Manufacturer registered with FDA
Sobytek Instruments Co.
SIALKOT, PUNJAB, Pakistan. Lists 7 dental device types with FDA across 1 registered establishment.
- Device types listed
- 7
- Brands and models
- 7
- 510(k) clearances
- 0as applicant
- Markets registered in
- 6199 registrations outside the US
- Establishments
- 1Pakistan
Registered in 6 markets
Where regulators' registries name Sobytek Instruments 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 | Sobytek Instruments Co. | 7 device types | — | Below |
| South Korea | MFDS | Manufacturer | SOBYTEK INSTRUMENTS Co.Sobytek Instruments Co. · Sobytek Instruments Co · +2 | 189 | 2006–2026 | Pure Global AI |
| Brazil | ANVISA | Manufacturer | Sobytek Instruments Co.SOBYTEK INSTRUMENTS CO. | 5 | 2015–2018 | Pure Global AI |
| European Union | EUDAMED | Manufacturer | Sobytek Instruments Co. | 3 | — | Pure Global AI |
| Colombia | INVIMA | Manufacturer | SOBYTEK INSTRUMENTS CO | 1 | — | Pure Global AI |
| Taiwan | TFDA | Manufacturer | SOBYTEK INSTRUMENTS CO. | 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 Sobytek Instruments 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 mirror | 2017 |
| Orthodontic Band PusherECS · Class 1 | Dental hand instruments | Maker | mirror handle | 2013 |
| Preformed Impression TrayEHY · Class 1 | Impression trays | Maker | TRAYS | 2005 |
| Irrigating Endodontic Periodontic SyringeEIC · Class 1 | Dental hand instruments | Maker | SYRINGE | 2005 |
| Dental Retractor AccessoriesEIF · Class 1 | Dental hand instruments | Maker | ACESSORIES RETRACTORS | 2005 |
| Collar and Crown ScissorsEIR · Class 1 | Dental hand instruments | Maker | scissors | 2005 |
| Orthodontic PlierJEX · Class 1 | Dental hand instruments | Maker | Pliers | 2005 |
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 |
|---|---|---|
| SOBYTEK INSTRUMENTS CO.FDA reg. 3004784004 | SIALKOT Punjab, Pakistan | Manufacturer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 9076464). 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.