Ortho Organizers
SAFARI NEON ELASTIC MEDIUM 1/8" (4.5oz)- CHIMPANZEE
36manufacturers in China registered for this device type
58catalogue numbers in this listing
Who Else Makes It
Concentrated in Zhejiang (14), Jiangsu (8), Shanghai (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 |
| Sino Ortho Limited | Hangzhou | Zhejiang | Contract manufacturer | 14 |
| Hangzhou Westlake Biomaterial Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 13 |
| Zhejiang Eksen Medical Technology Co., Ltd. | Huzhou | Zhejiang | Contract manufacturer | 9 |
| Zhejiang Risheng Medical Technology Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 8 |
| 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 |
| Wuxi Lyusmile IMP AND EXP Co., Ltd. | Wuxi | Jiangsu | Private-label distributor | 66 |
| Shanghai MU Promotions Co., Ltd. | Shanghai | Shanghai | Exporter | 62 |
| Hubei Guarddent Medical Technology Co., Ltd. | Wuhan | Hubei | Manufacturer | 60 |
| Tribest Dental Products Co Ltd | Yangzhong | Jiangsu | Contract manufacturer | 58 |
Showing 12 of 36. All 36 manufacturers in China registered for Band, Elastic, Orthodontic
Record
| Listed by | Ortho Organizers, Inc., United States |
|---|---|
| FDA product code | ECI |
| Device type | Band, Elastic, 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 6) |
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 |
| Distribution end date | 2023-06-08 |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 408-042 | In distribution | |
| 400-331 | In distribution | |
| 401-042S | In distribution | |
| 407-031S | In distribution | |
| 407-032S | In distribution | |
| 400-326 | In distribution | |
| 400-033 | In distribution | |
| 400-353 | In distribution | |
| 400-329 | In distribution | |
| 400-032 | In distribution | |
| 408-052 | In distribution | |
| 408-050 | In distribution | |
| 408-051 | In distribution | |
| 408-041 | In distribution | |
| 408-043 | In distribution | |
| 401-045S | In distribution | |
| 408-074 | In distribution | |
| 401-043S | In distribution | |
| 408-061 | In distribution | |
| 408-020 | In distribution | |
| 408-060 | In distribution | |
| 407-021S | In distribution | |
| 407-040S | In distribution | |
| 400-330 | In distribution | |
| 408-032 | In distribution | |
| 407-022S | In distribution | |
| 407-042S | In distribution | |
| 400-028 | In distribution | |
| 408-062 | In distribution | |
| 407-020S | In distribution | |
| 408-073 | In distribution | |
| 408-031 | In distribution | |
| 400-034 | In distribution | |
| 407-052S | In distribution | |
| 400-035 | In distribution | |
| 400-328 | In distribution | |
| 400-029 | In distribution | |
| 401-041S | In distribution | |
| 408-030 | In distribution | |
| 407-051S | In distribution | |
| 407-061S | In distribution | |
| 407-041S | In distribution | |
| 407-030S | In distribution | |
| 408-040 | In distribution | |
| 408-022 | In distribution | |
| 407-050S | In distribution | |
| 400-327 | In distribution | |
| 407-060S | In distribution | |
| 408-021 | In distribution | |
| 400-352 | In distribution | |
| 401-044S | In distribution | |
| 407-062S | In distribution | |
| 400-120 | Withdrawn | |
| 400-110 | Withdrawn | |
| 400-121 | Withdrawn | |
| 400-301 | Withdrawn | |
| 400-111 | Withdrawn | |
| 400-300 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Auradonics | Auradonics Incorporated | 743 |
| Advance Dental Products | THE Atlanta Dental Supply Company | 312 |
| Conlin Molar Band | Ortho Arch Company Inc | 308 |
| Elastic Chain | Ortho Organizers, Inc. | 248 |
| Ligatures | American Orthodontics | 233 |
| 3M™ AlastiK™ | 3M Unitek | 220 |
| Morelli | Dental Morelli Ltda. | 207 |
| Mirabay | Mirabay Orthodontics Corporation | 185 |
| Orthometric Elastomerics – Chain | Orthometric – Industria E Comercio DE Produtos Medicos E Odontologicos Ltda | 182 |
| Maximum | Ortho Technology, Inc. | 177 |
| Halo Molar Band | Ortho Arch Company Inc | 177 |
| Colored Chain | American Orthodontics | 168 |
Showing 12 of 474. All products under Band, Elastic, 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.