Manufacturer registered with FDA
Surgikare
SIALKOT, Pakistan. Lists 18 dental device types with FDA across 1 registered establishment.
- Device types listed
- 18
- Brands and models
- 18
- 510(k) clearances
- 0as applicant
- Markets registered in
- 552 registrations outside the US
- Establishments
- 1Pakistan
Registered in 5 markets
Where regulators' registries name Surgikare 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 | Surgikare | 18 device types | — | Below |
| United Kingdom | MHRA | Manufacturer | Surgikare | 39 | — | Pure Global AI |
| Brazil | ANVISA | Manufacturer | SURGIKARE | 10 | 2019–2019 | Pure Global AI |
| Australia | TGA | Manufacturer | Surgikare | 2 | 2024–2024 | Pure Global AI |
| Taiwan | TFDA | Manufacturer | SURGIKARE | 1 | 2023–2023 | 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 Surgikare 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 | 2009 |
| Mouth MirrorEAX · Class 1 | Dental hand instruments | Maker | MIRROR, MOUTH | 2009 |
| Rubber Dam ClampEEF · Class 1 | Rubber dam systems | Maker | CLAMP, RUBBER DAM | 2009 |
| Preformed Impression TrayEHY · Class 1 | Impression trays | Maker | TRAY, IMPRESSION, PREFORMED | 2009 |
| All Types RetractorEIG · Class 1 | Dental hand instruments | Maker | RETRACTOR, ALL TYPES | 2009 |
| Dental Wax CarverEIK · Class 1 | Dental hand instruments | Maker | CARVER, WAX, DENTAL | 2009 |
| Crown RemoverEIS · Class 1 | Dental hand instruments | Maker | REMOVER, CROWN | 2009 |
| Dental Plastic Filling InstrumentEIY · Class 1 | Dental hand instruments | Maker | INSTRUMENT, FILLING, PLASTIC, DENTAL | 2009 |
| Dental Instrument HandleEJB · Class 1 | Dental hand instruments | Maker | HANDLE, INSTRUMENT, DENTAL | 2009 |
| ArticulatorsEJP · Class 1 | Articulators & facebows | Maker | ARTICULATORS | 2009 |
| Operative ExplorerEKB · Class 1 | Dental hand instruments | Maker | EXPLORER, OPERATIVE | 2009 |
| Operative Dental ExcavatorEKC · Class 1 | Dental hand instruments | Maker | EXCAVATOR, DENTAL, OPERATIVE | 2009 |
| Operative Dental Amalgam CarverEKH · Class 1 | Dental hand instruments | Maker | CARVER, DENTAL AMALGAM, OPERATIVE | 2009 |
| Operative BurnisherEKJ · Class 1 | Dental hand instruments | Maker | BURNISHER, OPERATIVE | 2009 |
| Surgical Bone FileEMI · Class 1 | Dental hand instruments | Maker | FILE, BONE, SURGICAL | 2009 |
| Dental Surgical ElevatorEMJ · Class 1 | Dental hand instruments | Maker | ELEVATOR, SURGICAL, DENTAL | 2009 |
| Surgical Bone ChiselEML · Class 1 | Dental hand instruments | Maker | CHISEL, BONE, SURGICAL | 2009 |
| Periodontic ScalerEMN · Class 1 | Dental hand instruments | Maker | SCALER, PERIODONTIC | 2009 |
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 |
|---|---|---|
| SURGIKAREFDA reg. 3006059835 | SIALKOT Punjab, Pakistan | Foreign exporter, Manufacturer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 9036087). 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.