Manufacturer registered with FDA
DTS Digital Dental Lab
shenzhen, China. Lists 3 dental device types with FDA across 1 registered establishment.
- Device types listed
- 3
- Brands and models
- 1
- 510(k) clearances
- 0as applicant
- Markets registered in
- 49 registrations outside the US
- Establishments
- 1China
Registered in 4 markets
Where regulators' registries name DTS Digital Dental Lab 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 | DTS Digital Dental Lab | 3 device types | — | Below |
| Canada | Health Canada | Registration holder | DTS DIGITAL DENTAL LAB | 5 | 2025–2026 | Pure Global AI |
| Australia | TGA | Manufacturer | DTS digital dental lab | 3 | 2026–2026 | Pure Global AI |
| European Union | EUDAMED | Manufacturer | DTS Digital Dental Lab | 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 DTS Digital Dental Lab currently lists, by FDA device type, with the brand and model names on the listing.
| Device type | Category | Role | Brands and models | Listed since |
|---|---|---|---|---|
| Endosseous Dental Implant AbutmentNHA · Class 2 | Implant abutments | Maker | Dess Dental Smart Solution | 2022 |
| Orthodontic Screw Expansion RetainerDYJ · Class 1 | Retainers, expanders & headgear | Maker | — | 2022 |
| Endosseous Dental Implant AccessoriesNDP · Class 1 | Implant instruments & surgical kits | Maker | — | 2022 |
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 |
|---|---|---|
| DTS DIGITAL DENTAL LABFDA reg. 3021964955 | shenzhen Guangdong, China | Contract manufacturer, Foreign exporter, Manufacturer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10084206). 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.