Manufacturer registered with FDA
Wise Instruments
Sialkot, Pakistan. Lists 12 dental device types with FDA across 1 registered establishment.
- Device types listed
- 12
- Brands and models
- 0
- 510(k) clearances
- 0as applicant
- Markets registered in
- 24 registrations outside the US
- Establishments
- 1Pakistan
Registered in 2 markets
Where regulators' registries name Wise 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 | Wise Instruments | 12 device types | — | Below |
| Peru | DIGEMID | Manufacturer | WISE INSTRUMENTS | 4 | 2013–2025 | 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 Wise 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 | — | 2022 |
| All Types RetractorEIG · Class 1 | Dental hand instruments | Maker | — | 2022 |
| Crown RemoverEIS · Class 1 | Dental hand instruments | Maker | — | 2022 |
| Periodontic ProbeEIX · Class 1 | Dental hand instruments | Maker | — | 2022 |
| Dental Instrument HandleEJB · Class 1 | Dental hand instruments | Maker | — | 2022 |
| Cartridge SyringeEJI · Class 2 | Dental needles & syringes | Maker | — | 2022 |
| Surgical HemostatEMD · Class 1 | Dental hand instruments | Maker | — | 2022 |
| Surgical Tooth Extractor ForcepsEMG · Class 1 | Dental hand instruments | Maker | — | 2022 |
| Surgical Rongeur ForcepsEMH · Class 1 | Dental hand instruments | Maker | — | 2022 |
| Dental Surgical ElevatorEMJ · Class 1 | Dental hand instruments | Maker | — | 2022 |
| Periodontic ScalerEMN · Class 1 | Dental hand instruments | Maker | — | 2022 |
| Orthodontic PlierJEX · Class 1 | Dental hand instruments | Maker | — | 2022 |
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 |
|---|---|---|
| WISE INSTRUMENTSFDA reg. 3003882399 | Sialkot Punjab, Pakistan | Manufacturer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10086031). 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.