Generic Buccal Tubes

Tube Flangeless MAX Right 1ST Molar 018 Cast NON-Conv T-10 A=0 R=10 4.2MM W/Hook

Registry build 21.09.26
34manufacturers in China registered for this device type
799catalogue numbers in this listing

Who Else Makes It

Concentrated in Zhejiang (20), Jiangsu (4), Guangdong (4). 5 of them are registered as contract manufacturers, able to build to a buyer’s own specification.

Chinese manufacturers registered for FDA product code DZD
Manufacturer City Province Registered as Device types
Shenzhen Denco Medical Co., Ltd. Shenzhen Guangdong Contract manufacturer 52
Shenzhen Rogin Medical Co., Ltd. Shenzhen Guangdong Contract manufacturer 51
Sino Ortho Limited Hangzhou Zhejiang Contract manufacturer 14
Hangzhou Westlake Biomaterial Co., Ltd. Hangzhou Zhejiang Contract manufacturer 13
Hangzhou Xingchen 3B Dental Instrument & Materials Co., Ltd. Hangzhou Zhejiang Contract manufacturer 7
Wuxi Lyusmile IMP AND EXP Co., Ltd. Wuxi Jiangsu Private-label distributor 66
Zhejiang Yamei Medical Equipment Technology Co., Ltd. Yang Jiao Lang Zin’An Town Zhejiang Manufacturer 39
Henan Baistra Medical Devices Limited Zhengzhou Henan Manufacturer 34
Hangzhou Wise Medical Device Co., Ltd. Hangzhou Zhejiang Contract manufacturer 25
Changsha Nice Medical Instrument Limited Company Changsha Hunan Manufacturer 17
Guangzhou OO Medical Scientific Limited Guangzhou Guangdong Manufacturer 17
Orthguide Medical Technology (Jiangsu) Co., Ltd. Wuxi Jiangsu Contract manufacturer 17

Showing 12 of 34. All 34 manufacturers in China registered for Tube, Orthodontic

Record

Regulatory record for Generic Buccal Tubes
Listed by American Orthodontics, United States
FDA product code DZD
Device type Tube, Orthodontic
Device class Class 1
Regulation 21 CFR 872.5410
Establishment Contract manufacturer, Repacker / relabeller, Complaint-file establishment, Manufacturer
Premarket notification Exempt
Record published 2018-12-26
Record revised 2026-01-16 (version 6)

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 2025-07-24
UDI direct marking Exempt

Catalogue Numbers

Catalogue numbers for Generic Buccal Tubes
Catalogue number Size Status
004-026CR In distribution
004-882C In distribution
003-112CR In distribution
004-760CL In distribution
004-856C In distribution
851-783 In distribution
004-942C In distribution
003-291CL In distribution
004-484CM In distribution
004-762CL In distribution
004-265CR In distribution
004-533C In distribution
851-787 In distribution
004-528C In distribution
004-776CL In distribution
004-018L In distribution
004-610C In distribution
004-788CM In distribution
004-2935CR In distribution
004-794C In distribution
004-673C In distribution
004-352C In distribution
004-605C In distribution
004-532C In distribution
003-102CL In distribution
004-789CM In distribution
974-22-032872HM In distribution
004-409C In distribution
004-484CT In distribution
090-22-031490 In distribution
004-611CT In distribution
004-244R In distribution
004-3605C In distribution
004-891C In distribution
004-9425C In distribution
004-411CT In distribution
004-214CLH In distribution
004-6855C In distribution
003-2925CL In distribution
004-537C In distribution
003-062CR In distribution
004-553C In distribution
004-297CL In distribution
004-263CL In distribution
004-238CL In distribution
004-564C In distribution
004-534C In distribution
004-781C In distribution
004-22-031249HM In distribution
004-010L In distribution
004-685C In distribution
003-059CL In distribution
003-050CL In distribution
003-041CL In distribution
003-056CL In distribution
004-611C In distribution
004-479C In distribution
17R In distribution
003-052CR In distribution
004-384C In distribution
004-654C In distribution
004-552C In distribution
004-294CL In distribution
004-292CR In distribution
004-485CMT In distribution
004-025CL In distribution
004-329CMTL In distribution
003-290CR In distribution
004-259CL In distribution
004-323CR In distribution
004-8855C In distribution
004-769CR In distribution
004-235CL In distribution
004-024CL In distribution
004-883CM In distribution
003-030L In distribution
004-944C In distribution
004-239CR In distribution
004-765CR In distribution
004-782CT In distribution
004-361C In distribution
004-604C In distribution
004-240CL In distribution
004-609C In distribution
004-263CR In distribution
004-795C In distribution
004-020 In distribution
004-021 In distribution
004-290CR In distribution
004-262CL In distribution
004-554C In distribution
004-764CL In distribution
004-658C In distribution
004-025CR In distribution
004-329CMTR In distribution
003-056CR In distribution
004-549C In distribution
004-240CR In distribution
004-217CL In distribution
004-329CMR In distribution
004-854C In distribution
003-041CR In distribution
974-22-032870HM In distribution
003-259L In distribution
003-1105CR In distribution
004-3615C In distribution
004-652C In distribution
004-651C In distribution
004-885C In distribution
090-22-031488 In distribution
004-547C In distribution
004-682C In distribution
004-233CR In distribution
004-968C In distribution
004-22-031471HM In distribution
004-209CL In distribution
003-293CR In distribution
004-780C In distribution
003-110CR In distribution
003-103CR In distribution
004-761CL In distribution
004-238R In distribution
003-050CR In distribution
004-328CL In distribution
004-035692 In distribution
004-472C In distribution
004-238CR In distribution
003-013L In distribution
004-018R In distribution
004-294CR In distribution
004-209CR In distribution
004-4835C In distribution
003-111CR In distribution
004-026CL In distribution
004-359CM In distribution
003-042CR In distribution
851-784 In distribution
003-293L In distribution
004-22-031387HM In distribution
003-293CL In distribution
004-548C In distribution
003-248CR In distribution
004-287L In distribution
003-1125CL In distribution
004-410C In distribution
004-010R In distribution
004-293CL In distribution
004-237CR In distribution
004-351CM In distribution
003-034L In distribution
004-551C In distribution
003-249CR In distribution
004-351C In distribution
004-483CM In distribution
004-603C In distribution
004-359C In distribution
003-1115CL In distribution
004-540C In distribution
37R In distribution
004-2935CL In distribution
003-108CL In distribution
003-104CL In distribution
003-259R In distribution
004-883C In distribution
004-218CL In distribution
995-22-031499HM In distribution
004-291CR In distribution
004-411C In distribution
003-291CR In distribution
003-057CL In distribution
004-612CT In distribution
004-542C In distribution
851-770 In distribution
004-555C In distribution
004-760CR In distribution
003-253R In distribution
003-051CL In distribution
004-646C In distribution
004-412C In distribution
004-7905CM In distribution
004-531C In distribution
004-18-031478HM In distribution
004-362C In distribution
004-541C In distribution
004-763CR In distribution
003-034R In distribution
090-22-031493 In distribution
004-522C In distribution
004-884C In distribution
004-890C In distribution
004-265CL In distribution
004-782C In distribution
004-18-031466 In distribution
004-538C In distribution
004-762CR In distribution
003-040R In distribution
004-360CMT In distribution
004-024R In distribution
951-342 In distribution
004-22-031248HM In distribution
003-1065CR In distribution
004-536C In distribution
004-359CMT In distribution
004-238L In distribution
17RW In distribution
004-296CL In distribution
003-1105CL In distribution
004-272CR In distribution
004-236CR In distribution
004-215CR In distribution
004-478C In distribution
004-3605CMT In distribution
004-546C In distribution
003-246CR In distribution
004-544C In distribution
004-213CL In distribution
004-8845C In distribution
003-248CL In distribution
003-2915CL In distribution
004-674C In distribution
003-109CL In distribution
004-520C In distribution
004-672C In distribution
003-053CR In distribution
004-565C In distribution
004-608C In distribution
004-783CT In distribution
004-530C In distribution
004-216CR In distribution
004-306CL In distribution
004-776CR In distribution
003-055CL In distribution
003-111CL In distribution
004-22-031388HM In distribution
004-887C In distribution
004-3595C In distribution
004-3595CMT In distribution
003-297CL In distribution
004-303CL In distribution
090-22-031489 In distribution
953-342 In distribution
004-236CL In distribution
003-1115CR In distribution
004-765CL In distribution
004-764CR In distribution
004-354C In distribution
004-244L In distribution
004-888C In distribution
004-941C In distribution
003-105CL In distribution

Showing 250 of 300 catalogue numbers.

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
Tube, Orthodontic Forestadent Bernhard Förster GmbH 2,336
Tube, Orthodontic G & H Wire Company 758
Leone SPA Leone SPA 722
RMO RMO 697
Tube, Orthodontic Dentaurum GmbH & Co. KG 602
LP Low Profile American Orthodontics 506
3M™ Unitek™ Victory Series™ 3M Unitek 434
Buccal Tubes American Orthodontics 356
Peerless Buccal Tube Ormco Corporation 331
Empower Tube American Orthodontics 296
Mini Master Series American Orthodontics 289
ifit American Orthodontics 281

Showing 12 of 333. All products under Tube, 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