Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3004992978

FEI Number

3004992978

Entity Name

SHANGHAI KANGQIAO DENTAL INSTRUMENTS FACTORY

City/State/Country

SHANGHAI, CN

Establishment Address

957 KANGQIAO ROAD, PUDONG, SHANGHAI 201315, CN

Establishment Type(s)

Export Device to the United States But Perform No Other Operation on Device,Manufacture Medical Device

Owner / Operator

SHANGHAI KANGQIAO DENTAL INSTRUMENTS FACTORY (Owner Number: 9070000)

Owner / Operator Contact Address

957 KANGQIAO ROAD, PUDONG, SHANGHAI, CN-SH 201315, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Periotomes GRM 1/GRM 2 Retractors straight Retractors curved Cheek retractor Dressing forceps 125#/140#/160#/180#/200#/220#/250# Cotton & dressing pliers (double fold without pin) Cotton & dressing pliers satin surface ( with pin without tooth) Cotton&dressing pliers (double fold with pin with tooth) Cotton & dressing pliers (double fold with pin with tooth) Cotton & dressing pliers (single fold with pin) Cotton & dressing pliers (double fold no pin without tooth) Cotton & dressing pliers (single fold without pin) Cotton & dressing pliers (double fold without pin with tooth) Cotton & dressing pliers (double fold with pin) Cotton & dressing pliers (double fold no pin with tooth) Dental curettes round handle SR1/SR2 Dental curettes octagon handle SE1/SE2 Curettes R1/R2/R3/R4/R5/R6/R7/R8/R9/R10/R11/R12 (round handle) Curettes KC YG7/8;KC B1/2;KC L3/4 Curettes KC GL1/2;KC GL3/4;KC GL5/6;KC GL7/8;KC GL11/1;KC GL13/14;KC GL15/16;KC GL17/18 Curettes E1/E2/E3/E4/E5/E6/E7/E8/E9/E10/E11/E12 (eight-angle handle) Bone curettes E1/E2/E3/E4 Bone curettes R1/R2/R3/R4/KBC 2/KBC 3 Curettes KC C2R/2L;KC C4R/4L;KC C13/14;KC MC13/14;KC MC17/18;KC MC17S/18S Curettes 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 G17/18 Curettes F1/F2/F3 Curettes KC GM1/2;KC GM3/4;KC GM5/6;KC GM7/8;KC GM11/12;KC GM13/14;KC GM15/16 KRCL 84C/85C/86C/87C/88C KRM 1#/2#/3#/4#/5# Stainless TIP ( US size/Metric size) Aspirating syringes KAS C/W3 Aspirating syringes KAS C/W2 (stainless steel) needle dia.1.2 Aspirating syringes KAS CWA / KAS CWH Agar impression syringes needle dia.8 TIP ( US size/Metric size) PLASTER SCISSORS INSTRUMENT, CAST APPLICATION/REMOVAL, MANUAL Plaster frame; Plaster blade Amalgam carrier brass KAC A Amalgam 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) Amalgam carrier stainless steel KAC B Excavators E1/E2/E3/E4/E5/E6 (octagon handle) Excavators R1/R2/R3/R4/R5/R6 Excavators KEXC 17 / KEXC 18/ KEXC31L/ KEXC32L/ KEXC33L/ KEXC L32L Root elevators 6# SC5 Root elevators 3# SS4 Root elevators ES2/ES2.5/ES3/ES3.5/ES4/ES4.5/ES5/EC2/EC2.5/EC3/EC3.5/EC4/EC4.5/EC5/E302/E303 Root elevators S4/S5/S8/S9/S302/S303/S27/S28/S27s/S28s Root elevators 4# SC3 Root elevators 5# SC4 Root elevators 2# SS3 Root elevators 1# SS2.5 Root elevator type T 1/ T 2/T 3/ T 4 Root elevators WTTZS3.5/KLP ZS3.5/KLP FD3.5/KLP FS3.5/KLP ZS3.5/KLP S2.5/KLP S3/KLP S3.5/KLP S4/KLP S5/KLP C2.5/KLP C3/KLP C3.5/KLP C4/KLP C5 Dental stainless steel wire 30g 0.5mm/0.6mm/0.7mm/0.8mm/0.9mm/1mm/1.2mm/1.8mm Ligature wire 0.2mm/0.25mm/0.30mm/0.40mm Dental stainless steel wire 50g 0.5mm/0.6mm/0.7mm/0.8mm/0.9mm/1mm Carver For Silicone R2 Carver For Silicone R1 Wax carvers KWCW1 Wax carvers KWC1/KWC2 P.K.Thomas carver KWC PKT1/PKT2/PKT3/PKT4/PKT5 Wax carver KWC 5/6/7/8/9/10/11/12/C1/C2/C3/C4/C5/C6 Wax carvers E1/E2/E3/E4/E5/E6/E46/E47/E48/E31/Y1 Wax carver R5/ R6 (round handle) Gingival Separator KPPR3 Gingival Separator P24G Scalers KS JQ34/35/U15/30/H5/33/H6/7/204S/204SD/12 Scalers KS JQ1/YG15/U15/3/B/GF1/GF21/JQ30/33/JQ31/32 Scalers E1/E2/E3/E4/E5/E6/E7/E8/E9 (eight-angle handle) Scalers KS B2/3 Scalers KC MC13S/14S Scalers R1/R2/R3/R4/R5/R6/R7/R8/R9 (round handle) Periosteal KPR3/P24G Soft tissue expander RZZS 1/RZZS 2/RZZS 3/RZZS 4 Periosteal separators KPT3/KPT4/KPT5/KGS1/KGS2 Gingival cord packers KGCPCSI-1/170/174/ KGCPCSI-1 A (No Serration)/ 170A(No Serration) Gingival Separator KGS7/KGS8/KGS9 Gingival Separator F1/F2/E6/R6/KPT1/KPT2 Palatal bars L/M/S Lingual bars L/M/S Occlusal flat wire L/M/S Spreaders KRCP S20/S25/S30/S40/S50/S60 (5.5mm round handle) Mirror 1SZZP 4/3SZZP 4/SZZP 5/LSZP 5/L2SZP 5 Mouth mirrors handle CS octagon handle Mouth mirrors handle (stainless steel) Mouth mirrors 5 plain Mouth mirrors 4# Anti-heat Magnifying Mouth mirrors 4# autoclavable Magnifying Mouth mirrors 4# plain Mouth mirrors handle MHS SS Mouth mirrors 4# FS (rhodium plated)autoclavable plain Mouth mirrors Mouth mirrors 4# plain Magnifying Mouth mirrors handle SS round handle Mouth mirrors 5 Magnifying Mouth mirrors 4# Anti-heat plain Mouth mirrors 4# ZFS (rhodium plated)autoclavable plain ,one-piece type Mouth mirrors 4# plain BFP Mouth mirrors handle CS round handle Mouth mirrors 5# Anti-heat Magnifying Mouth mirrors 3# JFP plain Mouth mirrors handle SS octagon handle Micro Mirror WY1/WY2/ WJ1/WJ2 Mouth mirrors 5# Anti-heat plain Gum knife KK 15/16 / KGF8/ KO1/2 Gum knife octagon handle E4/E8/R4/R8/E1/E2 Burnishers E1/E2/E3/E4/E5/E6/E2-4/E3-8/E5-6/R26/27S Instrument trays (flat edge 20*11cm) Instrument trays (flat edge 20*12cm) Crown scissors 11cm, straight/ curved/ TC tip, straight /TC tip, curved/ straight, no plated/ curved, no plated Stainless Steel 1#/2#/3#/4#/5#//6# perforated Lower Partial impression tray (stainless steel) right Partial impression tray (stainless steel) left Stainless Steel 1#/2#/3#/4#/5#//6# perforated Upper Partial impression tray (stainless steel) premolar Partial impression tray right Aluminium impression tray 1#/2#/3#/3#/4#/5#/6#/( a pair) perforated Stainless Steel L/M/S non-perforated Upper Stainless steel Impression trays Non-perforated-round lower 1# Large/ 2# Medium/ 3# SMALL Denture duplicators Stainless Steel L/M/S non-perforated lower Stainless steel Impression trays perforated-round upper 1# Large/ 2# Medium/ 3# SMALL Stainless steel Impression trays perforated-round lower 1# Large/ 2# Medium/ 3# SMALL Stainless steel Impression trays Non-perforated-round upper 1# Large/ 2# Medium/ 3# SMALL Stainless steel Impression trays for implanting L/M/S Partial impression tray active Aluminium impression tray 1#2#/3# ( a pair) un-perforated Partial impression tray left Plastic filling kit II 5*1 (color plated) Sinus lifting kit Type I Periodontal kit 14x1 Bone spliting Chisels kit type I Plastic filling kit 7*1 (silicone handle) III Wax carvers kit type II Wax carvers kit type I Othordontic pliers kit Periodontal kit 4pcs Gracey curettes Plastic filling kit I 5*1 (plain surface) Periodontal kit 4pcs Gracey curettes (dia.9.5mm handle) Implant set Type II (17x1) /Type III (26x1) Periodontal kit 9pcs Gracey curettes Extracting teeth kit 17x1 Extracting forceps 65S/69S/150S/151S/C1/C17/C44/C48/C65/C69/C150/C151/C222/C210/C18L/C18R/14cm curved Extracting forceps for children 1#/2#/3#/4#/5#/6#/7#/8# Extracting forceps for adults 1#/8#/17#/23#/32#/44#/46#/48#/53L#/53R#/65#/69#/88L#/88R#/150#/151#/222#/10#/15#/16#/210#/ Sharpening stone 2-Trapeziform Sharpening stone 3-Rectangle Sharpening stone 4-Red stone Sharpening stone 1-round Color-coded instrument rings (Assorted colors, 8 colors, 20pcs each) Sharpenning guider (guider +3# stone) Tofflemire matrix Matrix bands (bean shape ) 1#/2#/3# matrix bands L/M/S Ivory Matrix holder Tofflemire matrix bands 20pcs/pack Scalpel Handle functional X3 Scalpel Handle 3# Scalpel Handle R3 Scalpel Handle XW Nerve broach handle type I Periodontal probe KP C11.5B (9.5mm round handle) Periodontal probe KP S23-C15 (5.6mm round handle) Periodontal probe KP W/KP C2/KP C12/KP C15/KP QW/KP Q2N (5.5mm round handle) Periodontal probe KP S23/C15 (5.5mm round handle) Periodontal probe E1 flat (4.5mm eight-angle handle) Periodontal probe KP C11.5B (5.5mm round handle) Periodontal probe KP WHO / KP C11.5B (3.5mm round handle) Towel clamp 9cm/10cm/11cm/14cm/16cm Orthodontic pliers CP/NP Suture remove pliers Laboratory pliers 121#/122#/127#/130#/134#/137#/138#/139#/147# Laboratory pliers 107#/111#/112#/113#/114#/115#/116#/118#/120# Crown remove pliers & Blade Orthodontic pliers 105G/134/200/ 201/210/231/1009/3471 Braces tweezers 1# 11cm/2# 12.5cm/3# 12.5cm/4# 13cm/5# 14cm Orthodontic pliers 64#/49#/68#/101/217/252/HW/YX1/YX2/YX3 Orthodontic Separator 151 Arch turret no gauge I/II Distal ending benders 502 Tissue pliers with hook 0.6mm/0.8mm/1mm/1.2mm Locked tweezers ZS6 Tissue pliers with teeth 0.6mm/0.8mm/1mm/1.2mm Bracket instrument KT5/TJZ1 Arch turret with gauge I/II EXPLORERS CYZ004B EXPLORERS CYZ005B EXPLORERS CYZ001A EXPLORERS CYZ002A EXPLORERS CYZ005A EXPLORERS CYZ003B EXPLORERS CYZ003A EXPLORERS CYZ001B EXPLORERS CYZ004A EXPLORERS CYZ002B Double end explorers KEX D2/D3/D3ES/D5/D6/D7/D11/D16/LD5/LD16 Explorers E3/E6/E7/E9/E10/E11/E12/E13/E14/E17/E21/E22/E23 Explorers R3/R6/R7/R9/R10/R11/R12/R13/R14/R17/R21/R22/R23 Single end explorers KEX S6/S7 S23 Explorers E1/E2/E3/E5/E6 laboratory hammer S/L Crown Remover/Spreaders 4# II Curved Curved tip Crown Remover/Spreaders 3# II Straight Straight tip Crown remover Root elevators for wisdom teeth KWTE3 Luxating elevators KELS3 Luxating elevators KELS2.5 Root elevators for wisdom teeth KWTE5 Luxating elevators KELC2.5 Luxating elevators KELC3 Luxating elevators KELS5 Luxating elevators KELC5 Root elevators for wisdom teeth KWTE4 Root elevators for wisdom teeth KWTE3.5 Root elevators for wisdom teeth KWTE2.5 Apical elevators E1/ E2/ E3 octagon handle Bone spreading system (straight 2.2mm/2.8mm/3.4mm/4mm) Luxating elevators (KELS2.5/KELS3/KELS5/KELC2.5/KELC3/KELC5) Apical elevators round handle R1/R2/R3/R5/R6 Bone spreading system (curved 2.2mm/2.8mm/3.4mm/4mm) Cleft palate instrument 3# / 4# / 5# Apical elevators hexagon handle HS1/HS2/HS3/HS5/HS6 Luxating elevator KELFD3.5 Sinas Lifting instrument KNTS25/KNTS30/KNTS35/KNTS40 Luxating elevators KELS4 Luxating elevator KELFS3.5 Luxating Elevators ZS3.5 Luxating elevators KELC4 Apical elevators HE1/HE2/HE3/H7/HE8/HE9/HE10 Luxating elevators KELS3.5 Luxating elevators KELC3.5 Palaster spatulas 4R Office Knife #5A, OK5A-U Plaster knives 5R/6R/7R/9R/12R Standard Lab Spatula-Rigid, LS8R-U Palaster spatulas Resin dresser octagon handle E1 Cement spatulas E1/E2/E3/HMX/H1/H22 Plaster spatulas 1R/2R/3R/4R/8R/10R/11R/13R Resin dresser round handle R1 Tapered Laboratory Spatula, LS7-U Ceramic spatulas H 1/H 22 Flask aluminium alloy 7/8 Bone Powder Bowl Flask Cuprum 7/8 Haemostatic Forceps 18cm Straight, Fine/ Curved, Fine/ Straight, no plated/ Curved, no plated Haemostatic Forceps 12.5cm/14cm/16cm/18cm/22cm/24cm Straight Haemostatic Forceps 12.5cm Straight, Fine/ Curved, Fine/ Straight, no plated/ Curved, no plated Haemostatic Forceps 22cm Straight, Fine Haemostatic Forceps 14cm Straight, Fine/ Curved, Fine/ Straight, no plated/ Curved, no plated Haemostatic Forceps 12.5cm/14cm/16cm/18cm/22cm/24cm Curved Haemostatic Forceps 16cm Straight, Fine/ Curved, Fine/ Straight, no plated/ Curved, no plated Haemostatic Forceps 20cm Straight, Fine/ Curved, Fine Band pusher Bone chisels 1/2/3/4 Dental chisels CPF1 Chisel 1#/2#/3#/4#/5#/6# Dental chisels C36/37 Bone chisels R1/R2/R3/R4/R5/R6 Dental chisels E1/E2/E3/E4/E5/E6 Bone spilting Chisel KGPZ15/ KGPZ20/ KGPZ25/ KGPZ3 Dental Operner dental winged mouth opener Dental Operner forceps mouth gag Heavy cutter Aspirator tip (Stainless steel) I/II/III Aspirator tip (Chrome) Aspirator tip type IV/ type V/ type II L Plastic filling instrument KPFIG3 Plastic filling instruments KPFI2 Plastic filling instrument KPFIG5 Plastic filling instrument KPFIG1 Plastic filling instruments set 5*1, type II (titanium coated) Plastic filling instruments set 5*1, type III Plastic filling instrument KPFIG2 Plastic filling instruments set 5*1, type I Plastic filling instruments KPFI1 Plastic filling instrument KPFIG6 Plastic filling instrument KPFIG4 Periodontal files E1/E2/E3/E4/E5/FS3/4S Plastic filling instruments KPFI M1/M2/M3/M4/M5/MH1/MH2/MH3/MH4/MH5 Plastic filling instrument KPFI GM1/GM2/GM3 Plastic filling instrument KPFIG7 Plastic filling instrument KPFIG8 Glass Ionomer Filling instrument KPICH Plastic filling instrument KPFI NTI Surgical mallet(stainless steel) silicon facing Surgical mallet copper facing Plant hammer Mallets for plant Surgical mallet ox-horn facing Carver For Silicone Amalgam carvers E1/E2/E3 (eight-angle handle) Amalgam carvers R1/R2/R3 (round handle) Measurement SDC/KDC 2/KDC 4 Articulating paper forceps straight Forceps for adults 1#/8#/17#/23#/32#/44#/46#/48#/53L#/53R#/65#/69#/88L# Articulating paper forceps curved Bone Rongeur Forceps Round Bone Rongeur Forceps Octangle Bone Rongeur Forceps Round 14cm Bone Rongeur Forceps Flat Forceps for children 1/2/3/4/5/6/7/8 Forceps for adults 88R#/150#/151#/222#/10#/15#/16#/210#/18L#/18R# Articulating paper forceps curved double tip 145mm Color-coded instrument rings (Green/Blue/Purple/Pink/Red/Grey/Orange/Yellow)

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
EIG	Retractor, All Types	Dental	Class 1	872.4565	2024-11-12
EFL	Forceps, Dressing, Dental	Dental	Class 1	872.4565	2005-02-01
EKT	Curette, Endodontic	Dental	Class 1	872.4565	2005-02-01
EID	Syringe, Restorative And Impression Material	Dental	Class 1	872.4565	2005-02-01
LGG	Instrument, Cast Application/Removal, Manual	Orthopedic	Class 1	888.5980	2011-12-01
EKI	Carrier, Amalgam, Operative	Dental	Class 1	872.4565	2005-02-01
EKC	Excavator, Dental, Operative	Dental	Class 1	872.4565	2005-02-01
KAD	Elevator, Ent	Ear, Nose, Throat	Class 1	874.4420	2012-10-19
DZC	Wire, Orthodontic	Dental	Class 1	872.5410	2024-11-12
EIK	Carver, Wax, Dental	Dental	Class 1	872.4565	2005-02-01
EMN	Scaler, Periodontic	Dental	Class 1	872.4565	2005-02-01
EHP	Clasp, Preformed	Dental	Class 1	872.3285	2005-02-22
EKK	Spreader, Pulp Canal Filling Material, Endodontic	Dental	Class 1	872.4565	2005-02-01
EAX	Mirror, Mouth	Dental	Class 1	872.4565	2005-02-01
EMO	Knife, Periodontic	Dental	Class 1	872.4565	2024-11-12
EKJ	Burnisher, Operative	Dental	Class 1	872.4565	2005-02-01
FSM	Tray, Surgical, Instrument	General, Plastic Surgery	Class 1	878.4800	2024-11-12
EIR	Scissors, Collar And Crown	Dental	Class 1	872.4565	2005-02-01
EHY	Tray, Impression, Preformed	Dental	Class 1	872.6880	2005-02-22
KDD	Kit, Surgical Instrument, Disposable	General, Plastic Surgery	Class 1	878.4800	2024-11-12
EMG	Forceps, Tooth Extractor, Surgical	Dental	Class 1	872.4565	2025-12-22
EKE	Curette, Operative	Dental	Class 1	872.4565	2005-02-22
JEP	Retainer, Matrix	Dental	Class 1	872.4565	2024-11-12
GDZ	Handle, Scalpel	General, Plastic Surgery	Class 1	878.4800	2024-11-12
EIX	Probe, Periodontic	Dental	Class 1	872.4565	2005-02-01
HXD	Clamp	General, Plastic Surgery	Class 1	878.4800	2024-11-12
JEX	Plier, Orthodontic	Dental	Class 1	872.4565	2005-02-01
EKB	Explorer, Operative	Dental	Class 1	872.4565	2005-02-01
FZY	Hammer, Surgical	General, Plastic Surgery	Class 1	878.4800	2024-11-12
EIS	Remover, Crown	Dental	Class 1	872.4565	2005-02-22
EMJ	Elevator, Surgical, Dental	Dental	Class 1	872.4565	2005-02-22
GAF	Spatula, Surgical, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4800	2005-02-22
NNI	Container, Specimen, Non-Sterile	Pathology	Class 1	864.3250	2024-11-12
EMD	Hemostat, Surgical	Dental	Class 1	872.4565	2024-11-12
ECS	Pusher, Band, Orthodontic	Dental	Class 1	872.4565	2005-02-01
EML	Chisel, Bone, Surgical	Dental	Class 1	872.4565	2005-02-01
KBN	Gag, Mouth	Ear, Nose, Throat	Class 1	874.4420	2024-11-12
HXZ	Cutter, Wire	Orthopedic	Class 1	888.4540	2024-11-12
EHZ	Evacuator, Oral Cavity	Dental	Class 1	872.6640	2024-11-12
EMR	File, Periodontic	Dental	Class 1	872.4565	2005-02-22
GFJ	Mallet, Surgical, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4800	2005-02-22
EKH	Carver, Dental Amalgam, Operative	Dental	Class 1	872.4565	2012-10-19
FTY	Tape, Measuring, Rulers And Calipers	General, Plastic Surgery	Class 1	878.4800	2024-11-12
EFK	Forceps, Articulation Paper	Dental	Class 1	872.4565	2005-02-01
EIF	Accessories, Retractor, Dental	Dental	Class 1	872.4565	2005-02-22

Official Correspondent

No official correspondent registered.

US Agent Details

Charles Mack Business: IRC USA Email: ircfda@gmail.com Phone: (931) 6254938

Related Public Records

Same Entity

SHANGHAI KANGQIAO DENTAL INSTRUMENTS FACTORY

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K112640	Ormco Corp.	HYPERELASTIC WIRE	2011-11-16
K851721	Artiberia	1200/1 TO 1240/15 VARIOUS TYPES OF DENTAL SCALERS	1985-07-02
K831136	Almore Intl., Inc.	DOUBLE BOW TOOTH SEPARATOR	1983-06-08

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0027-2016	Zimmer, Inc.	1	Zimmer Universal Locking System, Titanium 3.5mm. Zimmer Implant and Instrument Cases are reusable, non-implantable devices designed to facilitate organization, identification, storage, transportation, cleaning, and sterilization processing of reusable instruments and certain unused implantable devices.
Z-0039-2018	Teleflex Medical	1	Pilling Knife Handles: a) REF 352950 b) REF 352953 c) REF 352951 d) REF 352957 e) REF 352952 : Reusable surgical knife handles, which are intended for use with blades which are inserted into a slot in the handle.

Similar Registrations

Registration Number	Establishment Name	Location
3014647261	RETRACT EEZ, INC.	Largo, FL, US
3033892080	TALENT TECHNOLOGY MOULD CO., LIMITED	Shenzhen Guangdong, CN
1315756	Weco Manufacturing Group-Henrietta	Rochester, NY, US
3036269993	GUANGXI EHALL MEDICAL TECHNOLOGY CO.,LTD	Nanning Guangxi, CN
3011585752	HANGZHOU HAIZHU MIM PRODUCTS CO., LTD	Hangzhou Zhejiang, CN

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3004992978. Last updated year: 2026. Please use registration number 3004992978 when referencing this establishment in official correspondence.