Data / Medical devices / Switzerland / Polydentia S.A.
Polydentia S.A.: FDA-registered device maker in MEZZOVICO-Vira Ticino, Switzerland, 2 510(k) clearances
Polydentia S.A. is registered with the FDA (registration 8031054) in MEZZOVICO-Vira Ticino, Switzerland. It lists 7 device types. The FDA files 2 510(k) clearances under its listings, the newest dated July 22, 1996. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 8031054
- FEI number
- 1000558210
- Address
- Via Cantonale 47, MEZZOVICO-Vira Ticino, Switzerland, 6805
- Owner or operator
- Polydentia S.A. (9076845)
- Roles
- Manufacturer, Repackager or relabeler
- First device listed
- June 17, 1996
- Registered through
- 2026
- Brand names listed
- 3wedge, API autoclavable placement instrument, Abrasive Polishing Strip, Cotton Roll Holder, Diamond 24, Endo-Stops, F-Splint-Aid, F-Splint-Aid Slim and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Accessory, Surgical Apparel | LYU | 1 | Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Dispenser, Liquid Medication | KYX | 1 | Manufacturer | accessdata.fda.gov |
| Instruments, Dental Hand | DZN | 1 | Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Point, Abrasive | EHL | 1 | Manufacturer | accessdata.fda.gov |
| Post, Root Canal | ELR | 1 | Manufacturer | accessdata.fda.gov |
| Resin, Denture, Relining, Repairing, Rebasing | EBI | 2 | Manufacturer | accessdata.fda.gov |
| Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear) | HOY | 1 | 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 |
|---|---|---|---|---|---|---|
| July 22, 1996 | K962374 | FIBER-SPLINT ML MULTILAYER | EBI | Substantially Equivalent | Polydentia USA | accessdata.fda.gov |
| January 17, 1980 | K790555 | HEMO-WEDGE | DZN | Substantially Equivalent | Parker Laboratories, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Instruments, Dental Hand
- All makers of Accessory, Surgical Apparel
- All makers of Dispenser, Liquid Medication
- All makers of Resin, Denture, Relining, Repairing, Rebasing
- All makers of Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear)
- All makers of Post, Root Canal
Updated July 22, 1996. 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.