LP

DB Tube LP MAX Right 1ST Molar 022 Cast NON-Conv Gold TQ=-14 R=10 4.5MM W/Hook & MR PAD

Registry build 21.09.26
34manufacturers in China registered for this device type
128catalogue 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 LP
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 2017-11-30
Record revised 2025-05-16 (version 9)

Specifications

Specifications
MRI safety MR Unsafe
Single use Yes
Prescription Prescription only
Label carries lot or batch number, manufacturing date
Distribution end date 2022-01-31

Catalogue Numbers

Catalogue numbers for LP
Catalogue number Size Status
953-2008C In distribution
957-6001C In distribution
956-6009C In distribution
957-725CR In distribution
956-724CL In distribution
956-725CL In distribution
951-2027C In distribution
956-6024C In distribution
955-6008C In distribution
955-705CR In distribution
953-2028C In distribution
956-6027C In distribution
958-703CL In distribution
955-725CR In distribution
956-728CL In distribution
958-1028C In distribution
955-6028C In distribution
955-727CR In distribution
956-705CL In distribution
956-6004C In distribution
955-728CR In distribution
952-2008C In distribution
955-6006C In distribution
954-2007C In distribution
955-6023C In distribution
958-725CL In distribution
956-726CLX In distribution
955-703CR In distribution
955-708CR In distribution
956-6022C In distribution
957-1007C In distribution
958-1071C In distribution
955-6005C In distribution
955-706CR In distribution
952-2006C In distribution
954-2027C In distribution
958-6025C In distribution
952-2028C In distribution
956-723CL In distribution
957-6002C In distribution
956-708CL In distribution
958-723CL In distribution
951-2007C In distribution
955-6020C In distribution
956-6001C In distribution
955-724CR In distribution
955-6030C In distribution
957-723CR In distribution
956-727CLX In distribution
956-727CL In distribution
955-704CR In distribution
957-704CR In distribution
956-6031C In distribution
958-724CLX In distribution
955-723CR In distribution
957-1025C In distribution
955-726CR In distribution
957-1027C In distribution
958-6023C In distribution
951-2025C In distribution
956-707CL In distribution
957-6004C In distribution
958-705CL In distribution
955-6025C In distribution
958-1028CX In distribution
958-1026CX In distribution
958-1006C In distribution
955-727CRX In distribution
956-6029C In distribution
958-6005C In distribution
958-6000C In distribution
956-703CL In distribution
958-1008C In distribution
957-705CR In distribution
951-2005C In distribution
956-6002C In distribution
956-706CL In distribution
956-6007C In distribution
957-6024C In distribution
956-6021C In distribution
957-6022C In distribution
957-1050C In distribution
958-6003C In distribution
955-6000C In distribution
958-6020C In distribution
958-1051C In distribution
958-704CL In distribution
952-2026C In distribution
957-6021C In distribution
956-704CL In distribution
957-724CRX In distribution
958-1026C In distribution
955-6003C In distribution
957-1027CX In distribution
955-707CR In distribution
957-1070C In distribution
957-703CR In distribution
957-1025CX In distribution
956-726CL In distribution
955-6026C In distribution
955-726CRX In distribution
957-1005C In distribution
957-724CR In distribution
958-724CL In distribution
955-1026C Withdrawn
956-1005C Withdrawn
957-705CRG Withdrawn
955-706CRG Withdrawn
955-704CRG Withdrawn
956-6011C Withdrawn
957-1027CG Withdrawn
957-725CRG Withdrawn
956-1025C Withdrawn
951-2007CG Withdrawn
952-2008CG Withdrawn
956-726CLG Withdrawn
952-2028CG Withdrawn
956-704CLG Withdrawn
955-6010C Withdrawn
958-705CLG Withdrawn
955-1006C Withdrawn
956-706CLG Withdrawn
951-2027CG Withdrawn
955-726CRG Withdrawn
958-704CLG Withdrawn
958-725CLG Withdrawn
958-1028CG Withdrawn
957-704CRG Withdrawn

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
Tube, Orthodontic Forestadent Bernhard Förster GmbH 2,336
Generic Buccal Tubes American Orthodontics 799
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

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