Registered with FDA
DentiMax LLC / Arnett
Mesa, AZ, United States. Lists 1 dental device type with FDA across 1 registered establishment, and holds 3 510(k) clearances as applicant.
- Device types listed
- 1
- Brands and models
- 2
- 510(k) clearances
- 32009–2025
- Markets registered in
- 25 registrations outside the US
- Establishments
- 1United States
510(k) clearances per year, 2000–2026
Registered in 2 markets
Where regulators' registries name DentiMax LLC / Arnett as the manufacturer or the registration holder of a device.
| Market | Regulator | Named as | Name on the registry | Registrations | Issued | Records |
|---|---|---|---|---|---|---|
| United States | FDA | Lister | DentiMax LLC / Arnett | 3 clearances | 2009–2025 | Below |
| Canada | Health Canada | Registration holder | DENTIMAX | 5 | 2024–2026 | Pure Global AI |
Outside the US the count is of all the company's device registrations in that market, dental or not · matched by company name and country · registry data read 12 Nov 2026
Devices listed with FDA
What DentiMax LLC / Arnett currently lists, by FDA device type, with the brand and model names on the listing.
| Device type | Category | Role | Brands and models | Listed since |
|---|---|---|---|---|
| Digital Extraoral Source X-Ray SystemMUH · Class 2 | Dental X-ray units | Lister | DentiMaxOpenSensor | 2009 |
Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026
510(k) clearances
Clearances on which FDA names DentiMax LLC / Arnett as the applicant, including filings under its other names.
| Decided | 510(k) | Device | Device type |
|---|---|---|---|
| 24 Sep 2025 | K251206 | Digital X-Ray DentiMax Pro Imaging System | MUH Digital Extraoral Source X-Ray System |
| 13 Apr 2022 | K220556 | OpenSensorX Series | MUH Digital Extraoral Source X-Ray System |
| 30 Oct 2009 | K092547 | DENTIMAX DIGITAL X-RAY IMAGING SYSTEM SENSOR SIZE 1, 2, DENTIMAX USB CONTROL BOX | MUH Digital Extraoral Source X-Ray System |
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| DENTIMAX, INCFDA reg. 3007515144 | Mesa, AZ, United States | Repacker / relabeler |
Other names on FDA records
Dentimax
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10030840). FDA 510(k) premarket notification file. FDA data as of 2 Nov 2026; snapshot 12 Nov 2026. The location shown is the address on FDA's record.