Manufacturer registered with FDA
Leixir Resources Private Limited
GURGAON, India. Lists 8 dental device types with FDA across 1 registered establishment.
- Device types listed
- 8
- Brands and models
- 9
- 510(k) clearances
- 0as applicant
- Markets registered in
- 333 registrations outside the US
- Establishments
- 1India
Registered in 3 markets
Where regulators' registries name Leixir Resources 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 | Leixir Resources Private Limited | 8 device types | — | Below |
| United Kingdom | MHRA | Manufacturer | Leixir Resources Pvt. Ltd | 23 | — | Pure Global AI |
| India | CDSCO | Registration holder | Leixir Resources Private Limited | 10 | 2024–2025 | 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 Leixir Resources 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 |
|---|---|---|---|---|
| Endosseous Dental Implant AbutmentNHA · Class 2 | Implant abutments | Maker | Abutment, Implant, Dental, Endosseous- Biodenta customized abutment hybridAbutment, Implant, Dental, Endosseous- Biodenta Customized Abutment- Titanium | 2023 |
| Resin Filling Material CoatingEBD · Class 2 | — | Maker | Lucitone Digital Print Denture System | 2025 |
| Resin Temporary Crown and BridgeEBG · Class 2 | Temporary crown & bridge materials | Maker | Lucitone Digital Print Denture System | 2025 |
| Rebasing Repairing Relining Denture ResinEBI · Class 2 | Denture resins & teeth | Maker | Lucitone Digital Print Denture System | 2025 |
| Resin Tooth Bonding AgentKLE · Class 2 | Bonding agents | Maker | Lucitone Digital Print Denture System | 2025 |
| Disposable Fluoride TrayKMT · Class 1 | — | Maker | Bleaching Tray | 2020 |
| Endosseous Dental Implant AccessoriesNDP · Class 1 | Implant instruments & surgical kits | Maker | Accessories, implant, dental , endosseous | 2019 |
| Resin Denture Tooth Preformed Additively ManufacturedPZY · Class 2 | Denture resins & teeth | Maker | Lucitone Digital Print Denture System | 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 |
|---|---|---|
| M/S LEIXIR RESOURCES PVT. LTDFDA reg. 3014270094 | GURUGRAM Haryana, India | Contract manufacturer, Manufacturer |
Other names on FDA records
M/S Leixir Resources Pvt. Ltd.
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10056722). 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.