Young Specialties
022 L/R STD. DBL. Weld SZ#43.0
27manufacturers in China registered for this device type
84catalogue 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 | Young Innovations 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, Complaint-file establishment, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2024-11-04 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, manufacturing date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 722-430 | In distribution | |
| 721-320 | In distribution | |
| 722-410 | In distribution | |
| 770-726 | In distribution | |
| 717-315 | In distribution | |
| 717-440 | In distribution | |
| 718-430 | In distribution | |
| 770-829 | In distribution | |
| 770-706 | In distribution | |
| 770-731 | In distribution | |
| 721-430 | In distribution | |
| 770-629 | In distribution | |
| 721-410 | In distribution | |
| 770-828 | In distribution | |
| 770-729 | In distribution | |
| 717-415 | In distribution | |
| 770-730 | In distribution | |
| 770-708 | In distribution | |
| 717-435 | In distribution | |
| 771-705 | In distribution | |
| 771-708 | In distribution | |
| 770-707 | In distribution | |
| 722-435 | In distribution | |
| 770-207 | In distribution | |
| 721-405 | In distribution | |
| 770-206 | In distribution | |
| 722-420 | In distribution | |
| 770-305 | In distribution | |
| UL6-440 | In distribution | |
| 717-325 | In distribution | |
| 770-108 | In distribution | |
| 721-425 | In distribution | |
| 718-315 | In distribution | |
| 717-320 | In distribution | |
| 770-202 | In distribution | |
| 770-107 | In distribution | |
| 770-604 | In distribution | |
| 722-405 | In distribution | |
| 770-806 | In distribution | |
| 771-709 | In distribution | |
| 721-440 | In distribution | |
| 770-803 | In distribution | |
| UR6-006 | In distribution | |
| 770-529 | In distribution | |
| 771-703 | In distribution | |
| 722-325 | In distribution | |
| UR6-440 | In distribution | |
| 771-712 | In distribution | |
| 722-400 | In distribution | |
| 717-310 | In distribution | |
| 770-830 | In distribution | |
| 722-425 | In distribution | |
| 770-106 | In distribution | |
| 718-320 | In distribution | |
| 717-420 | In distribution | |
| UR6-008 | In distribution | |
| 721-310 | In distribution | |
| 718-435 | In distribution | |
| 718-425 | In distribution | |
| 717-330 | In distribution | |
| 771-701 | In distribution | |
| 770-831 | In distribution | |
| 770-728 | In distribution | |
| 770-807 | In distribution | |
| LR6-006 | In distribution | |
| 718-415 | In distribution | |
| 770-832 | In distribution | |
| 721-435 | In distribution | |
| 717-425 | In distribution | |
| 770-306 | In distribution | |
| 721-420 | In distribution | |
| 722-440 | In distribution | |
| 717-410 | In distribution | |
| UL6-006 | In distribution | |
| 722-415 | In distribution | |
| 718-310 | In distribution | |
| 718-440 | In distribution | |
| 721-315 | In distribution | |
| 770-732 | In distribution | |
| 771-704 | In distribution | |
| 721-400 | In distribution | |
| 721-415 | In distribution | |
| 771-702 | In distribution | |
| 717-430 | In distribution |
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.