Manufacturer registered with FDA
SITEC (Pvt.) Ltd.
SIALKOT, Pakistan. Lists 14 dental device types with FDA across 1 registered establishment.
- Device types listed
- 14
- Brands and models
- 13
- 510(k) clearances
- 0as applicant
- Markets registered in
- 35 registrations outside the US
- Establishments
- 1Pakistan
Registered in 3 markets
Where regulators' registries name SITEC (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 | SITEC (Pvt.) Ltd. | 14 device types | — | Below |
| Peru | DIGEMID | Manufacturer | SITEC (PVT) LTD | 4 | 2016–2022 | Pure Global AI |
| South Korea | MFDS | Manufacturer | SITEC (Pvt.) Ltd. | 1 | 2016–2016 | 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 SITEC (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 |
|---|---|---|---|---|
| Dental Hand InstrumentsDZN · Class 1 | Dental hand instruments | Maker | Instruments, Dental Hand | 2012 |
| Mouth MirrorEAX · Class 1 | Dental hand instruments | Maker | Mouth Mirror | 2012 |
| Irrigating (Dental) SyringeEIB · Class 1 | Dental hand instruments | Maker | Syringe, Irrigating (Dental) | 2020 |
| Irrigating Endodontic Periodontic SyringeEIC · Class 1 | Dental hand instruments | Maker | — | 2014 |
| All Types RetractorEIG · Class 1 | Dental hand instruments | Maker | Dental Retractors | 2016 |
| Collar and Crown ScissorsEIR · Class 1 | Dental hand instruments | Maker | Scissors, Collar and Crown | 2016 |
| Endodontic Root Canal PluggerEKR · Class 1 | Dental hand instruments | Maker | Plugger, Root Canal, Endodontic | 2020 |
| Surgical HemostatEMD · Class 1 | Dental hand instruments | Maker | Surgical Dental Hemostats, Various | 2009 |
| Surgical Tooth Extractor ForcepsEMG · Class 1 | Dental hand instruments | Maker | Surgical Tooth Extractor Forceps | 2009 |
| Surgical Rongeur ForcepsEMH · Class 1 | Dental hand instruments | Maker | Forceps, Rongeur, Surgical | 2020 |
| Surgical Bone FileEMI · Class 1 | Dental hand instruments | Maker | File, Bone, Surgical | 2012 |
| Surgical Bone ChiselEML · Class 1 | Dental hand instruments | Maker | Chisel, Bone, Surgical | 2012 |
| Surgical Osteotome ChiselEMM · Class 1 | Dental hand instruments | Maker | Chisel, Osteotome, Dental Surgical | 2009 |
| FacebowKCR · Class 1 | Articulators & facebows | Maker | Facebow | 2020 |
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 |
|---|---|---|
| SITEC (PVT.) LTD.FDA reg. 3007773213 | SIALKOT Punjab, Pakistan | Contract manufacturer, Manufacturer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10029945). 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.