Manufacturer registered with FDA
Endonest Medical Systems LLP
Patparganj, India. Lists 3 dental device types with FDA across 1 registered establishment.
- Device types listed
- 3
- Brands and models
- 6
- 510(k) clearances
- 0as applicant
- Markets registered in
- 231 registrations outside the US
- Establishments
- 1India
Registered in 2 markets
Where regulators' registries name Endonest Medical Systems LLP 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 | Endonest Medical Systems LLP | 3 device types | — | Below |
| India | CDSCO | Registration holder | Endonest Medical Systems LLP | 31 | 2023–2024 | 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 Endonest Medical Systems LLP currently lists, by FDA device type, with the brand and model names on the listing.
| Device type | Category | Role | Brands and models | Listed since |
|---|---|---|---|---|
| Dental Fiber Optic LightEAY · Class 1 | Dental operating lights | Maker | Light, Fiber Optic, EndoNest FOC, EndoNest Lights , EndoNest Cables , EndoNest All Type Cables | 2024 |
| All Types RetractorEIG · Class 1 | Dental hand instruments | Maker | Balfour Retractor, EndoNest All types Retractors (EN21-806)(EN21-807)EndoNest RETRACTOR, EndoNest ALL TYPES (Liver Ratractor, Nathanson Retractor, EndoNest Thomson RetractorEndoNest Snake Retractor,Fan Retractors) (EN801-100), en81-1002,EN21-801,EN21-804,EN21-805) | 2024 |
| Endosseous Dental Implant AccessoriesNDP · Class 1 | Implant instruments & surgical kits | Maker | EndoNest Dental ACCESSORIES, EndoNest IMPLANT, EndoNest DENTAL,EndoNest ENDOSSEOUS,EndoNest Dental Instruments, EndoNest Roungers' EN55-2001-------EN56-1000) | 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 |
|---|---|---|
| ENDONEST MEDICAL SYSTEMS LLPFDA reg. 3030516433 | PALGHAR Maharashtra, India | Manufacturer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10090090). 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.