Manufacturer registered with FDA
Produits Dentaires SA
VEVEY (SUISSE), Switzerland. Lists 17 dental device types with FDA across 1 registered establishment.
- Device types listed
- 17
- Brands and models
- 29
- 510(k) clearances
- 0as applicant
- Markets registered in
- 11130 registrations outside the US
- Establishments
- 1Switzerland
Registered in 11 markets
Where regulators' registries name Produits Dentaires SA 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 | Produits Dentaires SA | 17 device types | — | Below |
| Saudi Arabia | SFDA | Manufacturer | Produits Dentaires SA | 53 | — | Pure Global AI |
| European Union | EUDAMED | Registration holder | Produits Dentaires SA | 31 | — | Pure Global AI |
| United Kingdom | MHRA | Manufacturer | Produits Dentaires SA | 14 | — | Pure Global AI |
| Taiwan | TFDA | Manufacturer | PRODUITS DENTAIRES S.A.PRODUITS DENTAIRES SA | 11 | 2006–2024 | Pure Global AI |
| Australia | TGA | Manufacturer | Produits Dentaires SA | 8 | 2004–2024 | Pure Global AI |
| South Korea | MFDS | Manufacturer | Produits Dentaires SAPRODUITS DENTAIRES SA | 4 | 2003–2020 | Pure Global AI |
| Colombia | INVIMA | Manufacturer | PRODUITS DENTAIRES SA | 3 | — | Pure Global AI |
| Brazil | ANVISA | Manufacturer | PRODUITS DENTAIRES S.A. | 2 | 2022–2023 | Pure Global AI |
| Israel | AMAR | Manufacturer | PRODUITS DENTAIRES SAProduits Dentaires S.A. | 2 | — | Pure Global AI |
| Peru | DIGEMID | Manufacturer | PRODUITS DENTAIRES S.A. | 2 | 2024–2024 | 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 Produits Dentaires SA currently lists, by FDA device type, with the brand and model names on the listing.
| Device type | Category | Role | Brands and models | Listed since |
|---|---|---|---|---|
| Root Canal Filling ResinKIF · Class 2 | Root canal filling materials | Maker | OdneFillPD MTA White | 2013 |
| Orthodontic Material BandDYO · Class 1 | Orthodontic wires & bands | Maker | Matrix bands | 1983 |
| Intraoral Dental DrillDZA · Class 1 | Surgical drills & motors | Maker | Drill-A-Post | 1978 |
| Orthodontic Band SetterECR · Class 1 | Dental hand instruments | Maker | Universal Solder | 1986 |
| Articulation PaperEFH · Class 1 | — | Maker | Articulating paper | 1978 |
| Roll CottonEFN · Class 1 | — | Maker | Cotton PelletsCotton Pellets Dispenser | 1996 |
| Over the Counter Denture CleanserEFT · Class 1 | Denture cleansers & adhesives | Maker | Disclosing TabletsEffervescent Mouth Wash Tablets, Pink | 1978 |
| Polishing Agent StripEHM · Class 1 | Polishing & prophylaxis | Maker | Diamond Abrasive StripsOdus Universal StripsSteel Abrasive StripsTransparent Strips | 1978 |
| Irrigating Endodontic Periodontic SyringeEIC · Class 1 | Dental hand instruments | Maker | IrriFlexPlastic Pipettes | 1978 |
| Operative Amalgam CarrierEKI · Class 1 | Dental hand instruments | Maker | MAP OneMAP System | 1986 |
| Gutta-PerchaEKM · Class 1 | Root canal filling materials | Lister | Gutta-Percha Points | 1978 |
| Endodontic Paper PointEKN · Class 1 | Root canal filling materials | Lister | Absorbent Paper Points | 1978 |
| Root Canal PostELR · Class 1 | Root canal filling materials | Maker | Fibrapost Lux | 1981 |
| Preformed CrownELZ · Class 1 | — | Maker | Odus Pella Transparent Crown FormsPella Transparent Crown Forms | 1981 |
| Zinc Oxide EugenolEMB · Class 1 | Dental cements | Maker | EssenSealEugenolZinc Oxide | 2022 |
| Matrix RetainerJEP · Class 1 | Dental hand instruments | Maker | Tofflemire Matrix retainers | 1978 |
| Dental FlossJES · Class 1 | Floss & interdental cleaners | Maker | Dental flossDental Sticks | 1978 |
Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| PRODUITS DENTAIRES SAFDA reg. 8010414 | VEVEY (SUISSE) Vaud, Switzerland | Contract manufacturer, Foreign exporter, Manufacturer, Private-label distributor |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 8010414). 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.