The Orthodontic Store

.20 Variable Torque Appliance, Lower Left/Right 1St & 2Nd Bicuspid, .020

Registry build 21.09.26
52manufacturers in China registered for this device type
658catalogue 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 The Orthodontic Store
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
Record revised 2024-04-15 (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 Inner pack, inner pack of 10, inner, bag of 25, inner pack of 100, inner pack of 12
Distribution end date 2024-04-13

Catalogue Numbers

Catalogue numbers for The Orthodontic Store
Catalogue number Size Status
BD0255H In distribution
C0806H In distribution
B0254 In distribution
C0815 In distribution
B0815H In distribution
C0801 In distribution
717-300 In distribution
605-901 In distribution
A0154 In distribution
C0871 In distribution
BD0264H In distribution
BSR0816H In distribution
A3213H In distribution
A1605 In distribution
A1606 In distribution
605-915 In distribution
C0222 In distribution
A0264H In distribution
603-227 In distribution
B0807H In distribution
745-111 In distribution
A1972 In distribution
B0202 In distribution
B0804H In distribution
BSM0822 In distribution
A3205H In distribution
C0813H In distribution
BSM0866 In distribution
BD0260H In distribution
603-305 In distribution
B0267H In distribution
A1705H In distribution
A3266H In distribution
603-115 In distribution
A3252 In distribution
B0266H In distribution
745-350 In distribution
A1614 In distribution
C0265 In distribution
603-105 In distribution
A0254H In distribution
A1616H In distribution
A1716H In distribution
900-105 In distribution
A0256H In distribution
A0256 In distribution
A0255 In distribution
C0205 In distribution
A1716 In distribution
B0271 In distribution
603-303 In distribution
BSR0272 In distribution
715-335 In distribution
BSM0850 In distribution
A0205 In distribution
A1607H In distribution
BD0262PH In distribution
715-385 In distribution
B0263H In distribution
A0263 In distribution
A2057H In distribution
A3257H In distribution
A2051 In distribution
A3852 In distribution
C0216H In distribution
B0816H In distribution
30-WL4-2LK In distribution
605-604 In distribution
600-220 In distribution
C0215 In distribution
710-919T In distribution
603-302 In distribution
710-927T In distribution
A0204H In distribution
C0266 In distribution
A1979 In distribution
A2050 In distribution
A3855H In distribution
BSR0817H In distribution
603-202 In distribution
A0194 In distribution
BSR0807H In distribution
A0253 In distribution
C0815H In distribution
600-594 In distribution
605-803 In distribution
A1975 In distribution
A1993 In distribution
BSM0817H In distribution
600-808 In distribution
C0814H In distribution
603-102 In distribution
A1704H In distribution
A3264H In distribution
A0213 In distribution
A0207H In distribution
C0263 In distribution
C0253 In distribution
745-300 In distribution
A1741 In distribution
A0654H In distribution
B0813H In distribution
A3201 In distribution
C0267 In distribution
B0822 In distribution
C0245 In distribution
C0807H In distribution
C0814 In distribution
603-310 In distribution
30-WL4-2U In distribution
A3863H In distribution
603-309 In distribution
A0152 In distribution
B0204H In distribution
A3867 In distribution
C0206 In distribution
B0214H In distribution
A0263H In distribution
A3860 In distribution
C0200 In distribution
A3251 In distribution
600-212 In distribution
B0852 In distribution
A1706H In distribution
A0264 In distribution
30-WL4-2RK In distribution
710-920T In distribution
A3851 In distribution
603-518 In distribution
C0221 In distribution
B0260 In distribution
B0216 In distribution
A0174 In distribution
A3216 In distribution
A3214 In distribution
A1605H In distribution
603-110 In distribution
C0220 In distribution
A0513H In distribution
B0212H In distribution
A0124 In distribution
A0257H In distribution
C0816 In distribution
BSM0867 In distribution
A1725 In distribution
A0656H In distribution
BSR0867H In distribution
A3865H In distribution
A0257MH In distribution
B0201 In distribution
603-123 In distribution
BSR0857 In distribution
C0805H In distribution
A0150 In distribution
BSR0806H In distribution
605-209 In distribution
A1714H In distribution
C0204 In distribution
A3206 In distribution
605-723 In distribution
C0201 In distribution
C0251 In distribution
C0202 In distribution
600-207 In distribution
100199 In distribution
603-319 In distribution
605-709 In distribution
B0855H In distribution
C0257H In distribution
600-815 In distribution
B0272 In distribution
745-101 In distribution
A0504H In distribution
C0265H In distribution
A2056H In distribution
A1967 In distribution
A1710 In distribution
B0205H In distribution
BSM0801 In distribution
A0205H In distribution
B0865H In distribution
265-225 In distribution
A1604 In distribution
A1953 In distribution
C0260 In distribution
603-506 In distribution
A1956H In distribution
BSM0860 In distribution
A2064H In distribution
A3254H In distribution
BSM0815H In distribution
BSR0222 In distribution
603-521 In distribution
A1964H In distribution
B0806H In distribution
603-119 In distribution
30-WL5-2U In distribution
BSM0867H In distribution
C0802 In distribution
A0500 In distribution
A0255H In distribution
BD0262H In distribution
714-430 In distribution
A3866H In distribution
A1601 In distribution
A1714 In distribution
605-601 In distribution
B0851 In distribution
600-223 In distribution
A0212 In distribution
S-VNAT In distribution
A3250 In distribution
C0264 In distribution
C0806 In distribution
BSM0856 In distribution
BSR0806 In distribution
605-910 In distribution
A0103 In distribution
BSR0814 In distribution
C0867 In distribution
BSR0862H In distribution
BSR0816 In distribution
603-207 In distribution
605-706 In distribution
C0254 In distribution
A2062H In distribution
C0805 In distribution
A1717 In distribution
A3200 In distribution
A0655H In distribution
B0264 In distribution
603-505 In distribution
A1965H In distribution
A1615 In distribution
BSM0872 In distribution
BSR0815 In distribution
A2055H In distribution
A1951 In distribution
900-105W In distribution
A1962 In distribution
B0856 In distribution
BSR0851 In distribution
B0872 In distribution
605-718 In distribution
C0216 In distribution
600-224 In distribution
605-701 In distribution
A3850 In distribution
A1610 In distribution
S-SSNAT In distribution

Showing 250 of 300 catalogue numbers.

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
equilibrium® Dentaurum GmbH & Co. KG 646
Stainless Steel Brackets American Orthodontics 612

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