Manufacturer registered with FDA
ClaroNav Inc.
Toronto, Canada. Lists 3 dental device types with FDA across 1 registered establishment, and holds 3 510(k) clearances as applicant.
- Device types listed
- 3
- Brands and models
- 5
- 510(k) clearances
- 32016–2024
- Markets registered in
- 927 registrations outside the US
- Establishments
- 1Canada
510(k) clearances per year, 2007–2026
Registered in 9 markets
Where regulators' registries name ClaroNav Inc. 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 | ClaroNav Inc. | 3 clearances | 2016–2024 | Below |
| Costa Rica | Ministerio de Salud | Manufacturer | ClaroNav Inc | 5 | — | Pure Global AI |
| Canada | Health Canada | Registration holder | CLARONAV INC. | 4 | 2014–2016 | Pure Global AI |
| Serbia | ALIMS | Manufacturer | ClaroNav Inc. | 4 | 2023–2024 | Pure Global AI |
| Australia | TGA | Manufacturer | ClaroNav Inc | 3 | 2016–2026 | Pure Global AI |
| European Union | EUDAMED | Manufacturer | ClaroNav Inc. | 3 | — | Pure Global AI |
| Israel | AMAR | Manufacturer | ClaroNav Inc. | 3 | — | Pure Global AI |
| Taiwan | TFDA | Manufacturer | CLARONAV INC. | 3 | 2018–2024 | Pure Global AI |
| Brazil | ANVISA | Manufacturer | CLARONAV INC. | 2 | 2020–2025 | 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 ClaroNav Inc. 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 Stereotaxic InstrumentPLV · Class 2 | — | Maker | Navident | 2016 |
| Computer Assisted Design and Manufacturing (Cad/Cam) of Dental Restorations Optical Impression SystemNOF · Class 2 | Intraoral scanners | Maker | MicronMapperMicronMapper EVOTissueMapper | 2023 |
| Dental Navigation SystemQRY · Class 2 | — | Maker | Navident | 2024 |
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 |
|---|---|---|
| ClaroNav Inc.FDA reg. 3011874573 | Toronto Ontario, Canada | Manufacturer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10052787). 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.