Manufacturer registered with FDA
Reach Global India Pvt Ltd
Pune, India. Lists 2 dental device types with FDA across 1 registered establishment.
- Device types listed
- 2
- Brands and models
- 2
- 510(k) clearances
- 0as applicant
- Markets registered in
- 7103 registrations outside the US
- Establishments
- 1India
Registered in 7 markets
Where regulators' registries name Reach Global India Pvt Ltd 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 | Reach Global India Pvt Ltd | 2 device types | — | Below |
| India | CDSCO | Registration holder | Reach Global India Pvt. Ltd. | 72 | 2023–2026 | Pure Global AI |
| European Union | EUDAMED | Manufacturer | Reach Global India Pvt. Ltd. | 20 | — | Pure Global AI |
| Brazil | ANVISA | Manufacturer | Reach Global Índia Pvt. Ltd | 5 | 2015–2016 | Pure Global AI |
| Australia | TGA | Manufacturer | Reach Global India Pvt Ltd | 3 | 2023–2026 | Pure Global AI |
| Tanzania | TMDA | Manufacturer | REACH GLOBAL INDIA PVT. LTD. | 2 | 2026–2026 | Pure Global AI |
| Israel | AMAR | Manufacturer | Reach Global India Pvt. Ltd. | 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 Reach Global India Pvt Ltd currently lists, by FDA device type, with the brand and model names on the listing.
| Device type | Category | Role | Brands and models | Listed since |
|---|---|---|---|---|
| Endodontic Pulp Canal FileEKS · Class 1 | Endodontic files | Maker | ORO | 2025 |
| Preformed CrownELZ · Class 1 | — | Maker | Little crown | 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 |
|---|---|---|
| REACH GLOBAL INDIA PVT LTDFDA reg. 3021343214 | Pune Maharashtra, India | Manufacturer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10089347). 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.