Manufacturer registered with FDA
Hilbro Pvt Ltd
SIALKOT, Pakistan. Lists 5 dental device types with FDA across 1 registered establishment.
- Device types listed
- 5
- Brands and models
- 5
- 510(k) clearances
- 0as applicant
- Markets registered in
- 98,645 registrations outside the US
- Establishments
- 1Pakistan
Registered in 9 markets
Where regulators' registries name Hilbro 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 | Hilbro Pvt Ltd | 5 device types | — | Below |
| Thailand | Thai FDA | Manufacturer | HILBRO (PVT) LTD. | 8,540 | — | Pure Global AI |
| Saudi Arabia | SFDA | Manufacturer | Hilbro Private Limited | 32 | — | Pure Global AI |
| Australia | TGA | Manufacturer | Hilbro Pvt Ltd | 29 | 2015–2025 | Pure Global AI |
| Peru | DIGEMID | Manufacturer | HILBRO (PVT) LTDHILBRO (PVT) LTD. · HILBRO (PRIVATE) LIMITED · +1 | 20 | 2013–2025 | Pure Global AI |
| South Korea | MFDS | Manufacturer | HILBRO(PRIVATE)LIMITED | 16 | 2000–2000 | Pure Global AI |
| European Union | EUDAMED | Manufacturer | HILBRO (PVT.) LIMITED | 5 | — | Pure Global AI |
| Colombia | INVIMA | Manufacturer | HILBRO (PVT) LIMITEDHILBRO PVT LIMITED COMPANY | 2 | — | Pure Global AI |
| Taiwan | TFDA | Manufacturer | HILBRO LIMITED | 1 | 2006–2006 | 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 Hilbro 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 |
|---|---|---|---|---|
| Mouth MirrorEAX · Class 1 | Dental hand instruments | Maker | MIRROR, MOUTH | 2021 |
| Dental Dressing ForcepsEFL · Class 1 | Dental hand instruments | Maker | FORCEPS, DRESSING, DENTAL | 2004 |
| Dental Surgical Tissue ScissorsEGN · Class 1 | Dental hand instruments | Maker | SCISSORS, SURGICAL TISSUE, DENTAL | 2001 |
| Surgical Tooth Extractor ForcepsEMG · Class 1 | Dental hand instruments | Maker | FORCEPS, TOOTH EXTRACTOR, SURGICAL | 2024 |
| Orthodontic PlierJEX · Class 1 | Dental hand instruments | Maker | PLIER, ORTHODONTIC | 2018 |
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 |
|---|---|---|
| HILBRO (PVT) LTD.FDA reg. 8040884 | SIALKOT Punjab, Pakistan | Manufacturer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 8040884). 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.