Manufacturer registered with FDA
Intensiv SA
Collina d'Oro / Montagnola, Switzerland. Lists 4 dental device types with FDA across 1 registered establishment.
- Device types listed
- 4
- Brands and models
- 29
- 510(k) clearances
- 0as applicant
- Markets registered in
- 952 registrations outside the US
- Establishments
- 1Switzerland
Registered in 9 markets
Where regulators' registries name Intensiv 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 | Intensiv SA | 4 device types | — | Below |
| South Korea | MFDS | Manufacturer | Intensiv SAINTENSIV SA · Intensiv | 16 | 2001–2019 | Pure Global AI |
| Australia | TGA | Manufacturer | Intensiv SA | 15 | 2013–2018 | Pure Global AI |
| Canada | Health Canada | Registration holder | INTENSIV SA | 6 | 2009–2010 | Pure Global AI |
| European Union | EUDAMED | Manufacturer | Intensiv SA | 4 | — | Pure Global AI |
| Israel | AMAR | Manufacturer | INTENSIV SA | 4 | — | Pure Global AI |
| United Kingdom | MHRA | Manufacturer | Intensiv SA | 4 | — | Pure Global AI |
| Taiwan | TFDA | Manufacturer | INTENSIV SA | 2 | 2006–2015 | Pure Global AI |
| Brazil | ANVISA | Manufacturer | INTENSIV | 1 | 2011–2011 | 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 Intensiv 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 |
|---|---|---|---|---|
| Dental Diamond InstrumentDZP · Class 1 | Dental burs & diamonds | Maker | Intensiv Diamond Instruments FG and RA | 1996 |
| Polishing Agent StripEHM · Class 1 | Polishing & prophylaxis | Maker | Intensiv ApproxOpenerIntensiv BevelshapeIntensiv Metal Diamond StripsIntensiv Ortho-StripsIntensiv Ortho-Strips CoarseIntensiv Ortho-Strips One-SidedIntensiv Ortho-Strips OpenerIntensiv Ortho-Strips SetIntensiv Ortho-Strips SystemIntensiv Ortho-Strips System Central 8 moreIntensiv ProxoCoutour CoarseIntensiv ProxoPolishIntensiv ProxoshapeIntensiv Proxoshape CoarseIntensiv Proxoshape FlexibleIntensiv ProxoStripIntensiv ProxoStrip AnteriorIntensiv Rootshape | 2009 |
| Dental Instrument Depth GaugeEIL · Class 1 | Dental hand instruments | Maker | IPR-DC SetIPR-DC010/3IPR-DC015/3IPR-DC020/3IPR-DC025/3IPR-DC030/3IPR-DC040/3IPR-DC050/3IPR-DC100/3 | 2018 |
| Oral Cavity Abrasive Polishing AgentEJR · Class 1 | Polishing & prophylaxis | Maker | Intensiv UniglossPaste | 2009 |
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 |
|---|---|---|
| INTENSIV SAFDA reg. 8030958 | Collina d'Oro / Montagnola Ticino, Switzerland | Manufacturer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 9001345). 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.