Data / Medical devices / System, X-Ray, Extraoral Source, Digital / United States
FDA-registered makers of System, X-Ray, Extraoral Source, Digital in the United States: 14 establishments
14 establishments in the United States are registered with the FDA to make System, X-Ray, Extraoral Source, Digital (product code MUH). 14 have a 510(k) clearance or PMA approval on file and 1 has a recall event. FDA data exported November 2, 2026.
SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.
- Device
- System, X-Ray, Extraoral Source, Digital
- Product code
- MUH
- Country
- United States
Makers of System, X-Ray, Extraoral Source, Digital in the United States
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Carestream Dental LLC | Atlanta, GA, United States | Complaint file establishment, Specification developer | 3 | June 22, 2012 | 0 | 0 | 0 | api.fda.gov |
| Air Techniques, Inc. | Melville, NY, United States | Manufacturer | 2 | August 21, 2019 | 0 | 0 | 0 | api.fda.gov |
| Dentsply LLC | York, PA, United States | Complaint file establishment, Manufacturer | 2 | April 20, 2011 | 0 | 0 | 0 | api.fda.gov |
| Dental Imaging Technologies Corporation | Quakertown, PA, United States | Complaint file establishment, Manufacturer | 2 | November 21, 2023 | 0 | 2 | 0 | api.fda.gov |
| Jazz Imaging | San Jose, CA, United States | Manufacturer | 2 | December 10, 2021 | 0 | 0 | 0 | api.fda.gov |
| Midmark Corporation | Versailles, OH, United States | Manufacturer | 2 | November 22, 2011 | 0 | 0 | 0 | api.fda.gov |
| Cleartooth Electronics, Inc. | Boulder, CO, United States | Manufacturer | 1 | December 30, 2003 | 0 | 0 | 0 | api.fda.gov |
| Cyber Medical Imaging, Inc. | Los Angeles, CA, United States | Complaint file establishment, Manufacturer | 1 | December 13, 2001 | 0 | 0 | 0 | api.fda.gov |
| Handpiece Headquarters - HPR Inc. | Placentia, CA, United States | Manufacturer, Specification developer | 1 | August 31, 2022 | 0 | 0 | 0 | api.fda.gov |
| Qpix Solutions, Inc. | Morrisville, NC, United States | Manufacturer | 1 | November 10, 2025 | 0 | 0 | 0 | api.fda.gov |
| SMK Imaging LLC | Elmsford, NY, United States | Manufacturer | 1 | December 27, 2012 | 0 | 0 | 0 | api.fda.gov |
| Sota Cloud Corporation | Orange, CA, United States | Manufacturer | 1 | March 3, 2026 | 0 | 0 | 0 | api.fda.gov |
| Sota Precision Optics, Inc. | Orange, CA, United States | Manufacturer | 1 | November 6, 2020 | 0 | 0 | 0 | api.fda.gov |
| Zinnovi Inc. | Schaumburg, IL, United States | Manufacturer | 1 | July 5, 2024 | 0 | 0 | 0 | api.fda.gov |
Updated November 2, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.