Manufacturer registered with FDA
Pro-Dex Inc
Irvine, CA, United States. Lists 1 dental device type with FDA across 2 registered establishments.
- Device types listed
- 1
- Brands and models
- 1
- 510(k) clearances
- 0as applicant
- Markets registered in
- 998 registrations outside the US
- Establishments
- 2United States
Registered in 9 markets
Where regulators' registries name Pro-Dex Inc as the manufacturer or the registration holder of a device.
| Market | Regulator | Named as | Name on the registry | Registrations | Issued | Records |
|---|---|---|---|---|---|---|
| United States | FDA | Manufacturer | Pro-Dex Inc | 1 device types | — | Below |
| Canada | Health Canada | Registration holder | PRO-DEX, INC. | 52 | 2002–2024 | Pure Global AI |
| European Union | EUDAMED | Manufacturer | Pro-Dex, Inc. | 22 | — | Pure Global AI |
| United Kingdom | MHRA | Manufacturer | Pro-Dex Inc. | 9 | — | Pure Global AI |
| Australia | TGA | Manufacturer | Pro-Dex Inc | 7 | 2020–2021 | Pure Global AI |
| Israel | AMAR | Manufacturer | Pro-Dex Inc. | 3 | — | Pure Global AI |
| South Korea | MFDS | Manufacturer | PRO-DEX, INC.Pro-Dex, Inc. | 2 | 2021–2026 | Pure Global AI |
| Taiwan | TFDA | Manufacturer | PRO-DEX, INC. | 2 | 2025–2026 | Pure Global AI |
| Hong Kong | MDD | Manufacturer | Pro-Dex, Inc. | 1 | 2026–2026 | 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 Pro-Dex Inc currently lists, by FDA device type, with the brand and model names on the listing.
| Device type | Category | Role | Brands and models | Listed since |
|---|---|---|---|---|
| Periodontic ScalerEMN · Class 1 | Dental hand instruments | Maker | Dynatip P/N 3293 Tip, Cover / Protector | 2021 |
Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| Pro-Dex IncFDA reg. 3024788684 | Tustin, CA, United States | Complaint file establishment, Specification developer |
| PRO-DEX, INC.FDA reg. 2081135 | Irvine, CA, United States | Complaint file establishment, Specification developer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 2081135). 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.