Manufacturer registered with FDA
Emerald Instruments
SIALKOT, PUNJAB, Pakistan. Lists 15 dental device types with FDA across 1 registered establishment.
- Device types listed
- 15
- Brands and models
- 15
- 510(k) clearances
- 0as applicant
- Markets registered in
- 45 registrations outside the US
- Establishments
- 1Pakistan
Registered in 4 markets
Where regulators' registries name Emerald Instruments 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 | Emerald Instruments | 15 device types | — | Below |
| European Union | EUDAMED | Manufacturer | Emerald Instruments | 2 | — | Pure Global AI |
| Taiwan | TFDA | Manufacturer | EMERALD INSTRUMENTS | 2 | 2014–2014 | Pure Global AI |
| South Korea | MFDS | Manufacturer | EMERALD INSTRUMENTS | 1 | 2017–2017 | 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 Emerald Instruments 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 | 2007 |
| Mouth MirrorEAX · Class 1 | Dental hand instruments | Maker | MIRROR, MOUTH | 2019 |
| Articulation Paper ForcepsEFK · Class 1 | Dental hand instruments | Maker | FORCEPS, ARTICULATION PAPER | 2019 |
| Dental Dressing ForcepsEFL · Class 1 | Dental hand instruments | Maker | FORCEPS, DRESSING, DENTAL | 2019 |
| Periodontic ProbeEIX · Class 1 | Dental hand instruments | Maker | PROBE, PERIODONTIC | 2019 |
| Dental Plastic Filling InstrumentEIY · Class 1 | Dental hand instruments | Maker | INSTRUMENT, FILLING, PLASTIC, DENTAL | 2023 |
| Cartridge SyringeEJI · Class 2 | Dental needles & syringes | Maker | Syringe, cartridge | 2023 |
| Operative Dental ExcavatorEKC · Class 1 | Dental hand instruments | Maker | EXCAVATOR, DENTAL, OPERATIVE | 2023 |
| Operative BurnisherEKJ · Class 1 | Dental hand instruments | Maker | BURNISHER, OPERATIVE | 2019 |
| Surgical Tooth Extractor ForcepsEMG · Class 1 | Dental hand instruments | Maker | FORCEPS, TOOTH EXTRACTOR, SURGICAL | 2007 |
| Dental Surgical ElevatorEMJ · Class 1 | Dental hand instruments | Maker | ELEVATOR, SURGICAL, DENTAL | 2017 |
| Periodontic ScalerEMN · Class 1 | Dental hand instruments | Maker | SCALER, PERIODONTIC | 2007 |
| Periodontic CuretteEMS · Class 1 | Dental hand instruments | Maker | CURETTE, PERIODONTIC | 2019 |
| Orthodontic PlierJEX · Class 1 | Dental hand instruments | Maker | PLIER, ORTHODONTIC | 2007 |
| Endosseous Dental Implant AccessoriesNDP · Class 1 | Implant instruments & surgical kits | Maker | Accessories, implant, dental, endosseous | 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 |
|---|---|---|
| EMERALD INSTRUMENTSFDA reg. 3005973280 | SIALKOT Punjab, Pakistan | Manufacturer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 9045610). 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.