Proclinic
Barra Ligaduras ELAST.120 Fosf Brill
36manufacturers in China registered for this device type
49catalogue numbers in this listing
2recalls on this code
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 | G & H Wire Company, United States |
|---|---|
| FDA product code | ECI |
| Device type | Band, Elastic, Orthodontic |
| Device class | Class 1 |
| Regulation | 21 CFR 872.5410 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2025-03-26 |
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 |
| Packaging | Pack of 50 |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| L8170 | In distribution | ||
| L8164 | 46 | In distribution | |
| L8179 | In distribution | ||
| L8147 | 46 | In distribution | |
| L8180 | 100 | In distribution | |
| L8174 | In distribution | ||
| L8152 | 46 | In distribution | |
| L8165 | In distribution | ||
| L8173 | In distribution | ||
| L8169 | In distribution | ||
| L8182 | 100 | In distribution | |
| L8181 | 100 | In distribution | |
| L8158 | 46 | In distribution | |
| L8156 | 46 | In distribution | |
| L8191 | 100 | In distribution | |
| L8167 | In distribution | ||
| L8160 | 46 | In distribution | |
| L8187 | 100 | In distribution | |
| L8193 | 100 | In distribution | |
| L8150 | 46 | In distribution | |
| L8151 | 46 | In distribution | |
| L8185 | 100 | In distribution | |
| L8172 | In distribution | ||
| L8176 | In distribution | ||
| L8159 | 46 | In distribution | |
| L8192 | 100 | In distribution | |
| L8153 | 46 | In distribution | |
| L8155 | 46 | In distribution | |
| L8194 | 100 | In distribution | |
| L8186 | 100 | In distribution | |
| L8168 | In distribution | ||
| L8188 | 100 | In distribution | |
| L8177 | In distribution | ||
| L8162 | 46 | In distribution | |
| L8157 | 46 | In distribution | |
| L8190 | 100 | In distribution | |
| L8171 | In distribution | ||
| L8189 | 100 | In distribution | |
| L8175 | In distribution | ||
| L8148 | 46 | In distribution | |
| L8154 | 46 | In distribution | |
| L8178 | In distribution | ||
| L8163 | 46 | In distribution | |
| L8166 | In distribution | ||
| L8184 | 100 | In distribution | |
| L8183 | 100 | In distribution | |
| L8161 | 46 | In distribution | |
| L8146 | 46 | In distribution | |
| L8149 | 46 | In distribution |
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
Recalls
2 of these are Class II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2023-12-21 | Class II | Packaging process control | Latex elastic bands were labeled as non-latex elastic bands, an allergic rx can occur due to patient latex allergy | 81 pk (100/pk) | |
| 2021-01-21 | Class II | Process control | The text on the patient pack is correct and the product itself remains unchanged. FlexMedics does not expect device failures; Instead, there is an opportunity for misuse of the device if the label is not read. If the band is too small, the | 371 pks of 100 elastics (Domestic 127 pks, Foreign 244 pks) | 2021-09-20 |
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.