LP Low Profile

DB Tube LP Mand Right 2ND Molar 022 Cast NON-Conv Gold TQ=-10 R=0 3.2MM W/Hook & MR PAD

Registry build 21.09.26
34manufacturers in China registered for this device type
506catalogue 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 Low Profile
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 2018-05-25
Record revised 2025-05-16 (version 7)

Specifications

Specifications
MRI safety MR Unsafe
Single use Yes
Prescription Prescription only
Over the counter Yes
Label carries lot or batch number, manufacturing date
Distribution end date 2024-09-28

Catalogue Numbers

Catalogue numbers for LP Low Profile
Catalogue number Size Status
953-812C In distribution
004-1028C In distribution
953-807C In distribution
956-22-038019HM In distribution
955-22-038016HM In distribution
951-801C In distribution
996-726CR In distribution
003-707CL In distribution
996-1028C In distribution
953-3000C In distribution
003-6001C In distribution
958-3005C In distribution
956-1041C In distribution
958-1035C In distribution
958-1048C In distribution
957-3016C In distribution
958-22-031255HM In distribution
004-1027C In distribution
954-3013C In distribution
956-1044C In distribution
974-726CL In distribution
951-3004C In distribution
951-3003C In distribution
003-704CL In distribution
957-810C In distribution
003-703CL In distribution
004-3018C In distribution
004-1037C In distribution
958-2008C In distribution
003-724CR In distribution
956-1031C In distribution
955-1033C In distribution
954-824C In distribution
004-2025C In distribution
953-3007C In distribution
003-6028C In distribution
951-3006CX In distribution
003-705CR In distribution
953-823C In distribution
953-3002C In distribution
004-800C In distribution
003-6002C In distribution
953-821C In distribution
997-1047C In distribution
958-2028C In distribution
953-805C In distribution
998-1046C In distribution
004-3015C In distribution
003-6000C In distribution
958-2006C In distribution
952-3009C In distribution
003-727CR In distribution
47LIW In distribution
956-1039C In distribution
951-806C In distribution
003-727CL In distribution
952-3014C In distribution
954-815CX In distribution
952-3005C In distribution
955-1043C In distribution
955-814C In distribution
957-1005CAU In distribution
974-726CR In distribution
004-3006C In distribution
951-810C In distribution
004-3019C In distribution
975-726CL In distribution
003-728CR In distribution
954-813C In distribution
958-22-038021HM In distribution
003-707CR In distribution
004-2005C In distribution
957-1041C In distribution
956-3013C In distribution
957-3004C In distribution
003-6027C In distribution
004-3007C In distribution
955-1048C In distribution
957-22-038020HM In distribution
952-805C In distribution
004-3008C In distribution
003-6010C In distribution
956-815C In distribution
953-814C In distribution
003-6029C In distribution
004-810C In distribution
958-1033C In distribution
004-1045C In distribution
951-804C In distribution
004-1038C In distribution
004-1041C In distribution
952-800C In distribution
996-801C In distribution
954-3015C In distribution
004-22-038015HM In distribution
003-6022C In distribution
003-6011C In distribution
957-1031C In distribution
952-3011CX In distribution
003-725CL In distribution
956-806C In distribution
958-22-038023HM In distribution
003-6030C In distribution
004-805C In distribution
955-706CRAU In distribution
956-707CLAU In distribution
004-3000C In distribution
003-706CL In distribution
957-22-031254HM In distribution
004-3009C In distribution
004-814C In distribution
955-707CRAU In distribution
003-706CR In distribution
004-1031C In distribution
004-821C In distribution
955-1040C In distribution
37RW In distribution
954-810C In distribution
954-3006C In distribution
004-3002C In distribution
954-815C In distribution
957-2027C In distribution
958-1028CAU In distribution
951-3010C In distribution
958-1046C In distribution
004-1040C In distribution
996-800C In distribution
958-3017C In distribution
996-1027C In distribution
47RW In distribution
956-3006C In distribution
003-6024C In distribution
955-805C In distribution
003-703CR In distribution
954-801C In distribution
956-22-038017HM In distribution
004-22-038012HM In distribution
951-803C In distribution
003-6021C In distribution
956-1032C In distribution
004-1042C In distribution
956-1042C In distribution
955-1035C In distribution
003-6005C In distribution
955-807C In distribution
951-3010CX In distribution
004-1048C In distribution
004-1071C In distribution
952-3002C In distribution
952-3007C In distribution
974-725CL In distribution
952-2008CAU In distribution
951-3016C In distribution
974-725CR In distribution
004-2028C In distribution
003-6008C In distribution
956-804C In distribution
958-1040C In distribution
957-2005C In distribution
957-1032C In distribution
953-811C In distribution
003-6020C In distribution
955-726CRAU In distribution
954-3004C In distribution
004-808C In distribution
956-706CLAU In distribution
003-728CL In distribution
004-2008C In distribution
957-1042C In distribution
956-1037C In distribution
951-3001C In distribution
004-2006C In distribution
004-3012C In distribution
003-705CL In distribution
952-811C In distribution
004-2007C In distribution
004-1030C In distribution
954-22-031392HM In distribution
952-3012C In distribution
958-811C In distribution
004-1005C In distribution
004-815C In distribution
004-1070C In distribution
003-6007C In distribution
953-800C In distribution
004-1032C In distribution
957-2007C In distribution
952-3011C In distribution
003-723CL In distribution
004-1034C In distribution
953-3012C In distribution
953-3014C In distribution
004-813C In distribution
004-809C In distribution
974-1027C In distribution
957-1049C In distribution
952-3000C In distribution
954-804C In distribution
004-3004C In distribution
004-3017C In distribution
955-1030C In distribution
975-726CR In distribution
957-1047C In distribution
004-811C In distribution
956-813C In distribution
956-1049C In distribution
003-724CL In distribution
958-1045C In distribution
951-2007CAU In distribution
003-726CL In distribution
952-3017C In distribution
003-725CR In distribution
954-3003C In distribution
004-1036C In distribution
952-812C In distribution
004-1008C In distribution
004-2027C In distribution
004-3016C In distribution
958-2026C In distribution
954-3001C In distribution
004-807C In distribution
952-3007CX In distribution
004-801C In distribution
958-1006CAU In distribution
955-812C In distribution
957-1027CAU In distribution
004-3005C In distribution
952-3019C In distribution
003-6004C In distribution
004-1007C In distribution
004-806C In distribution
003-6003C In distribution
956-18-031259HM In distribution
004-1046C In distribution
951-813C In distribution
004-3010C In distribution
004-1043C In distribution
004-803C In distribution
004-22-038014HM In distribution
956-1034C In distribution
004-824C In distribution
004-2026C In distribution
003-723CR In distribution
957-2025C In distribution
37LIW In distribution
957-1044C In distribution
958-3014C In distribution
951-808C In distribution
004-1035C In distribution
957-1034C 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
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
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