Dental › Therapeutic

Who Makes It in China?

168 manufacturers in China hold an FDA registration for a device type in this section, concentrated in Guangdong, Zhejiang and Jiangsu, and 16 other provinces. 41 of them are contract manufacturers. Chinese manufacturers are registered for 22 of 37 device types here.

14 of those 22 device types need no premarket submission before sale in the United States. The FDA has recorded 118 recalls across the section’s product codes; the root causes it names most often are Device Design (27), Process control (12) and Labeling mix-ups (4).

The Largest Device Types Made in China

The device types with the most Chinese manufacturers are Bracket, Metal, Orthodontic (52), Wire, Orthodontic (43), Ring, Teething, Non-Fluid Filled (42), Band, Elastic, Orthodontic (36) and Tube, Orthodontic (34). All 22 device types in this section with a Chinese manufacturer, most manufacturers first:

Bracket, Metal, Orthodontic 52 manufacturers
Wire, Orthodontic 43 manufacturers
Ring, Teething, Non-Fluid Filled 42 manufacturers
Band, Elastic, Orthodontic 36 manufacturers
Tube, Orthodontic 34 manufacturers
Retainer, Screw Expansion, Orthodontic 30 manufacturers
Band, Preformed, Orthodontic 27 manufacturers
Clamp, Wire, Orthodontic 27 manufacturers
Spring, Orthodontic 22 manufacturers
Positioner, Tooth, Preformed 19 manufacturers
Maintainer, Space Preformed, Orthodontic 18 manufacturers
Ring, Teething, Fluid-Filled 18 manufacturers
Band, Material, Orthodontic 16 manufacturers
Aligner, Sequential 14 manufacturers
Device, Anti-Snoring 8 manufacturers
Indirect Bonding Tray 6 manufacturers
Device, Jaw Repositioning 4 manufacturers
Orthodontic Software 4 manufacturers
Bracket, Ceramic, Orthodontic 1 manufacturer
Neuromuscular Tongue Muscle Stimulator For The Reduction Of Snoring And Obstructive Sleep Apnea 1 manufacturer
Pillow, Cervical (For Mild Sleep Apnea) 1 manufacturer
Tongue Suspension System 1 manufacturer

Wire, Orthodontic

Sample Ovoid TNT Nickel Titanium Archwire

2 catalogue numbers from ONTL016SAM, listed by Reliance Orthodontic Products, Inc., United States, under Wire, Orthodontic. 43 manufacturers in China are registered for this product code.

Bracket, Ceramic, Orthodontic

TipEdge Plus Ceramic Brackets

.022" Lower Bicuspid - CCW 4.5 MM, Purple I.D. -20 Torque, 0 TIP

Bracket, Ceramic, Orthodontic

RSR-18-031

Catalogue number RSR-18-031, listed by GNI Co., Ltd., South Korea, under Bracket, Ceramic, Orthodontic. 1 manufacturer in China is registered for this product code.

Spring, Orthodontic

Mirabay

Open Coil Spring Constant Force Niti 0.010X0.030 15 Inch Spool

Clamp, Wire, Orthodontic

Printed Lower Crown Pack for Herbst LL6 8mm

Catalogue number 901612, listed by Specialty Appliances, LLC, United States, under Clamp, Wire, Orthodontic. 27 manufacturers in China are registered for this product code.

Band, Preformed, Orthodontic

RMO

BOX Band MAX 1-2BIC/MAN 1ST BI

Bracket, Ceramic, Orthodontic

Clarion™ MBT Metal-Lined Ceramic Brackets (KIT)

CLARION™ MBT .018 HK/345 KIT W/CASE Clarion™ ceramic brackets feature a nickel-free silver alloy-lined archwire slot, making them a safe alternative for nickel sensitive patients. The metal…

Bracket, Metal, Orthodontic

Alias Lingual Bracket

Alias-Lingual Bracket System SPK UP/LO 7X7 18

Bracket, Metal, Orthodontic

ZAM-22-053

Catalogue number ZAM-22-053, listed by GNI Co., Ltd., South Korea, under Bracket, Metal, Orthodontic. 52 manufacturers in China are registered for this product code.

Device, Anti-Snoring

The Panthera Anti-Snoring Device

The Panthera Anti-Snoring Device is a removable intraoral device used for treating snoring and mild to moderate obstructive sleep apnea. It consists of two custom fabricated splints that…

Wire, Orthodontic

EverWhite Wire

WIRE EVERWHITE NITI UPPER 016x022 FORM III 5/PK

Wire, Orthodontic

Beta Titanium Intrusion Archwire

.016 X .022 Upper/Long Beta Titanium Intrusion Archwires

Maintainer, Space Preformed, Orthodontic

OrthoFX

FXBright Aligners FXBright Aligners appears to whiten teeth while correcting dentition.

Device, Jaw Repositioning

Narval CC

Connecting Rods Pack - Lower Range

Bracket, Metal, Orthodontic

Metal Bracket Premium Elite Roth 0.018 – U3L(23) – 5UN

Catalogue number 11.20.1323, listed by Orthometric - Industria E Comercio DE Produtos Medicos E Odontologicos Ltda, under Bracket, Metal, Orthodontic. 52 manufacturers in China are registered for this product code.

Band, Preformed, Orthodontic

Ortho-Tain, Inc

Ortho Tain Positioner Regular BH

Bracket, Metal, Orthodontic

23x KLO Metal Self-Ligating Narrow -5.2

2 catalogue numbers from BR23X-V, listed by Zhejiang Headway Medical Equipment Co., Ltd., China, under Bracket, Metal, Orthodontic. 52 manufacturers in China are registered for this product code.

Clamp, Wire, Orthodontic

Adapt Appliance

Catalogue number 1019, listed by Digital Dental Laboratories, Inc, under Clamp, Wire, Orthodontic. 27 manufacturers in China are registered for this product code.

Retainer, Screw Expansion, Orthodontic

Five Star Bilateral Distalizer – Lower

Catalogue number 5300358, listed by Five Star Orthodontic Laboratory & Supply, Inc., United States, under Retainer, Screw Expansion, Orthodontic. 30 manufacturers in China are registered for this product code.

Spring, Orthodontic

Super High Hat Safety Pin

Catalogue number 202-412, listed by TP Orthodontics, Inc., United States, under Spring, Orthodontic. 22 manufacturers in China are registered for this product code.

Band, Elastic, Orthodontic

Delta Force Rotation Wedge

Delta Force Rotation Wedge - Silver

Aligner, Sequential

Naturally White

Naturally White Retainer

Neuromuscular Tongue Muscle Stimulator For The Reduction Of Snoring And Obstructive Sleep Apnea

eXciteOSA

eXciteOSA remote control. eXciteOSA is intended for the reduction of primary snoring and obstructive sleep apnoea by strengthening tongue muscles via electrical muscle stimulation.

Bracket, Metal, Orthodontic

Insignia

Insignia SL Single Patient KIT Mexicali

Clamp, Wire, Orthodontic

Pk1

Catalogue number 1248, listed by Digital Dental Laboratories, Inc, under Clamp, Wire, Orthodontic. 27 manufacturers in China are registered for this product code.

Band, Preformed, Orthodontic

Pedo OnBrace Crown UL6 (5/pk)

Catalogue number 901413, listed by Specialty Appliances, LLC, United States, under Band, Preformed, Orthodontic. 27 manufacturers in China are registered for this product code.

Spring, Orthodontic

Farrari 1

Catalogue number 0470, listed by Digital Dental Laboratories, Inc, under Spring, Orthodontic. 22 manufacturers in China are registered for this product code.

Tube, Orthodontic

Second Molar Single Tube

UR 2nd Molar W/O Distal Extension Torque -10, Tip 0, Distal Offset 14 0.56 mm x 0.71 mm (.022" x .028") 3.3 mm

Wire, Orthodontic

M-Series Cu Nitanium® Expansion Wires

TWO.FIVE .019 x .025 M-Expansion Cu Nitanium® 27° Narrow Archwire w/stops

Tube, Orthodontic

Molar Distalizing Arch

Molar Distalizing Arch - SS Size 4 (2)

Spring, Orthodontic

Orthodontic Torque Spring 18×25 Small 10 UN

Catalogue number 36.14.1825, listed by Orthometric - Industria E Comercio DE Produtos Medicos E Odontologicos Ltda, under Spring, Orthodontic. 22 manufacturers in China are registered for this product code.

Wire, Orthodontic

Speed Wire – Stainless Steel

2 catalogue numbers from 07540295000185, listed by Hespeler Orthodontics Limited, Canada, under Wire, Orthodontic. 43 manufacturers in China are registered for this product code.

Aligner, Sequential

Invisalign System – Lite

Catalogue number 9002, listed by Align Technology, Inc., United States, under Aligner, Sequential. 14 manufacturers in China are registered for this product code.

Bracket, Metal, Orthodontic

TruEase

TruEase Bite Corrector Double Lock Standard Size 27-36mm 1-Set (1 of each- left, right)

Positioner, Tooth, Preformed

Acco Expander

Catalogue number 3000-0018, listed by Allesee AOA-PRO, under Positioner, Tooth, Preformed. 19 manufacturers in China are registered for this product code.

Bracket, Metal, Orthodontic

MiniScope/Hex Accessories

Catalogue number MATER98A, listed by Allesee AOA-PRO, under Bracket, Metal, Orthodontic. 52 manufacturers in China are registered for this product code.

Bracket, Metal, Orthodontic

AdvanSync Accessories

2 catalogue numbers from 1904-0101, listed by Allesee AOA-PRO, under Bracket, Metal, Orthodontic. 52 manufacturers in China are registered for this product code.

Wire, Orthodontic

Speed Coaxial Archwire

2 catalogue numbers from 07540295000123, listed by Hespeler Orthodontics Limited, Canada, under Wire, Orthodontic. 43 manufacturers in China are registered for this product code.

Wire, Orthodontic

Pozziloy Retainer Wire

Pozziloy Retainer WIRE.0.30

Bracket, Metal, Orthodontic

G-Coating Bracket, Roth.022, UL5, W/mesial Hk

Catalogue number MG20-015Hm, listed by Astar Orthodontics Inc., China, under Bracket, Metal, Orthodontic. 52 manufacturers in China are registered for this product code.

Wire, Orthodontic

Vari-Simplex – Archwire

Arch Alexand SST LO SML 016X022 PK/10

Clamp, Wire, Orthodontic

The Orthodontic Store

Shorty Preformed Ligatures, Off White Plastic Coated, .010

Bracket, Metal, Orthodontic

Metal Bracket Advanced Series MBT 0.018 -L5R(45) – 10UN

Catalogue number 10.11.2645, listed by Orthometric - Industria E Comercio DE Produtos Medicos E Odontologicos Ltda, under Bracket, Metal, Orthodontic. 52 manufacturers in China are registered for this product code.

Bracket, Ceramic, Orthodontic

Ceramic Bracket Iceram Roth 0.018 – L3L(33) – 1UN

Catalogue number 10.80.1133, listed by Orthometric - Industria E Comercio DE Produtos Medicos E Odontologicos Ltda, under Bracket, Ceramic, Orthodontic. 1 manufacturer in China is registered for this product code.

Wire, Orthodontic

Q.C.M.Retainer Wire

"This product can be used to make a very aesthetic retainer called ""Q.C.M. Retainer"". The Q.C.M.Retainer is not only crystal clear, but also has a 3 mm width of the plastic resin part,…

Device, Anti-Snoring

ema-FH

ema-Fixed Hinge

Positioner, Tooth, Preformed

Motto

Motto Retainer

Band, Elastic, Orthodontic

3 catalogue numbers from 01-1102, listed by Biomet Microfixation, United States, under Band, Elastic, Orthodontic. 36 manufacturers in China are registered for this product code.

Band, Preformed, Orthodontic

Direct Bond Button

Lingual Button DB Rnd Base Microetched 10 pk

Spring, Orthodontic

Elgiloy

Coil SP ELG 010X045X5MM PKG50

Bracket, Metal, Orthodontic

Ormesh

Ormesh Mini-D Mtwn Urcus W/HK 0T10A 018

Band, Elastic, Orthodontic

Orthometric Elastic Chain 1.5m – Long – Neon Yellow

Catalogue number 60.05.7046, listed by Orthometric - Industria E Comercio DE Produtos Medicos E Odontologicos Ltda, under Band, Elastic, Orthodontic. 36 manufacturers in China are registered for this product code.

Tube, Orthodontic

SBN-M18-361G

Catalogue number SBN-M18-361G, listed by GNI Co., Ltd., South Korea, under Tube, Orthodontic. 34 manufacturers in China are registered for this product code.

Aligner, Sequential

Clear Image Aligner Advanced: Dual

Catalogue number 700023, listed by Specialty Appliances, LLC, United States, under Aligner, Sequential. 14 manufacturers in China are registered for this product code.

Positioner, Tooth, Preformed

Dental LT Comfort Resin

Dental LT Comfort Resin V1.1 (5L Cartridge)

Aligner, Sequential

H.I.T.

H.I.T. - Tack System-Hooks/Pk of 50

Spring, Orthodontic

RPE With Veltri Screw

Catalogue number 0869, listed by Digital Dental Laboratories, Inc, under Spring, Orthodontic. 22 manufacturers in China are registered for this product code.

Positioner, Tooth, Preformed

Biocryl® C Rose-Transparent

BIOCRYL® C 2.0 x 125 mm, rose-transparent

Retainer, Screw Expansion, Orthodontic

Jackson – Lower

Catalogue number 5000170, listed by Five Star Orthodontic Laboratory & Supply, Inc., United States, under Retainer, Screw Expansion, Orthodontic. 30 manufacturers in China are registered for this product code.

Wire, Orthodontic

KIT Archwire Sequence Heavy

Catalogue number 51.35.2803, listed by Orthometric - Industria E Comercio DE Produtos Medicos E Odontologicos Ltda, under Wire, Orthodontic. 43 manufacturers in China are registered for this product code.

Band, Elastic, Orthodontic

Safe-T-TIE™ Ligature Ties

Safe-T-Tie™ Ligature Ties / Chain Elastics Combo Kit (12 colors)

Band, Preformed, Orthodontic

OnBrace Crown UL3 W/ AWT (5/pk)

Catalogue number 901422, listed by Specialty Appliances, LLC, United States, under Band, Preformed, Orthodontic. 27 manufacturers in China are registered for this product code.

Retainer, Screw Expansion, Orthodontic

Flip-Lock® Arm-Right

Catalogue number 900450, listed by Specialty Appliances, LLC, United States, under Retainer, Screw Expansion, Orthodontic. 30 manufacturers in China are registered for this product code.

Clamp, Wire, Orthodontic

Variable Crimpable Hook

11 catalogue numbers from VCH-R-3, listed by Dentos, Incorporated, South Korea, under Clamp, Wire, Orthodontic. 27 manufacturers in China are registered for this product code.

Band, Elastic, Orthodontic

Orthoflexy Elastomeric – Chain 4.5m – Long (.166″)- Metalic Navy

Catalogue number 60.05.7236, listed by Orthometric - Industria E Comercio DE Produtos Medicos E Odontologicos Ltda, under Band, Elastic, Orthodontic. 36 manufacturers in China are registered for this product code.

Band, Elastic, Orthodontic

Elastomeric Chain Orthometric – 4,5m – Medium – Coral

Catalogue number 60.05.6157, listed by Orthometric - Industria E Comercio DE Produtos Medicos E Odontologicos Ltda, under Band, Elastic, Orthodontic. 36 manufacturers in China are registered for this product code.

Positioner, Tooth, Preformed

Biocryl® C Clear

BIOCRYL® C 2.0 x 125 mm, clear

Bracket, Ceramic, Orthodontic

Glam®

Glam Ceramic Brackets McLaughlin Bennett 5.0 .018" 20 Brackets 3-5 w. hook T -1° / A 0°

Device, Anti-Snoring

Ortho-Tain, Inc

Snore Cure

Band, Preformed, Orthodontic

OnBrace Crown UR7 W/ AWT (5/pk)

Catalogue number 901419, listed by Specialty Appliances, LLC, United States, under Band, Preformed, Orthodontic. 27 manufacturers in China are registered for this product code.

Positioner, Tooth, Preformed