15/2003SE |
| K021450 | Clinpro Prophy PowderKOJ · Traditional | 3M Espe AG Dental Products | 08/01/2002SE |
| K014188 | New Prophy PowderKOJ · Traditional | Dentsply Intl. | 03/15/2002SE |
| K014252 | JetstreamKOJ · Traditional | Deldent , Ltd. | 02/19/2002SE |
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| K201127 | DEFEND Ear-loop Face MasksFXX · Abbreviated | 04/14/2021SE |
| K171377 | Young INFINITY Cordless Handpiece SystemEKX · Traditional | 08/20/2018SE |
| K153334 | Oral-B 5% Sodium Fluoride VarnishLBH · Traditional | 05/20/2016SE |
| K932255 | Young D'GranulatorKMW · Traditional | 04/15/1994SE |
| K875340 | Jetpolisher(Tm)KOJ · Traditional | 06/10/1988SE |
| K875339 | Jetpolisher Airpolishing PowderEJR · Traditional | 04/18/1988SE |
| K821484 | Dawn Low Speed Handpiece SystemEFB · Traditional | 06/09/1982SE |
| K790723 | Prophylaxis Cups and PolishersEHK · Traditional | 06/15/1979SE |
| K790722 | Prophylaxis AngleEGS · Traditional | 06/15/1979SE |
Questions and answers
When was Young Prophy System, PS Unit cleared by the FDA?
Young Prophy System, PS Unit (K903284) received a 510(k) decision of Substantially Equivalent on December 17, 1990, 148 days after the submission was received.
What is the product code of K903284?
The FDA product code is KOJ – Airbrush, a Class II (moderate risk) device regulated under 21 CFR 872.6080.