Data / Medical devices / Switzerland / Saremco Dental AG
Saremco Dental AG: FDA-registered device maker in 9445 Rebstein Sankt Gallen, Switzerland, 3 510(k) clearances
Saremco Dental AG is registered with the FDA (registration 3008582054) in 9445 Rebstein Sankt Gallen, Switzerland. It lists 4 device types. The FDA files 3 510(k) clearances under its listings, the newest dated December 5, 2025. Registered through 2026. FDA data exported November 3, 2026.
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- FDA registration number
- 3008582054
- Address
- Gewerbestrasse 4, 9445 Rebstein Sankt Gallen, Switzerland, Rebstein
- Owner or operator
- Saremco Dental AG (10084365)
- Roles
- Complaint file establishment, Manufacturer
- First device listed
- February 14, 2022
- Registered through
- 2026
- Brand names listed
- els extra low shrinkage® composite, els unibond, saremco print Crowntec
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Additively Manufactured, Preformed, Resin Denture Tooth | PZY | 2 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| Agent, Tooth Bonding, Resin | KLE | 2 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| Crown And Bridge, Temporary, Resin | EBG | 2 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| Material, Tooth Shade, Resin | EBF | 2 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| December 5, 2025 | K252151 | els unibond | KLE | Substantially Equivalent | Saremco Dental AG | accessdata.fda.gov |
| June 27, 2024 | K240823 | els extra low shrinkage® composite & els extra low shrinkage® flow | EBF | Substantially Equivalent | Saremco Dental AG | accessdata.fda.gov |
| January 21, 2022 | K213343 | Saremco Print CROWNTEC | EBF | Substantially Equivalent | Saremco Dental AG | accessdata.fda.gov |
Compare with other makers
- All makers of Agent, Tooth Bonding, Resin
- All makers of Additively Manufactured, Preformed, Resin Denture Tooth
- All makers of Material, Tooth Shade, Resin
- All makers of Crown And Bridge, Temporary, Resin
Updated December 5, 2025. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.