Leone SPA
CALIBRA 1ST MOL BANDS W/G8025-02 n.LL 27
27manufacturers in China registered for this device type
2,549catalogue 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 | Leone SPA, Italy |
|---|---|
| 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 | 2020-07-14 |
| Record revised | 2021-12-08 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| E1465-02 | In distribution | |
| E1303-932 | In distribution | |
| E1475-27 | In distribution | |
| E8300-13 | In distribution | |
| E2705-27 | In distribution | |
| E8920-06 | In distribution | |
| E1600-19 | In distribution | |
| E1565-13 | In distribution | |
| E8920-27 | In distribution | |
| E5551-25 | In distribution | |
| E8971-06 | In distribution | |
| E8530-01 | In distribution | |
| E5551-02 | In distribution | |
| E1460-31 | In distribution | |
| E1560-02 | In distribution | |
| E2205-16 | In distribution | |
| E8860-23 | In distribution | |
| E8961-07 | In distribution | |
| E9300-37 | In distribution | |
| E6500-02 | In distribution | |
| E8303-903 | In distribution | |
| E2300-01 | In distribution | |
| E1570-19 | In distribution | |
| E1600-34 | In distribution | |
| E2705-01 | In distribution | |
| E1703-907 | In distribution | |
| E8205-31 | In distribution | |
| E1425-16 | In distribution | |
| E5105-11 | In distribution | |
| E2605-09 | In distribution | |
| E8200-06 | In distribution | |
| E8830-25 | In distribution | |
| E8920-12 | In distribution | |
| E2705-21 | In distribution | |
| E1560-35 | In distribution | |
| E2300-17 | In distribution | |
| E1475-01 | In distribution | |
| E2205-09 | In distribution | |
| E8700-26 | In distribution | |
| E1535-09 | In distribution | |
| E1205-07 | In distribution | |
| E8200-10 | In distribution | |
| E8830-29 | In distribution | |
| E1465-19 | In distribution | |
| E1560-28 | In distribution | |
| E2605-01 | In distribution | |
| E8605-02 | In distribution | |
| E8830-17 | In distribution | |
| E1425-22 | In distribution | |
| E1520-31 | In distribution | |
| E2200-19 | In distribution | |
| E8703-908 | In distribution | |
| E1203-926 | In distribution | |
| E1600-04 | In distribution | |
| E1570-31 | In distribution | |
| E2305-32 | In distribution | |
| E2700-24 | In distribution | |
| E8700-21 | In distribution | |
| E8920-20 | In distribution | |
| E1460-26 | In distribution | |
| E1305-31 | In distribution | |
| E9600-34 | In distribution | |
| E1525-19 | In distribution | |
| E8205-09 | In distribution | |
| E1305-09 | In distribution | |
| E2205-03 | In distribution | |
| E8600-25 | In distribution | |
| E1460-18 | In distribution | |
| E8600-28 | In distribution | |
| E1300-19 | In distribution | |
| E1200-35 | In distribution | |
| E5151-24 | In distribution | |
| E5505-15 | In distribution | |
| E1203-906 | In distribution | |
| E1600-32 | In distribution | |
| E9600-355 | In distribution | |
| E1200-22 | In distribution | |
| E8930-11 | In distribution | |
| E8300-16 | In distribution | |
| E1475-04 | In distribution | |
| E1575-08 | In distribution | |
| E1420-09 | In distribution | |
| E1475-35 | In distribution | |
| E1560-29 | In distribution | |
| E5505-11 | In distribution | |
| E8930-08 | In distribution | |
| E9200-37 | In distribution | |
| E8600-15 | In distribution | |
| E1530-24 | In distribution | |
| E6500-03 | In distribution | |
| E1430-11 | In distribution | |
| E1603-936 | In distribution | |
| E8971-21 | In distribution | |
| E8205-11 | In distribution | |
| E8930-15 | In distribution | |
| E1703-922 | In distribution | |
| E5551-06 | In distribution | |
| E1203-903 | In distribution | |
| E2205-15 | In distribution | |
| E1565-29 | In distribution | |
| E5151-21 | In distribution | |
| E8920-21 | In distribution | |
| E8970-08 | In distribution | |
| E9300-295 | In distribution | |
| E1300-36 | In distribution | |
| E8300-90 | In distribution | |
| E1203-912 | In distribution | |
| E5151-07 | In distribution | |
| E1535-18 | In distribution | |
| E2200-29 | In distribution | |
| E2700-12 | In distribution | |
| E5151-02 | In distribution | |
| E8303-932 | In distribution | |
| E1470-13 | In distribution | |
| E1203-928 | In distribution | |
| E5505-31 | In distribution | |
| E9300-395 | In distribution | |
| E8860-15 | In distribution | |
| E8560-12 | In distribution | |
| E2300-09 | In distribution | |
| E5151-14 | In distribution | |
| E8605-14 | In distribution | |
| E2200-18 | In distribution | |
| E9600-325 | In distribution | |
| E9600-37 | In distribution | |
| E1520-08 | In distribution | |
| E1705-06 | In distribution | |
| E8960-16 | In distribution | |
| E8705-15 | In distribution | |
| E8830-32 | In distribution | |
| E1565-14 | In distribution | |
| E2305-01 | In distribution | |
| E1705-25 | In distribution | |
| E1570-14 | In distribution | |
| E1520-16 | In distribution | |
| E1603-903 | In distribution | |
| E8600-01 | In distribution | |
| E8303-920 | In distribution | |
| E1700-25 | In distribution | |
| E2600-23 | In distribution | |
| E5551-19 | In distribution | |
| E1560-32 | In distribution | |
| E8920-08 | In distribution | |
| E8603-926 | In distribution | |
| E8205-21 | In distribution | |
| E1300-02 | In distribution | |
| E8930-13 | In distribution | |
| E8970-92 | In distribution | |
| E1520-12 | In distribution | |
| E1560-26 | In distribution | |
| E2600-32 | In distribution | |
| E8705-18 | In distribution | |
| E8930-01 | In distribution | |
| E9200-335 | In distribution | |
| E1600-21 | In distribution | |
| E8570-15 | In distribution | |
| E8830-20 | In distribution | |
| E8200-90 | In distribution | |
| E1520-92 | In distribution | |
| E1525-11 | In distribution | |
| E1520-07 | In distribution | |
| E2200-08 | In distribution | |
| E8520-05 | In distribution | |
| E8705-07 | In distribution | |
| E1200-34 | In distribution | |
| E1705-14 | In distribution | |
| E2705-20 | In distribution | |
| E8830-12 | In distribution | |
| E8870-32 | In distribution | |
| E8200-32 | In distribution | |
| E8970-25 | In distribution | |
| E1435-17 | In distribution | |
| E8830-30 | In distribution | |
| E9700-38 | In distribution | |
| E1465-04 | In distribution | |
| E8830-02 | In distribution | |
| E1603-933 | In distribution | |
| E8970-05 | In distribution | |
| E1420-11 | In distribution | |
| E5501-09 | In distribution | |
| E8205-25 | In distribution | |
| E1435-28 | In distribution | |
| E8870-29 | In distribution | |
| E1575-32 | In distribution | |
| E5100-18 | In distribution | |
| E8600-05 | In distribution | |
| E1425-34 | In distribution | |
| E1560-06 | In distribution | |
| E8971-31 | In distribution | |
| E9200-355 | In distribution | |
| E2700-03 | In distribution | |
| E1570-29 | In distribution | |
| E2705-11 | In distribution | |
| E8870-24 | In distribution | |
| E8305-29 | In distribution | |
| E1435-08 | In distribution | |
| E9200-385 | In distribution | |
| E1603-902 | In distribution | |
| E8920-23 | In distribution | |
| E8203-927 | In distribution | |
| E8930-32 | In distribution | |
| E9600-29 | In distribution | |
| E5151-31 | In distribution | |
| E2200-32 | In distribution | |
| E5551-13 | In distribution | |
| E8303-929 | In distribution | |
| E2305-19 | In distribution | |
| E2700-18 | In distribution | |
| E5105-07 | In distribution | |
| E5500-32 | In distribution | |
| E8700-03 | In distribution | |
| E1203-913 | In distribution | |
| E1570-24 | In distribution | |
| E1603-901 | In distribution | |
| E2200-22 | In distribution | |
| E8961-05 | In distribution | |
| E9300-36 | In distribution | |
| E1420-16 | In distribution | |
| E2300-12 | In distribution | |
| E1703-927 | In distribution | |
| E5151-12 | In distribution | |
| E9200-39 | In distribution | |
| E5101-09 | In distribution | |
| E1570-02 | In distribution | |
| E2700-01 | In distribution | |
| E8870-30 | In distribution | |
| E8971-23 | In distribution | |
| E8700-18 | In distribution | |
| E8860-31 | In distribution | |
| E5151-08 | In distribution | |
| E8200-24 | In distribution | |
| E8605-28 | In distribution | |
| E8305-10 | In distribution | |
| E1700-23 | In distribution | |
| E8971-30 | In distribution | |
| E1560-15 | In distribution | |
| E2205-29 | In distribution | |
| E8560-90 | In distribution | |
| E8830-04 | In distribution | |
| E1203-925 | In distribution | |
| E1700-04 | In distribution | |
| E1460-22 | In distribution | |
| E8305-11 | In distribution | |
| E2305-30 | In distribution | |
| E1700-03 | In distribution | |
| E1425-33 | In distribution | |
| E1525-04 | In distribution | |
| E2700-13 | In distribution | |
| E1603-905 | In distribution | |
| E2205-18 | 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 |
| 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 |
| 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.