Manufacturer registered with FDA
Orthocell Limited
Perth, Australia. Lists 1 dental device type with FDA across 1 registered establishment, and holds 1 510(k) clearance as applicant.
- Device types listed
- 1
- Brands and models
- 2
- 510(k) clearances
- 12021–2021
- Markets registered in
- 813 registrations outside the US
- Establishments
- 1Australia
510(k) clearances per year, 2007–2026
Registered in 8 markets
Where regulators' registries name Orthocell Limited 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 | Orthocell Limited | 1 clearances | 2021–2021 | Below |
| Australia | TGA | Manufacturer | Orthocell Ltd | 4 | 2017–2023 | Pure Global AI |
| Canada | Health Canada | Registration holder | ORTHOCELL LTD | 3 | 2024–2025 | Pure Global AI |
| United Kingdom | MHRA | Manufacturer | Orthocell Limited | 2 | — | Pure Global AI |
| Brazil | ANVISA | Manufacturer | ORTHOCELL LTD | 1 | 2025–2025 | Pure Global AI |
| Colombia | INVIMA | Manufacturer | ORTHOCELL LTD. | 1 | — | Pure Global AI |
| European Union | EUDAMED | Manufacturer | Orthocell Ltd | 1 | — | Pure Global AI |
| Hong Kong | MDD | Manufacturer | Orthocell Ltd | 1 | 2025–2025 | 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 Orthocell Limited 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 Animal Source BarrierNPL · Class 2 | Bone grafts & membranes | Maker | perFORMStriate+ | 2021 |
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 |
|---|---|---|
| ORTHOCELL LIMITEDFDA reg. 3014015147 | Perth Western Australia, Australia | Manufacturer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10081188). 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.