MUHClass II
System, X-Ray, Extraoral Source, Digital
21 CFR 872.1800 / Dental
MUH is the FDA product code for System, X-Ray, Extraoral Source, Digital, a class II device type, regulated under 21 CFR 872.1800. As of , FDA records hold 206 510(k) clearances under this code, the most recent dated , and 9 recalls.
Classification record
- Product code
- MUH
- Device name
- System, X-Ray, Extraoral Source, Digital
- 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
- 206
- Ingested recalls
- 9
Clearances, product code MUH
By decision yearShow the numbers
| Year | Clearances |
|---|---|
| 1998 | 3 |
| 1999 | 6 |
| 2000 | 6 |
| 2001 | 6 |
| 2002 | 6 |
| 2003 | 5 |
| 2004 | 8 |
| 2005 | 2 |
| 2006 | 15 |
| 2007 | 11 |
| 2008 | 8 |
| 2009 | 9 |
| 2010 | 9 |
| 2011 | 10 |
| 2012 | 9 |
| 2013 | 9 |
| 2014 | 8 |
| 2015 | 12 |
| 2016 | 6 |
| 2017 | 9 |
| 2018 | 3 |
| 2019 | 5 |
| 2020 | 5 |
| 2021 | 10 |
| 2022 | 7 |
| 2023 | 11 |
| 2024 | 4 |
| 2025 | 3 |
| 2026 | 1 |
Applicants with the most clearances
Product code MUH| Applicant | Clearances |
|---|---|
| Vatech Co., Ltd. | 8 |
| Genoray Co., Ltd. | 7 |
| Sirona Dental Systems GmbH | 7 |
| Palodex Group Oy | 6 |
| Trophy | 6 |
| Planmeca Oy | 5 |
| Schick Technologies, Inc. | 5 |
| Soredex Palodex Group Oy | 5 |
| Cefla S.C. | 4 |
| Dexcowin Co., Ltd. | 4 |
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.
