Manufacturer registered with FDA

Falcon Surgical Co. (Pvt.) Ltd.

Sialkot, Pakistan. Lists 83 dental device types with FDA across 1 registered establishment.

FDA owner/operator8040278Manufacturer

Device types listed: 83
Brands and models: 83
510(k) clearances: 0as applicant
Markets registered in: 81,274 registrations outside the US
Establishments: 1Pakistan

Registered in 8 markets

Where regulators' registries name Falcon Surgical Co. (Pvt.) Ltd. as the manufacturer or the registration holder of a device.

All markets

RegisteredHome: PakistanOne marker per market

Market	Regulator	Named as	Name on the registry	Registrations	Issued	Records
United States	FDA	Manufacturer	Falcon Surgical Co. (Pvt.) Ltd.	83 device types	—	Below
Thailand	Thai FDA	Manufacturer	FALCON SURGICAL CO.,(PVT) LTD.	1,077	—	Pure Global AI
United Kingdom	MHRA	Manufacturer	Falcon Surgical Co. (Pvt) Ltd.	126	—	Pure Global AI
European Union	EUDAMED	Manufacturer	Falcon Surgical Co. (Pvt.) Ltd	28	—	Pure Global AI
Serbia	ALIMS	Manufacturer	Falcon Surgical Co. (Pvt.) Ltd.	27	2022–2022	Pure Global AI
South Korea	MFDS	Manufacturer	Falcon Surgical Co.(Pvt) Ltd.FALCON SURGICAL CO. (PVT) LTD · Falcon Surgical Co. (Pvt) Ltd. · +2	14	2008–2013	Pure Global AI
Australia	TGA	Manufacturer	Falcon Surgical Co Pvt Ltd	1	2024–2024	Pure Global AI
Taiwan	TFDA	Manufacturer	FALCON SURGICAL CO. (PVT.) LTD.	1	2009–2009	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 Falcon Surgical Co. (Pvt.) Ltd. currently lists, by FDA device type, with the brand and model names on the listing.

Device type	Category	Role	Brands and models	Listed since
Saliva Ejector MouthpieceDYN · Class 1	—	Maker	Mouthpiece, Saliva Ejector	1984
Intraoral Dental DrillDZA · Class 1	Surgical drills & motors	Maker	Dental Drill	1984
Dental NeedleDZM · Class 1	Dental needles & syringes	Maker	Dental Needle	1984
Dental Hand InstrumentsDZN · Class 1	Dental hand instruments	Maker	Dental Instruments	2003
Dental Diamond InstrumentDZP · Class 1	Dental burs & diamonds	Maker	Dental Instrument, Diamond Coated	1984
Mouth MirrorEAX · Class 1	Dental hand instruments	Maker	MIrror	2003
Orthodontic Wire ClampECN · Class 1	—	Maker	Clamp, Wire, Orthodontic	1984
Orthodontic Ligature Tucking InstrumentECP · Class 1	Dental hand instruments	Maker	Ligature Instrument	2003
Orthodontic Band SetterECR · Class 1	Dental hand instruments	Maker	Setter, Band, Orthodontic	1984
Orthodontic Band PusherECS · Class 1	Dental hand instruments	Maker	Pusher, Band, Orthodontic	2003
Orthodontic Band DriverECT · Class 1	Dental hand instruments	Maker	Driver, Band, Orthodontic	2003
Rubber Dam ClampEEF · Class 1	Rubber dam systems	Maker	Rubber Dam Clamp	2003
Disk GuardEEJ · Class 1	—	Maker	Disk Guard	2006
Articulation Paper ForcepsEFK · Class 1	Dental hand instruments	Maker	Articulation Forceps	1984
Dental Dressing ForcepsEFL · Class 1	Dental hand instruments	Maker	Forceps	1984
Dental Surgical Tissue ScissorsEGN · Class 1	Dental hand instruments	Maker	Scissors	1984
X-Ray Film HolderEGZ · Class 1	—	Maker	X-Ray Holder	2003
Abrasive DiskEHJ · Class 1	Polishing & prophylaxis	Maker	DISK, ABRASIVE	2023
Prophylaxis CupEHK · Class 1	Polishing & prophylaxis	Maker	CUP, PROPHYLAXIS	2023
Preformed ClaspEHP · Class 1	—	Maker	CLASP, PREFORMED	2023
Preformed Impression TrayEHY · Class 1	Impression trays	Maker	TRAY, IMPRESSION, PREFORMED	2003
Oral Cavity EvacuatorEHZ · Class 1	Suction & evacuation units	Maker	Evacuator, oral cavity	2023
Irrigating (Dental) SyringeEIB · Class 1	Dental hand instruments	Maker	Syringe, Irrigating (Dental)	2023
Irrigating Endodontic Periodontic SyringeEIC · Class 1	Dental hand instruments	Maker	Dental Syringe	1984
Restorative and Impression Material SyringeEID · Class 1	Dental hand instruments	Maker	Syringe, Restorative And Impression Material	2023
Dental Retractor AccessoriesEIF · Class 1	Dental hand instruments	Maker	Retractors	2003
All Types RetractorEIG · Class 1	Dental hand instruments	Maker	Retractor	1984
Dental Wax CarverEIK · Class 1	Dental hand instruments	Maker	Dental Carver	2003
Dental Instrument Depth GaugeEIL · Class 1	Dental hand instruments	Maker	Depth Gauge	2003
Collar and Crown ScissorsEIR · Class 1	Dental hand instruments	Maker	Scissors, Collar And Crown	1984
Crown RemoverEIS · Class 1	Dental hand instruments	Maker	Crown Remover	2003
Periodontic ProbeEIX · Class 1	Dental hand instruments	Maker	Dental Probe	2003
Dental Plastic Filling InstrumentEIY · Class 1	Dental hand instruments	Maker	INSTRUMENT, FILLING, PLASTIC, DENTAL	2003
Dental Instrument HandleEJB · Class 1	Dental hand instruments	Maker	Dental Handle	2003
Rubber Dam FrameEJE · Class 1	Rubber dam systems	Maker	Rubber Dam Frame	2003
Rubber Dam Clamp ForcepsEJG · Class 1	Rubber dam systems	Maker	Forceps, Rubber Dam Clamp	2003
Cartridge SyringeEJI · Class 2	Dental needles & syringes	Maker	Dental Cartridge, Syringe	2021
Dental BurEJL · Class 1	Dental burs & diamonds	Maker	Dental Bur	1984
ArticulatorsEJP · Class 1	Articulators & facebows	Maker	Articulators	2003
Wire ClaspEJW · Class 1	—	Maker	CLASP, WIRE	2023
Operative PliersEJY · Class 1	Dental hand instruments	Maker	Pliers	1984
Operative Margin Finishing KnifeEJZ · Class 1	Dental hand instruments	Maker	KNIFE, MARGIN FINISHING, OPERATIVE	2003
Operative Margin Finishing FileEKA · Class 1	Dental hand instruments	Maker	File, Margin Finishing, Operative	2003
Operative ExplorerEKB · Class 1	Dental hand instruments	Maker	Explorer	2003
Operative Dental ExcavatorEKC · Class 1	Dental hand instruments	Maker	Excavator	2003
Operative Cutting InstrumentEKD · Class 1	Dental hand instruments	Maker	Cutting Instrument	1984
Operative CuretteEKE · Class 1	Dental hand instruments	Maker	Curette	2003
Operative Matrix Contouring InstrumentEKF · Class 1	Dental hand instruments	Maker	INSTRUMENT, CONTOURING, MATRIX, OPERATIVE	2003
Operative Amalgam and Foil CondenserEKG · Class 1	Dental hand instruments	Maker	Condenser	2003
Operative Dental Amalgam CarverEKH · Class 1	Dental hand instruments	Maker	Dental Carver	2003
Operative Amalgam CarrierEKI · Class 1	Dental hand instruments	Maker	Amalgam Carrier	2003
Operative BurnisherEKJ · Class 1	Dental hand instruments	Maker	Burnisher	2003
Endodontic Pulp Canal Filling Material SpreaderEKK · Class 1	Dental hand instruments	Maker	SPREADER, PULP CANAL FILLING MATERIAL, ENDODONTIC	2023
Endodontic Pulp Canal ReamerEKP · Class 1	Endodontic files	Maker	REAMER, PULP CANAL, ENDODONTIC	2023
Endodontic Root Canal PluggerEKR · Class 1	Dental hand instruments	Maker	Plugger	2003
Endodontic CuretteEKT · Class 1	Dental hand instruments	Maker	Curette	2003
Calculus Removal Hand InstrumentELA · Class 1	Dental hand instruments	Maker	INSTRUMENT, HAND, CALCULUS REMOVAL	2003
Surgical HemostatEMD · Class 1	Dental hand instruments	Maker	Hemostat	1984
Surgical Biopsy PunchEME · Class 1	Dental hand instruments	Maker	Punch, Biopsy, Surgical	1984
Surgical Tooth Extractor ForcepsEMG · Class 1	Dental hand instruments	Maker	Tooth Forceps	1984
Surgical Rongeur ForcepsEMH · Class 1	Dental hand instruments	Maker	Rongeur	1984
Surgical Bone FileEMI · Class 1	Dental hand instruments	Maker	Bone File	2003
Dental Surgical ElevatorEMJ · Class 1	Dental hand instruments	Maker	Elevator	2003
Dental Surgical CuretteEMK · Class 1	Dental hand instruments	Maker	Curette	2003
Surgical Bone ChiselEML · Class 1	Dental hand instruments	Maker	Bone Chisel	2003
Surgical Osteotome ChiselEMM · Class 1	Dental hand instruments	Maker	Osteotome	2003
Periodontic ScalerEMN · Class 1	Dental hand instruments	Maker	Scaler, Periodontic	2003
Periodontic KnifeEMO · Class 1	Dental hand instruments	Maker	KNIFE, PERIODONTIC	2003
Periodontic HoeEMQ · Class 1	Dental hand instruments	Maker	HOE, PERIODONTIC	2003
Periodontic FileEMR · Class 1	Dental hand instruments	Maker	File, Periodontic	2003
Periodontic CuretteEMS · Class 1	Dental hand instruments	Maker	Curette	2003
Matrix RetainerJEP · Class 1	Dental hand instruments	Maker	Retainer, Matrix	2003
Orthodontic PlierJEX · Class 1	Dental hand instruments	Maker	Pliers	2003
Tube Impression and MatrixKCQ · Class 1	—	Maker	Tube Impression And Matrix	2023
FacebowKCR · Class 1	Articulators & facebows	Maker	Facebow	2003
Disposable Fluoride TrayKMT · Class 1	—	Maker	TRAY, FLUORIDE, DISPOSABLE	2009
Preformed Tooth PositionerKMY · Class 1	Retainers, expanders & headgear	Maker	Positioner	2019
Resin ApplicatorKXR · Class 1	—	Maker	APPLICATOR, RESIN	2023
Tongue ScraperLCN · Class 1	—	Maker	SCRAPER, TONGUE	2023
Endosseous Dental Implant AccessoriesNDP · Class 1	Implant instruments & surgical kits	Maker	Accessories, implant, dental, endosseous	2003
General Purpose Dental TrayOFX · Class 1	—	Maker	General Purpose Dental Tray (Kit)	2009
Dental Implant Surgical TrayOFY · Class 1	Implant instruments & surgical kits	Maker	Dental Implant Surgical Tray (Kit)	2009
Dental Foam Protector IntraoralPFL · Class 1	—	Maker	Intraoral, dental foam protector	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
Falcon Surgical Co. (Pvt.) Ltd.FDA reg. 8040278	Sialkot Punjab, Pakistan	Manufacturer

Sources

FDA establishment registration & device listing (search FDA, owner/operator 8040278). 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.