Elite
Elite ASM 022/045 MC UR6 CONV TBT -14T 0A 10DOff CLT 40.5
27manufacturers in China registered for this device type
722catalogue 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 | Ortho Organizers, Inc., United States |
|---|---|
| FDA product code | ECM |
| Device type | Band, Preformed, Orthodontic |
| Device class | Class 1 |
| Regulation | 21 CFR 872.5410 |
| Establishment | Specification developer, Repacker / relabeller, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2017-09-08 |
| Record revised | 2025-12-30 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, manufacturing date |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 900-0168-315-3 | In distribution | |
| 900-12281-370-3 | In distribution | |
| 900-02281-430-3 | In distribution | |
| 900-1218-310-3 | In distribution | |
| 900-0228-370-3 | In distribution | |
| 900-16581-405-3 | In distribution | |
| 900-1668-380-3 | In distribution | |
| 900-11681-340-3 | In distribution | |
| 900-0158-325-3 | In distribution | |
| 900-17281-320-3 | In distribution | |
| 900-1228-340-3 | In distribution | |
| 900-12181-325-3 | In distribution | |
| 900-1658-305-3 | In distribution | |
| 900-0218-415-3 | In distribution | |
| 900-01681-400-3 | In distribution | |
| 900-0158-330-3 | In distribution | |
| 900-0218-320-3 | In distribution | |
| 900-0218-315-3 | In distribution | |
| 900-1158-440-3 | In distribution | |
| 900-02181-330-3 | In distribution | |
| 900-1228-350-3 | In distribution | |
| 900-1668-335-3 | In distribution | |
| 900-0218-420-3 | In distribution | |
| 900-02281-415-3 | In distribution | |
| 900-0228-415-3 | In distribution | |
| 900-1228-300-3 | In distribution | |
| 900-11681-325-3 | In distribution | |
| 900-12181-355-3 | In distribution | |
| 900-0158-295-3 | In distribution | |
| 900-02281-400-3 | In distribution | |
| 900-0168-420-3 | In distribution | |
| 900-16681-345-3 | In distribution | |
| 900-17181-335-3 | In distribution | |
| 900-1728-315-3 | In distribution | |
| 900-1668-355-3 | In distribution | |
| 900-12281-420-3 | In distribution | |
| 900-01581-425-3 | In distribution | |
| 900-17181-360-3 | In distribution | |
| 900-17281-430-3 | In distribution | |
| 900-11681-365-3 | In distribution | |
| 900-1168-350-3 | In distribution | |
| 900-0168-360-3 | In distribution | |
| 900-1658-350-3 | In distribution | |
| 900-12181-345-3 | In distribution | |
| 900-1158-295-3 | In distribution | |
| 900-02281-375-3 | In distribution | |
| 900-0228-425-3 | In distribution | |
| 900-01581-420-3 | In distribution | |
| 900-0158-310-3 | In distribution | |
| 900-0218-300-3 | In distribution | |
| 900-0228-380-3 | In distribution | |
| 900-01581-375-3 | In distribution | |
| 900-1658-355-3 | In distribution | |
| 900-1168-305-3 | In distribution | |
| 900-1668-430-3 | In distribution | |
| 900-02281-340-3 | In distribution | |
| 900-1158-315-3 | In distribution | |
| 900-1718-410-3 | In distribution | |
| 900-01581-320-3 | In distribution | |
| 900-0228-360-3 | In distribution | |
| 900-01581-355-3 | In distribution | |
| 900-17181-310-3 | In distribution | |
| 900-16581-355-3 | In distribution | |
| 900-1668-365-3 | In distribution | |
| 900-110066E-3CW | In distribution | |
| 900-1158-395-3 | In distribution | |
| 900-0228-395-3 | In distribution | |
| 900-0168-400-3 | In distribution | |
| 900-1668-390-3 | In distribution | |
| 900-02181-340-3 | In distribution | |
| 900-12181-405-3 | In distribution | |
| 900-01681-435-3 | In distribution | |
| 900-1228-410-3 | In distribution | |
| 900-17281-395-3 | In distribution | |
| 900-1228-380-3 | In distribution | |
| 900-02281-300-3 | In distribution | |
| 900-17181-350-3 | In distribution | |
| 900-17281-295-3 | In distribution | |
| 900-17181-415-3 | In distribution | |
| 900-01681-355-3 | In distribution | |
| 900-11681-315-3 | In distribution | |
| 900-1158-375-3 | In distribution | |
| 900-1228-425-3 | In distribution | |
| 900-02281-425-3 | In distribution | |
| 900-16581-330-3 | In distribution | |
| 900-1158-350-3 | In distribution | |
| 900-17181-435-3 | In distribution | |
| 900-12181-315-3 | In distribution | |
| 900-1658-430-3 | In distribution | |
| 900-17281-315-3 | In distribution | |
| 900-0228-310-3 | In distribution | |
| 900-01681-335-3 | In distribution | |
| 900-02181-305-3 | In distribution | |
| 900-1158-300-3 | In distribution | |
| 900-02281-395-3 | In distribution | |
| 900-01681-430-3 | In distribution | |
| 900-1718-370-3 | In distribution | |
| 900-1228-355-3 | In distribution | |
| 900-17181-375-3 | In distribution | |
| 900-0168-435-3 | In distribution | |
| 900-16681-425-3 | In distribution | |
| 900-17181-420-3 | In distribution | |
| 900-16681-400-3 | In distribution | |
| 900-1728-370-3 | In distribution | |
| 900-1228-335-3 | In distribution | |
| 900-16681-420-3 | In distribution | |
| 900-1168-440-3 | In distribution | |
| 900-1228-315-3 | In distribution | |
| 900-12181-340-3 | In distribution | |
| 900-11681-425-3 | In distribution | |
| 900-02181-430-3 | In distribution | |
| 900-01581-310-3 | In distribution | |
| 900-0168-320-3 | In distribution | |
| 900-1718-330-3 | In distribution | |
| 900-16581-320-3 | In distribution | |
| 900-02181-345-3 | In distribution | |
| 900-17281-345-3 | In distribution | |
| 900-1718-350-3 | In distribution | |
| 900-1218-305-3 | In distribution | |
| 900-02281-410-3 | In distribution | |
| 900-1218-420-3 | In distribution | |
| 900-1168-360-3 | In distribution | |
| 900-11581-360-3 | In distribution | |
| 900-12181-400-3 | In distribution | |
| 900-1728-440-3 | In distribution | |
| 900-01581-340-3 | In distribution | |
| 900-1168-295-3 | In distribution | |
| 900-1218-390-3 | In distribution | |
| 900-12181-385-3 | In distribution | |
| 900-01681-380-3 | In distribution | |
| 900-0158-395-3 | In distribution | |
| 900-0228-340-3 | In distribution | |
| 900-1168-330-3 | In distribution | |
| 900-0168-340-3 | In distribution | |
| 900-0228-330-3 | In distribution | |
| 900-1668-310-3 | In distribution | |
| 900-16681-370-3 | In distribution | |
| 900-0168-370-3 | In distribution | |
| 900-1728-360-3 | In distribution | |
| 900-17281-300-3 | In distribution | |
| 900-12281-340-3 | In distribution | |
| 900-02181-350-3 | In distribution | |
| 900-1218-415-3 | In distribution | |
| 900-02281-335-3 | In distribution | |
| 900-16581-400-3 | In distribution | |
| 900-1228-370-3 | In distribution | |
| 900-16581-315-3 | In distribution | |
| 900-17181-355-3 | In distribution | |
| 900-02181-400-3 | In distribution | |
| 900-0218-370-3 | In distribution | |
| 900-02181-390-3 | In distribution | |
| 900-11681-370-3 | In distribution | |
| 900-0218-325-3 | In distribution | |
| 900-17281-370-3 | In distribution | |
| 900-17281-375-3 | In distribution | |
| 900-1728-340-3 | In distribution | |
| 900-1658-370-3 | In distribution | |
| 900-0168-310-3 | In distribution | |
| 900-0218-390-3 | In distribution | |
| 900-11581-410-3 | In distribution | |
| 900-1668-435-3 | In distribution | |
| 900-0158-350-3 | In distribution | |
| 900-16681-405-3 | In distribution | |
| 900-0158-390-3 | In distribution | |
| 900-11581-295-3 | In distribution | |
| 900-1218-435-3 | In distribution | |
| 900-0228-315-3 | In distribution | |
| 900-11581-310-3 | In distribution | |
| 900-12181-300-3 | In distribution | |
| 900-16681-305-3 | In distribution | |
| 900-0168-430-3 | In distribution | |
| 900-0168-425-3 | In distribution | |
| 900-17281-340-3 | In distribution | |
| 900-16681-295-3 | In distribution | |
| 900-17181-395-3 | In distribution | |
| 900-1168-415-3 | In distribution | |
| 900-1218-340-3 | In distribution | |
| 900-11681-360-3 | In distribution | |
| 900-1718-310-3 | In distribution | |
| 900-0168-390-3 | In distribution | |
| 900-02181-375-3 | In distribution | |
| 900-02181-435-3 | In distribution | |
| 900-1668-325-3 | In distribution | |
| 900-1718-320-3 | In distribution | |
| 900-1168-340-3 | In distribution | |
| 900-1728-310-3 | In distribution | |
| 900-16581-305-3 | In distribution | |
| 900-12281-410-3 | In distribution | |
| 900-1668-340-3 | In distribution | |
| 900-16581-340-3 | In distribution | |
| 900-02181-320-3 | In distribution | |
| 900-12281-295-3 | In distribution | |
| 900-1658-380-3 | In distribution | |
| 900-1168-435-3 | In distribution | |
| 900-1168-325-3 | In distribution | |
| 900-1718-355-3 | In distribution | |
| 900-0218-355-3 | In distribution | |
| 900-12281-310-3 | In distribution | |
| 900-16581-440-3 | In distribution | |
| 900-16681-435-3 | In distribution | |
| 900-0168-300-3 | In distribution | |
| 900-1218-405-3 | In distribution | |
| 900-02281-435-3 | In distribution | |
| 900-01581-295-3 | In distribution | |
| 900-01681-300-3 | In distribution | |
| 900-11681-295-3 | In distribution | |
| 900-1228-375-3 | In distribution | |
| 900-1668-360-3 | In distribution | |
| 900-1658-335-3 | In distribution | |
| 900-1228-360-3 | In distribution | |
| 900-11581-355-3 | In distribution | |
| 900-17181-325-3 | In distribution | |
| 900-02181-370-3 | In distribution | |
| 900-11581-350-3 | In distribution | |
| 900-1658-405-3 | In distribution | |
| 900-1228-405-3 | In distribution | |
| 900-0158-440-3 | In distribution | |
| 900-0168-395-3 | In distribution | |
| 900-0158-340-3 | In distribution | |
| 900-0168-335-3 | In distribution | |
| 900-0228-365-3 | In distribution | |
| 900-1718-420-3 | In distribution | |
| 900-12281-305-3 | In distribution | |
| 900-12281-325-3 | In distribution | |
| 900-1728-380-3 | In distribution | |
| 900-16581-375-3 | In distribution | |
| 900-12281-365-3 | In distribution | |
| 900-1218-375-3 | In distribution | |
| 900-1728-365-3 | In distribution | |
| 900-12281-345-3 | In distribution | |
| 900-17181-305-3 | In distribution | |
| 900-01681-395-3 | In distribution | |
| 900-02281-295-3 | In distribution | |
| 900-1218-325-3 | In distribution | |
| 900-16581-310-3 | In distribution | |
| 900-02281-405-3 | In distribution | |
| 900-1658-440-3 | In distribution | |
| 900-0158-430-3 | In distribution | |
| 900-12281-430-3 | In distribution | |
| 900-1718-375-3 | In distribution | |
| 900-11581-435-3 | In distribution | |
| 900-1718-335-3 | In distribution | |
| 900-01581-405-3 | In distribution | |
| 900-1158-430-3 | In distribution | |
| 900-1168-425-3 | In distribution | |
| 900-0228-430-3 | In distribution | |
| 900-01681-420-3 | In distribution | |
| 900-1718-300-3 | In distribution | |
| 900-01681-350-3 | In distribution | |
| 900-17181-405-3 | 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 |
| Rollo Bands | American Orthodontics | 660 |
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.