Data / Medical devices / United States / Dental Monitoring
Dental Monitoring: FDA-registered device maker in Austin, TX, United States, 1 510(k) clearance
Dental Monitoring is registered with the FDA (registration 3016367529) in Austin, TX, United States. It lists 4 device types. The FDA files 1 510(k) clearance under its listings, the newest dated May 17, 2024. Registered through 2026. FDA data exported November 3, 2026.
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- FDA registration number
- 3016367529
- Address
- 10801 N Mopac Expy, Austin, TX, United States, 78759
- Owner or operator
- Dental Monitoring (10052763)
- Roles
- Complaint file establishment
- First device listed
- October 5, 2016
- Registered through
- 2026
- Brand names listed
- DM Cheek Retractor, DM ScanBox, DentalMonitoring, LED Adapter, ScanBox pro
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Accessories, Retractor, Dental | EIF | 1 | Complaint file establishment | accessdata.fda.gov |
| Dental Image Analyzer | SBC | 2 | Complaint file establishment | accessdata.fda.gov |
| Light, Operating, Dental | EAZ | 1 | Complaint file establishment | accessdata.fda.gov |
| Retractor, All Types | EIG | 1 | Complaint file establishment | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| May 17, 2024 | DEN230035 | DentalMonitoring | SBC | Unknown | Dental Monitoring Sas | accessdata.fda.gov |
Compare with other makers
- All makers of Accessories, Retractor, Dental
- All makers of Light, Operating, Dental
- All makers of Retractor, All Types
Updated May 17, 2024. 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.