Dental › Surgical

Which Manufacturers in China Work in This Section?

307 manufacturers in China hold an FDA registration for a device type in this section, concentrated in Guangdong, Jiangsu and Zhejiang, and 19 other provinces. 58 of them are contract manufacturers. Chinese manufacturers are registered for 77 of 99 device types here.

68 of those 77 device types need no premarket submission before sale in the United States. The FDA has recorded 267 recalls across the section’s product codes; the root causes it names most often are Packaging process control (31), Device Design (25) and Process control (20).

Which Device Types Are Made in China?

The device types with the most Chinese manufacturers are Mirror, Mouth (94), Instruments, Dental Hand (64), Needle, Dental (56), Unit, Syringe, Air And/Or Water (56) and File, Pulp Canal, Endodontic (53). All 77 device types in this section with a Chinese manufacturer, most manufacturers first:

Mirror, Mouth 94 manufacturers
Instruments, Dental Hand 64 manufacturers
Needle, Dental 56 manufacturers
Unit, Syringe, Air And/Or Water 56 manufacturers
File, Pulp Canal, Endodontic 53 manufacturers
Syringe, Restorative And Impression Material 49 manufacturers
Retractor, All Types 45 manufacturers
Accessories, Retractor, Dental 37 manufacturers
Probe, Periodontic 34 manufacturers
Scaler, Periodontic 34 manufacturers
Syringe, Periodontic, Endodontic, Irrigating 32 manufacturers
Aligner, Bracket, Orthodontic 30 manufacturers
Handle, Instrument, Dental 29 manufacturers
Plier, Orthodontic 28 manufacturers
Instrument, Filling, Plastic, Dental 23 manufacturers
Forceps, Dressing, Dental 22 manufacturers
Syringe, Irrigating (Dental) 22 manufacturers
Drill, Dental, Intraoral 20 manufacturers
Forceps, Tooth Extractor, Surgical 20 manufacturers
Plugger, Root Canal, Endodontic 19 manufacturers
Spreader, Pulp Canal Filling Material, Endodontic 17 manufacturers
Light, Operating, Dental 16 manufacturers
Scaler, Ultrasonic 14 manufacturers
Instrument, Hand, Calculus Removal 13 manufacturers
Retainer, Matrix 13 manufacturers
Pusher, Band, Orthodontic 12 manufacturers
Broach, Endodontic 10 manufacturers
Gauge, Depth, Instrument, Dental 10 manufacturers
Handpiece, Air-Powered, Dental 10 manufacturers
Handpiece, Direct Drive, Ac-Powered 10 manufacturers
Instrument, Contouring, Matrix, Operative 10 manufacturers
Instrument, Ligature Tucking, Orthodontic 10 manufacturers
Reamer, Pulp Canal, Endodontic 10 manufacturers
Handpiece, Contra- And Right-Angle Attachment, Dental 9 manufacturers
Explorer, Operative 8 manufacturers
Preparer, Root Canal Endodontic 8 manufacturers
Setter, Band, Orthodontic 8 manufacturers
Instrument, Diamond, Dental 7 manufacturers
Light, Surgical Headlight 7 manufacturers
Carrier, Amalgam, Operative 6 manufacturers
Elevator, Surgical, Dental 6 manufacturers
File, Bone, Surgical 6 manufacturers
Scissors, Surgical Tissue, Dental 6 manufacturers
Burnisher, Operative 5 manufacturers
Carver, Dental Amalgam, Operative 5 manufacturers
Chisel, Bone, Surgical 5 manufacturers
Excavator, Dental, Operative 5 manufacturers
File, Periodontic 5 manufacturers
Instrument, Cutting, Operative 5 manufacturers
Pliers, Operative 5 manufacturers
Remover, Crown 5 manufacturers
Carver, Wax, Dental 4 manufacturers
Chisel, Osteotome, Surgical 4 manufacturers
Controller, Foot, Handpiece And Cord 4 manufacturers
Curette, Surgical, Dental 4 manufacturers
Driver, Band, Orthodontic 4 manufacturers
Forceps, Articulation Paper 4 manufacturers
Hemostat, Surgical 4 manufacturers
Curette, Operative 3 manufacturers
Curette, Periodontic 3 manufacturers
Lapping Tool Kit 3 manufacturers
Oral Surgery Tray 3 manufacturers
Plate, Bone 3 manufacturers
Scissors, Collar And Crown 3 manufacturers
Screw, Fixation, Intraosseous 3 manufacturers
Condenser, Amalgam And Foil, Operative 2 manufacturers
Drill, Bone, Powered 2 manufacturers
Forceps, Rongeur, Surgical 2 manufacturers
Hoe, Periodontic 2 manufacturers
Knife, Periodontic 2 manufacturers
Light, Fiber Optic, Dental 2 manufacturers
Curette, Endodontic 1 manufacturer
Dental Prophylaxis Kit 1 manufacturer
File, Margin Finishing, Operative 1 manufacturer
Handpiece, Rotary Bone Cutting 1 manufacturer
Parallelometer 1 manufacturer
Punch, Biopsy, Surgical 1 manufacturer

Forceps, Articulation Paper

Articulating Paper

Double check, 50 microns. Straight, Red & Blue, 144 strips

Unit, Syringe, Air And/Or Water

Essentials by 3d Dental

Essentials Plastic NO Core White Tips 250/BAG *spree TIP Style**

File, Pulp Canal, Endodontic

K-Files 29mm 015

Catalogue number 129029.015-0, listed by Diaswiss SA, under File, Pulp Canal, Endodontic. 53 manufacturers in China are registered for this product code.

File, Pulp Canal, Endodontic

DiaFlexy-R 21mm 045, Pu: 6pcs

Catalogue number 921021R.045, listed by Diaswiss SA, under File, Pulp Canal, Endodontic. 53 manufacturers in China are registered for this product code.

Unit, Syringe, Air And/Or Water

Safe Dent

A90126MC Air Water Syringe Tip "MULTI COLOR" (250) bag

Instruments, Dental Hand

UF(II) Narrow Solid Abutment Driver

2 catalogue numbers from UNHDS 4006A, listed by DIO Corporation, South Korea, under Instruments, Dental Hand. 64 manufacturers in China are registered for this product code.

Drill, Bone, Powered

NP 3.3mm Externally Cooled Drill, 8.5 – 15.0mm

Catalogue number 905365, listed by Sterngold Dental LLC, United States, under Drill, Bone, Powered. 2 manufacturers in China are registered for this product code.

Drill, Bone, Powered

Instrument Set “Endo”

2 catalogue numbers from 07173300, listed by W&H Dentalwerk Bürmoos GmbH, Austria, under Drill, Bone, Powered. 2 manufacturers in China are registered for this product code.

File, Pulp Canal, Endodontic

Aurum (Blue T2.5 Refill 31mm)

Catalogue number 5093, listed by Meta Biomed Co., Ltd., South Korea, under File, Pulp Canal, Endodontic. 53 manufacturers in China are registered for this product code.

Knife, Periodontic

Quinelato

Goldman Fox tissue nipper

Drill, Bone, Powered

Stern IC 2.8 Mm Drill

Catalogue number 905705, listed by Sterngold Dental LLC, United States, under Drill, Bone, Powered. 2 manufacturers in China are registered for this product code.

Handpiece, Contra- And Right-Angle Attachment, Dental

FutureMaster

FutureMaster ES/M4 AMP, Handpieces package(MT2010-S (maxso air motor), HP3008 (airlight high speed), ST2010 (maxso straight nose low speed), and SL2026 (maxso low speed contra angle).

Instruments, Dental Hand

DIO Screw Driver Ratchet Wrench (Nobel)

3 catalogue numbers from WHD 1715A, listed by DIO Corporation, South Korea, under Instruments, Dental Hand. 64 manufacturers in China are registered for this product code.

Drill, Dental, Intraoral

Drill Root-Ex Short 1,1 Mm Single

Catalogue number 935K.011med-0, listed by Diaswiss SA, under Drill, Dental, Intraoral. 20 manufacturers in China are registered for this product code.

Handle, Instrument, Dental

MARK3

Disposable Micro Applicators Regular Assorted Colors (Blue,Green,Orange,Purple) 400/bx. 40bx/cs. - MARK3*

Handpiece, Air-Powered, Dental

Midwest Tradition® Pro

Midwest Tradition® Pro TBF

Handpiece, Air-Powered, Dental

WP-66 M Proxeo 4: 1

Catalogue number 30190000, listed by W&H Dentalwerk Bürmoos GmbH, Austria, under Handpiece, Air-Powered, Dental. 10 manufacturers in China are registered for this product code.

Pliers, Operative

121

Catalogue number 121, listed by Zatty Industria Comercio Importacao E Exportacao DE Instrumentacao Cirurgica E Odontologica Ltda, under Pliers, Operative. 5 manufacturers in China are registered for this product code.

Drill, Bone, Powered

Vsrg

2 catalogue numbers from VSRG120V2, listed by Nakanishi Inc., Japan, under Drill, Bone, Powered. 2 manufacturers in China are registered for this product code.

File, Pulp Canal, Endodontic

Scott’s Select K-Files 6/pk 21mm # 15-40 Asst

ENDODONTIC K-FILES (6/pack) Length: 21mm, Size: 15-40 (Assorted), Material: Stainless Steel; For more information:

File, Bone, Surgical

V. Mueller

V. Mueller ORAL BONE FILE DOUBLE-ENDED, SERRATED ENDS 30 X 7MM and 5MM ROUNDED OVERALL LENGTH 7-1/4 inches 18.4CM

Punch, Biopsy, Surgical

Salvin Stainless Steel Multi-Use Rotary Tissue Punch – 4mm

5 catalogue numbers from PUNCH-4-ROTARY, listed by Salvin Dental Specialties, LLC, United States, under Punch, Biopsy, Surgical. 1 manufacturer in China is registered for this product code.

File, Pulp Canal, Endodontic

ProShape Cyclone 06 Size 35 25MM

Catalogue number PS350625, listed by Endo Direct, LLC, United States, under File, Pulp Canal, Endodontic. 53 manufacturers in China are registered for this product code.

Controller, Foot, Handpiece And Cord

ELECTROmatic TM

Catalogue number 1.011.2100, listed by Kavo Dental Gmbh, Germany, under Controller, Foot, Handpiece And Cord. 4 manufacturers in China are registered for this product code.

File, Pulp Canal, Endodontic

K File 31mm 45

Catalogue number ZKFILE3145, listed by Nusmile, Ltd, United States, under File, Pulp Canal, Endodontic. 53 manufacturers in China are registered for this product code.

Instruments, Dental Hand

Myclip 2.0 Includes Restorative Trial Set

Catalogue number 6305, listed by Polydentia SA, under Instruments, Dental Hand. 64 manufacturers in China are registered for this product code.

Curette, Periodontic

Curette D/E GR 3-4 Regular Xlst HD Handle

Catalogue number 70-5101XLSTHD, listed by W.H. Holden, Inc., under Curette, Periodontic. 3 manufacturers in China are registered for this product code.

Instruments, Dental Hand

Contoured Wood Wedges 15mm Yellow Refill

2 catalogue numbers from 095415, listed by Clinician'S Choice Dental Products, Inc., Canada, under Instruments, Dental Hand. 64 manufacturers in China are registered for this product code.

Handle, Instrument, Dental

Repair Kit

11 catalogue numbers from RKARN, listed by Shinhung MST Co., Ltd., South Korea, under Handle, Instrument, Dental. 29 manufacturers in China are registered for this product code.

Knife, Periodontic

Medicon

Kirkland gingivectomy knife d/e

Instrument, Diamond, Dental

FG Zirconia Diamond 877k Box 6pcs

Catalogue number 314Z877K.016-bo, listed by Diaswiss SA, under Instrument, Diamond, Dental. 7 manufacturers in China are registered for this product code.

Curette, Periodontic

Curette D/E Langer 5-6 CH Handle

Catalogue number 70-5166CH, listed by W.H. Holden, Inc., under Curette, Periodontic. 3 manufacturers in China are registered for this product code.

Scaler, Periodontic

Scaler D/E H6-H7 HD Handle

Catalogue number 70-4166HD, listed by W.H. Holden, Inc., under Scaler, Periodontic. 34 manufacturers in China are registered for this product code.

Retainer, Matrix

House Brand Dentistry

HSB - Tofflemire Matrix Retainer Universal Adult

Elevator, Surgical, Dental

Elevator #8 Crane Pick

Catalogue number 10-4536, listed by W.H. Holden, Inc., under Elevator, Surgical, Dental. 6 manufacturers in China are registered for this product code.

Handle, Instrument, Dental

Nobil Metal SPA

LV SFE 50% Insert. Tool / Screw Driver

Syringe, Restorative And Impression Material

Dental Mini Cartridge Dispenser

Dispenser used with Synthetic bone void filler for dental applications

Scaler, Periodontic

Prodont-Holliger

instr.dble n128-l5 mini bliss

Hemostat, Surgical

Kohdent

Forceps for broken root-nerv-pins-90- - 90 degree angled - flat -diamond-

Instruments, Dental Hand

Needle Holder – T/C

Needle holder is a surgical instrument, similar to a hemostat, used to hold a suturing needle for closing wounds during suturing and surgical procedures. These Needle holders have tungsten…

File, Pulp Canal, Endodontic

Scott’s Select K-Files 6/pk 21mm # 70

ENDODONTIC K-FILES (6/pack) Length: 21mm, Size: 70, Material: Stainless Steel; For more information:

Syringe, Restorative And Impression Material

Intra-Oral-Tip Yellow 100

Catalogue number 01965, listed by bisico Bielefelder Dentalsilicone GmbH & Co. KG, under Syringe, Restorative And Impression Material. 49 manufacturers in China are registered for this product code.

Drill, Dental, Intraoral

Peeso 32mm 070

Catalogue number 525032.070-0, listed by Diaswiss SA, under Drill, Dental, Intraoral. 20 manufacturers in China are registered for this product code.

Forceps, Tooth Extractor, Surgical

Intrace USA

Dental Extraction Forceps, Fig. 150 (Cryer Pattern), Universal Upper, Symmetrical Slender Jaws, Finger-Ring Handle, Stainless Steel, Reusable.

Instruments, Dental Hand

DryShield

DryShield - Isolation System

File, Pulp Canal, Endodontic

Peeso Reamers

Peeso Reamer Stainless Size 1-6 32mm

Syringe, Restorative And Impression Material

Mixing Tip Green 1: 1 48

Catalogue number 66001989, listed by Kulzer SRL, Romania, under Syringe, Restorative And Impression Material. 49 manufacturers in China are registered for this product code.

Instruments, Dental Hand

Locator Guide

Locator Angle Measurement Guide

Controller, Foot, Handpiece And Cord

S-NW SPI

Foot Control SPI

Forceps, Dressing, Dental

Tissue Forceps, Allis 4×5, 6″ Straight

Catalogue number 13-0091, listed by W.H. Holden, Inc., under Forceps, Dressing, Dental. 22 manufacturers in China are registered for this product code.

Instruments, Dental Hand

Straight Osteotome

2.65mm Straight Osteotome 2.65mm Diameter

Scissors, Surgical Tissue, Dental

Scissors Kelly Straight 6 1/4″ Suture Notch

Catalogue number 11-0046-1, listed by W.H. Holden, Inc., under Scissors, Surgical Tissue, Dental. 6 manufacturers in China are registered for this product code.

File, Pulp Canal, Endodontic

X-Plorer™ Canal Navigation Files 15/.01 (21mm)

2 catalogue numbers from 319003, listed by Clinician'S Choice Dental Products, Inc., Canada, under File, Pulp Canal, Endodontic. 53 manufacturers in China are registered for this product code.

Retainer, Matrix

Denovo Preformed Matrix Bands Kit

Denovo Preformed Matrix Band Kit - Pediatric 3/16 Professional

Instruments, Dental Hand

Quad Key

Quad Key Composite

Instruments, Dental Hand

ITL Dental

ITL latch grip driver - Long - .050

Curette, Periodontic

Curette D/E GR 11-12 XLG Rigid HF Handle

Catalogue number 70-5105XLRHF, listed by W.H. Holden, Inc., under Curette, Periodontic. 3 manufacturers in China are registered for this product code.

Pliers, Operative

Small Heavy CUT

Catalogue number 266P, listed by Zatty Industria Comercio Importacao E Exportacao DE Instrumentacao Cirurgica E Odontologica Ltda, under Pliers, Operative. 5 manufacturers in China are registered for this product code.

Chisel, Osteotome, Surgical

Osteotomes- 6mm OSC 120mm L

Catalogue number 20-0131OSC, listed by W.H. Holden, Inc., under Chisel, Osteotome, Surgical. 4 manufacturers in China are registered for this product code.

Retainer, Matrix

SurgiMac

Tofflemire Matrix Retainers, Eco series

Instruments, Dental Hand

Mixing Wells – 144 Count

Catalogue number 20Z496V, listed by Zirc Dental Products, Inc., United States, under Instruments, Dental Hand. 64 manufacturers in China are registered for this product code.

Curette, Operative

Darby Dental Supply, LLC

Curette DE 12 (Lucas 87)

Controller, Foot, Handpiece And Cord

SiroCam AF+

2 catalogue numbers from 6389212, listed by Sirona Dental Systems Gmbh, Germany, under Controller, Foot, Handpiece And Cord. 4 manufacturers in China are registered for this product code.

Instrument, Cutting, Operative

Microcut Manual

Microcut Manual - 10 units (EN/FR)

Scissors, Surgical Tissue, Dental

Scissors MICRO-SURG-7″-CRV-REG.BL

Catalogue number 22-0311, listed by W.H. Holden, Inc., under Scissors, Surgical Tissue, Dental. 6 manufacturers in China are registered for this product code.

File, Bone, Surgical

Bone File #10

Catalogue number 10-5210, listed by W.H. Holden, Inc., under File, Bone, Surgical. 6 manufacturers in China are registered for this product code.

Scaler, Periodontic

Iris

#7-8 Younger Good Iris® Silicone Double End Curette

Forceps, Tooth Extractor, Surgical

Extraction Forceps #588 Witzel Upper Roots

Catalogue number 10-0588-1, listed by W.H. Holden, Inc., under Forceps, Tooth Extractor, Surgical. 20 manufacturers in China are registered for this product code.

Scaler, Ultrasonic

PRO AS-Dynaled MU M4 KIT

Catalogue number PRO AS-DYNALED MU M4 KIT, listed by Nakanishi Inc., Japan, under Scaler, Ultrasonic. 14 manufacturers in China are registered for this product code.

Handpiece, Air-Powered, Dental

Schick

Universal Sheaths Size 1 (300/PKG) Universal Sheaths Size 1 (300/PKG)

Elevator, Surgical, Dental

Root Elevator Heidbrink #2 EH-SM S/E

Catalogue number 10-5042E, listed by W.H. Holden, Inc., under Elevator, Surgical, Dental. 6 manufacturers in China are registered for this product code.

Scaler, Ultrasonic

Stern Weber

The device is a dental unit consisting of components and/or devices that are functionally connected, such as the patient dental chair, dental unit, dental handpieces, multifunction pedal…

Plate, Bone

ProPlan CMF

Patient Specific Instrument and Planning Kit, Mandible Reconstruction, no model

Reamer, Pulp Canal, Endodontic

Lentulo, 25, 29

Catalogue number EPC2925, listed by Endoperfection Ltd, United Kingdom, under Reamer, Pulp Canal, Endodontic. 10 manufacturers in China are registered for this product code.

Retractor, All Types

Tongue-Guide™ Standard Pro

Catalogue number 60200, listed by Armor Dental Corp, United States, under Retractor, All Types. 45 manufacturers in China are registered for this product code.

Hemostat, Surgical

Tanaka Dental

Tanaka Hemostat

Scissors, Surgical Tissue, Dental

Scissors Mayo 6 3/4″ Straight TC

Catalogue number 30-0111, listed by W.H. Holden, Inc., under Scissors, Surgical Tissue, Dental. 6 manufacturers in China are registered for this product code.

Curette, Operative

Curette Molt 2/4 Angd HF Olsen D/E

Catalogue number 10-5106-2H/O, listed by W.H. Holden, Inc., under Curette, Operative. 3 manufacturers in China are registered for this product code.

Curette, Periodontic

Curette D/E Columbia 13/14 HF Handle

Catalogue number 70-5137HF, listed by W.H. Holden, Inc., under Curette, Periodontic. 3 manufacturers in China are registered for this product code.

Accessories, Retractor, Dental

Hand Held Cheek Retractors

2 catalogue numbers from 6070541508, listed by Maxill, Inc., Canada, under Accessories, Retractor, Dental. 37 manufacturers in China are registered for this product code.

Plate, Bone

GBR System Bone Plate

The FDA filing describes the GBR System as a rigid fixation system consisting of plates and screws in multiple configurations. Its intended use is to stabilize and fixate bone grafts,…

Syringe, Periodontic, Endodontic, Irrigating

27ga Vista Probe Tips

Catalogue number 315627, listed by Vista Dental, under Syringe, Periodontic, Endodontic, Irrigating. 32 manufacturers in China are registered for this product code.

Drill, Dental, Intraoral

Conical Drill # Large

Catalogue number Conical Drill # Large, listed by Overfibers SRL, under Drill, Dental, Intraoral. 20 manufacturers in China are registered for this product code.

Mirror, Mouth

3 catalogue numbers from 09-0590, listed by Biomet Microfixation, United States, under Mirror, Mouth. 94 manufacturers in China are registered for this product code.

Reamer, Pulp Canal, Endodontic

Dental › Surgical

Which Manufacturers in China Work in This Section?

Which Device Types Are Made in China?

Where China Actually Supplies