Manufacturer registered with FDA
Mothers Medica 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
- 23 registrations outside the US
- Establishments
- 1India
Registered in 2 markets
Where regulators' registries name Mothers Medica 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 | Mothers Medica Private Limited | 3 device types | — | Below |
| India | CDSCO | Registration holder | MOTHERS MEDICA PRIVATE LIMITED | 3 | 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 Mothers Medica 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 WireDZC · Class 1 | Orthodontic wires & bands | Maker | Nanoalign | 2025 |
| Dental BurEJL · Class 1 | Dental burs & diamonds | Maker | MM BURSNanoalign | 2025 |
| Endodontic Pulp Canal FileEKS · Class 1 | Endodontic files | Maker | FLEXER | 2025 |
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 |
|---|---|---|
| MOTHERS MEDICA PRIVATE LIMITEDFDA reg. 3038187461 | Chennai Tamil Nadu, India | Manufacturer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10093097). 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.