Manufacturer registered with FDA
DiamoDent
Dana Point, CA, United States. Lists 1 dental device type with FDA across 1 registered establishment, and holds 3 510(k) clearances as applicant.
- Device types listed
- 1
- Brands and models
- 1
- 510(k) clearances
- 32000–2004
- Markets registered in
- 244 registrations outside the US
- Establishments
- 1United States
510(k) clearances per year, 2000–2026
Registered in 2 markets
Where regulators' registries name DiamoDent 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 | DiamoDent | 3 clearances | 2000–2004 | Below |
| Canada | Health Canada | Registration holder | DIAMODENTDIAMODENT INC. | 44 | 2015–2016 | 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 DiamoDent currently lists, by FDA device type, with the brand and model names on the listing.
| Device type | Category | Role | Brands and models | Listed since |
|---|---|---|---|---|
| Root-Form Endosseous ImplantDZE · Class 2 | Dental implants | Maker | UCLA | 2008 |
Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026
510(k) clearances
Clearances on which FDA names DiamoDent as the applicant.
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| DIAMODENTFDA reg. 2031884 | Dana Point, CA, United States | Manufacturer, Specification developer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 9039378). 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.