Manufacturer registered with FDA
Roott LLC
Tamarac, FL, United States. Lists 2 dental device types with FDA across 1 registered establishment, and holds 1 510(k) clearance as applicant.
- Device types listed
- 2
- Brands and models
- 4
- 510(k) clearances
- 12022–2022
- Markets registered in
- 344 registrations outside the US
- Establishments
- 1United States
510(k) clearances per year, 2007–2026
Registered in 3 markets
Where regulators' registries name Roott 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 | Roott LLC | 1 clearances | 2022–2022 | Below |
| European Union | EUDAMED | Manufacturer | TRATE AGROOTT AG | 35 | — | Pure Global AI |
| Saudi Arabia | SFDA | Manufacturer | TRATE AG | 9 | — | 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 Roott 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 |
|---|---|---|---|---|
| Root-Form Endosseous ImplantDZE · Class 2 | Dental implants | Maker | TRATE DENTAL IMPLANT SYSTEMTRATE DENTAL IMPLANT SYSTEM - ROOT IMPLANT AND ABUTMENT | 2024 |
| Endosseous Dental Implant AbutmentNHA · Class 2 | Implant abutments | Maker | TRATE DENTAL IMPLANT SYSTEMTRATE DENTAL IMPLANT SYSTEM - ROOT IMPLANT AND ABUTMENT | 2024 |
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 |
|---|---|---|
| TRATE LLCFDA reg. 3030690317 | Tamarac, FL, United States | Specification developer |
Other names on FDA records
Trate AG
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10090363). 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.