BioPassive®

BioQuick Universal Molarbracket .022" on Big-foot-pad mand. 6+7 right passive

Registry build 21.09.26
52manufacturers in China registered for this device type
582catalogue 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 BioPassive®
Listed by Forestadent Bernhard Förster GmbH
FDA product code EJF
Device type Bracket, Metal, Orthodontic
Device class Class 1
Regulation 21 CFR 872.5410
Premarket notification Exempt
Record published 2019-09-24

Specifications

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

Catalogue Numbers

Catalogue numbers for BioPassive®
Catalogue number Size Per pack Status
-731P0101 In distribution
-706P0842 In distribution
-731P1413-005 5 In distribution
-730P1513-100 100 In distribution
-730P1711-100 100 In distribution
-731P0303-100 100 In distribution
-730P0711-010 10 In distribution
-730P0313 In distribution
-731P0713-100 100 In distribution
-733P0201-005 5 In distribution
-730P1413-100 100 In distribution
-732P0513-010 10 In distribution
-732P0303-005 5 In distribution
P730B0732-010 10 In distribution
-730P0303 In distribution
-732P1603-100 100 In distribution
-730P0313-100 100 In distribution
-731P1613 In distribution
-731P0503-100 100 In distribution
P730B1734-005 5 In distribution
-730P0503-010 10 In distribution
-733P1513 In distribution
-732P0503-005 5 In distribution
-706P0998 In distribution
-732P0311-010 10 In distribution
-731P1611-005 5 In distribution
-731P1413-100 100 In distribution
-733P0503-100 100 In distribution
-730P1403 In distribution
-731P0501-100 100 In distribution
-732P0401 In distribution
-731P0511 In distribution
-732P1611-100 100 In distribution
-733P0101-100 100 In distribution
-733P0413-010 10 In distribution
-730P1503-005 5 In distribution
-732P1603-005 5 In distribution
-731P1613-005 5 In distribution
-706P0981 In distribution
-730P1203-100 100 In distribution
-733P1503-010 10 In distribution
-730P0501-010 10 In distribution
-730P0313-010 10 In distribution
-731P1731 In distribution
-732P0313-005 5 In distribution
-706P1000 In distribution
-731P0103-010 10 In distribution
-730P0201-100 100 In distribution
-733P1511-010 10 In distribution
-732P0501 In distribution
-706P0847 In distribution
-730P1413 In distribution
-733P1511 In distribution
-733P1411 In distribution
-732P0511-100 100 In distribution
-733P0303-100 100 In distribution
-731P1601-100 100 In distribution
-732P0511-005 5 In distribution
P731B0732-010 10 In distribution
-731P0301 In distribution
-731P1613-010 10 In distribution
-731P1403-005 5 In distribution
-730P1501-100 100 In distribution
-706-1140 In distribution
-733P0411-010 10 In distribution
-733P1613-100 100 In distribution
-732P1203-005 5 In distribution
-733P0401 In distribution
-732P1401-010 10 In distribution
-730P1611 In distribution
-730P1603 In distribution
-730P1603-010 10 In distribution
-733P0511-100 100 In distribution
-731P0513-010 10 In distribution
-730P0511-005 5 In distribution
-733P0313-005 5 In distribution
-730P1503-100 100 In distribution
P730B1732 In distribution
-731P0303 In distribution
-730P0511-100 100 In distribution
-730P1411-010 10 In distribution
-732P1603-010 10 In distribution
-732P0413-005 5 In distribution
-732P0313 In distribution
-733P0201-100 100 In distribution
-733P1401-005 5 In distribution
-730P1501 In distribution
-730P1203-010 10 In distribution
-706P0853 In distribution
P731B1732-010 10 In distribution
P730B1734-100 100 In distribution
-732P0403 In distribution
-730P0511-010 10 In distribution
P730B0732-005 5 In distribution
-733P1613 In distribution
-731P1503-010 10 In distribution
-733P1403-010 10 In distribution
-733P0103-005 5 In distribution
-730P1511-005 5 In distribution
-732P0513-005 5 In distribution
P731B1732-100 100 In distribution
-732P1201-005 5 In distribution
-730P1731 In distribution
-730P0311-005 5 In distribution
-732P1413-100 100 In distribution
-706P0974 In distribution
-733P0503 In distribution
P730B0734 In distribution
-732P0201 In distribution
-732P0313-100 100 In distribution
-731P0513-005 5 In distribution
-730P1503 In distribution
-732P1501-010 10 In distribution
-730P0513 In distribution
P730B1732-005 5 In distribution
-732P1201-100 100 In distribution
-731P1503-100 100 In distribution
-731P0511-005 5 In distribution
-731P0731-005 5 In distribution
-733P0513-005 5 In distribution
-732P1203-010 10 In distribution
-733P0311 In distribution
-731P1511-005 5 In distribution
P731B0734-100 100 In distribution
-731P1501 In distribution
-732P0203-005 5 In distribution
-730P1513 In distribution
-732P0403-100 100 In distribution
-732P1613-010 10 In distribution
-706P0975 In distribution
-730P0301 In distribution
-730P1411-100 100 In distribution
-733P0101-005 5 In distribution
-733P0101-010 10 In distribution
-733P0203-100 100 In distribution
-730P1411-005 5 In distribution
-706P0973 In distribution
-730P0103-005 5 In distribution
-730P0513-010 10 In distribution
-731P1501-100 100 In distribution
-733P0203-010 10 In distribution
-732P0201-005 5 In distribution
-730P0731 In distribution
-730P1513-010 10 In distribution
P731B0734-005 5 In distribution
-733P0411-005 5 In distribution
-733P0403-100 100 In distribution
-731P0311 In distribution
-730P1613-100 100 In distribution
-730P0513-100 100 In distribution
-730P1413-005 5 In distribution
-730P1603-100 100 In distribution
-706-1137 In distribution
-731P1711-100 100 In distribution
P731B1734-100 100 In distribution
-732P0413 In distribution
P731B0732 In distribution
-731P0711-010 10 In distribution
-731P1603-010 10 In distribution
-733P0301-010 10 In distribution
-730P1403-100 100 In distribution
-733P0501 In distribution
-731P0103-005 5 In distribution
-706P0859 In distribution
-730P1711 In distribution
-730P1201-005 5 In distribution
-730P0733-100 100 In distribution
-730P1503-010 10 In distribution
-731P0103 In distribution
-733P1501-100 100 In distribution
-732P1403 In distribution
-732P0303-010 10 In distribution
P730B1732-100 100 In distribution
-731P1711-005 5 In distribution
-732P0301-100 100 In distribution
-733P0513-010 10 In distribution
-706P0982 In distribution
-733P0501-010 10 In distribution
-731P0201 In distribution
-730P1501-010 10 In distribution
-731P0301-010 10 In distribution
-730P0503-100 100 In distribution
-733P0501-005 5 In distribution
-731P0101-100 100 In distribution
-731P1411-010 10 In distribution
-733P1401-010 10 In distribution
-732P1413-005 5 In distribution
-732P0413-010 10 In distribution
-733P0311-010 10 In distribution
-732P1411 In distribution
-731P1733-010 10 In distribution
-706P0995 In distribution
-730P0301-100 100 In distribution
-730P0103-100 100 In distribution
-733P1503 In distribution
-733P0403-010 10 In distribution
-731P0713-005 5 In distribution
-706-1138 In distribution
-731P1603-005 5 In distribution
-732P0201-010 10 In distribution
-730P1713-010 10 In distribution
-733P1603 In distribution
-731P0513-100 100 In distribution
-706P0989 In distribution
-730P0101-010 10 In distribution
-706P0985 In distribution
-731P0313-005 5 In distribution
-706P0994 In distribution
-731P0711-100 100 In distribution
-731P1401-005 5 In distribution
-706P0979 In distribution
-730P0733-005 5 In distribution
-706P0864 In distribution
-732P1401 In distribution
-733P0503-005 5 In distribution
-732P1501-005 5 In distribution
-730P0203-005 5 In distribution
-730P0101-005 5 In distribution
-730P0311-100 100 In distribution
-731P1613-100 100 In distribution
-706P0843 In distribution
-732P1411-010 10 In distribution
P730B0734-005 5 In distribution
-731P1513-005 5 In distribution
-731P0201-100 100 In distribution
-733P0101 In distribution
-706P0858 In distribution
-731P0203-005 5 In distribution
-730P1613 In distribution
-732P0411 In distribution
-732P0513-100 100 In distribution
P731B0734 In distribution
-733P0301-100 100 In distribution
-732P0311-100 100 In distribution
-731P0731 In distribution
-733P0401-010 10 In distribution
-733P1501-005 5 In distribution
-732P1503-005 5 In distribution
-730P0511 In distribution
-731P0503-010 10 In distribution
-730P0711-100 100 In distribution
-732P0401-005 5 In distribution
-733P0503-010 10 In distribution
-730P0711 In distribution
-732P0411-005 5 In distribution
-733P0203-005 5 In distribution
-733P1601-005 5 In distribution
-733P0103 In distribution
-732P0501-005 5 In distribution
-730P0303-100 100 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
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