Registered with FDA
MEDEALIS GmbH
Abtsteinach, Germany. Lists 3 dental device types with FDA across 1 registered establishment.
- Device types listed
- 3
- Brands and models
- 3
- 510(k) clearances
- 0as applicant
- Markets registered in
- 664 registrations outside the US
- Establishments
- 1Germany
Registered in 6 markets
Where regulators' registries name MEDEALIS GmbH as the manufacturer or the registration holder of a device.
| Market | Regulator | Named as | Name on the registry | Registrations | Issued | Records |
|---|---|---|---|---|---|---|
| United States | FDA | Lister | MEDEALIS GmbH | 3 device types | — | Below |
| United Kingdom | MHRA | Manufacturer | MEDEALIS GmbH | 24 | — | Pure Global AI |
| Australia | TGA | Manufacturer | Medealis GmbH | 16 | 2024–2026 | Pure Global AI |
| European Union | EUDAMED | Registration holder | MEDEALIS GmbH | 13 | — | Pure Global AI |
| Serbia | ALIMS | Manufacturer | MEDEALIS GmbH | 8 | 2024–2024 | Pure Global AI |
| South Korea | MFDS | Manufacturer | Medealis GmbH^(주)메가젠임플란트Medealis GmbH | 3 | 2024–2025 | 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 MEDEALIS GmbH 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 | Lister | DESS Dental Smart Solutions | 2025 |
| Root-Form Endosseous ImplantDZE · Class 2 | Dental implants | Lister | DESS Dental Smart Solutions | 2025 |
| Endosseous Dental Implant AccessoriesNDP · Class 1 | Implant instruments & surgical kits | Lister | DESS Dental Smart Solutions | 2025 |
Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026
Also lists devices cleared under other names
MEDEALIS GmbH lists these devices with FDA today. The clearance names a different applicant, as happens after a rename, an acquisition or a private-label agreement.
Original applicants: Terrats Medical, S.L. (8).
| Decided | 510(k) | Device | Applicant | Device type |
|---|---|---|---|---|
| 16 Apr 2026 | K253804 | DESS Dental Smart Solutions | Terrats Medical, S.L. | NHA Endosseous Dental Implant Abutment |
| 31 Oct 2025 | K251547 | DESS Dental Smart Solutions | Terrats Medical, S.L. | NHA Endosseous Dental Implant Abutment |
| 23 Jul 2025 | K251280 | DESS® Dental Implants | Terrats Medical, S.L. | DZE Root-Form Endosseous Implant |
| 5 Nov 2024 | K242340 | DESS Dental Smart Solutions | Terrats Medical, S.L. | NHA Endosseous Dental Implant Abutment |
| 27 Oct 2022 | K222288 | DESS Dental Smart Solutions | Terrats Medical, S.L. | NHA Endosseous Dental Implant Abutment |
| 11 Mar 2022 | K212628 | DESS Dental Smart Solutions | Terrats Medical, S.L. | NHA Endosseous Dental Implant Abutment |
| 10 Nov 2019 | K191986 | DESS Dental Smart Solutions | Terrats Medical, S.L. | NHA Endosseous Dental Implant Abutment |
| 8 Aug 2017 | K170588 | DESS Dental Smart Solutions | Terrats Medical, S.L. | NHA Endosseous Dental Implant Abutment |
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| MEDEALIS GMBHFDA reg. 3017064961 | Abtsteinach Hesse, Germany | Foreign exporter |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10094093). 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.