EKXClass I
Handpiece, Direct Drive, Ac-Powered
21 CFR 872.4200 / Dental
EKX is the FDA product code for Handpiece, Direct Drive, Ac-Powered, a class I device type, regulated under 21 CFR 872.4200. As of , FDA records hold 89 510(k) clearances under this code, the most recent dated , and no recalls.
Classification record
- Product code
- EKX
- Device name
- Handpiece, Direct Drive, Ac-Powered
- Regulation
- 21 CFR 872.4200
- Device class
- Class I
- Review panel
- Dental
- Submission type
- 510(k)
- Implant
- No
- Life sustaining or supporting
- No
- GMP exempt
- No
- Third party review eligible
- Yes
- Ingested clearances
- 90
- Ingested recalls
- 0
Clearances, product code EKX
By decision yearShow the numbers
| Year | Clearances |
|---|---|
| 1976 | 1 |
| 1978 | 1 |
| 1980 | 1 |
| 1982 | 2 |
| 1983 | 1 |
| 1987 | 2 |
| 1991 | 1 |
| 1992 | 1 |
| 1993 | 1 |
| 1994 | 1 |
| 1997 | 1 |
| 1998 | 1 |
| 1999 | 4 |
| 2001 | 2 |
| 2003 | 4 |
| 2004 | 3 |
| 2005 | 2 |
| 2006 | 2 |
| 2007 | 1 |
| 2008 | 3 |
| 2009 | 4 |
| 2010 | 3 |
| 2011 | 4 |
| 2012 | 2 |
| 2013 | 2 |
| 2014 | 3 |
| 2015 | 3 |
| 2016 | 3 |
| 2017 | 2 |
| 2018 | 3 |
| 2019 | 3 |
| 2020 | 1 |
| 2021 | 5 |
| 2022 | 3 |
| 2023 | 4 |
| 2024 | 4 |
| 2025 | 5 |
| 2026 | 1 |
Applicants with the most clearances
Product code EKX| Applicant | Clearances |
|---|---|
| J. Morita USA, Inc. | 6 |
| Aseptico, Inc. | 5 |
| Osstell AB | 4 |
| Perimetrics, Inc | 3 |
| Saeshin Precision Co., Ltd. | 3 |
| W & H DentalWerk Buermoos GmbH | 3 |
| Advanced Technology Research (A.T.R.) S.r.l. | 2 |
| Chiron Vision Corp. | 2 |
| Dentsply Sirona Inc | 2 |
| Guilin Woodpecker Medical Instrument Co., Ltd | 2 |
Companies listing this code with FDA
Companies whose registered establishments list this codeFIRST ARTICLE / WEEKLY
What cleared, what was recalled, and what changed in the standards. One edition a week for the people who make medical devices.