EHDClass II
Unit, X-Ray, Extraoral With Timer
21 CFR 872.1800 / Dental
EHD is the FDA product code for Unit, X-Ray, Extraoral With Timer, a class II device type, regulated under 21 CFR 872.1800. As of , FDA records hold 190 510(k) clearances under this code, the most recent dated , and 18 recalls.
Classification record
- Product code
- EHD
- Device name
- Unit, X-Ray, Extraoral With Timer
- Regulation
- 21 CFR 872.1800
- Device class
- Class II
- Review panel
- Dental
- Submission type
- 510(k)
- Implant
- No
- Life sustaining or supporting
- No
- GMP exempt
- No
- Third party review eligible
- Yes
- Ingested clearances
- 191
- Ingested recalls
- 18
Clearances, product code EHD
By decision yearShow the numbers
| Year | Clearances |
|---|---|
| 1977 | 1 |
| 1978 | 3 |
| 1980 | 2 |
| 1981 | 1 |
| 1985 | 1 |
| 1986 | 3 |
| 1987 | 4 |
| 1988 | 3 |
| 1989 | 1 |
| 1990 | 1 |
| 1991 | 2 |
| 1992 | 2 |
| 1993 | 7 |
| 1994 | 3 |
| 1995 | 2 |
| 1996 | 7 |
| 1997 | 14 |
| 1998 | 5 |
| 1999 | 7 |
| 2000 | 11 |
| 2001 | 3 |
| 2002 | 6 |
| 2003 | 9 |
| 2004 | 8 |
| 2005 | 8 |
| 2006 | 2 |
| 2007 | 1 |
| 2008 | 5 |
| 2009 | 4 |
| 2010 | 4 |
| 2011 | 3 |
| 2012 | 2 |
| 2013 | 4 |
| 2014 | 3 |
| 2015 | 1 |
| 2016 | 2 |
| 2017 | 4 |
| 2018 | 5 |
| 2019 | 4 |
| 2020 | 2 |
| 2021 | 1 |
| 2022 | 8 |
| 2023 | 8 |
| 2024 | 7 |
| 2025 | 1 |
| 2026 | 6 |
Applicants with the most clearances
Product code EHD| Applicant | Clearances |
|---|---|
| Planmeca Oy | 13 |
| Villa Sistemi Medicali S.p.A. | 7 |
| Digimed Co., Ltd | 6 |
| Trophy Radiologie | 6 |
| Vatech Co., Ltd. | 6 |
| KaVo Dental Technologies, LLC | 5 |
| Dentsply Intl. | 4 |
| Gendex Corp. | 4 |
| Instrumentarium Corp. | 4 |
| Genoray Co., Ltd. | 3 |
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.