Manufacturer registered with FDA
Polydentia S.A.
Mezzovico- Vira, Switzerland. Lists 4 dental device types with FDA across 1 registered establishment.
- Device types listed
- 4
- Brands and models
- 67
- 510(k) clearances
- 0as applicant
- Markets registered in
- 12176 registrations outside the US
- Establishments
- 1Switzerland
Registered in 12 markets
Where regulators' registries name Polydentia S.A. 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 | Polydentia S.A. | 4 device types | — | Below |
| European Union | EUDAMED | Registration holder | Polydentia SA | 63 | — | Pure Global AI |
| Serbia | ALIMS | Manufacturer | Polydentia SA | 33 | 2023–2024 | Pure Global AI |
| South Korea | MFDS | Manufacturer | POLYDENTIA SAPolydentia SA | 29 | 1999–2026 | Pure Global AI |
| Brazil | ANVISA | Manufacturer | POLYDENTIA SA | 23 | 2019–2025 | Pure Global AI |
| United Kingdom | MHRA | Manufacturer | POLYDENTIA SA | 10 | — | Pure Global AI |
| Saudi Arabia | SFDA | Manufacturer | POLYDENTIA SA | 5 | — | Pure Global AI |
| Taiwan | TFDA | Manufacturer | POLYDENTIA SA | 5 | 2006–2026 | Pure Global AI |
| Peru | DIGEMID | Manufacturer | POLYDENTIA SAPOLYDENTIA S.A. | 3 | 2024–2024 | Pure Global AI |
| Australia | TGA | Manufacturer | Polydentia SA | 2 | 2026–2026 | Pure Global AI |
| Israel | AMAR | Manufacturer | POLYDENTIA SAPolydentia SA | 2 | — | Pure Global AI |
| China | NMPA | Registration holder | POLYDENTIA SA 保利登特股份公司 | 1 | — | 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 Polydentia S.A. currently lists, by FDA device type, with the brand and model names on the listing.
| Device type | Category | Role | Brands and models | Listed since |
|---|---|---|---|---|
| Dental Hand InstrumentsDZN · Class 1 | Dental hand instruments | Maker | API autoclavable placement instrumentclip&SplintCotton Roll HolderDiamond 24Endo-StopsHemo-WedgeID-RingsInterdental Wood WedgesJunior LumiContrast Sectional MatricesJunior Quickmat sectional matrices 42 moreLumiContrastMacro-WedgesMatricesMaxi ID-RingsMaximat PlusmyClip 2myClip JuniormyForcepsmyJunior KitmyQuickmat All-round introkitmyQuickmat classico kitmyQuickmat Classico starter kitmyQuickmat Forte starter kitmyQuickmat Prime kitmyQuickmatrix forcepsmyRing classicomyRing JuniormyRing PrimemyTines GOmyTines Junior RefillmyTines Large RefillmyTines Medium RefillmyTines PrimemyTines RefillmyTines Small RefillmyWedgeQuickmat All-roundQuickmat Deluxe KitQuickmat PrimeQuickmatFITQuickmatFLEXQuickring ForcepsStop-CardThe WedgeUnica anterior introkitUnica anterior matricesUnica master kitUnica minideep anteriorUnica ProximalUnica Proximal DeepWedges3wedge | 1996 |
| Rebasing Repairing Relining Denture ResinEBI · Class 2 | Denture resins & teeth | Maker | F-Splint-AidF-Splint-Aid SlimFiber-BondFiber-PlastFiber-SplintFiber-Splint Lab BridgeFiber-Splint Lab RetFiber-Splint Lab- SystemFiber-Splint ML Mini Starter KitFiber-Splint ML Multy-Layer 2 moreFiber-Splint OrthoFiber-Splint Ortho Evolution | 2007 |
| Abrasive PointEHL · Class 1 | Polishing & prophylaxis | Maker | Abrasive Polishing StripTria-Shine | 2009 |
| Root Canal PostELR · Class 1 | Root canal filling materials | Maker | Polydentia GF Posts | 2009 |
Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026
Also lists devices cleared under other names
Polydentia S.A. lists these devices with FDA today. The clearance names a different applicant, as happens after a rename, an acquisition or a private-label agreement.
Original applicants: Polydentia USA (1), Parker Laboratories, Inc. (1).
| Decided | 510(k) | Device | Applicant | Device type |
|---|---|---|---|---|
| 22 Jul 1996 | K962374 | FIBER-SPLINT ML MULTILAYER | Polydentia USA | EBI Rebasing Repairing Relining Denture Resin |
| 17 Jan 1980 | K790555 | HEMO-WEDGE | Parker Laboratories, Inc. | DZN Dental Hand Instruments |
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| POLYDENTIA S.A.FDA reg. 8031054 | MEZZOVICO-Vira Ticino, Switzerland | Manufacturer, Repacker / relabeler |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 9076845). 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.