Manufacturer registered with FDA
Saremco Dental AG
Rebstein, Switzerland. Lists 4 dental device types with FDA across 1 registered establishment, and holds 4 510(k) clearances as applicant.
- Device types listed
- 4
- Brands and models
- 5
- 510(k) clearances
- 42022–2025
- Markets registered in
- 942 registrations outside the US
- Establishments
- 1Switzerland
510(k) clearances per year, 2007–2026
Registered in 9 markets
Where regulators' registries name Saremco Dental AG 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 | Saremco Dental AG | 4 clearances | 2022–2025 | Below |
| Canada | Health Canada | Registration holder | SAREMCO DENTAL AG | 24 | 2012–2025 | Pure Global AI |
| Australia | TGA | Manufacturer | Saremco Dental AG | 5 | 2020–2026 | Pure Global AI |
| Egypt | EDA | Manufacturer | Saremco Dental AG, | 4 | 2026–2026 | Pure Global AI |
| United Kingdom | MHRA | Manufacturer | Saremco Dental AG | 3 | — | Pure Global AI |
| European Union | EUDAMED | Manufacturer | Saremco Dental AG | 2 | — | Pure Global AI |
| Israel | AMAR | Manufacturer | SAREMCO DENTAL AG | 2 | — | Pure Global AI |
| Serbia | ALIMS | Manufacturer | SAREMCO DENTAL AG | 1 | 2024–2024 | Pure Global AI |
| Taiwan | TFDA | Manufacturer | SAREMCO Dental AG | 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 Saremco Dental AG currently lists, by FDA device type, with the brand and model names on the listing.
| Device type | Category | Role | Brands and models | Listed since |
|---|---|---|---|---|
| Resin Tooth Shade MaterialEBF · Class 2 | Dental composites | Maker | els extra low shrinkage® compositesaremco print Crowntec | 2022 |
| Resin Temporary Crown and BridgeEBG · Class 2 | Temporary crown & bridge materials | Maker | saremco print Crowntec | 2022 |
| Resin Tooth Bonding AgentKLE · Class 2 | Bonding agents | Maker | els unibond | 2026 |
| Resin Denture Tooth Preformed Additively ManufacturedPZY · Class 2 | Denture resins & teeth | Maker | saremco print Crowntec | 2022 |
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 Saremco Dental AG as the applicant.
| Decided | 510(k) | Device | Device type |
|---|---|---|---|
| 5 Dec 2025 | K252151 | els unibond | KLE Resin Tooth Bonding Agent |
| 27 Jun 2024 | K240823 | els extra low shrinkage® composite & els extra low shrinkage® flow | EBF Resin Tooth Shade Material |
| 14 Nov 2023 | K232050 | saremco print BRIDGETEC | EBF Resin Tooth Shade Material |
| 21 Jan 2022 | K213343 | Saremco Print CROWNTEC | EBF Resin Tooth Shade Material |
Some of these clearances are listed with FDA today by another company: Vertex-Dental B.V. (1).
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| SAREMCO DENTAL AGFDA reg. 3008582054 | 9445 Rebstein Sankt Gallen, Switzerland | Complaint file establishment, Manufacturer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10084365). 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.