Manufacturer registered with FDA
Ototronix, LLC
Saint Paul, MN, United States. Lists 1 dental device type with FDA across 1 registered establishment, and holds 1 510(k) clearance as applicant.
- Device types listed
- 1
- Brands and models
- 1
- 510(k) clearances
- 12014–2014
- Markets registered in
- 37 registrations outside the US
- Establishments
- 1United States
510(k) clearances per year, 2007–2026
Registered in 3 markets
Where regulators' registries name Ototronix, LLC 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 | Ototronix, LLC | 1 clearances | 2014–2014 | Below |
| Colombia | INVIMA | Registration holder | OTOTRONIX, LLCOTOTRONIX LLC | 4 | — | Pure Global AI |
| Canada | Health Canada | Registration holder | OTOTRONIX LLC | 3 | 2007–2014 | 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 Ototronix, LLC currently lists, by FDA device type, with the brand and model names on the listing.
| Device type | Category | Role | Brands and models | Listed since |
|---|---|---|---|---|
| Nose and Throat Ear CementNEA · Class 2 | — | Maker | ProCem | 2014 |
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 |
|---|---|---|
| Ototronix, LLC (Minnesota)FDA reg. 3012118649 | White Bear Township, MN, United States | Manufacturer |
Other names on FDA records
Ototronix, LLC (Minnesota)
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10031730). 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.