Ifit
DB Tube Ifit Mini Wraparound UL 2ND MOL 022 NON-Conv T-14 R=0 2.5MM W/HK
34manufacturers in China registered for this device type
281catalogue 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.
| 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
| 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 | 2024-04-05 |
| Record revised | 2025-05-12 (version 7) |
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 | 2024-10-11 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 955-22-036476HM | In distribution | |
| 1953-22-016224HM | In distribution | |
| 1957-22-016184HM | In distribution | |
| 1952-22-016125HM | In distribution | |
| 1953-22-016136HM | In distribution | |
| 004-22-029458HM | In distribution | |
| 931-22-030675HM | In distribution | |
| 1956-22-016193HM | In distribution | |
| 1951-18-016214HM | In distribution | |
| 934-22-030688HM | In distribution | |
| 004-22-036460HM | In distribution | |
| 932-22-030684HM | In distribution | |
| 1954-18-016227HM | In distribution | |
| 1951-18-016218HM | In distribution | |
| 932-18-030674HM | In distribution | |
| 004-18-036459HM | In distribution | |
| 1958-18-000002HM | In distribution | |
| 1951-22-016116HM | In distribution | |
| 1952-22-035574HM | In distribution | |
| 1956-22-016197HM | In distribution | |
| 933-22-030691HM | In distribution | |
| 932-22-030680HM | In distribution | |
| 004-18-036458HM | In distribution | |
| 004-18-029449HM | In distribution | |
| 957-22-036552HM | In distribution | |
| 955-18-029500HM | In distribution | |
| 934-18-030686HM | In distribution | |
| 004-22-036457HM | In distribution | |
| 1952-22-032948HM | In distribution | |
| 004-22-036461HM | In distribution | |
| 1952-22-016153HM | In distribution | |
| 1952-18-016219HM | In distribution | |
| 1951-22-016124HM | In distribution | |
| 004-18-029453HM | In distribution | |
| 1952-22-035578HM | In distribution | |
| 1952-22-016213HM | In distribution | |
| 1952-18-016207HM | In distribution | |
| 1954-22-016237HM | In distribution | |
| 955-18-036482HM | In distribution | |
| 1953-18-016226HM | In distribution | |
| 955-22-029474HM | In distribution | |
| 1956-18-016203HM | In distribution | |
| 004-22-036456HM | In distribution | |
| 1956-18-016191HM | In distribution | |
| 956-22-029475HM | In distribution | |
| 1955-22-000023HM | In distribution | |
| 956-22-036489HM | In distribution | |
| 1955-22-016188HM | In distribution | |
| 1955-18-000033HM | In distribution | |
| 955-18-029472HM | In distribution | |
| 933-22-030695HM | In distribution | |
| 956-18-036479HM | In distribution | |
| 931-18-030681HM | In distribution | |
| 004-18-029457HM | In distribution | |
| 004-22-036469HM | In distribution | |
| 1958-22-016181HM | In distribution | |
| 1955-18-016194HM | In distribution | |
| 1951-22-032947HM | In distribution | |
| 958-22-029471HM | In distribution | |
| 958-18-029465HM | In distribution | |
| 1958-18-016175HM | In distribution | |
| 1951-18-016146HM | In distribution | |
| 956-18-029477HM | In distribution | |
| 1956-18-000030HM | In distribution | |
| 1955-18-016198HM | In distribution | |
| 956-22-036485HM | In distribution | |
| 1951-22-016148HM | In distribution | |
| 1952-22-016121HM | In distribution | |
| 004-18-036466HM | In distribution | |
| 1958-22-000008HM | In distribution | |
| 1956-22-000032HM | In distribution | |
| 957-18-036546HM | In distribution | |
| 957-22-029466HM | In distribution | |
| 932-22-030676HM | In distribution | |
| 931-22-030683HM | In distribution | |
| 1957-22-035569HM | In distribution | |
| 956-18-036475HM | In distribution | |
| 1958-22-016177HM | In distribution | |
| 1954-18-016235HM | In distribution | |
| 1958-22-016185HM | In distribution | |
| 1956-22-000020HM | In distribution | |
| 1955-22-016192HM | In distribution | |
| 1958-18-016179HM | In distribution | |
| 1956-22-000016HM | In distribution | |
| 1955-22-016200HM | In distribution | |
| 1953-22-016128HM | In distribution | |
| 004-18-029452HM | In distribution | |
| 957-18-036550HM | In distribution | |
| 1958-18-000042HM | In distribution | |
| 004-18-029448HM | In distribution | |
| 1957-22-000011HM | In distribution | |
| 933-18-030693HM | In distribution | |
| 004-22-029454HM | In distribution | |
| 1951-22-016152HM | In distribution | |
| 956-18-036487HM | In distribution | |
| 1951-18-016206HM | In distribution | |
| 933-22-032962HM | In distribution | |
| 1954-18-016135HM | In distribution | |
| 1956-22-000028HM | In distribution | |
| 004-18-029460HM | In distribution | |
| 1954-18-016231HM | In distribution | |
| 1952-22-016221HM | In distribution | |
| 004-22-036465HM | In distribution | |
| 1958-18-000006HM | In distribution | |
| 1955-22-000031HM | In distribution | |
| 1954-22-016233HM | In distribution | |
| 931-22-030679HM | In distribution | |
| 1955-18-000021HM | In distribution | |
| 957-22-036548HM | In distribution | |
| 1958-22-000012HM | In distribution | |
| 1952-22-016217HM | In distribution | |
| 1954-22-016141HM | In distribution | |
| 956-22-029479HM | In distribution | |
| 956-22-036481HM | In distribution | |
| 1958-22-035570HM | In distribution | |
| 1957-22-016176HM | In distribution | |
| 1952-22-016145HM | In distribution | |
| 004-22-029455HM | In distribution | |
| 1957-22-000007HM | In distribution | |
| 1957-18-016182HM | In distribution | |
| 1952-18-016119HM | In distribution | |
| 1957-18-000001HM | In distribution | |
| 1955-22-016204HM | In distribution | |
| 1956-22-000024HM | In distribution | |
| 1956-18-016199HM | In distribution | |
| 004-22-029462HM | In distribution | |
| 956-22-029503HM | In distribution | |
| 1952-18-016143HM | In distribution | |
| 1952-22-016209HM | In distribution | |
| 958-22-036553HM | In distribution | |
| 1952-18-016151HM | In distribution | |
| 1955-22-000027HM | In distribution | |
| 1958-18-016183HM | In distribution | |
| 1954-22-016129HM | In distribution | |
| 1957-18-000009HM | In distribution | |
| 1958-18-000046HM | In distribution | |
| 934-22-032963HM | In distribution | |
| 934-18-030694HM | In distribution | |
| 1952-22-016149HM | In distribution | |
| 1955-18-016190HM | In distribution | |
| 004-18-036463HM | In distribution | |
| 1953-18-016130HM | In distribution | |
| 1958-22-000004HM | In distribution | |
| 1952-18-035572HM | In distribution | |
| 1951-22-016220HM | In distribution | |
| 1955-22-000019HM | In distribution | |
| 958-22-029467HM | In distribution | |
| 934-18-030690HM | In distribution | |
| 1954-22-016133HM | In distribution | |
| 1952-18-016215HM | In distribution | |
| 1953-18-016126HM | In distribution | |
| 956-18-029473HM | In distribution | |
| 957-22-029470HM | In distribution | |
| 1951-18-035571HM | In distribution | |
| 1953-18-016138HM | In distribution | |
| 1956-22-016205HM | In distribution | |
| 1952-18-035576HM | In distribution | |
| 1953-18-016134HM | In distribution | |
| 955-18-029476HM | In distribution | |
| 1953-22-016232HM | In distribution | |
| 957-18-029464HM | In distribution | |
| 932-18-030678HM | In distribution | |
| 1953-18-016222HM | In distribution | |
| 958-18-029469HM | In distribution | |
| 1955-18-000013HM | In distribution | |
| 004-22-029463HM | In distribution | |
| 1957-18-000037HM | In distribution | |
| 1954-22-016137HM | In distribution | |
| 004-22-029459HM | In distribution | |
| 1951-18-016114HM | In distribution | |
| 955-18-036478HM | In distribution | |
| 1953-22-016236HM | In distribution | |
| 1957-18-016174HM | In distribution | |
| 1951-18-016150HM | In distribution | |
| 004-22-036468HM | In distribution | |
| 1957-18-016178HM | In distribution | |
| 1955-22-000015HM | In distribution | |
| 1954-18-016139HM | In distribution | |
| 955-18-036474HM | In distribution | |
| 956-22-036477HM | In distribution | |
| 1954-22-016229HM | In distribution | |
| 1957-22-000039HM | In distribution | |
| 1955-18-016202HM | In distribution | |
| 1956-18-000022HM | In distribution | |
| 1957-18-000005HM | In distribution | |
| 931-18-030673HM | In distribution | |
| 1955-18-016186HM | In distribution | |
| 933-18-030689HM | In distribution | |
| 932-18-030682HM | In distribution | |
| 1953-18-016234HM | In distribution | |
| 1955-18-000029HM | In distribution | |
| 1954-18-016131HM | In distribution | |
| 1951-22-016212HM | In distribution | |
| 1955-18-000025HM | In distribution | |
| 004-22-029450HM | In distribution | |
| 1953-22-016228HM | In distribution | |
| 1956-22-016189HM | In distribution | |
| 1958-22-000048HM | In distribution | |
| 1951-22-016208HM | In distribution | |
| 1957-22-000043HM | In distribution | |
| 955-18-036486HM | In distribution | |
| 1957-22-000047HM | In distribution | |
| 955-22-029502HM | In distribution | |
| 1954-18-016223HM | In distribution | |
| 1952-22-016117HM | In distribution | |
| 1957-18-000045HM | In distribution | |
| 1952-18-016123HM | In distribution | |
| 1956-18-000014HM | In distribution | |
| 1951-22-016144HM | In distribution | |
| 1955-22-000035HM | In distribution | |
| 1951-22-035573HM | In distribution | |
| 004-18-036455HM | In distribution | |
| 1952-18-016147HM | In distribution | |
| 1953-22-016140HM | In distribution | |
| 004-18-036454HM | In distribution | |
| 004-18-036467HM | In distribution | |
| 1956-22-016201HM | In distribution | |
| 1951-22-016216HM | In distribution | |
| 1957-18-000041HM | In distribution | |
| 1953-22-016132HM | In distribution | |
| 1958-18-000010HM | In distribution | |
| 957-18-029468HM | In distribution | |
| 1952-18-016115HM | In distribution | |
| 1958-22-000044HM | In distribution | |
| 1955-18-000017HM | In distribution | |
| 1951-18-016122HM | In distribution | |
| 1953-18-016230HM | In distribution | |
| 958-22-036549HM | In distribution | |
| 1956-18-016195HM | In distribution | |
| 1951-18-035575HM | In distribution | |
| 1951-18-016210HM | In distribution | |
| 1951-18-016142HM | In distribution | |
| 931-18-030677HM | In distribution | |
| 1956-18-000034HM | In distribution | |
| 1954-22-016225HM | In distribution | |
| 955-22-036488HM | In distribution | |
| 004-22-036464HM | In distribution | |
| 1956-18-016187HM | In distribution | |
| 958-18-036551HM | In distribution | |
| 1951-22-035577HM | In distribution | |
| 1957-22-016180HM | In distribution | |
| 933-22-030687HM | In distribution | |
| 1958-18-000038HM | In distribution | |
| 1958-22-000040HM | In distribution | |
| 1957-22-000003HM | In distribution | |
| 004-22-029451HM | In distribution | |
| 956-18-029501HM | In distribution | |
| 1955-22-016196HM | In distribution | |
| 004-18-036462HM | In distribution | |
| 955-22-036480HM | In distribution |
Showing 250 of 281 catalogue numbers.
Same 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.