Micadent
FDA 510(k) K964059 · Hampton Research
510(k) numberK964059
Submission
- Device name
- Micadent
- Applicant
- Hampton Research
Oklahoma City, OK, US - Received
- October 9, 1996
- Decision date
- December 19, 1996
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Other 510(k)s with product code KOJ
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| 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 |
Questions and answers
When was Micadent cleared by the FDA?
Micadent (K964059) received a 510(k) decision of Substantially Equivalent on December 19, 1996, 71 days after the submission was received.
What is the product code of K964059?
The FDA product code is KOJ – Airbrush, a Class II (moderate risk) device regulated under 21 CFR 872.6080.