Lotus Plus DS

Lotus Plus DS P D-SUPER 022 UR4/5 Hk Rx -11° Tor. +2° Ang.+2OS(10PK)

Registry build 21.09.26
52manufacturers in China registered for this device type
420catalogue 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 Lotus Plus DS
Listed by Ortho Technology, Inc., United States
FDA product code EJF
Device type Bracket, Metal, Orthodontic
Device class Class 1
Regulation 21 CFR 872.5410
Premarket notification Exempt
Record published 2019-05-03
Record revised 2024-12-18 (version 2)

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Single use Yes
Prescription Prescription only
Supplied as a kit Yes
Label carries lot or batch number, manufacturing date
Distribution end date 2024-09-18
UDI direct marking Exempt

Catalogue Numbers

Catalogue numbers for Lotus Plus DS
Catalogue number Size Status
LPAR22-074 In distribution
LPPDL22-012 In distribution
LPAR22-033 In distribution
LPPD22-011 In distribution
LPAR22-012 In distribution
LPPD22-042 In distribution
LPPR22-031 In distribution
LPPD22-051 In distribution
LPPDL22-033 In distribution
LPPR22-011 In distribution
LPPR22-051 In distribution
LPPD22-043 In distribution
LPAR22-1345 In distribution
LPPD22-033 In distribution
LPPR22-033 In distribution
LPAR22-052 In distribution
LPPM22-1345 In distribution
LPAR22-072 In distribution
LPAR22-001 In distribution
LPPDL22-043 In distribution
LPPR22-001 In distribution
LPPD22-022 In distribution
LPPR22-061 In distribution
LPPR22-074 In distribution
LPPD22-034 In distribution
LPPD22-032 In distribution
LPAR22-062 In distribution
LPPD22-1345 In distribution
LPPR22-034 In distribution
LPPD22-074 In distribution
LPAR22-002 In distribution
LPAR22-071 In distribution
LPPD22-001 In distribution
LPPD22-1300 In distribution
LPPDL22-034 In distribution
LPPR22-022 In distribution
LPPR22-052 In distribution
LPPD22-012 In distribution
LPAR22-063 In distribution
LPPDL22-011 In distribution
LPPD22-063 In distribution
LPPDL22-041 In distribution
LPPR22-1300 In distribution
LPPDL22-051 In distribution
LPPDL22-042 In distribution
LPAR22-1300 In distribution
LPPD22-021 In distribution
LPPD22-071 In distribution
LPAR22-051 In distribution
LPPM22-1300 In distribution
LPAR22-040 In distribution
LPPR22-021 In distribution
LPPD22-062 In distribution
LPPDL22-031 In distribution
LPPR22-040 In distribution
LPPR22-063 In distribution
LPAR22-061 In distribution
LPPD22-031 In distribution
LPPDL22-021 In distribution
LPPD22-002 In distribution
LPPD22-052 In distribution
LPAR22-073 In distribution
LPAR22-021 In distribution
LPPDL22-032 In distribution
LPPD22-073 In distribution
LPPDL22-044 In distribution
LPPD22-041 In distribution
LPPR22-032 In distribution
LPPDL22-002 In distribution
LPAR22-011 In distribution
LPPR22-002 In distribution
LPPR22-072 In distribution
LPPR22-064 In distribution
LPAR22-022 In distribution
LPPR22-073 In distribution
LPPD22-044 In distribution
LPPR22-012 In distribution
LPPD22-064 In distribution
LPPDL22-052 In distribution
LPPDL22-022 In distribution
LPPD22-072 In distribution
LPPD22-061 In distribution
LPAR22-064 In distribution
LPPR22-062 In distribution
LPAR22-031 In distribution
LPPR22-071 In distribution
LPPR22-1345 In distribution
LPPDL22-001 In distribution
LPAR22-034 In distribution
LPAR22-032 In distribution
LPADL22-002 Withdrawn
LPPDS22-061 Withdrawn
LPPR18-073 Withdrawn
LPPDS22-012 Withdrawn
LPPDS22-031 Withdrawn
LPADL22-044 Withdrawn
LPAM22-063 Withdrawn
LPAM18-024 Withdrawn
LPAD22-041 Withdrawn
LPAM22-024 Withdrawn
LPPR22-1000 Withdrawn
LPPM22-071 Withdrawn
LPADL22-063 Withdrawn
LPHMBD-1345 Withdrawn
LPAM18-033 Withdrawn
LPAM18-034 Withdrawn
LPAD22-042 Withdrawn
LPAM18-032 Withdrawn
LPAR22-1000 Withdrawn
LPPM18-040 Withdrawn
LPPDS22-032 Withdrawn
LPPR22-023 Withdrawn
LPHD22-3-1345 Withdrawn
LPPM22-022 Withdrawn
LPPM18-031 Withdrawn
LPPDS22-074 Withdrawn
LPAR18-062 Withdrawn
LPPM18-062 Withdrawn
LPAM18-073 Withdrawn
LPAR18-024 Withdrawn
LPPM18-033 Withdrawn
LPADS22-054 Withdrawn
LPPDS22-002 Withdrawn
LPADL22-051 Withdrawn
LPADL22-1000 Withdrawn
LPPD22-053 Withdrawn
LPADL22-032 Withdrawn
LPADS22-034 Withdrawn
LPAR18-001 Withdrawn
LPPDS22-1000 Withdrawn
LPAM18-072 Withdrawn
LPAD22-032 Withdrawn
LPPM18-1345 Withdrawn
LPPM18-023 Withdrawn
LPAD22-031 Withdrawn
LPPM18-002 Withdrawn
LPAM18-040 Withdrawn
LPPM18-021 Withdrawn
LPAR22-023 Withdrawn
LPAR18-1345 Withdrawn
LPADL22-031 Withdrawn
LPADL22-024 Withdrawn
LPADL22-074 Withdrawn
LPAD22-023 Withdrawn
LPAM18-064 Withdrawn
LPAR18-063 Withdrawn
LPPR18-051 Withdrawn
LPPDS22-033 Withdrawn
LPADL22-022 Withdrawn
LPPM18-024 Withdrawn
LPPM22-032 Withdrawn
LPAD22-011 Withdrawn
LPAD22-021 Withdrawn
LPAM22-064 Withdrawn
LPADS22-072 Withdrawn
LPPDL22-054 Withdrawn
LPAM18-1300 Withdrawn
LPPM22-021 Withdrawn
LPADS22-012 Withdrawn
LPPM22-063 Withdrawn
LPAM22-052 Withdrawn
LPPM18-064 Withdrawn
LPADS22-032 Withdrawn
LPADL22-041 Withdrawn
LPAD22-072 Withdrawn
LPPDS22-034 Withdrawn
LPADL22-042 Withdrawn
LPPM18-012 Withdrawn
LPPDS22-022 Withdrawn
LPPDS22-063 Withdrawn
LPPDL22-074 Withdrawn
LPADS22-061 Withdrawn
LPADS22-074 Withdrawn
LPADL22-053 Withdrawn
LPPDS22-023 Withdrawn
LPAD22-1300 Withdrawn
LPPR18-034 Withdrawn
LPAM22-011 Withdrawn
LPPR18-074 Withdrawn
LPPR22-024 Withdrawn
LPAM18-074 Withdrawn
LPAM22-012 Withdrawn
LPAD22-074 Withdrawn
LPHRBD-1345 Withdrawn
LPAR18-022 Withdrawn
LPPD22-023 Withdrawn
LPADS22-022 Withdrawn
LPPM22-002 Withdrawn
LPHM22-2-1345 Withdrawn
LPAD22-073 Withdrawn
LPPDS22-071 Withdrawn
LPPDS22-001 Withdrawn
LPAM22-034 Withdrawn
LPPM18-001 Withdrawn
LPPR18-021 Withdrawn
LPADS22-031 Withdrawn
LPADS22-064 Withdrawn
LPPM22-074 Withdrawn
LPPDL22-023 Withdrawn
LPAD22-064 Withdrawn
LPAM18-063 Withdrawn
LPPM22-1000 Withdrawn
LPPM22-064 Withdrawn
LPAM18-071 Withdrawn
LPADS22-073 Withdrawn
LPAD22-001 Withdrawn
LPPM22-024 Withdrawn
LPPDS22-011 Withdrawn
LPPDS22-054 Withdrawn
LPAM22-074 Withdrawn
LPPD22-024 Withdrawn
LPPM22-051 Withdrawn
LPPR18-022 Withdrawn
LPADS22-001 Withdrawn
LPAM18-053 Withdrawn
LPAD22-061 Withdrawn
LPHR22-2-1345 Withdrawn
LPPM22-061 Withdrawn
LPAD22-1000 Withdrawn
LPADS22-024 Withdrawn
LPADS22-044 Withdrawn
LPHR22-3-1345 Withdrawn
LPHD22-2-1300 Withdrawn
LPPDS22-052 Withdrawn
LPADS22-023 Withdrawn
LPAD22-022 Withdrawn
LPAM22-033 Withdrawn
LPPDL22-1345 Withdrawn
LPADL22-033 Withdrawn
LPAR18-002 Withdrawn
LPAR18-011 Withdrawn
LPAR18-071 Withdrawn
LPPR18-023 Withdrawn
LPAD22-033 Withdrawn
LPPM22-053 Withdrawn
LPPR18-072 Withdrawn
LPADS22-021 Withdrawn
LPADL22-034 Withdrawn
LPPDL22-064 Withdrawn
LPPR18-012 Withdrawn
LPADS22-1000 Withdrawn
LPPM22-054 Withdrawn
LPADS22-011 Withdrawn
LPADL22-001 Withdrawn
LPAR18-053 Withdrawn
LPAM22-054 Withdrawn
LPPDS22-053 Withdrawn
LPPM18-034 Withdrawn
LPPR18-1300 Withdrawn
LPADL22-012 Withdrawn

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