Manufacturer registered with FDA
STONE Instruments company
Sialkot, Pakistan. Lists 4 dental device types with FDA across 1 registered establishment.
- Device types listed
- 4
- Brands and models
- 4
- 510(k) clearances
- 0as applicant
- Markets registered in
- 44 registrations outside the US
- Establishments
- 1Pakistan
Registered in 4 markets
Where regulators' registries name STONE Instruments company 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 | STONE Instruments company | 4 device types | — | Below |
| Brazil | ANVISA | Manufacturer | STONE INSTRUMENTS CO | 2 | 2017–2025 | Pure Global AI |
| South Korea | MFDS | Manufacturer | STONE Instruments company | 1 | 2003–2003 | Pure Global AI |
| Taiwan | TFDA | Manufacturer | STONE INSTRUMENTS CO. | 1 | 2020–2020 | 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 STONE Instruments company currently lists, by FDA device type, with the brand and model names on the listing.
| Device type | Category | Role | Brands and models | Listed since |
|---|---|---|---|---|
| Shellac Base PlateEEA · Class 1 | — | Maker | PLATE, BASE, SHELLAC | 2016 |
| Dental Retractor AccessoriesEIF · Class 1 | Dental hand instruments | Maker | ACCESSORIES, RETRACTOR, DENTAL | 2025 |
| All Types RetractorEIG · Class 1 | Dental hand instruments | Maker | RETRACTOR, ALL TYPES | 2012 |
| Orthodontic PlierJEX · Class 1 | Dental hand instruments | Maker | PLIER, ORTHODONTIC | 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 |
|---|---|---|
| STONE INSTRUMENTS CO.FDA reg. 9614093 | SIALKOT Punjab, Pakistan | Contract manufacturer, Manufacturer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 9040276). 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.