Manufacturer registered with FDA
Laparomed Private Limited
Mumbai, India. Lists 15 dental device types with FDA across 1 registered establishment.
- Device types listed
- 15
- Brands and models
- 15
- 510(k) clearances
- 0as applicant
- Markets registered in
- 250 registrations outside the US
- Establishments
- 1India
Registered in 2 markets
Where regulators' registries name Laparomed 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 | Laparomed Private Limited | 15 device types | — | Below |
| India | CDSCO | Registration holder | Laparomed Private Limited | 50 | 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 Laparomed 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 |
|---|---|---|---|---|
| Mouth MirrorEAX · Class 1 | Dental hand instruments | Maker | MOUTH MIRROR AND HANDLES | 2026 |
| Resin Impression Tray MaterialEBH · Class 1 | Impression trays | Maker | IMPRESSION TRAYS | 2026 |
| Orthodontic Wire ClampECN · Class 1 | — | Maker | ORTHPAEDIC INSTRUMENTS (BAND PUSHER, LIGATURE DIRECTOR, PLIERS) | 2026 |
| All Types RetractorEIG · Class 1 | Dental hand instruments | Maker | CHEEK RETRACTORS | 2026 |
| Dental Wax CarverEIK · Class 1 | Dental hand instruments | Maker | WAX AND MATERIAL KNIVES | 2026 |
| Crown RemoverEIS · Class 1 | Dental hand instruments | Maker | CROWN REMOVERS | 2026 |
| Periodontic ProbeEIX · Class 1 | Dental hand instruments | Maker | EXPLORERS & PROBES | 2026 |
| Rubber Dam Clamp ForcepsEJG · Class 1 | Rubber dam systems | Maker | RUBBER DAM INSTRUMENTS (FRAME, CLAMPS, PUNCH, FORCEP KIT) | 2026 |
| Cartridge SyringeEJI · Class 2 | Dental needles & syringes | Maker | DENTAL SYRINGES CARTRIDGES | 2026 |
| Operative Dental ExcavatorEKC · Class 1 | Dental hand instruments | Maker | EXCAVATORS | 2026 |
| Operative BurnisherEKJ · Class 1 | Dental hand instruments | Maker | FILLING INSTRUMNENTS (BURNISHERS, SPATULA, GAUZE PACKER, AMALGAM CARVERS, AMALGAM CARRIERS, AMALGAM GUN, WELL) | 2026 |
| Surgical Tooth Extractor ForcepsEMG · Class 1 | Dental hand instruments | Maker | EXTRACTING FORCEPS | 2026 |
| Dental Surgical ElevatorEMJ · Class 1 | Dental hand instruments | Maker | DENTAL ELEVATORS | 2026 |
| Dental Surgical CuretteEMK · Class 1 | Dental hand instruments | Maker | SCALERS & DENTAL CURETTES | 2026 |
| Matrix RetainerJEP · Class 1 | Dental hand instruments | Maker | MATRIX BAND AND RESTRAINERS | 2026 |
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 |
|---|---|---|
| LAPAROMED PRIVATE LIMITEDFDA reg. 3045853999 | Mumbai Maharashtra, India | Manufacturer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10095817). 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.