Truform
MX 1 MOL BD KT UNI/STD N/L 153
27manufacturers in China registered for this device type
411catalogue numbers in this listing
Who Else Makes It
Concentrated in Zhejiang (17), Jiangsu (4), Guangdong (4). 6 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 |
| Hangzhou Westlake Biomaterial Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 13 |
| Zhejiang Eksen Medical Technology Co., Ltd. | Huzhou | Zhejiang | Contract manufacturer | 9 |
| Hangzhou Xingchen 3B Dental Instrument & Materials Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 7 |
| Yancheng Denrum Medical Apparatus Co., Ltd. | Yancheng | Jiangsu | Contract manufacturer | 5 |
| Debo Medical Technology (Shijiazhuang) Co., Ltd. | Shijiazhuang | Hebei | Contract manufacturer | 117 |
| Zogear Medical Co., Ltd. | Yizheng | Jiangsu | Contract manufacturer | 75 |
| Zhejiang Yamei Medical Equipment Technology Co., Ltd. | Yang Jiao Lang Zin’An Town | Zhejiang | Manufacturer | 39 |
| Hangzhou Wise Medical Device Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 25 |
| Guangzhou OO Medical Scientific Limited | Guangzhou | Guangdong | Manufacturer | 17 |
| Orthguide Medical Technology (Jiangsu) Co., Ltd. | Wuxi | Jiangsu | Contract manufacturer | 17 |
Showing 12 of 27. All 27 manufacturers in China registered for Band, Preformed, Orthodontic
Record
| Listed by | RMO, United States |
|---|---|
| FDA product code | ECM |
| Device type | Band, Preformed, Orthodontic |
| Device class | Class 1 |
| Regulation | 21 CFR 872.5410 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2024-09-02 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Prescription | Prescription only |
| Latex | Contains natural rubber latex |
| Label carries | lot or batch number, expiry date, manufacturing date |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| L00820 | 5 | In distribution | |
| L00649 | 5 | In distribution | |
| B00712 | 5 | In distribution | |
| L00684 | 5 | In distribution | |
| L00665 | 5 | In distribution | |
| B00727 | 5 | In distribution | |
| B00626 | 5 | In distribution | |
| K00510 | 153 | In distribution | |
| B00552 | 5 | In distribution | |
| R00679 | 5 | In distribution | |
| K00149 | 100 | In distribution | |
| L00689 | 5 | In distribution | |
| L00664 | 5 | In distribution | |
| L00636 | 5 | In distribution | |
| B00624 | 5 | In distribution | |
| R00712 | 5 | In distribution | |
| B00716 | 5 | In distribution | |
| R00647 | 5 | In distribution | |
| L00686 | 5 | In distribution | |
| R00603 | 5 | In distribution | |
| B00926 | 5 | In distribution | |
| R00711 | 5 | In distribution | |
| B00278 | 5 | In distribution | |
| K00556 | 176 | In distribution | |
| L00667 | 5 | In distribution | |
| L00595 | 5 | In distribution | |
| B00649 | 5 | In distribution | |
| L00644 | 5 | In distribution | |
| B00633 | 5 | In distribution | |
| L00714 | 5 | In distribution | |
| R00822 | 5 | In distribution | |
| L00674 | 5 | In distribution | |
| B00761 | 5 | In distribution | |
| R00674 | 5 | In distribution | |
| K00054 | 87 | In distribution | |
| B00650 | 5 | In distribution | |
| B00600 | 5 | In distribution | |
| R00716 | 5 | In distribution | |
| R00634 | 5 | In distribution | |
| B00625 | 5 | In distribution | |
| K00050 | 107 | In distribution | |
| B00715 | 5 | In distribution | |
| B00602 | 5 | In distribution | |
| B00606 | 5 | In distribution | |
| B00754 | 5 | In distribution | |
| R00642 | 5 | In distribution | |
| K00051 | 109 | In distribution | |
| B00612 | 5 | In distribution | |
| R00717 | 5 | In distribution | |
| R00682 | 5 | In distribution | |
| L00634 | 5 | In distribution | |
| R00644 | 5 | In distribution | |
| B00279 | 5 | In distribution | |
| L00685 | 5 | In distribution | |
| R00667 | 5 | In distribution | |
| K00159 | 100 | In distribution | |
| L00825 | 5 | In distribution | |
| B00648 | 5 | In distribution | |
| K00560 | 176 | In distribution | |
| L00633 | 5 | In distribution | |
| L00608 | 5 | In distribution | |
| B00749 | 5 | In distribution | |
| R00680 | 5 | In distribution | |
| B00711 | 5 | In distribution | |
| L00615 | 5 | In distribution | |
| R00825 | 5 | In distribution | |
| L00646 | 5 | In distribution | |
| R00826 | 5 | In distribution | |
| B00720 | 5 | In distribution | |
| K00334 | 176 | In distribution | |
| B00724 | 5 | In distribution | |
| B00277 | 10 | In distribution | |
| R00817 | 5 | In distribution | |
| R00827 | 5 | In distribution | |
| L00621 | 5 | In distribution | |
| B00632 | 5 | In distribution | |
| L00630 | 5 | In distribution | |
| L00808 | 5 | In distribution | |
| R00684 | 5 | In distribution | |
| B00777 | 5 | In distribution | |
| L00599 | 5 | In distribution | |
| B00638 | 5 | In distribution | |
| L00716 | 5 | In distribution | |
| B00639 | 5 | In distribution | |
| R00823 | 5 | In distribution | |
| R00689 | 5 | In distribution | |
| L00717 | 5 | In distribution | |
| B00643 | 5 | In distribution | |
| B00618 | 5 | In distribution | |
| R00601 | 5 | In distribution | |
| B00714 | 5 | In distribution | |
| R00656 | 5 | In distribution | |
| B00767 | 5 | In distribution | |
| R00608 | 5 | In distribution | |
| R00595 | 5 | In distribution | |
| R00651 | 5 | In distribution | |
| L00671 | 5 | In distribution | |
| R00831 | 5 | In distribution | |
| R00637 | 5 | In distribution | |
| R00830 | 5 | In distribution | |
| L00606 | 5 | In distribution | |
| L00821 | 5 | In distribution | |
| R00612 | 5 | In distribution | |
| L00683 | 5 | In distribution | |
| K00558 | 218 | In distribution | |
| B00603 | 5 | In distribution | |
| R00654 | 5 | In distribution | |
| R00665 | 5 | In distribution | |
| L00632 | 5 | In distribution | |
| L00600 | 5 | In distribution | |
| R00625 | 5 | In distribution | |
| R00683 | 5 | In distribution | |
| B00645 | 5 | In distribution | |
| L00593 | 5 | In distribution | |
| B00631 | 5 | In distribution | |
| R00821 | 5 | In distribution | |
| L00829 | 5 | In distribution | |
| B00617 | 5 | In distribution | |
| B00655 | 5 | In distribution | |
| R00676 | 5 | In distribution | |
| R00828 | 5 | In distribution | |
| B00598 | 5 | In distribution | |
| B00758 | 5 | In distribution | |
| R00618 | 5 | In distribution | |
| L00596 | 5 | In distribution | |
| L00622 | 5 | In distribution | |
| L00679 | 5 | In distribution | |
| L00645 | 5 | In distribution | |
| R00807 | 5 | In distribution | |
| R00636 | 5 | In distribution | |
| B00713 | 5 | In distribution | |
| R00627 | 5 | In distribution | |
| L00819 | 5 | In distribution | |
| R00593 | 5 | In distribution | |
| R00605 | 5 | In distribution | |
| R00812 | 5 | In distribution | |
| R00620 | 5 | In distribution | |
| R00824 | 5 | In distribution | |
| B00723 | 5 | In distribution | |
| L00597 | 5 | In distribution | |
| R00604 | 5 | In distribution | |
| B00644 | 5 | In distribution | |
| B00282 | 5 | In distribution | |
| B00729 | 5 | In distribution | |
| L00620 | 5 | In distribution | |
| K00522 | 180 | In distribution | |
| R00655 | 5 | In distribution | |
| B00554 | 5 | In distribution | |
| B00596 | 5 | In distribution | |
| K00514 | 194 | In distribution | |
| B00609 | 5 | In distribution | |
| B00608 | 5 | In distribution | |
| R00600 | 5 | In distribution | |
| B00635 | 5 | In distribution | |
| R00820 | 5 | In distribution | |
| R00675 | 5 | In distribution | |
| R00649 | 5 | In distribution | |
| L00601 | 5 | In distribution | |
| L00629 | 5 | In distribution | |
| R00643 | 5 | In distribution | |
| R00650 | 5 | In distribution | |
| B00752 | 5 | In distribution | |
| L00594 | 5 | In distribution | |
| L00710 | 5 | In distribution | |
| L00642 | 5 | In distribution | |
| K00329 | 131 | In distribution | |
| B00750 | 5 | In distribution | |
| K00144 | 100 | In distribution | |
| R00809 | 5 | In distribution | |
| B00721 | 5 | In distribution | |
| L00607 | 5 | In distribution | |
| B00746 | 5 | In distribution | |
| L00816 | 5 | In distribution | |
| L00828 | 5 | In distribution | |
| R00639 | 5 | In distribution | |
| R00617 | 5 | In distribution | |
| L00807 | 5 | In distribution | |
| R00677 | 5 | In distribution | |
| B00771 | 5 | In distribution | |
| B00753 | 5 | In distribution | |
| L00711 | 5 | In distribution | |
| K00145 | 100 | In distribution | |
| B00604 | 5 | In distribution | |
| R00626 | 5 | In distribution | |
| L00655 | 5 | In distribution | |
| L00672 | 5 | In distribution | |
| B00620 | 5 | In distribution | |
| B00281 | 5 | In distribution | |
| L00670 | 5 | In distribution | |
| B00717 | 5 | In distribution | |
| B00627 | 5 | In distribution | |
| B00652 | 5 | In distribution | |
| B00759 | 5 | In distribution | |
| L00680 | 5 | In distribution | |
| R00641 | 5 | In distribution | |
| B00319 | 5 | In distribution | |
| R00818 | 5 | In distribution | |
| R00633 | 5 | In distribution | |
| K00512 | 214 | In distribution | |
| B00628 | 5 | In distribution | |
| R00714 | 5 | In distribution | |
| B00726 | 5 | In distribution | |
| L00830 | 5 | In distribution | |
| K00146 | 100 | In distribution | |
| L00613 | 5 | In distribution | |
| L00817 | 5 | In distribution | |
| L00625 | 5 | In distribution | |
| R00811 | 5 | In distribution | |
| L00678 | 5 | In distribution | |
| B00546 | 5 | In distribution | |
| R00810 | 5 | In distribution | |
| L00614 | 5 | In distribution | |
| B00656 | 5 | In distribution | |
| B00748 | 5 | In distribution | |
| L00624 | 5 | In distribution | |
| B00762 | 5 | In distribution | |
| B00610 | 5 | In distribution | |
| B00651 | 5 | In distribution | |
| B00622 | 5 | In distribution | |
| K00158 | 100 | In distribution | |
| L00826 | 5 | In distribution | |
| R00687 | 5 | In distribution | |
| R00806 | 5 | In distribution | |
| L00612 | 5 | In distribution | |
| L00602 | 5 | In distribution | |
| L00668 | 5 | In distribution | |
| L00648 | 5 | In distribution | |
| B00629 | 5 | In distribution | |
| B00597 | 5 | In distribution | |
| R00715 | 5 | In distribution | |
| K00516 | 180 | In distribution | |
| L00675 | 5 | In distribution | |
| L00822 | 5 | In distribution | |
| R00673 | 5 | In distribution | |
| L00641 | 5 | In distribution | |
| R00640 | 5 | In distribution | |
| K00052 | 92 | In distribution | |
| B00636 | 5 | In distribution | |
| B00605 | 5 | In distribution | |
| B00765 | 5 | In distribution | |
| B00280 | 5 | In distribution | |
| L00628 | 5 | In distribution | |
| R00669 | 5 | In distribution | |
| B00770 | 5 | In distribution | |
| B00593 | 5 | In distribution | |
| R00624 | 5 | In distribution | |
| L00712 | 5 | In distribution | |
| R00609 | 5 | In distribution | |
| R00615 | 5 | In distribution | |
| L00827 | 5 | In distribution |
Showing 250 of 300 catalogue numbers.
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Band, Preformed, Orthodontic | Forestadent Bernhard Förster GmbH | 8,646 |
| TruFit 2.0 | Ortho Technology, Inc. | 4,890 |
| TruFit™ | Ortho Organizers, Inc. | 3,943 |
| Leone SPA | Leone SPA | 2,549 |
| dentaform® | Dentaurum GmbH & Co. KG | 1,763 |
| Band Assemblies | Ortho Organizers, Inc. | 1,642 |
| 3M™ Victory Series™ | 3M Unitek | 1,388 |
| The Orthodontic Store | Young Innovations Inc. | 925 |
| Elite® Band Assemblies | Ortho Organizers, Inc. | 924 |
| TruFit™ 2.0 | Ortho Organizers, Inc. | 916 |
| 3M™ Unitek™ | 3M Unitek | 771 |
| Elite | Ortho Organizers, Inc. | 722 |
Showing 12 of 154. All products under Band, Preformed, 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.