Manufacturer registered with FDA
Dantech Digital Dental Solutions Private Limited
Chennai, India. Lists 3 dental device types with FDA across 1 registered establishment.
- Device types listed
- 3
- Brands and models
- 4
- 510(k) clearances
- 0as applicant
- Markets registered in
- 346 registrations outside the US
- Establishments
- 1India
Registered in 3 markets
Where regulators' registries name Dantech Digital Dental Solutions Private 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 | Dantech Digital Dental Solutions Private Limited | 3 device types | — | Below |
| United Kingdom | MHRA | Manufacturer | DANTECH DIGITAL DENTAL SOLUTIONS PRIVATE LIMITED | 34 | — | Pure Global AI |
| India | CDSCO | Registration holder | Dantech Digital Dental Solutions Pvt. Ltd. | 12 | 2025–2026 | 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 Dantech Digital Dental Solutions Private 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 |
|---|---|---|---|---|
| Orthodontic Space Preformed MaintainerDYT · Class 1 | Retainers, expanders & headgear | Maker | Orthodontic Retainer | 2025 |
| Preformed Impression TrayEHY · Class 1 | Impression trays | Maker | Teeth Whitening Trays | 2025 |
| Endosseous Dental Implant AccessoriesNDP · Class 1 | Implant instruments & surgical kits | Maker | Dental Implantation Drilling Template, Custom-madeSurgical Guide | 2026 |
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 |
|---|---|---|
| DANTECH DIGITAL DENTAL SOLUTIONS PRIVATE LIMITEDFDA reg. 3030516430 | Chennai Tamil Nadu, India | Manufacturer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10090122). 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.