Marquis

Marquis 022 LL3 Hk Roth Rx -11° Tor. +5° Ang. (10PK)

Registry build 21.09.26
52manufacturers in China registered for this device type
96catalogue 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 Marquis
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 2019-05-02
Record revised 2025-01-07 (version 2)

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
Distribution end date 2024-09-03
UDI direct marking Exempt

Catalogue Numbers

Catalogue numbers for Marquis
Catalogue number Size Status
M18-030 Withdrawn
M18-021 Withdrawn
M22-060 Withdrawn
M22-070 Withdrawn
M22-022 Withdrawn
M18-071 Withdrawn
M22-011 Withdrawn
M18-001 Withdrawn
320-22-3340 Withdrawn
320-22-5900 Withdrawn
320-22-4510 Withdrawn
M18-011 Withdrawn
M18-031 Withdrawn
M18-002 Withdrawn
320-22-4350 Withdrawn
320-22-3410 Withdrawn
320-22-1300 Withdrawn
M22-012 Withdrawn
320-22-4410 Withdrawn
M22-053 Withdrawn
M22-1345 Withdrawn
M18-023 Withdrawn
320-22-3310 Withdrawn
M22-052 Withdrawn
M18-1300 Withdrawn
M22-032 Withdrawn
M22-001 Withdrawn
M22-062 Withdrawn
320-22-2050 Withdrawn
320-22-3350 Withdrawn
M18-024 Withdrawn
M18-440 Withdrawn
320-22-2100 Withdrawn
320-22-2011 Withdrawn
M18-2000 Withdrawn
M18-1345 Withdrawn
320-22-2350 Withdrawn
M18-052 Withdrawn
M18-400 Withdrawn
M22-023 Withdrawn
M22-024 Withdrawn
M22-054 Withdrawn
320-22-6500 Withdrawn
M22-400 Withdrawn
M22-072 Withdrawn
M18-420 Withdrawn
320-22-6800 Withdrawn
M18-051 Withdrawn
320-22-4310 Withdrawn
320-22-3300 Withdrawn
M18-062 Withdrawn
320-22-3510 Withdrawn
M22-002 Withdrawn
M18-032 Withdrawn
320-22-4340 Withdrawn
M18-012 Withdrawn
M18-430 Withdrawn
320-22-6400 Withdrawn
M22-410 Withdrawn
M18-410 Withdrawn
320-22-1900 Withdrawn
M18-070 Withdrawn
M22-031 Withdrawn
320-22-4300 Withdrawn
M22-061 Withdrawn
M18-040 Withdrawn
M22-030 Withdrawn
M18-061 Withdrawn
320-22-1200 Withdrawn
M22-1300 Withdrawn
320-22-2051 Withdrawn
M22-040 Withdrawn
320-22-2310 Withdrawn
320-22-2300 Withdrawn
M22-1000 Withdrawn
M18-022 Withdrawn
M22-021 Withdrawn
320-22-2010 Withdrawn
320-22-2900 Withdrawn
M18-053 Withdrawn
M18-1000 Withdrawn
M18-060 Withdrawn
M22-071 Withdrawn
320-22-2200 Withdrawn
M22-430 Withdrawn
M22-2000 Withdrawn
320-22-1310 Withdrawn
320-22-1340 Withdrawn
M18-072 Withdrawn
M18-054 Withdrawn
M22-440 Withdrawn
M22-420 Withdrawn
320-22-1100 Withdrawn
320-22-1350 Withdrawn
320-22-2340 Withdrawn
M22-051 Withdrawn

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