Manufacturer registered with FDA
Implacil DE Bortoli Material Odontologico Ltda
Sao Paulo, Brazil. Lists 3 dental device types with FDA across 1 registered establishment, and holds 2 510(k) clearances as applicant.
- Device types listed
- 3
- Brands and models
- 6
- 510(k) clearances
- 22020–2021
- Markets registered in
- 21 registrations outside the US
- Establishments
- 1Brazil
510(k) clearances per year, 2007–2026
Registered in 2 markets
Where regulators' registries name Implacil DE Bortoli Material Odontologico Ltda 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 | Implacil DE Bortoli Material Odontologico Ltda | 2 clearances | 2020–2021 | Below |
| Colombia | INVIMA | Manufacturer | IMPLACIL DE BORTOLI MATERIAL ODONTOLÓGICO LTDA. | 1 | — | 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 Implacil DE Bortoli Material Odontologico Ltda 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 | Abutment, Implant, Dental, Endosseous - Implacil Implant SystemImplacil Implant SystemImplant, Endosseous, Root-Form - Implacil Implant System | 2020 |
| Endosseous Dental Implant AccessoriesNDP · Class 1 | Implant instruments & surgical kits | Maker | Accessories, Implant, Dental, Endosseous - Accessories, Implant, Dental, Endosseous | 2019 |
| Endosseous Dental Implant AbutmentNHA · Class 2 | Implant abutments | Maker | Abutment, Implant, Dental, Endosseous - Implacil Implant SystemImplant, Endosseous, Root-Form - Implacil Implant System | 2020 |
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 |
|---|---|---|
| IMPLACIL DE BORTOLI MATERIAL ODONTOLOGICO LTDAFDA reg. 3015775866 | Sao Paulo, Brazil | Manufacturer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10061070). 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.