Manufacturer registered with FDA
Laxmi Dental Limited
Palghar, 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
- 337 registrations outside the US
- Establishments
- 1India
Registered in 3 markets
Where regulators' registries name Laxmi Dental 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 | Laxmi Dental Limited | 3 device types | — | Below |
| United Kingdom | MHRA | Manufacturer | Laxmi Dental Limited | 34 | — | Pure Global AI |
| India | CDSCO | Registration holder | Laxmi Dental Limited | 3 | 2023–2025 | 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 Laxmi Dental 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 |
|---|---|---|---|---|
| Impression MaterialELW · Class 2 | Impression materials | Maker | MATERIAL, IMPRESSION | 2008 |
| Preformed CrownELZ · Class 1 | — | Maker | — | 2020 |
| Sequential AlignerNXC · Class 2 | Clear aligners | Maker | Illusion Aligner FlxIllusion Aligner ProIllusion Aligners | 2023 |
Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026
Also lists devices cleared under other names
Laxmi Dental Limited lists these devices with FDA today. The clearance names a different applicant, as happens after a rename, an acquisition or a private-label agreement.
Original applicants: Laxmi Dental Exports Pvt, Ltd. (1), Exacta Dental Products, Inc. (1).
| Decided | 510(k) | Device | Applicant | Device type |
|---|---|---|---|---|
| 26 Apr 2021 | K211010 | Illusion Aligners | Laxmi Dental Exports Pvt, Ltd. | NXC Sequential Aligner |
| 13 Jan 2006 | K053427 | FRESH, DENTAL IMPRESSION MATERIAL | Exacta Dental Products, Inc. | ELW Impression Material |
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| Laxmi Dental LimitedFDA reg. 3004793856 | Palghar Maharashtra, India | Foreign exporter, Manufacturer, Remanufacturer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 9067431). 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.