Manufacturer registered with FDA
Soadco, S.L.
ESCALDES-ENGORDANY, Andorra. Lists 3 dental device types with FDA across 1 registered establishment, and holds 9 510(k) clearances as applicant.
- Device types listed
- 3
- Brands and models
- 19
- 510(k) clearances
- 92002–2023
- Markets registered in
- 3119 registrations outside the US
- Establishments
- 1Andorra
510(k) clearances per year, 2000–2026
Registered in 3 markets
Where regulators' registries name Soadco, 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 | Soadco, S.L. | 9 clearances | 2002–2023 | Below |
| Saudi Arabia | SFDA | Manufacturer | SOADCO, S.L. | 71 | — | Pure Global AI |
| European Union | EUDAMED | Manufacturer | SOADCO, S.L. | 48 | — | 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 Soadco, 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 | KLOCKNER ABUTMENTSKlockner Dental Implant AbutmentsKlockner Dental Implant Abutments (II)Klockner Vega Dental Implant SystemKlockner Vega TiBase for CEREC® | 2013 |
| Root-Form Endosseous ImplantDZE · Class 2 | Dental implants | Maker | Essential Cone (EC)Essential ECKEssential Solid (ES)KLOCKNER DENTAL IMPLANT S3KLOCKNER DENTAL IMPLANTS S3M FAMILKlockner Essential dental implantsKlockner Essential Implant SystemKlockner Vega Dental Implant SystemModel Essential Cone 1.5NK2 3 moreS4S6SK2 | 2004 |
| Endosseous Dental Implant AccessoriesNDP · Class 1 | Implant instruments & surgical kits | Maker | VARIOUS TYPES OF ACCE | 2006 |
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 Soadco, S.L. as the applicant.
| Decided | 510(k) | Device | Device type |
|---|---|---|---|
| 24 Apr 2023 | K230103 | Klockner Abutments | NHA Endosseous Dental Implant Abutment |
| 16 Nov 2017 | K170022 | Klockner Vega TiBase for CEREC | NHA Endosseous Dental Implant Abutment |
| 8 Apr 2016 | K153098 | KLOCKNER VEGA DENTAL IMPLANT SYSTEM | DZE Root-Form Endosseous Implant |
| 29 Jan 2016 | K151194 | KLOCKNER DENTAL IMPLANT ABUTMENTS (II) | NHA Endosseous Dental Implant Abutment |
| 19 Jul 2013 | K122988 | KLOCKNER DENTAL IMPLANT ABUTMENTS | NHA Endosseous Dental Implant Abutment |
| 25 Nov 2008 | K082200 | KLOCKNER ESSENTIAL DENTAL IMPLANTS SYSTEM, MODEL ESSENTIAL CONE 1.5 | DZE Root-Form Endosseous Implant |
| 3 Jul 2008 | K080224 | KLOCKNER ESSENTIAL DENTAL IMPLANTS SYSTEM, MODELS ESSENTIAL CONE (EC), ESSENTIAL SOLID (ES) AND ECK | DZE Root-Form Endosseous Implant |
| 30 Jan 2006 | K052654 | KLOCKNER DENTAL IMPLANT, MODEL S3M | DZE Root-Form Endosseous Implant |
| 4 Jun 2002 | K010132 | KLOCKNER DENTAL IMPLANTS, MODELS SK, NK, IK, S3, AND S4 | DZE Root-Form Endosseous Implant |
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| SOADCO, S.L.FDA reg. 9617542 | ESCALDES-ENGORDANY, Andorra | Manufacturer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 9044378). 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.