Registered with FDA
Gestion Boucher/Durette
MONTREAL, Canada. Lists 1 dental device type with FDA across 1 registered establishment.
- Device types listed
- 1
- Brands and models
- 1
- 510(k) clearances
- 0as applicant
- Markets registered in
- 850 registrations outside the US
- Establishments
- 1Canada
Registered in 8 markets
Where regulators' registries name Gestion Boucher/Durette as the manufacturer or the registration holder of a device.
| Market | Regulator | Named as | Name on the registry | Registrations | Issued | Records |
|---|---|---|---|---|---|---|
| United States | FDA | Lister | Gestion Boucher/Durette | 1 device types | — | Below |
| Canada | Health Canada | Registration holder | OCULO-PLASTIK, INC. | 17 | 1999–2015 | Pure Global AI |
| South Korea | MFDS | Manufacturer | OCULO-PLASTIK, Inc.OCULO-PLASTIK Inc. · OCULO-PLASTIK, INC. · +2 | 16 | 2004–2023 | Pure Global AI |
| Brazil | ANVISA | Manufacturer | OCULO-PLASTIK. INCÓculo-Plastik Inc. | 8 | 2010–2011 | Pure Global AI |
| Taiwan | TFDA | Manufacturer | OCULO-PLASTIK, INC. | 3 | 2013–2017 | Pure Global AI |
| United Kingdom | MHRA | Manufacturer | Oculo-Plastik, Inc | 3 | — | Pure Global AI |
| European Union | EUDAMED | Manufacturer | Oculo-Plastik, Inc. | 2 | — | Pure Global AI |
| Australia | TGA | Manufacturer | Oculo-Plastik Inc | 1 | 2007–2007 | 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 Gestion Boucher/Durette currently lists, by FDA device type, with the brand and model names on the listing.
| Device type | Category | Role | Brands and models | Listed since |
|---|---|---|---|---|
| Intraoral Dental WaxEGD · Class 1 | — | Lister | Hard Inlay Wax | 2015 |
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 |
|---|---|---|
| OCULO PLASTIK, INC.FDA reg. 8022166 | MONTREAL Quebec, Canada | Repacker / relabeler |
Other names on FDA records
Oculo-Plastik, Inc
Sources
FDA establishment registration & device listing (search FDA, owner/operator 8022167). 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.