Data / Medical devices / India / Laxmi Dental Limited
Laxmi Dental Limited: FDA-registered device maker in Palghar Maharashtra, India, 2 510(k) clearances
Laxmi Dental Limited is registered with the FDA (registration 3004793856) in Palghar Maharashtra, India. It lists 11 device types. The FDA files 2 510(k) clearances under its listings, the newest dated April 26, 2021. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3004793856
- Address
- Survey no. 201/1, Village Gundle Boisar (East), Boisar, Palghar Maharashtra, India, 401501
- Owner or operator
- Laxmi Dental Limited (9067431)
- Roles
- Exporter to the US, Manufacturer, Remanufacturer
- First device listed
- March 18, 2008
- Registered through
- 2026
- Brand names listed
- Dentures, full, Dentures, partial, Illusion Aligner Flx, Illusion Aligner Pro, Illusion Aligners, MATERIAL, IMPRESSION, Prosthesis, orthodontic, Restoration, base metal and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Aligner, Sequential | NXC | 2 | Exporter to the US, Manufacturer, Remanufacturer | accessdata.fda.gov |
| Crown, Preformed | ELZ | 1 | Manufacturer | accessdata.fda.gov |
| Dentures, Full | NSL | N | Manufacturer | accessdata.fda.gov |
| Dentures, Partial | NSK | N | Manufacturer | accessdata.fda.gov |
| Material, Impression | ELW | 2 | Exporter to the US, Manufacturer | accessdata.fda.gov |
| Prosthesis, Orthodontic | NSR | N | Manufacturer | accessdata.fda.gov |
| Restoration, Base Metal | NSQ | N | Manufacturer | accessdata.fda.gov |
| Restoration, Noble Metal | NSJ | N | Manufacturer | accessdata.fda.gov |
| Restoration, Porcelain | NSP | N | Manufacturer | accessdata.fda.gov |
| Restoration, Porcelain-Fused-To-Metal | NSO | N | Manufacturer | accessdata.fda.gov |
| Restoration, Resin, Crown And Bridge | NSN | N | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| April 26, 2021 | K211010 | Illusion Aligners | NXC | Substantially Equivalent | Laxmi Dental Exports Pvt, Ltd. | accessdata.fda.gov |
| January 13, 2006 | K053427 | FRESH, DENTAL IMPRESSION MATERIAL | ELW | Substantially Equivalent | Exacta Dental Products, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Restoration, Resin, Crown And Bridge
- All makers of Prosthesis, Orthodontic
- All makers of Restoration, Noble Metal
- All makers of Restoration, Porcelain
- All makers of Dentures, Full
- All makers of Restoration, Base Metal
Updated April 26, 2021. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.