Manufacturer registered with FDA
Shanghai Kangqiao Dental Instruments Factory
SHANGHAI, China. Lists 37 dental device types with FDA across 1 registered establishment.
- Device types listed
- 37
- Brands and models
- 308
- 510(k) clearances
- 0as applicant
- Markets registered in
- 44 registrations outside the US
- Establishments
- 1China
Registered in 4 markets
Where regulators' registries name Shanghai Kangqiao Dental Instruments Factory as the manufacturer or the registration holder of a device.
RegisteredHome: ChinaOne marker per market
| Market | Regulator | Named as | Name on the registry | Registrations | Issued | Records |
|---|---|---|---|---|---|---|
| United States | FDA | Manufacturer | Shanghai Kangqiao Dental Instruments Factory | 37 device types | — | Below |
| South Korea | MFDS | Manufacturer | Shanghai Kangqiao Dental Instruments Factory | 2 | 2005–2007 | Pure Global AI |
| European Union | EUDAMED | Manufacturer | SHANGHAI KANGQIAO DENTAL INSTRUMENTS FACTORY | 1 | — | Pure Global AI |
| Taiwan | TFDA | Manufacturer | SHANGHAI KANGQIAO DENTAL INSTRUMENTS FACTORY | 1 | 2010–2010 | 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 Shanghai Kangqiao Dental Instruments Factory 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 WireDZC · Class 1 | Orthodontic wires & bands | Maker | Dental stainless steel wire 30g 0.5mm/0.6mm/0.7mm/0.8mm/0.9mm/1mm/1.2mm/1.8mmDental stainless steel wire 50g 0.5mm/0.6mm/0.7mm/0.8mm/0.9mm/1mmLigature wire 0.2mm/0.25mm/0.30mm/0.40mm | 2024 |
| Dental Hand InstrumentsDZN · Class 1 | Dental hand instruments | Maker | Gap Increasing instrumentMathiew Needle holder TC with gold plating 125mm/140mm/160mm/180mmMicro needle holder 14cm/16cm curved lockableMicro needle holder 14cm/16cm straight lockableNeedle holder 12.5cm/14cm/16cm/18cm FineNeedle holder 12.5cm/14cm/16cm/18cm Fine, no platedNeedle holder 12.5cm/14cm/16cm/18cm Fine, SuturedNeedle holder 12.5cm/14cm/16cm/18cm Fine, Sutured, curvedNeedle holder 12.5cm/14cm/16cm/18cm Fine, Sutured, no platedNeedle holder 14cm/16cm Fine, curved 2 moreNeedle holder 14cm/16cm/18cm RoughNeedle holder TC with gold plating 125mm/140mm/160mm/180mm | 2024 |
| Mouth MirrorEAX · Class 1 | Dental hand instruments | Maker | Micro Mirror WY1/WY2/ WJ1/WJ2Mirror 1SZZP 4/3SZZP 4/SZZP 5/LSZP 5/L2SZP 5Mouth mirrorsMouth mirrors 3# JFP plainMouth mirrors 4# Anti-heat MagnifyingMouth mirrors 4# Anti-heat plainMouth mirrors 4# autoclavable MagnifyingMouth mirrors 4# FS (rhodium plated)autoclavable plainMouth mirrors 4# plainMouth mirrors 4# plain BFP 12 moreMouth mirrors 4# plain MagnifyingMouth mirrors 4# ZFS (rhodium plated)autoclavable plain ,one-piece typeMouth mirrors 5 MagnifyingMouth mirrors 5 plainMouth mirrors 5# Anti-heat MagnifyingMouth mirrors 5# Anti-heat plainMouth mirrors handle (stainless steel)Mouth mirrors handle CS octagon handleMouth mirrors handle CS round handleMouth mirrors handle MHS SSMouth mirrors handle SS octagon handleMouth mirrors handle SS round handle | 2005 |
| Orthodontic Wire ClampECN · Class 1 | — | Maker | ARCH WIRES | 2005 |
| Orthodontic Band PusherECS · Class 1 | Dental hand instruments | Maker | Band pusher | 2005 |
| Articulation Paper ForcepsEFK · Class 1 | Dental hand instruments | Maker | Articulating paper forceps curvedArticulating paper forceps curved double tip 145mmArticulating paper forceps straightBone Rongeur Forceps FlatBone Rongeur Forceps OctangleBone Rongeur Forceps RoundBone Rongeur Forceps Round 14cmForceps for adults 1#/8#/17#/23#/32#/44#/46#/48#/53L#/53R#/65#/69#/88L#Forceps for adults 88R#/150#/151#/222#/10#/15#/16#/210#/18L#/18R#Forceps for children 1/2/3/4/5/6/7/8 | 2005 |
| Dental Dressing ForcepsEFL · Class 1 | Dental hand instruments | Maker | Cotton & dressing pliers (double fold no pin with tooth)Cotton & dressing pliers (double fold no pin without tooth)Cotton & dressing pliers (double fold with pin with tooth)Cotton & dressing pliers (double fold with pin)Cotton & dressing pliers (double fold without pin with tooth)Cotton & dressing pliers (double fold without pin)Cotton & dressing pliers (single fold with pin)Cotton & dressing pliers (single fold without pin)Cotton & dressing pliers satin surface ( with pin without tooth)Cotton&dressing pliers (double fold with pin with tooth) 1 moreDressing forceps 125#/140#/160#/180#/200#/220#/250# | 2005 |
| Dental Surgical Tissue ScissorsEGN · Class 1 | Dental hand instruments | Maker | Gum scissor curved/small curved/No plated small curved/double curved/22cmGum scissor straightGum scissor with stainless steel curvedGum scissor with stainless steel straightGum scissor with TC TIP curvedOphthalmic scissors 10cm CurvedOphthalmic scissors 10cm Curved (No plated)Ophthalmic scissors 10cm StraightOphthalmic scissors 10cm Straight (No plated)Orthodontic pliers 105G/134/200/ 201/210/231/1009/3471 14 morePlaster shear 16cm/20cmSurgical scissors 12.5cm/14cm/16cm curved and sharp roundSurgical scissors 12.5cm/14cm/16cm straight and sharp roundSurgical scissors 12.5cm/14cm/16cm/18cm CurvedSurgical scissors 12.5cm/14cm/16cm/18cm Curved (No plated)Surgical scissors 12.5cm/14cm/16cm/18cm curved and roundSurgical scissors 12.5cm/14cm/16cm/18cm StraightSurgical scissors 12.5cm/14cm/16cm/18cm Straight (No plated)Surgical scissors 12.5cm/14cm/16cm/18cm straight and roundTC Gum scissor straightTC Ophthalmic scissors 10cm CurvedTC Ophthalmic scissors 10cm StraightTissue scissors 14cm/16cm/18cm/20cm/22cm/25cm curvedTissue scissors 14cm/16cm/18cm/20cm/22cm/25cm straight | 2005 |
| Preformed ClaspEHP · Class 1 | — | Maker | Lingual bars L/M/SOcclusal flat wire L/M/SPalatal bars L/M/S | 2005 |
| Preformed Impression TrayEHY · Class 1 | Impression trays | Maker | Aluminium impression tray 1#/2#/3#/3#/4#/5#/6#/( a pair) perforatedAluminium impression tray 1#2#/3# ( a pair) un-perforatedDenture duplicatorsPartial impression tray (stainless steel) leftPartial impression tray (stainless steel) premolarPartial impression tray (stainless steel) rightPartial impression tray activePartial impression tray leftPartial impression tray rightStainless Steel 1#/2#/3#/4#/5#//6# perforated Lower 8 moreStainless Steel 1#/2#/3#/4#/5#//6# perforated UpperStainless steel Impression trays for implanting L/M/SStainless steel Impression trays Non-perforated-round lower 1# Large/ 2# Medium/ 3# SMALLStainless steel Impression trays Non-perforated-round upper 1# Large/ 2# Medium/ 3# SMALLStainless steel Impression trays perforated-round lower 1# Large/ 2# Medium/ 3# SMALLStainless steel Impression trays perforated-round upper 1# Large/ 2# Medium/ 3# SMALLStainless Steel L/M/S non-perforated lowerStainless Steel L/M/S non-perforated Upper | 2005 |
| Oral Cavity EvacuatorEHZ · Class 1 | Suction & evacuation units | Maker | Aspirator tip (Chrome)Aspirator tip (Stainless steel) I/II/IIIAspirator tip type IV/ type V/ type II L | 2024 |
| Restorative and Impression Material SyringeEID · Class 1 | Dental hand instruments | Maker | Agar impression syringesAspirating syringes KAS C/W2 (stainless steel)Aspirating syringes KAS C/W3Aspirating syringes KAS CWA / KAS CWHneedle dia.1.2needle dia.8Stainless TIP ( US size/Metric size)TIP ( US size/Metric size) | 2005 |
| Dental Retractor AccessoriesEIF · Class 1 | Dental hand instruments | Maker | Color-coded instrument rings (Green/Blue/Purple/Pink/Red/Grey/Orange/Yellow) | 2005 |
| All Types RetractorEIG · Class 1 | Dental hand instruments | Maker | Cheek retractorPeriotomes GRM 1/GRM 2Retractors curvedRetractors straight | 2024 |
| Dental Wax CarverEIK · Class 1 | Dental hand instruments | Maker | Carver For Silicone R1Carver For Silicone R2P.K.Thomas carver KWC PKT1/PKT2/PKT3/PKT4/PKT5Wax carver KWC 5/6/7/8/9/10/11/12/C1/C2/C3/C4/C5/C6Wax carver R5/ R6 (round handle)Wax carvers E1/E2/E3/E4/E5/E6/E46/E47/E48/E31/Y1Wax carvers KWC1/KWC2Wax carvers KWCW1 | 2005 |
| Collar and Crown ScissorsEIR · Class 1 | Dental hand instruments | Maker | Crown scissors 11cm, straight/ curved/ TC tip, straight /TC tip, curved/ straight, no plated/ curved, no plated | 2005 |
| Crown RemoverEIS · Class 1 | Dental hand instruments | Maker | Crown removerCrown Remover/Spreaders 3# II StraightCrown Remover/Spreaders 4# II CurvedCurved tipStraight tip | 2005 |
| Periodontic ProbeEIX · Class 1 | Dental hand instruments | Maker | Nerve broach handle type IPeriodontal probe E1 flat (4.5mm eight-angle handle)Periodontal probe KP C11.5B (5.5mm round handle)Periodontal probe KP C11.5B (9.5mm round handle)Periodontal probe KP S23-C15 (5.6mm round handle)Periodontal probe KP S23/C15 (5.5mm round handle)Periodontal probe KP W/KP C2/KP C12/KP C15/KP QW/KP Q2N (5.5mm round handle)Periodontal probe KP WHO / KP C11.5B (3.5mm round handle) | 2005 |
| Operative ExplorerEKB · Class 1 | Dental hand instruments | Maker | Double end explorers KEX D2/D3/D3ES/D5/D6/D7/D11/D16/LD5/LD16EXPLORERS CYZ001AEXPLORERS CYZ001BEXPLORERS CYZ002AEXPLORERS CYZ002BEXPLORERS CYZ003AEXPLORERS CYZ003BEXPLORERS CYZ004AEXPLORERS CYZ004BEXPLORERS CYZ005A 5 moreEXPLORERS CYZ005BExplorers E1/E2/E3/E5/E6Explorers E3/E6/E7/E9/E10/E11/E12/E13/E14/E17/E21/E22/E23Explorers R3/R6/R7/R9/R10/R11/R12/R13/R14/R17/R21/R22/R23Single end explorers KEX S6/S7 S23 | 2005 |
| Operative Dental ExcavatorEKC · Class 1 | Dental hand instruments | Maker | Excavators E1/E2/E3/E4/E5/E6 (octagon handle)Excavators KEXC 17 / KEXC 18/ KEXC31L/ KEXC32L/ KEXC33L/ KEXC L32LExcavators R1/R2/R3/R4/R5/R6 | 2005 |
| Operative CuretteEKE · Class 1 | Dental hand instruments | Maker | Color-coded instrument rings (Assorted colors, 8 colors, 20pcs each)Sharpening stone 1-roundSharpening stone 2-TrapeziformSharpening stone 3-RectangleSharpening stone 4-Red stoneSharpenning guider (guider +3# stone) | 2005 |
| Operative Dental Amalgam CarverEKH · Class 1 | Dental hand instruments | Maker | Amalgam carvers E1/E2/E3 (eight-angle handle)Amalgam carvers R1/R2/R3 (round handle)Carver For Silicone | 2012 |
| Operative Amalgam CarrierEKI · Class 1 | Dental hand instruments | Maker | Amalgam carrier brass KAC AAmalgam carrier stainless steel KAC BAmalgam pluggers E1/E1.5/E2/E2.5/E3/E1-2/E1.5-2.5/E3×1-1×3 (eight-angle handle)Amalgam pluggers R1 / R1.5 / R2 / R2.5 / R3 (round handle)Amalgam pluggers R1-2 / R1.5-2.5 (round handle) | 2005 |
| Operative BurnisherEKJ · Class 1 | Dental hand instruments | Maker | Burnishers E1/E2/E3/E4/E5/E6/E2-4/E3-8/E5-6/R26/27S | 2005 |
| Endodontic Pulp Canal Filling Material SpreaderEKK · Class 1 | Dental hand instruments | Maker | Spreaders KRCP S20/S25/S30/S40/S50/S60 (5.5mm round handle) | 2005 |
| Endodontic Root Canal PluggerEKR · Class 1 | Dental hand instruments | Maker | Bone powder pluggers Type G/I/IIICement pluggers E1 / E2# / E3 / E4 (eight-angle handle)Cement pluggers KCP2Cement pluggers R1/R2/R3/R4 (round handle)ENDO Pluggers EJD05, EJD065, EJD08, EJD10, EJD12, EJD05/065, EJD08/10Pluggers/Condensers KRCP 1/3Pluggers/Condensers KRCP 30/8/8.5/9/9.5/10/10.5/11/11.5/12 (5.5mm round handle)Pluggers/Condensers KRCP 4/7Pluggers/Condensers KRCP 5/7Pluggers/Condensers KRCP 5/8 6 morePluggers/Condensers KRCP 6/10Pluggers/Condensers KRCP 8A/8.5A/9A/9.5A/10A/10.5A/11A/11.5A/12A/30A (5.5mm round handle)Pluggers/Condensers KRCP 9/11Pluggers/Condensers KRCP T30Root-canal pluggers E1/ E2/ E3/ E4 (4.5mm eight-angle handle)Root-canal pluggers R1/R2/ R3/ R4 (5mm round handle) | 2005 |
| Endodontic CuretteEKT · Class 1 | Dental hand instruments | Maker | Bone curettes E1/E2/E3/E4Bone curettes R1/R2/R3/R4/KBC 2/KBC 3Curettes E1/E2/E3/E4/E5/E6/E7/E8/E9/E10/E11/E12 (eight-angle handle)Curettes F1/F2/F3Curettes KC C2R/2L;KC C4R/4L;KC C13/14;KC MC13/14;KC MC17/18;KC MC17S/18SCurettes KC G1/2; KC G3/4;KC G5/6;KC G7/8;KC G9/1;KC G11/12;KC G13/14;KC G15/16;KC G17/18Curettes KC GL1/2;KC GL3/4;KC GL5/6;KC GL7/8;KC GL11/1;KC GL13/14;KC GL15/16;KC GL17/18Curettes KC GM1/2;KC GM3/4;KC GM5/6;KC GM7/8;KC GM11/12;KC GM13/14;KC GM15/16Curettes KC YG7/8;KC B1/2;KC L3/4Curettes R1/R2/R3/R4/R5/R6/R7/R8/R9/R10/R11/R12 (round handle) 4 moreDental curettes octagon handle SE1/SE2Dental curettes round handle SR1/SR2KRCL 84C/85C/86C/87C/88CKRM 1#/2#/3#/4#/5# | 2005 |
| Surgical HemostatEMD · Class 1 | Dental hand instruments | Maker | Haemostatic Forceps 12.5cm Straight, Fine/ Curved, Fine/ Straight, no plated/ Curved, no platedHaemostatic Forceps 12.5cm/14cm/16cm/18cm/22cm/24cm CurvedHaemostatic Forceps 12.5cm/14cm/16cm/18cm/22cm/24cm StraightHaemostatic Forceps 14cm Straight, Fine/ Curved, Fine/ Straight, no plated/ Curved, no platedHaemostatic Forceps 16cm Straight, Fine/ Curved, Fine/ Straight, no plated/ Curved, no platedHaemostatic Forceps 18cm Straight, Fine/ Curved, Fine/ Straight, no plated/ Curved, no platedHaemostatic Forceps 20cm Straight, Fine/ Curved, FineHaemostatic Forceps 22cm Straight, Fine | 2024 |
| Surgical Tooth Extractor ForcepsEMG · Class 1 | Dental hand instruments | Maker | Extracting forceps 65S/69S/150S/151S/C1/C17/C44/C48/C65/C69/C150/C151/C222/C210/C18L/C18R/14cm curvedExtracting forceps for adults 1#/8#/17#/23#/32#/44#/46#/48#/53L#/53R#/65#/69#/88L#/88R#/150#/151#/222#/10#/15#/16#/210#/Extracting forceps for children 1#/2#/3#/4#/5#/6#/7#/8# | 2025 |
| Surgical Bone FileEMI · Class 1 | Dental hand instruments | Maker | Bone files R1/R2 | 2005 |
| Dental Surgical ElevatorEMJ · Class 1 | Dental hand instruments | Maker | Apical elevators E1/ E2/ E3 octagon handleApical elevators HE1/HE2/HE3/H7/HE8/HE9/HE10Apical elevators hexagon handle HS1/HS2/HS3/HS5/HS6Apical elevators round handle R1/R2/R3/R5/R6Bone spreading system (curved 2.2mm/2.8mm/3.4mm/4mm)Bone spreading system (straight 2.2mm/2.8mm/3.4mm/4mm)Cleft palate instrument 3# / 4# / 5#Luxating elevator KELFD3.5Luxating elevator KELFS3.5Luxating elevators (KELS2.5/KELS3/KELS5/KELC2.5/KELC3/KELC5) 17 moreLuxating elevators KELC2.5Luxating elevators KELC3Luxating elevators KELC3.5Luxating elevators KELC4Luxating elevators KELC5Luxating elevators KELS2.5Luxating elevators KELS3Luxating elevators KELS3.5Luxating elevators KELS4Luxating elevators KELS5Luxating Elevators ZS3.5Root elevators for wisdom teeth KWTE2.5Root elevators for wisdom teeth KWTE3Root elevators for wisdom teeth KWTE3.5Root elevators for wisdom teeth KWTE4Root elevators for wisdom teeth KWTE5Sinas Lifting instrument KNTS25/KNTS30/KNTS35/KNTS40 | 2005 |
| Surgical Bone ChiselEML · Class 1 | Dental hand instruments | Maker | Bone chisels 1/2/3/4Bone chisels R1/R2/R3/R4/R5/R6Bone spilting Chisel KGPZ15/ KGPZ20/ KGPZ25/ KGPZ3Chisel 1#/2#/3#/4#/5#/6#Dental chisels C36/37Dental chisels CPF1Dental chisels E1/E2/E3/E4/E5/E6 | 2005 |
| Periodontic ScalerEMN · Class 1 | Dental hand instruments | Maker | Gingival cord packers KGCPCSI-1/170/174/ KGCPCSI-1 A (No Serration)/ 170A(No Serration)Gingival Separator F1/F2/E6/R6/KPT1/KPT2Gingival Separator KGS7/KGS8/KGS9Gingival Separator KPPR3Gingival Separator P24GPeriosteal KPR3/P24GPeriosteal separators KPT3/KPT4/KPT5/KGS1/KGS2Scalers E1/E2/E3/E4/E5/E6/E7/E8/E9 (eight-angle handle)Scalers KC MC13S/14SScalers KS B2/3 4 moreScalers KS JQ1/YG15/U15/3/B/GF1/GF21/JQ30/33/JQ31/32Scalers KS JQ34/35/U15/30/H5/33/H6/7/204S/204SD/12Scalers R1/R2/R3/R4/R5/R6/R7/R8/R9 (round handle)Soft tissue expander RZZS 1/RZZS 2/RZZS 3/RZZS 4 | 2005 |
| Periodontic KnifeEMO · Class 1 | Dental hand instruments | Maker | Gum knife KK 15/16 / KGF8/ KO1/2Gum knife octagon handle E4/E8/R4/R8/E1/E2 | 2024 |
| Periodontic FileEMR · Class 1 | Dental hand instruments | Maker | Glass Ionomer Filling instrument KPICHPeriodontal files E1/E2/E3/E4/E5/FS3/4SPlastic filling instrument KPFI GM1/GM2/GM3Plastic filling instrument KPFI NTIPlastic filling instrument KPFIG1Plastic filling instrument KPFIG2Plastic filling instrument KPFIG3Plastic filling instrument KPFIG4Plastic filling instrument KPFIG5Plastic filling instrument KPFIG6 8 morePlastic filling instrument KPFIG7Plastic filling instrument KPFIG8Plastic filling instruments KPFI M1/M2/M3/M4/M5/MH1/MH2/MH3/MH4/MH5Plastic filling instruments KPFI1Plastic filling instruments KPFI2Plastic filling instruments set 5*1, type IPlastic filling instruments set 5*1, type II (titanium coated)Plastic filling instruments set 5*1, type III | 2005 |
| Matrix RetainerJEP · Class 1 | Dental hand instruments | Maker | Ivory Matrix holderMatrix bands (bean shape ) 1#/2#/3#matrix bands L/M/STofflemire matrixTofflemire matrix bands 20pcs/pack | 2024 |
| Orthodontic PlierJEX · Class 1 | Dental hand instruments | Maker | Arch turret no gauge I/IIArch turret with gauge I/IIBraces tweezers 1# 11cm/2# 12.5cm/3# 12.5cm/4# 13cm/5# 14cmBracket instrument KT5/TJZ1Crown remove pliers & BladeDistal ending benders 502Laboratory pliers 107#/111#/112#/113#/114#/115#/116#/118#/120#Laboratory pliers 121#/122#/127#/130#/134#/137#/138#/139#/147#Locked tweezers ZS6Orthodontic pliers 105G/134/200/ 201/210/231/1009/3471 6 moreOrthodontic pliers 64#/49#/68#/101/217/252/HW/YX1/YX2/YX3Orthodontic pliers CP/NPOrthodontic Separator 151Suture remove pliersTissue pliers with hook 0.6mm/0.8mm/1mm/1.2mmTissue pliers with teeth 0.6mm/0.8mm/1mm/1.2mm | 2005 |
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 |
|---|---|---|
| SHANGHAI KANGQIAO DENTAL INSTRUMENTS FACTORYFDA reg. 3004992978 | SHANGHAI, China | Foreign exporter, Manufacturer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 9070000). 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.