Manufacturer registered with FDA
Shalatco (Pvt) Ltd
Sialkot, Pakistan. Lists 4 dental device types with FDA across 1 registered establishment.
- Device types listed
- 4
- Brands and models
- 12
- 510(k) clearances
- 0as applicant
- Markets registered in
- 24 registrations outside the US
- Establishments
- 1Pakistan
Registered in 2 markets
Where regulators' registries name Shalatco (Pvt) Ltd 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 | Shalatco (Pvt) Ltd | 4 device types | — | Below |
| Australia | TGA | Manufacturer | Shalatco Pvt Ltd | 4 | 2009–2009 | 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 Shalatco (Pvt) Ltd currently lists, by FDA device type, with the brand and model names on the listing.
| Device type | Category | Role | Brands and models | Listed since |
|---|---|---|---|---|
| All Types RetractorEIG · Class 1 | Dental hand instruments | Maker | Eye retractors | 2025 |
| Periodontic ProbeEIX · Class 1 | Dental hand instruments | Maker | Dental ProbesStylet Probes | 2025 |
| Surgical HemostatEMD · Class 1 | Dental hand instruments | Maker | Crile ForcepsKelly ForcepsKocher ForcepsMosquito ForcepsPean ForcepsTubing Clamps | 2025 |
| Surgical Tooth Extractor ForcepsEMG · Class 1 | Dental hand instruments | Maker | Lower molars Extracting forcepTooth Forceps, Dental extraction forcepsUpper molars Extracting forcep | 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 |
|---|---|---|
| SHALATCO (PVT) LTDFDA reg. 3009496321 | Sialkot Punjab, Pakistan | Manufacturer, Specification developer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10093766). 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.