Manufacturer registered with FDA
Swengg Co
Sialkot, Pakistan. Lists 10 dental device types with FDA across 1 registered establishment.
- Device types listed
- 10
- Brands and models
- 10
- 510(k) clearances
- 0as applicant
- Markets registered in
- 313 registrations outside the US
- Establishments
- 1Pakistan
Registered in 3 markets
Where regulators' registries name Swengg Co 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 | Swengg Co | 10 device types | — | Below |
| European Union | EUDAMED | Manufacturer | SWENGG CO | 8 | — | Pure Global AI |
| Peru | DIGEMID | Manufacturer | SWENGG CO. | 5 | 2021–2022 | 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 Swengg Co 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 | Dental / Mouth Mirror | 2016 |
| Rubber Dam ClampEEF · Class 1 | Rubber dam systems | Maker | Rubber Dam Clamp / punches | 2016 |
| Dental Dressing ForcepsEFL · Class 1 | Dental hand instruments | Maker | Dental Forceps | 2016 |
| Irrigating Endodontic Periodontic SyringeEIC · Class 1 | Dental hand instruments | Maker | Dental Syringe Irrigation | 2016 |
| All Types RetractorEIG · Class 1 | Dental hand instruments | Maker | General Surgery Retractors | 2019 |
| Periodontic ProbeEIX · Class 1 | Dental hand instruments | Maker | Dental Probes | 2016 |
| Dental Plastic Filling InstrumentEIY · Class 1 | Dental hand instruments | Maker | Dental Plastic Filling Instruments | 2016 |
| Dental Instrument HandleEJB · Class 1 | Dental hand instruments | Maker | Handles & Hand Held Dental Instruments | 2016 |
| Operative ExplorerEKB · Class 1 | Dental hand instruments | Maker | Explorers - Dental | 2016 |
| Surgical HemostatEMD · Class 1 | Dental hand instruments | Maker | Dental Hemostatic Forceps | 2019 |
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 |
|---|---|---|
| SWENGG COFDA reg. 3009255580 | Sialkot Punjab, Pakistan | Manufacturer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10051062). 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.