RMO
A06012 D02303 MNR/MXL DBL MOL.018 +.040GIN 0A 0T 0DO HK
34manufacturers in China registered for this device type
697catalogue 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 | RMO, United States |
|---|---|
| FDA product code | DZD |
| Device type | Tube, Orthodontic |
| Device class | Class 1 |
| Regulation | 21 CFR 872.5410 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2024-08-15 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Latex | Contains natural rubber latex |
| Label carries | lot or batch number, manufacturing date |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| A05670 | 10 | In distribution | |
| A08850 | 10 | In distribution | |
| A05687 | 10 | In distribution | |
| A05526 | 10 | In distribution | |
| A04362 | 10 | In distribution | |
| A08690 | 10 | In distribution | |
| A05678 | 10 | In distribution | |
| A01173 | 10 | In distribution | |
| A05657 | 10 | In distribution | |
| A06121 | 10 | In distribution | |
| A05602 | 10 | In distribution | |
| A05401 | 10 | In distribution | |
| A08122 | 10 | In distribution | |
| A00962 | 10 | In distribution | |
| A08048 | 10 | In distribution | |
| A04838 | 10 | In distribution | |
| A05677 | 10 | In distribution | |
| A08205 | 10 | In distribution | |
| A00952 | 10 | In distribution | |
| A06161 | 10 | In distribution | |
| A08073 | 10 | In distribution | |
| A08767 | 10 | In distribution | |
| A05504 | 10 | In distribution | |
| A08263 | 10 | In distribution | |
| A01171 | 10 | In distribution | |
| A05622 | 10 | In distribution | |
| KM05412 | 24 | In distribution | |
| A08518 | 10 | In distribution | |
| A05522 | 10 | In distribution | |
| A08809 | 10 | In distribution | |
| A04846 | 10 | In distribution | |
| A04385 | 10 | In distribution | |
| A05655 | 10 | In distribution | |
| A08506 | 10 | In distribution | |
| A00964 | 10 | In distribution | |
| A08744 | 10 | In distribution | |
| A06779 | 10 | In distribution | |
| A08067 | 10 | In distribution | |
| A08773 | 10 | In distribution | |
| A08208 | 10 | In distribution | |
| A01161 | 10 | In distribution | |
| A08780 | 10 | In distribution | |
| A08804 | 10 | In distribution | |
| A08016 | 10 | In distribution | |
| A05661 | 10 | In distribution | |
| A08365 | 10 | In distribution | |
| A08849 | 10 | In distribution | |
| A05608 | 10 | In distribution | |
| A06105 | 10 | In distribution | |
| A05411 | 10 | In distribution | |
| A06108 | 10 | In distribution | |
| A08302 | 10 | In distribution | |
| A05614 | 10 | In distribution | |
| A08800 | 10 | In distribution | |
| A05615 | 10 | In distribution | |
| A08630 | 10 | In distribution | |
| A08115 | 10 | In distribution | |
| A05606 | 10 | In distribution | |
| A08299 | 10 | In distribution | |
| A06140 | 10 | In distribution | |
| A08777 | 10 | In distribution | |
| A08604 | 10 | In distribution | |
| A04850 | 10 | In distribution | |
| A00476 | 100 | In distribution | |
| A08691 | 10 | In distribution | |
| A06104 | 10 | In distribution | |
| A08194 | 10 | In distribution | |
| A08182 | 10 | In distribution | |
| A01179 | 10 | In distribution | |
| A04387 | 10 | In distribution | |
| A18753 | 10 | In distribution | |
| A06735 | 10 | In distribution | |
| A04842 | 10 | In distribution | |
| A06734 | 10 | In distribution | |
| A05683 | 10 | In distribution | |
| A06730 | 10 | In distribution | |
| A05708 | 10 | In distribution | |
| A08810 | 10 | In distribution | |
| A05609 | 10 | In distribution | |
| A06773 | 88,579 | In distribution | |
| A08845 | 10 | In distribution | |
| A01032 | 10 | In distribution | |
| A04983 | 10 | In distribution | |
| A08735 | 10 | In distribution | |
| A05529 | 10 | In distribution | |
| A04935 | 10 | In distribution | |
| A08857 | 10 | In distribution | |
| A08565 | 10 | In distribution | |
| A01294 | 10 | In distribution | |
| A00283 | 10 | In distribution | |
| A08412 | 10 | In distribution | |
| A08687 | 10 | In distribution | |
| A05428 | 10 | In distribution | |
| A05604 | 10 | In distribution | |
| A05603 | 10 | In distribution | |
| A05664 | 10 | In distribution | |
| A01194 | 10 | In distribution | |
| A04395 | 10 | In distribution | |
| A05686 | 10 | In distribution | |
| A05500 | 10 | In distribution | |
| A08200 | 10 | In distribution | |
| A08461 | 10 | In distribution | |
| A08043 | 10 | In distribution | |
| A08042 | 10 | In distribution | |
| A08495 | 10 | In distribution | |
| A08134 | 10 | In distribution | |
| A04370 | 10 | In distribution | |
| A08513 | 10 | In distribution | |
| A05681 | 10 | In distribution | |
| A01162 | 10 | In distribution | |
| A04386 | 10 | In distribution | |
| A05652 | 10 | In distribution | |
| A08732 | 10 | In distribution | |
| A05424 | 10 | In distribution | |
| A18759 | 10 | In distribution | |
| A05658 | 10 | In distribution | |
| A08775 | 10 | In distribution | |
| A08851 | 10 | In distribution | |
| A08575 | 10 | In distribution | |
| A06143 | 10 | In distribution | |
| A08567 | 10 | In distribution | |
| A05690 | 10 | In distribution | |
| A00173 | 10 | In distribution | |
| A08061 | 10 | In distribution | |
| A06153 | 10 | In distribution | |
| A08410 | 10 | In distribution | |
| A08369 | 10 | In distribution | |
| A06083 | 10 | In distribution | |
| A08611 | 10 | In distribution | |
| A05671 | 10 | In distribution | |
| A08622 | 10 | In distribution | |
| A06160 | 10 | In distribution | |
| A08689 | 10 | In distribution | |
| A06103 | 10 | In distribution | |
| A01170 | 10 | In distribution | |
| A08555 | 10 | In distribution | |
| A08049 | 10 | In distribution | |
| A08360 | 10 | In distribution | |
| A04969 | 10 | In distribution | |
| A05712 | 10 | In distribution | |
| A08574 | 10 | In distribution | |
| A08081 | 10 | In distribution | |
| A05650 | 10 | In distribution | |
| A08521 | 10 | In distribution | |
| A00039 | 100 | In distribution | |
| A08572 | 10 | In distribution | |
| A01181 | 10 | In distribution | |
| A00719 | 100 | In distribution | |
| A08507 | 10 | In distribution | |
| A08635 | 10 | In distribution | |
| A08295 | 10 | In distribution | |
| A08203 | 10 | In distribution | |
| A05619 | 10 | In distribution | |
| A04853 | 10 | In distribution | |
| A08640 | 10 | In distribution | |
| A05682 | 10 | In distribution | |
| A05404 | 10 | In distribution | |
| A05507 | 10 | In distribution | |
| A05623 | 10 | In distribution | |
| A06770 | 10 | In distribution | |
| A05665 | 10 | In distribution | |
| A06102 | 10 | In distribution | |
| A00236 | 10 | In distribution | |
| A00966 | 10 | In distribution | |
| A04360 | 10 | In distribution | |
| A00954 | 10 | In distribution | |
| A08404 | 10 | In distribution | |
| A08040 | 10 | In distribution | |
| A08195 | 10 | In distribution | |
| A08569 | 10 | In distribution | |
| A06144 | 10 | In distribution | |
| A05729 | 10 | In distribution | |
| A08124 | 10 | In distribution | |
| A01197 | 10 | In distribution | |
| A06142 | 10 | In distribution | |
| A05410 | 10 | In distribution | |
| A01180 | 10 | In distribution | |
| A08066 | 10 | In distribution | |
| A05620 | 10 | In distribution | |
| A08770 | 10 | In distribution | |
| A06148 | 10 | In distribution | |
| A08840 | 10 | In distribution | |
| A08776 | 10 | In distribution | |
| A06111 | 10 | In distribution | |
| A06785 | 10 | In distribution | |
| A05612 | 10 | In distribution | |
| A08631 | 10 | In distribution | |
| A08401 | 10 | In distribution | |
| A08183 | 10 | In distribution | |
| A04991 | 10 | In distribution | |
| A08133 | 10 | In distribution | |
| A08501 | 10 | In distribution | |
| A05406 | 10 | In distribution | |
| A06742 | 10 | In distribution | |
| A06732 | 10 | In distribution | |
| A08185 | 10 | In distribution | |
| A05659 | 10 | In distribution | |
| A08032 | 10 | In distribution | |
| A08196 | 10 | In distribution | |
| A08382 | 10 | In distribution | |
| A08746 | 10 | In distribution | |
| A01133 | 10 | In distribution | |
| A08187 | 10 | In distribution | |
| A18750 | 10 | In distribution | |
| A08074 | 10 | In distribution | |
| A06781 | 10 | In distribution | |
| A08853 | 10 | In distribution | |
| A08038 | 10 | In distribution | |
| A05610 | 10 | In distribution | |
| A08566 | 10 | In distribution | |
| A08628 | 10 | In distribution | |
| A05688 | 10 | In distribution | |
| KM05112 | 20 | In distribution | |
| A08260 | 10 | In distribution | |
| A08612 | 10 | In distribution | |
| A05617 | 10 | In distribution | |
| A05616 | 10 | In distribution | |
| A04839 | 10 | In distribution | |
| A18760 | 10 | In distribution | |
| A04372 | 10 | In distribution | |
| A08402 | 10 | In distribution | |
| A08823 | 10 | In distribution | |
| A18761 | 10 | In distribution | |
| A08822 | 10 | In distribution | |
| A18752 | 10 | In distribution | |
| A04361 | 10 | In distribution | |
| A08620 | 10 | In distribution | |
| A04848 | 10 | In distribution | |
| A08035 | 10 | In distribution | |
| A01164 | 10 | In distribution | |
| A05656 | 10 | In distribution | |
| A18755 | 10 | In distribution | |
| A06107 | 10 | In distribution | |
| A08181 | 10 | In distribution | |
| A04978 | 10 | In distribution | |
| A06784 | 10 | In distribution | |
| A08050 | 10 | In distribution | |
| A05715 | 10 | In distribution | |
| A06100 | 10 | In distribution | |
| A04397 | 10 | In distribution | |
| A05735 | 10 | In distribution | |
| A08052 | 10 | In distribution | |
| A00788 | 10 | In distribution | |
| A18754 | 10 | In distribution | |
| A08020 | 10 | In distribution | |
| A08387 | 10 | In distribution | |
| A08685 | 10 | In distribution | |
| A05405 | 10 | In distribution | |
| A08509 | 10 | In distribution | |
| A05423 | 10 | In distribution |
Showing 250 of 300 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 |
| 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.