Manufacturer registered with FDA
Surgiscape
Sialkot, Pakistan. Lists 31 dental device types with FDA across 1 registered establishment.
- Device types listed
- 31
- Brands and models
- 35
- 510(k) clearances
- 0as applicant
- Markets registered in
- 21 registrations outside the US
- Establishments
- 1Pakistan
Registered in 2 markets
Where regulators' registries name Surgiscape as the manufacturer or the registration holder of a device.
RegisteredHome: PakistanOne marker per market
| Market | Regulator | Named as | Name on the registry | Registrations | Issued | Records |
|---|---|---|---|---|---|---|
| United States | FDA | Manufacturer | Surgiscape | 31 device types | — | Below |
| South Korea | MFDS | Manufacturer | Surgiscape | 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 Surgiscape 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 | 2023 |
| Mouth MirrorEAX · Class 1 | Dental hand instruments | Maker | MIRROR, MOUTH | 2023 |
| Orthodontic Ligature Tucking InstrumentECP · Class 1 | Dental hand instruments | Maker | INSTRUMENT, LIGATURE TUCKING, ORTHODONTIC | 2023 |
| Rubber Dam ClampEEF · Class 1 | Rubber dam systems | Maker | CLAMP, RUBBER DAM | 2023 |
| Dental Dressing ForcepsEFL · Class 1 | Dental hand instruments | Maker | FORCEPS, DRESSING, DENTAL | 2023 |
| Dental Surgical Tissue ScissorsEGN · Class 1 | Dental hand instruments | Maker | SCISSORS, SURGICAL TISSUE, DENTAL | 2023 |
| Preformed Impression TrayEHY · Class 1 | Impression trays | Maker | TRAY, IMPRESSION, PREFORMED | 2023 |
| All Types RetractorEIG · Class 1 | Dental hand instruments | Maker | Army Navy Retractor, Double End, Set of 2, 8 ½Baby Weitlaner Retractor 2 x 3 Prongs Blunt Satin 4''Goelet Retractor, Double End 30 x 31 mm and 37 x 40 mm, Satin 7 1/2''Weitlaner Retractor 3 x 4 Prongs Blunt Satin 5 1/2"Weitlaner Retractor 3 x 4 Prongs Blunt Satin 6 1/2" | 2023 |
| Dental Wax CarverEIK · Class 1 | Dental hand instruments | Maker | CARVER, WAX, DENTAL | 2023 |
| Crown RemoverEIS · Class 1 | Dental hand instruments | Maker | REMOVER, CROWN | 2023 |
| Periodontic ProbeEIX · Class 1 | Dental hand instruments | Maker | PROBE, PERIODONTIC | 2023 |
| Dental Plastic Filling InstrumentEIY · Class 1 | Dental hand instruments | Maker | INSTRUMENT, FILLING, PLASTIC, DENTAL | 2023 |
| Dental Instrument HandleEJB · Class 1 | Dental hand instruments | Maker | HANDLE, INSTRUMENT, DENTAL | 2023 |
| ArticulatorsEJP · Class 1 | Articulators & facebows | Maker | ARTICULATORS | 2023 |
| Operative PliersEJY · Class 1 | Dental hand instruments | Maker | Pliers, operative | 2023 |
| Operative ExplorerEKB · Class 1 | Dental hand instruments | Maker | EXPLORER, OPERATIVE | 2023 |
| Operative Dental ExcavatorEKC · Class 1 | Dental hand instruments | Maker | EXCAVATOR, DENTAL, OPERATIVE | 2023 |
| Operative CuretteEKE · Class 1 | Dental hand instruments | Maker | CURETTE, OPERATIVE | 2023 |
| Operative Dental Amalgam CarverEKH · Class 1 | Dental hand instruments | Maker | CARVER, DENTAL AMALGAM, OPERATIVE | 2023 |
| Operative Amalgam CarrierEKI · Class 1 | Dental hand instruments | Maker | CARRIER, AMALGAM, OPERATIVE | 2023 |
| Operative BurnisherEKJ · Class 1 | Dental hand instruments | Maker | BURNISHER, OPERATIVE | 2023 |
| Surgical Biopsy PunchEME · Class 1 | Dental hand instruments | Maker | PUNCH, BIOPSY, SURGICAL | 2023 |
| Surgical Tooth Extractor ForcepsEMG · Class 1 | Dental hand instruments | Maker | FORCEPS, TOOTH EXTRACTOR, SURGICAL | 2023 |
| Surgical Bone FileEMI · Class 1 | Dental hand instruments | Maker | FILE, BONE, SURGICAL | 2023 |
| Dental Surgical ElevatorEMJ · Class 1 | Dental hand instruments | Maker | ELEVATOR, SURGICAL, DENTAL | 2023 |
| Dental Surgical CuretteEMK · Class 1 | Dental hand instruments | Maker | CURETTE, SURGICAL, DENTAL | 2023 |
| Surgical Bone ChiselEML · Class 1 | Dental hand instruments | Maker | CHISEL, BONE, SURGICAL | 2023 |
| Surgical Osteotome ChiselEMM · Class 1 | Dental hand instruments | Maker | CHISEL, OSTEOTOME, SURGICAL | 2023 |
| Periodontic ScalerEMN · Class 1 | Dental hand instruments | Maker | SCALER, PERIODONTIC | 2023 |
| Periodontic FileEMR · Class 1 | Dental hand instruments | Maker | FILE, PERIODONTIC | 2023 |
| Orthodontic PlierJEX · Class 1 | Dental hand instruments | Maker | PLIER, ORTHODONTIC | 2023 |
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 |
|---|---|---|
| SURGISCAPEFDA reg. 3022862651 | Sialkot Punjab, Pakistan | Manufacturer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10087211). 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.