Manufacturer registered with FDA
Kashmir Surgical Works
AMBALA, India. Lists 2 dental device types with FDA across 1 registered establishment.
- Device types listed
- 2
- Brands and models
- 2
- 510(k) clearances
- 0as applicant
- Markets registered in
- 211 registrations outside the US
- Establishments
- 1India
Registered in 2 markets
Where regulators' registries name Kashmir Surgical Works 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 | Kashmir Surgical Works | 2 device types | — | Below |
| India | CDSCO | Registration holder | KASHMIR SURGICAL WORKS | 11 | 2026–2026 | 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 Kashmir Surgical Works currently lists, by FDA device type, with the brand and model names on the listing.
| Device type | Category | Role | Brands and models | Listed since |
|---|---|---|---|---|
| Denture Repair KitEBO · Class 2 | — | Maker | Denture Repair Kit | 2023 |
| Digital Extraoral Source X-Ray SystemMUH · Class 2 | Dental X-ray units | Maker | Dental RVG | 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
Kashmir Surgical Works 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: Gendex Dental Systems (1).
| Decided | 510(k) | Device | Applicant | Device type |
|---|---|---|---|---|
| 10 Mar 2006 | K060178 | VIX WIN PRO | Gendex Dental Systems | MUH Digital Extraoral Source X-Ray System |
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| KASHMIR SURGICAL WORKSFDA reg. 3004765453 | AMBALA Haryana, India | Foreign exporter, Manufacturer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10087074). 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.