Manufacturer registered with FDA
LASAK s.r.o.
Praha 9, Czechia. Lists 1 dental device type with FDA across 1 registered establishment.
- Device types listed
- 1
- Brands and models
- 1
- 510(k) clearances
- 0as applicant
- Markets registered in
- 5109 registrations outside the US
- Establishments
- 1Czechia
Registered in 5 markets
Where regulators' registries name LASAK s.r.o. 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 | LASAK s.r.o. | 1 device types | — | Below |
| European Union | EUDAMED | Manufacturer | LASAK s.r.o. | 100 | — | Pure Global AI |
| Taiwan | TFDA | Manufacturer | LASAK s.r.o.LASAK S.R.O. | 5 | 2010–2017 | Pure Global AI |
| Colombia | INVIMA | Registration holder | LASAK, S.L. | 3 | — | Pure Global AI |
| South Korea | MFDS | Manufacturer | LASAK s.r.o. | 1 | 2013–2013 | 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 LASAK s.r.o. currently lists, by FDA device type, with the brand and model names on the listing.
| Device type | Category | Role | Brands and models | Listed since |
|---|---|---|---|---|
| Endosseous Dental Implant AbutmentNHA · Class 2 | Implant abutments | Maker | GenTek | 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 |
|---|---|---|
| LASAK S.R.O.FDA reg. 3010869261 | Praha 9 Praha, Hlavni Mesto, Czechia | Contract manufacturer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10090808). 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.