Manufacturer registered with FDA
Weldon Instruments
Sialkot, Pakistan. Lists 9 dental device types with FDA across 1 registered establishment.
- Device types listed
- 9
- Brands and models
- 9
- 510(k) clearances
- 0as applicant
- Markets registered in
- 33,361 registrations outside the US
- Establishments
- 1Pakistan
Registered in 3 markets
Where regulators' registries name Weldon 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 | Weldon Instruments | 9 device types | — | Below |
| European Union | EUDAMED | Manufacturer | Weldon Instruments | 3,340 | — | Pure Global AI |
| Brazil | ANVISA | Manufacturer | WELDON INSTRUMENTS | 21 | 2014–2022 | 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 Weldon 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 |
|---|---|---|---|---|
| Resin Impression Tray MaterialEBH · Class 1 | Impression trays | Maker | EBH / MATERIAL, IMPRESSION TRAY, RESIN | 2011 |
| Preformed Impression TrayEHY · Class 1 | Impression trays | Maker | EHY / TRAY, IMPRESSION, PREFORMED | 2020 |
| Oral Cavity EvacuatorEHZ · Class 1 | Suction & evacuation units | Maker | Evacuator, oral cavity | 2024 |
| All Types RetractorEIG · Class 1 | Dental hand instruments | Maker | EIG / RETRACTOR, ALL TYPES | 2011 |
| Operative Cutting InstrumentEKD · Class 1 | Dental hand instruments | Maker | INSTRUMENT, CUTTING, OPERATIVE | 2021 |
| Dental Surgical ElevatorEMJ · Class 1 | Dental hand instruments | Maker | EMJ / ELEVATOR, SURGICAL, DENTAL | 2011 |
| Surgical Bone ChiselEML · Class 1 | Dental hand instruments | Maker | EML / CHISEL, BONE, SURGICAL | 2011 |
| Orthodontic PlierJEX · Class 1 | Dental hand instruments | Maker | JEX / PLIER, ORTHODONTIC | 2021 |
| Dental Sonography Device for Monitoring Jaw SoundsNFQ · Class 1 | — | Maker | NFQ / Device, dental sonography, for monitoring jaw sounds | 2011 |
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 |
|---|---|---|
| Weldon InstrumentsFDA reg. 3005418651 | Sialkot Punjab, Pakistan | Manufacturer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10034876). 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.