Manufacturer registered with FDA
Terrats Medical, S.L.
Barbera del Valles, Spain. Lists 4 dental device types with FDA across 1 registered establishment, and holds 23 510(k) clearances as applicant.
- Device types listed
- 4
- Brands and models
- 9
- 510(k) clearances
- 232017–2026
- Markets registered in
- 10745 registrations outside the US
- Establishments
- 1Spain
510(k) clearances per year, 2007–2026
Registered in 10 markets
Where regulators' registries name Terrats 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 | Terrats Medical, S.L. | 23 clearances | 2017–2026 | Below |
| Canada | Health Canada | Registration holder | TERRATS MEDICAL S.L. | 608 | 2015–2026 | Pure Global AI |
| Serbia | ALIMS | Manufacturer | TERRATS MEDICAL, S.L. | 40 | 2022–2026 | Pure Global AI |
| Australia | TGA | Manufacturer | Terrats Medical SL | 36 | 2013–2026 | Pure Global AI |
| Costa Rica | Ministerio de Salud | Manufacturer | TERRATS MEDICAL S.L.TERRATS MEDICAL, S.L. | 23 | — | Pure Global AI |
| Saudi Arabia | SFDA | Manufacturer | TERRATS MEDICAL SL | 15 | — | Pure Global AI |
| United Kingdom | MHRA | Manufacturer | Terrats Medical S.L. | 15 | — | Pure Global AI |
| Taiwan | TFDA | Manufacturer | TERRATS MEDICAL, SL.Terrats Medical, S.L. | 5 | 2023–2026 | Pure Global AI |
| Israel | AMAR | Manufacturer | TERRATS MEDICAL, S.L.Terrats Medical SL | 2 | — | Pure Global AI |
| Hong Kong | MDD | Manufacturer | TERRATS MEDICAL, S.L. | 1 | 2026–2026 | 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 Terrats 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 |
|---|---|---|---|---|
| Endosseous Dental Implant AbutmentNHA · Class 2 | Implant abutments | Maker | ArgenDESS Dental Smart SolutionsDIRECTarchINTEGRATED DENTAL SYSTEMSTerrats Medical S.L.TERRATS MEDICAL, S.L. | 2017 |
| Dental Abutment Design Software for Dental LaboratoryPNP · Class 2 | Dental design & orthodontic software | Maker | Terrats Medical S.L. | 2023 |
| Root-Form Endosseous ImplantDZE · Class 2 | Dental implants | Maker | Terrats Medical S.L. | 2021 |
| Endosseous Dental Implant AccessoriesNDP · Class 1 | Implant instruments & surgical kits | Maker | DESS Dental Smart Solutions | 2019 |
Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026
510(k) clearances
Clearances on which FDA names Terrats Medical, S.L. as the applicant.
| Decided | 510(k) | Device | Device type |
|---|---|---|---|
| 9 Jun 2026 | K260564 | DESS Dental Smart Solutions | NHA Endosseous Dental Implant Abutment |
| 16 Apr 2026 | K253804 | DESS Dental Smart Solutions | NHA Endosseous Dental Implant Abutment |
| 31 Oct 2025 | K251547 | DESS Dental Smart Solutions | NHA Endosseous Dental Implant Abutment |
| 23 Oct 2025 | K252384 | DESS® Dental Smart Solutions | NHA Endosseous Dental Implant Abutment |
| 23 Jul 2025 | K251280 | DESS® Dental Implants | DZE Root-Form Endosseous Implant |
| 22 May 2025 | K250639 | DESS Dental Smart Solutions | NHA Endosseous Dental Implant Abutment |
| 14 Feb 2025 | K243212 | DESS Dental Smart Solutions | NHA Endosseous Dental Implant Abutment |
| 5 Nov 2024 | K242340 | DESS Dental Smart Solutions | NHA Endosseous Dental Implant Abutment |
| 26 Aug 2024 | K240982 | DESS Dental Smart Solutions | NHA Endosseous Dental Implant Abutment |
| 24 Apr 2024 | K240208 | DESS Dental Smart Solutions | NHA Endosseous Dental Implant Abutment |
| 5 Jan 2024 | K233316 | DESS Dental Smart Solutions | NHA Endosseous Dental Implant Abutment |
| 14 Aug 2023 | K231434 | DESS Dental Smart Solutions | NHA Endosseous Dental Implant Abutment |
| 13 Apr 2023 | K230143 | DESS Dental Smart Solutions | NHA Endosseous Dental Implant Abutment |
| 9 Mar 2023 | K221301 | DESS Dental Smart Solutions | NHA Endosseous Dental Implant Abutment |
| 27 Oct 2022 | K222288 | DESS Dental Smart Solutions | NHA Endosseous Dental Implant Abutment |
| 26 Oct 2022 | K222269 | DESS Dental Smart Solutions | NHA Endosseous Dental Implant Abutment |
| 11 Mar 2022 | K212628 | DESS Dental Smart Solutions | NHA Endosseous Dental Implant Abutment |
| 14 Dec 2021 | K212538 | DESS Dental Implants | DZE Root-Form Endosseous Implant |
| 10 Dec 2021 | K212577 | DESS Dental Smart Solutions | NHA Endosseous Dental Implant Abutment |
| 4 Aug 2021 | K203464 | DESS Dental Smart Solutions | NHA Endosseous Dental Implant Abutment |
| 10 Nov 2019 | K191986 | DESS Dental Smart Solutions | NHA Endosseous Dental Implant Abutment |
| 15 Jun 2018 | K173908 | DESS Dental Smart Solutions | NHA Endosseous Dental Implant Abutment |
| 8 Aug 2017 | K170588 | DESS Dental Smart Solutions | NHA Endosseous Dental Implant Abutment |
Some of these clearances are listed with FDA today by another company: National Dentex LLC (11), Young Innovations Inc (7), Nobel Biocare Services AG (6), Osteon Medical (5), The Argen Corporation (1), Digital Age Dental Laboratories, Ltd. (1).
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| TERRATS MEDICAL, S.L.FDA reg. 3014118611 | Barbera del Valles Barcelona, Spain | Contract manufacturer, Manufacturer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10056484). 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.