Aditek
Molar Band UR 38,5 w/10
36manufacturers in China registered for this device type
132catalogue 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 | Aditek DO Brasil S/A |
|---|---|
| FDA product code | ECI |
| Device type | Band, Elastic, Orthodontic |
| Device class | Class 1 |
| Regulation | 21 CFR 872.5410 |
| Premarket notification | Exempt |
| Record published | 2023-09-04 |
| Record revised | 2024-05-16 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Distribution end date | 2023-09-04 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 04.01.2440 | In distribution | |
| 04.01.4390 | In distribution | |
| 04.01.1350 | In distribution | |
| 04.01.1385 | In distribution | |
| 04.01.3365 | In distribution | |
| 04.01.4340 | In distribution | |
| 04.01.4415 | In distribution | |
| 04.01.3415 | In distribution | |
| 04.01.3380 | In distribution | |
| 04.01.4325 | In distribution | |
| 04.01.1340 | In distribution | |
| 04.01.4410 | In distribution | |
| 04.01.4335 | In distribution | |
| 04.01.1395 | In distribution | |
| 04.01.2365 | In distribution | |
| 04.01.3405 | In distribution | |
| 04.01.1285 | In distribution | |
| 04.01.2405 | In distribution | |
| 04.01.3375 | In distribution | |
| 04.01.4375 | In distribution | |
| 04.01.3430 | In distribution | |
| 04.01.1425 | In distribution | |
| 04.01.2340 | In distribution | |
| 04.01.1345 | In distribution | |
| 04.01.4420 | In distribution | |
| 04.01.4425 | In distribution | |
| 04.01.1430 | In distribution | |
| 04.01.4310 | In distribution | |
| 04.01.2420 | In distribution | |
| 04.01.3320 | In distribution | |
| 04.01.2330 | In distribution | |
| 04.01.1335 | In distribution | |
| 04.01.3280 | In distribution | |
| 04.01.4350 | In distribution | |
| 04.01.2355 | In distribution | |
| 04.01.3440 | In distribution | |
| 04.01.2285 | In distribution | |
| 04.01.1320 | In distribution | |
| 04.01.4440 | In distribution | |
| 04.01.3385 | In distribution | |
| 04.01.1440 | In distribution | |
| 04.01.1415 | In distribution | |
| 04.01.3310 | In distribution | |
| 04.01.1370 | In distribution | |
| 04.01.2430 | In distribution | |
| 04.01.2295 | In distribution | |
| 04.01.2320 | In distribution | |
| 04.01.3400 | In distribution | |
| 04.01.3290 | In distribution | |
| 04.01.3340 | In distribution | |
| 04.01.4315 | In distribution | |
| 04.01.4385 | In distribution | |
| 04.01.3315 | In distribution | |
| 04.01.4300 | In distribution | |
| 04.01.2360 | In distribution | |
| 04.01.1310 | In distribution | |
| 04.01.4320 | In distribution | |
| 04.01.2380 | In distribution | |
| 04.01.1295 | In distribution | |
| 04.01.1280 | In distribution | |
| 04.01.4345 | In distribution | |
| 04.01.2415 | In distribution | |
| 04.01.3330 | In distribution | |
| 04.01.4360 | In distribution | |
| 04.01.3355 | In distribution | |
| 04.01.2315 | In distribution | |
| 04.01.3420 | In distribution | |
| 04.01.1360 | In distribution | |
| 04.01.3345 | In distribution | |
| 04.01.3425 | In distribution | |
| 04.01.2435 | In distribution | |
| 04.01.3285 | In distribution | |
| 04.01.3295 | In distribution | |
| 04.01.4280 | In distribution | |
| 04.01.3360 | In distribution | |
| 04.01.2280 | In distribution | |
| 04.01.4365 | In distribution | |
| 04.01.4295 | In distribution | |
| 04.01.2345 | In distribution | |
| 04.01.4435 | In distribution | |
| 04.01.1375 | In distribution | |
| 04.01.1420 | In distribution | |
| 04.01.4430 | In distribution | |
| 04.01.1330 | In distribution | |
| 04.01.2325 | In distribution | |
| 04.01.2395 | In distribution | |
| 04.01.2290 | In distribution | |
| 04.01.1365 | In distribution | |
| 04.01.2425 | In distribution | |
| 04.01.2305 | In distribution | |
| 04.01.2335 | In distribution | |
| 04.01.1290 | In distribution | |
| 04.01.2300 | In distribution | |
| 04.01.1390 | In distribution | |
| 04.01.3325 | In distribution | |
| 04.01.4380 | In distribution | |
| 04.01.1435 | In distribution | |
| 04.01.2370 | In distribution | |
| 04.01.2400 | In distribution | |
| 04.01.3335 | In distribution | |
| 04.01.3300 | In distribution | |
| 04.01.4305 | In distribution | |
| 04.01.1325 | In distribution | |
| 04.01.1300 | In distribution | |
| 04.01.2385 | In distribution | |
| 04.01.4330 | In distribution | |
| 04.01.3305 | In distribution | |
| 04.01.4400 | In distribution | |
| 04.01.3435 | In distribution | |
| 04.01.2375 | In distribution | |
| 04.01.1355 | In distribution | |
| 04.01.1400 | In distribution | |
| 04.01.3350 | In distribution | |
| 04.01.2350 | In distribution | |
| 04.01.2390 | In distribution | |
| 04.01.3410 | In distribution | |
| 04.01.1405 | In distribution | |
| 04.01.4290 | In distribution | |
| 04.01.1315 | In distribution | |
| 04.01.2410 | In distribution | |
| 04.01.4285 | In distribution | |
| 04.01.4395 | In distribution | |
| 04.01.4370 | In distribution | |
| 04.01.2310 | In distribution | |
| 04.01.3370 | In distribution | |
| 04.01.1305 | In distribution | |
| 04.01.4405 | In distribution | |
| 04.01.1410 | In distribution | |
| 04.01.3390 | In distribution | |
| 04.01.4355 | In distribution | |
| 04.01.3395 | In distribution | |
| 04.01.1380 | 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.