Manufacturer registered with FDA
Surgicrafts
Sialkot, Pakistan. Lists 41 dental device types with FDA across 1 registered establishment.
- Device types listed
- 41
- Brands and models
- 41
- 510(k) clearances
- 0as applicant
- Markets registered in
- 411 registrations outside the US
- Establishments
- 1Pakistan
Registered in 4 markets
Where regulators' registries name Surgicrafts 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 | Surgicrafts | 41 device types | — | Below |
| European Union | EUDAMED | Manufacturer | Surgicrafts | 8 | — | Pure Global AI |
| Taiwan | TFDA | Manufacturer | SURGICRAFTSSURGICRAFTS LIMITED | 2 | 2008–2026 | Pure Global AI |
| South Korea | MFDS | Manufacturer | SURGICRAFTS | 1 | 2024–2024 | 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 Surgicrafts currently lists, by FDA device type, with the brand and model names on the listing.
| Device type | Category | Role | Brands and models | Listed since |
|---|---|---|---|---|
| Orthodontic Screw Expansion RetainerDYJ · Class 1 | Retainers, expanders & headgear | Maker | DYJ / RETAINER, SCREW EXPANSION, ORTHODONTIC | 2024 |
| Intraoral Dental DrillDZA · Class 1 | Surgical drills & motors | Maker | DZA / DRILL, DENTAL, INTRAORAL | 2020 |
| Mouth MirrorEAX · Class 1 | Dental hand instruments | Maker | EAX / MIRROR, MOUTH | 2020 |
| Suction Operatory UnitEBR · Class 1 | Suction & evacuation units | Maker | EBR / UNIT, SUCTION OPERATORY | 2024 |
| Orthodontic Preformed BandECM · Class 1 | Orthodontic wires & bands | Maker | ECM / BAND, PREFORMED, ORTHODONTIC | 2024 |
| Rubber Dam ClampEEF · Class 1 | Rubber dam systems | Maker | EEF / CLAMP, RUBBER DAM | 2020 |
| Dental Dressing ForcepsEFL · Class 1 | Dental hand instruments | Maker | EFL / FORCEPS, DRESSING, DENTAL | 2020 |
| Dental Surgical Tissue ScissorsEGN · Class 1 | Dental hand instruments | Maker | EGN / SCISSORS, SURGICAL TISSUE, DENTAL | 2020 |
| X-Ray Film HolderEGZ · Class 1 | — | Maker | EGZ / Holder, film, x-ray | 2020 |
| Preformed Impression TrayEHY · Class 1 | Impression trays | Maker | EHY / TRAY, IMPRESSION, PREFORMED | 2020 |
| Irrigating (Dental) SyringeEIB · Class 1 | Dental hand instruments | Maker | EIB - Syringe, irrigating (dental) | 2024 |
| All Types RetractorEIG · Class 1 | Dental hand instruments | Maker | EIG / RETRACTOR, ALL TYPES | 2020 |
| Dental Wax CarverEIK · Class 1 | Dental hand instruments | Maker | EIK / CARVER, WAX, DENTAL | 2020 |
| Dental Instrument Depth GaugeEIL · Class 1 | Dental hand instruments | Maker | EIL / GAUGE, DEPTH, INSTRUMENT, DENTAL | 2020 |
| Crown RemoverEIS · Class 1 | Dental hand instruments | Maker | EIS / REMOVER, CROWN | 2020 |
| Periodontic ProbeEIX · Class 1 | Dental hand instruments | Maker | EIX / PROBE, PERIODONTIC | 2020 |
| Dental Plastic Filling InstrumentEIY · Class 1 | Dental hand instruments | Maker | EIY / INSTRUMENT, FILLING, PLASTIC, DENTAL | 2020 |
| Dental Instrument HandleEJB · Class 1 | Dental hand instruments | Maker | EJB / HANDLE, INSTRUMENT, DENTAL | 2020 |
| Cartridge SyringeEJI · Class 2 | Dental needles & syringes | Maker | EJI / Syringe, cartridge | 2020 |
| ArticulatorsEJP · Class 1 | Articulators & facebows | Maker | EJP / ARTICULATORS | 2020 |
| Operative Margin Finishing FileEKA · Class 1 | Dental hand instruments | Maker | EKA / FILE, MARGIN FINISHING, OPERATIVE | 2020 |
| Operative ExplorerEKB · Class 1 | Dental hand instruments | Maker | EKB / EXPLORER, OPERATIVE | 2020 |
| Operative Dental ExcavatorEKC · Class 1 | Dental hand instruments | Maker | EKC / EXCAVATOR, DENTAL, OPERATIVE | 2020 |
| Operative Dental Amalgam CarverEKH · Class 1 | Dental hand instruments | Maker | EKH / CARVER, DENTAL AMALGAM, OPERATIVE | 2020 |
| Operative Amalgam CarrierEKI · Class 1 | Dental hand instruments | Maker | EKI / CARRIER, AMALGAM, OPERATIVE | 2020 |
| Endodontic Root Canal PluggerEKR · Class 1 | Dental hand instruments | Maker | EKR / PLUGGER, ROOT CANAL, ENDODONTIC | 2020 |
| Surgical HemostatEMD · Class 1 | Dental hand instruments | Maker | EMD / HEMOSTAT, SURGICAL | 2020 |
| Surgical Biopsy PunchEME · Class 1 | Dental hand instruments | Maker | EME / PUNCH, BIOPSY, SURGICAL | 2021 |
| Surgical Tooth Extractor ForcepsEMG · Class 1 | Dental hand instruments | Maker | EMG / FORCEPS, TOOTH EXTRACTOR, SURGICAL | 2020 |
| Surgical Rongeur ForcepsEMH · Class 1 | Dental hand instruments | Maker | EMH / FORCEPS, RONGEUR, SURGICAL | 2020 |
| Surgical Bone FileEMI · Class 1 | Dental hand instruments | Maker | EMI / FILE, BONE, SURGICAL | 2020 |
| Dental Surgical ElevatorEMJ · Class 1 | Dental hand instruments | Maker | EMJ / ELEVATOR, SURGICAL, DENTAL | 2020 |
| Dental Surgical CuretteEMK · Class 1 | Dental hand instruments | Maker | EMK / CURETTE, SURGICAL, DENTAL | 2021 |
| Surgical Bone ChiselEML · Class 1 | Dental hand instruments | Maker | EML / CHISEL, BONE, SURGICAL | 2020 |
| Surgical Osteotome ChiselEMM · Class 1 | Dental hand instruments | Maker | CHISEL, OSTEOTOME, SURGICAL | 2020 |
| Periodontic KnifeEMO · Class 1 | Dental hand instruments | Maker | EMO / KNIFE, PERIODONTIC | 2024 |
| Periodontic CuretteEMS · Class 1 | Dental hand instruments | Maker | EMS / CURETTE, PERIODONTIC | 2020 |
| Matrix RetainerJEP · Class 1 | Dental hand instruments | Maker | JEP / RETAINER, MATRIX | 2020 |
| Orthodontic PlierJEX · Class 1 | Dental hand instruments | Maker | JEX / PLIER, ORTHODONTIC | 2020 |
| Endosseous Dental Implant AccessoriesNDP · Class 1 | Implant instruments & surgical kits | Maker | NDP / Accessories, implant, dental, endosseous | 2020 |
| Accessories Operative Dental UnitNRD · Class 1 | — | Maker | NRD / Unit, operative dental, accessories | 2020 |
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 |
|---|---|---|
| SURGICRAFTSFDA reg. 3008808049 | Sialkot Punjab, Pakistan | Manufacturer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10076187). 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.