Manufacturer registered with FDA
Orikam Healthcare India Private Limited
Gurgaon, India. Lists 3 dental device types with FDA across 1 registered establishment.
- Device types listed
- 3
- Brands and models
- 16
- 510(k) clearances
- 0as applicant
- Markets registered in
- 2126 registrations outside the US
- Establishments
- 1India
Registered in 2 markets
Where regulators' registries name Orikam Healthcare India 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 | Orikam Healthcare India Private Limited | 3 device types | — | Below |
| India | CDSCO | Registration holder | Orikam Healthcare India Pvt. Ltd.Orikam Healthcare India Private Limited | 126 | 2023–2026 | 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 Orikam Healthcare India 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 |
|---|---|---|---|---|
| Gutta-PerchaEKM · Class 1 | Root canal filling materials | Maker | Neoendo, Neoendo Gutta Percha Points, Gutta Percha Points | 2024 |
| Endodontic Paper PointEKN · Class 1 | Root canal filling materials | Maker | Neoendo, Neoendo Absorbent Paper Points, Absorbent Paper Points | 2024 |
| Endodontic Pulp Canal FileEKS · Class 1 | Endodontic files | Maker | MyEndoMyEndo Glide FileMyEndo T Blue FileMyEndo T FileNeoendo Flex FilesNEOENDO FLEX GLIDENEOENDO NEOBLUENeoendo NeoglideNEOENDO NEOHYBRIDNEOENDO NEOTAPER 4 moreNEOENDO PEDOFLEXNeoendo Retreatment FileNeoendo SNeoeondo | 2023 |
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 |
|---|---|---|
| Orikam Healthcare India Private LimitedFDA reg. 3030378557 | Gurgaon Haryana, India | Manufacturer, Repacker / relabeler |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10089628). 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.