Data / Medical devices / United States / Dentimax, Inc
Dentimax, Inc: FDA-registered device maker in Mesa, AZ, United States, 2 510(k) clearances
Dentimax, Inc is registered with the FDA (registration 3007515144) in Mesa, AZ, United States. It lists 1 device type. The FDA files 2 510(k) clearances under its listings, the newest dated April 13, 2022. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3007515144
- Address
- 4700 E Southern Ave, Mesa, AZ, United States, 85206
- Owner or operator
- DentiMax LLC / Arnett (10030840)
- Roles
- Repackager or relabeler
- First device listed
- November 17, 2009
- Registered through
- 2026
- Brand names listed
- DentiMax, OpenSensor
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| System, X-Ray, Extraoral Source, Digital | MUH | 2 | Repackager or relabeler | 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 |
|---|---|---|---|---|---|---|
| April 13, 2022 | K220556 | OpenSensorX Series | MUH | Substantially Equivalent | Dentimax, Inc. | accessdata.fda.gov |
| October 30, 2009 | K092547 | DENTIMAX DIGITAL X-RAY IMAGING SYSTEM SENSOR SIZE 1, 2, DENTIMAX USB CONTROL BOX | MUH | Substantially Equivalent | Dentimax | accessdata.fda.gov |
Compare with other makers
Updated April 13, 2022. 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.