Nu-Edge Cobalt Chromium Brackets

LR 2nd BI W/DISTAL HK VERTICAL SLOT Torque -22, Tip 0 Gingival Offset 0.56mm (0.022")

Registry build 21.09.26
52manufacturers in China registered for this device type
217catalogue 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 Nu-Edge Cobalt Chromium Brackets
Listed by TP Orthodontics, Inc., United States
FDA product code EJF
Device type Bracket, Metal, Orthodontic
Device class Class 1
Regulation 21 CFR 872.5410
Establishment Repacker / relabeller, Manufacturer
Premarket notification Exempt
Record published 2022-02-01

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Single use Yes
Label carries lot or batch number, expiry date

Catalogue Numbers

Catalogue numbers for Nu-Edge Cobalt Chromium Brackets
Catalogue number Size Status
293-206 In distribution
293-7251 In distribution
293-0471 In distribution
293-294 In distribution
293-3331 In distribution
293-1101 In distribution
293-7661 In distribution
293-703 In distribution
293-3992 In distribution
293-0991 In distribution
293-7301 In distribution
293-390 In distribution
293-291 In distribution
293-3751 In distribution
293-0501 In distribution
293-810 In distribution
293-7721 In distribution
293-7121 In distribution
293-2691 In distribution
293-3621 In distribution
293-8301 In distribution
293-3261 In distribution
293-0261 In distribution
293-401S In distribution
293-3651 In distribution
293-3981 In distribution
293-7161 In distribution
293-8271 In distribution
293-0631 In distribution
293-7731 In distribution
293-008 In distribution
293-0191 In distribution
293-0921 In distribution
293-0101 In distribution
293-7181 In distribution
293-7211 In distribution
293-7711 In distribution
293-3101 In distribution
293-3982 In distribution
293-7551 In distribution
293-812 In distribution
293-7111 In distribution
293-701 In distribution
293-0901 In distribution
293-0601 In distribution
293-0911 In distribution
293-8211 In distribution
293-0141 In distribution
293-0231 In distribution
293-156 In distribution
293-391 In distribution
293-1501 In distribution
293-0591 In distribution
293-0111 In distribution
293-0521 In distribution
293-0201 In distribution
293-106 In distribution
293-3231 In distribution
293-3641 In distribution
293-0251 In distribution
293-3741 In distribution
293-4201 In distribution
293-7131 In distribution
293-3161 In distribution
293-3131 In distribution
293-3942 In distribution
293-7281 In distribution
293-2701 In distribution
293-3871 In distribution
293-3181 In distribution
293-4071 In distribution
293-3842 In distribution
293-700 In distribution
293-0621 In distribution
293-0641 In distribution
293-3571 In distribution
293-3301 In distribution
293-7541 In distribution
293-2781 In distribution
293-0221 In distribution
293-290 In distribution
293-8241 In distribution
293-1601 In distribution
293-0981 In distribution
293-8261 In distribution
293-705 In distribution
293-3311 In distribution
293-3701 In distribution
293-0551 In distribution
293-3551 In distribution
293-4061 In distribution
293-3111 In distribution
293-4301 In distribution
293-3171 In distribution
293-0541 In distribution
293-7601 In distribution
293-3961 In distribution
293-7201 In distribution
293-7241 In distribution
293-0151 In distribution
293-1461 In distribution
293-3191 In distribution
293-4311 In distribution
293-0821 In distribution
293-3281 In distribution
293-8251 In distribution
293-0211 In distribution
293-402 In distribution
293-0121 In distribution
293-3861 In distribution
293-3691 In distribution
293-384 In distribution
293-3601 In distribution
293-0851 In distribution
293-4121 In distribution
293-0841 In distribution
293-8221 In distribution
293-400 In distribution
293-0271 In distribution
293-7641 In distribution
293-7701 In distribution
293-152 In distribution
293-3991 In distribution
293-002 In distribution
293-3141 In distribution
293-7141 In distribution
293-7171 In distribution
293-0561 In distribution
293-7771 In distribution
293-3721 In distribution
293-381 In distribution
293-3792 In distribution
293-3731 In distribution
293-8201 In distribution
293-1671 In distribution
293-1091 In distribution
293-8311 In distribution
293-155 In distribution
293-3611 In distribution
293-4131 In distribution
293-7271 In distribution
293-0161 In distribution
293-0171 In distribution
293-8281 In distribution
293-1121 In distribution
293-1011 In distribution
293-1081 In distribution
293-382 In distribution
293-1611 In distribution
293-4261 In distribution
293-380 In distribution
293-0611 In distribution
293-3241 In distribution
293-0931 In distribution
293-4271 In distribution
293-3881 In distribution
293-7311 In distribution
293-808 In distribution
293-3541 In distribution
293-0491 In distribution
293-7221 In distribution
293-3671 In distribution
293-207 In distribution
293-7651 In distribution
293-3151 In distribution
293-004 In distribution
293-0581 In distribution
293-704 In distribution
293-3581 In distribution
293-3771 In distribution
293-1511 In distribution
293-8231 In distribution
293-0831 In distribution
293-107 In distribution
293-3791 In distribution
293-3201 In distribution
293-0241 In distribution
293-3711 In distribution
293-157 In distribution
293-2791 In distribution
293-0651 In distribution
293-118 In distribution
293-7611 In distribution
293-0131 In distribution
293-7151 In distribution
293-7261 In distribution
293-383 In distribution
293-3631 In distribution
293-3681 In distribution
293-003 In distribution
293-3591 In distribution
293-0571 In distribution
293-153 In distribution
293-3561 In distribution
293-3892 In distribution
293-3882 In distribution
293-3321 In distribution
293-811 In distribution
293-807 In distribution
293-393 In distribution
293-7631 In distribution
293-3781 In distribution
293-3971 In distribution
293-006 In distribution
293-3761 In distribution
293-7581 In distribution
293-3782 In distribution
293-3891 In distribution
293-3121 In distribution
293-3251 In distribution
293-1001 In distribution
293-000 In distribution
293-3221 In distribution
293-0181 In distribution
293-7761 In distribution
293-7101 In distribution
293-393E 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