Manufacturer registered with FDA
Ziacom Medical, S.L.
Pinto, Spain. Lists 5 dental device types with FDA across 1 registered establishment, and holds 1 510(k) clearance as applicant.
- Device types listed
- 5
- Brands and models
- 13
- 510(k) clearances
- 12019–2019
- Markets registered in
- 367 registrations outside the US
- Establishments
- 1Spain
510(k) clearances per year, 2007–2026
Registered in 3 markets
Where regulators' registries name Ziacom Medical, S.L. 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 | Ziacom Medical, S.L. | 1 clearances | 2019–2019 | Below |
| European Union | EUDAMED | Manufacturer | Ziacom Implants SLU | 64 | — | Pure Global AI |
| Colombia | INVIMA | Registration holder | ZIACOM MEDICAL, SL. | 3 | — | 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 Ziacom Medical, S.L. 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 | CORVENZiacom ZinicZiacom Zinic MTZiacom Zinic MTXZiacom Zinic SX | 2020 |
| Abrasive DiskEHJ · Class 1 | Polishing & prophylaxis | Lister | JOTA | 2025 |
| Dental BurEJL · Class 1 | Dental burs & diamonds | Maker | Ziacom | 2017 |
| Endosseous Dental Implant AccessoriesNDP · Class 1 | Implant instruments & surgical kits | Maker | Ziacom Instruments | 2020 |
| Endosseous Dental Implant AbutmentNHA · Class 2 | Implant abutments | Maker | CORVENZiacom ZinicZiacom Zinic MTZiacom Zinic MTXZiacom Zinic SX | 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 |
|---|---|---|
| ZIACOM IMPLANTS SLUFDA reg. 3013547803 | Pinto Madrid(Province), Spain | Complaint file establishment, Foreign exporter, Manufacturer |
Other names on FDA records
Ziacom Implants SLU
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10054858). 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.