Manufacturer registered with FDA
Acteon Manufacturing
MERIGNAC, France. Lists 1 dental device type with FDA across 1 registered establishment.
- Device types listed
- 1
- Brands and models
- 3
- 510(k) clearances
- 0as applicant
- Markets registered in
- 840 registrations outside the US
- Establishments
- 1France
Registered in 8 markets
Where regulators' registries name Acteon Manufacturing 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 | Acteon Manufacturing | 1 device types | — | Below |
| European Union | EUDAMED | Manufacturer | ACTEON MANUFACTURING | 15 | — | Pure Global AI |
| Canada | Health Canada | Registration holder | ACTEON MANUFACTURING | 12 | 2008–2023 | Pure Global AI |
| Australia | TGA | Manufacturer | Acteon Manufacturing | 5 | 2008–2020 | Pure Global AI |
| Serbia | ALIMS | Manufacturer | Acteon Manufacturing | 3 | 2022–2025 | Pure Global AI |
| South Korea | MFDS | Manufacturer | Acteon Manufacturing | 2 | 2001–2026 | Pure Global AI |
| Taiwan | TFDA | Manufacturer | ACTEON MANUFACTURING | 2 | 2019–2026 | Pure Global AI |
| China | NMPA | Registration holder | 法国艾龙公司ACTEON MANUFACTURING | 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 Acteon Manufacturing currently lists, by FDA device type, with the brand and model names on the listing.
| Device type | Category | Role | Brands and models | Listed since |
|---|---|---|---|---|
| Air and/or Water Syringe UnitECB · Class 1 | Dental hand instruments | Maker | Art by RISKONTROLClassic by RISKONTROLTotal Protect by RISKONTROL | 2016 |
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 |
|---|---|---|
| ACTEON MANUFACTURINGFDA reg. 3003677417 | Merignac Gironde, France | Specification developer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 9069839). 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.