Young Specialties

YS SL ROTH 022 L 1/2 UNV - 5PK - Self-Litigating Metal Bracket

Registry build 21.09.26
52manufacturers in China registered for this device type
73catalogue 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 Young Specialties
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 2024-06-26
Record revised 2024-01-03 (version 3)

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 Case, inner pack of 5, inner pack, inner pack of 10

Catalogue Numbers

Catalogue numbers for Young Specialties
Catalogue number Size Status
MSLM22UR3H In distribution
MSLM22LL5 In distribution
MSLR22UR5 In distribution
710-104 In distribution
MSLM22UR4H In distribution
MSLR22UL1 In distribution
716-420 In distribution
MSLM22UL1 In distribution
MSLR22UL5H In distribution
MSLR22LL4 In distribution
710-106 In distribution
710-105 In distribution
710-107 In distribution
MSLM22LR5H In distribution
710-103 In distribution
MSLM022K In distribution
MSLM22UR5 In distribution
MSLM22LR4H In distribution
MSLM22UL4 In distribution
MSLR22UL5 In distribution
MSLR22UR3H In distribution
716-415 In distribution
265-500 In distribution
MSLR22LL3H In distribution
MSLR22UL4H In distribution
MSLR22LR3H In distribution
MSLR022K In distribution
MSLR22LL5H In distribution
265-525 In distribution
MSLM22UL5H In distribution
710-121 In distribution
MSLR22UL2 In distribution
MSLR22UR2 In distribution
MSLR22L12U In distribution
710-102 In distribution
MSLM22L12U In distribution
710-101 In distribution
MSLR22UL4 In distribution
MSLM22UR5H In distribution
710-125 In distribution
716-410 In distribution
716-335 In distribution
MSLM22UL3H In distribution
MSLR22LR5H In distribution
MSLM22LR5 In distribution
710-120 In distribution
MSLM22LR4 In distribution
MSLX022K In distribution
MSLR22UR4 In distribution
MSLR22UR1 In distribution
265-515 In distribution
MSLR22LR4H In distribution
MSLR22UR5H In distribution
MSLR22LL4H In distribution
MSLM22UR4 In distribution
MSLM22LL5H In distribution
710-119 In distribution
605-721 In distribution
MSLM22LR3H In distribution
MSLR22LL5 In distribution
MSLM22UL5 In distribution
MSLM22LL3H In distribution
MSLR22UL3H In distribution
MSLR22UR4H In distribution
MSLR22LR4 In distribution
MSLM22UL4H In distribution
710-115 In distribution
MSLM22UR2 In distribution
605-725 In distribution
605-717 In distribution
MSLM22UR1 In distribution
MSLM22UL2 In distribution
MSLR22LR5 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