Manufacturer registered with FDA
FFDM Tivoly
BOURGES CEDEX, France. Lists 5 dental device types with FDA across 1 registered establishment.
- Device types listed
- 5
- Brands and models
- 9
- 510(k) clearances
- 0as applicant
- Markets registered in
- 610 registrations outside the US
- Establishments
- 1France
Registered in 6 markets
Where regulators' registries name FFDM Tivoly 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 | FFDM Tivoly | 5 device types | — | Below |
| South Korea | MFDS | Manufacturer | FFDM TIVOLY | 3 | 2000–2019 | Pure Global AI |
| European Union | EUDAMED | Manufacturer | FFDM TIVOLY | 2 | — | Pure Global AI |
| Israel | AMAR | Manufacturer | FFDM TIVOLYFFDM-TIVOLY | 2 | — | Pure Global AI |
| Peru | DIGEMID | Manufacturer | FFDM-TIVOLY | 2 | 2012–2022 | Pure Global AI |
| Colombia | INVIMA | Manufacturer | FFDM TIVOLY | 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 FFDM Tivoly currently lists, by FDA device type, with the brand and model names on the listing.
| Device type | Category | Role | Brands and models | Listed since |
|---|---|---|---|---|
| Endodontic Pulp Canal Filling Material SpreaderEKK · Class 1 | Dental hand instruments | Maker | LenhloPaste Filler TSSpreader, Pulp Canal Filling Material | 1986 |
| Endodontic Pulp Canal ReamerEKP · Class 1 | Endodontic files | Maker | All-Steel Engine ReamerHand Reamer | 1986 |
| Endodontic Pulp Canal FileEKS · Class 1 | Endodontic files | Maker | HEDSTROM FILEK-FILE | 1986 |
| Endosseous Dental Implant AccessoriesNDP · Class 1 | Implant instruments & surgical kits | Maker | — | 2025 |
| Fixture Mount KitNYE · Class 1 | Implant instruments & surgical kits | Maker | Dental Fixture Mount KitUniversal Post Remover | 2012 |
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 |
|---|---|---|
| FFDM TIVOLYFDA reg. 8023007 | BOURGES CEDEX Centre-Val de Loire, France | Contract manufacturer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 8023007). 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.