Ortho Quest

Accent Lng Root Torque Lo1/2 Black/Black

Registry build 21.09.26
52manufacturers in China registered for this device type
37catalogue numbers in this listing

Who Else Makes It

Concentrated in Zhejiang (19), Guangdong (11), Jiangsu (9). 6 of them are registered as contract manufacturers, able to build to a buyer’s own specification.

Chinese manufacturers registered for FDA product code EJF
Manufacturer City Province Registered as Device types
Shenzhen Denco Medical Co., Ltd. Shenzhen Guangdong Contract manufacturer 52
Sino Ortho Limited Hangzhou Zhejiang Contract manufacturer 14
Hangzhou Westlake Biomaterial Co., Ltd. Hangzhou Zhejiang Contract manufacturer 13
Chengdu Sani Medical Equipment Co., Ltd. Chengdu Sichuan Contract manufacturer 12
Hangzhou Xingchen 3B Dental Instrument & Materials Co., Ltd. Hangzhou Zhejiang Contract manufacturer 7
Yancheng Denrum Medical Apparatus Co., Ltd. Yancheng Jiangsu Contract manufacturer 5
Debo Medical Technology (Shijiazhuang) Co., Ltd. Shijiazhuang Hebei Contract manufacturer 117
Wuxi Lyusmile IMP AND EXP Co., Ltd. Wuxi Jiangsu Private-label distributor 66
Shanghai MU Promotions Co., Ltd. Shanghai Shanghai Exporter 62
Guangzhou Four E’s Scientific Co., Ltd. Guangzhou Guangdong Contract manufacturer 61
Hubei Guarddent Medical Technology Co., Ltd. Wuhan Hubei Manufacturer 60
Tribest Dental Products Co Ltd Yangzhong Jiangsu Contract manufacturer 58

Showing 12 of 52. All 52 manufacturers in China registered for Bracket, Metal, Orthodontic

Record

Regulatory record for Ortho Quest
Listed by Young Innovations Inc., United States
FDA product code EJF
Device type Bracket, Metal, Orthodontic
Device class Class 1
Regulation 21 CFR 872.5410
Establishment Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer
Premarket notification Exempt
Record published 2022-11-01

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Sterilisation Moist Heat or Steam Sterilization
Single use Yes
Prescription Prescription only
Label carries lot or batch number, manufacturing date
Packaging Inner pack

Catalogue Numbers

Catalogue numbers for Ortho Quest
Catalogue number Size Status
A0268H In distribution
PA0262H In distribution
PA0267H In distribution
A0101 In distribution
PA0251 In distribution
A0100 In distribution
PA0350 In distribution
A0668H In distribution
PA0256H In distribution
A0102 In distribution
PA0265H In distribution
PA0362H In distribution
A0215H In distribution
PA0463H In distribution
PA0450 In distribution
PA0351 In distribution
A0258H In distribution
PA0257H In distribution
PA0260 In distribution
A0669H In distribution
PA0452 In distribution
PA0264H In distribution
PA0462H In distribution
PA0252 In distribution
A0269H In distribution
PA0460-LING In distribution
PA0353 In distribution
PA0451 In distribution
PA0266H In distribution
PA0263H In distribution
PA0352 In distribution
PA0363H In distribution
PA0460-LAB In distribution
PA0453 In distribution
PA0254H In distribution
PA0255H In distribution
PA0253 In distribution

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
Leone SPA Leone SPA 2,306
BioQuick® Forestadent Bernhard Förster GmbH 1,842
Mini Master Series American Orthodontics 1,505
Mini-Mono® Forestadent Bernhard Förster GmbH 1,225
LP Low Profile American Orthodontics 1,204
Mini Sprint® Forestadent Bernhard Förster GmbH 1,193
Empower Bracket American Orthodontics 1,175
Legend GC Orthodontics America Inc. 1,098
Master Series American Orthodontics 1,084
Experience® GC Orthodontics America Inc. 770
The Orthodontic Store Young Innovations Inc. 658
equilibrium® Dentaurum GmbH & Co. KG 646

Showing 12 of 876. All products under Bracket, Metal, Orthodontic

Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.

Where China Actually Supplies

Every device page names the company that lists it and the factories registered to make the same thing. These are the sections with the most of them.

5,100manufacturers registered in China
2,581device types they are registered for
340,248device records, each naming its maker
31provinces with a registered manufacturer