Manufacturer registered with FDA
HILBRO International (Pvt) Ltd.
SIALKOT, Pakistan. Lists 17 dental device types with FDA across 1 registered establishment.
- Device types listed
- 17
- Brands and models
- 25
- 510(k) clearances
- 0as applicant
- Markets registered in
- 6276 registrations outside the US
- Establishments
- 1Pakistan
Registered in 6 markets
Where regulators' registries name HILBRO International (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 International (Pvt) Ltd. | 17 device types | — | Below |
| South Korea | MFDS | Manufacturer | HILBRO INTERNATIONAL(PVT) LTD.Hilbro International (Private) Limited · HILBRO INTERNATIONAL LIMITED. · +2 | 258 | 1999–2024 | Pure Global AI |
| European Union | EUDAMED | Manufacturer | HILBRO International (Pvt) Ltd. | 14 | — | Pure Global AI |
| Colombia | INVIMA | Manufacturer | HILBRO INTERNATIONAL (PVT) LTD | 2 | — | Pure Global AI |
| Taiwan | TFDA | Manufacturer | HILBRO INTERNATIONAL (PRIVATE) LIMITED. | 1 | 2006–2006 | Pure Global AI |
| Tanzania | TMDA | Manufacturer | HILBRO INTERNATIONAL (PVT) LTD. | 1 | 2025–2025 | 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 International (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 | Hilbro Intl mouth mirror | 2015 |
| Surgical Headlight LightEBA · Class 1 | Dental operating lights | Maker | Hilbro Intl surgical headlight light | 2015 |
| Rubber Dam ClampEEF · Class 1 | Rubber dam systems | Maker | CLAMP, RUBBER DAM | 2021 |
| Articulation Paper ForcepsEFK · Class 1 | Dental hand instruments | Maker | Forceps, Articulation PaperHilbro Intl articulating paper frcp | 2009 |
| Dental Dressing ForcepsEFL · Class 1 | Dental hand instruments | Maker | Forceps, Dressing, DentalHilbro Intl dental dressing forcep | 2009 |
| Dental Surgical Tissue ScissorsEGN · Class 1 | Dental hand instruments | Maker | Surgical Dental Scissors for Tissue | 2026 |
| Preformed Impression TrayEHY · Class 1 | Impression trays | Maker | Tray Impression Perforated | 2011 |
| Dental Retractor AccessoriesEIF · Class 1 | Dental hand instruments | Maker | Dental RetractorRETRACTOR | 1999 |
| All Types RetractorEIG · Class 1 | Dental hand instruments | Maker | RETRACTORRetractor all types | 1999 |
| Collar and Crown ScissorsEIR · Class 1 | Dental hand instruments | Maker | Scissors, Collar and Crown | 2011 |
| Dental Plastic Filling InstrumentEIY · Class 1 | Dental hand instruments | Maker | INSTRUMENT, FILLING, PLASTIC, DENTAL | 2021 |
| Rubber Dam Clamp ForcepsEJG · Class 1 | Rubber dam systems | Maker | Forceps, Rubber Dam ClampHilbro Intl Rubber dam clamp forcep | 2009 |
| Surgical HemostatEMD · Class 1 | Dental hand instruments | Maker | Forceps, Hemostat, SurgicalHilbro Intl surgical hemostat | 2009 |
| Surgical Tooth Extractor ForcepsEMG · Class 1 | Dental hand instruments | Maker | Forceps, Tooth Extracting, SurgicalHilbro Intl tooth extrctr surg frcp | 2009 |
| Surgical Rongeur ForcepsEMH · Class 1 | Dental hand instruments | Maker | FORCEPSForceps - Rongeur | 1999 |
| Periodontic ScalerEMN · Class 1 | Dental hand instruments | Maker | Hilbro Intl periodontic scaler | 2015 |
| 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 INTERNATIONAL (PVT) LIMITEDFDA reg. 3003431869 | SIALKOT Punjab, Pakistan | Contract manufacturer, Manufacturer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 9036420). 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.