Accent Buccal Tube
Orthos Accent UFS 15SGL NDX -10TX22 L
34manufacturers in China registered for this device type
114catalogue numbers in this listing
Who Else Makes It
Concentrated in Zhejiang (20), Jiangsu (4), Guangdong (4). 5 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 |
| Sino Ortho Limited | Hangzhou | Zhejiang | Contract manufacturer | 14 |
| Hangzhou Westlake Biomaterial Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 13 |
| Hangzhou Xingchen 3B Dental Instrument & Materials Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 7 |
| Wuxi Lyusmile IMP AND EXP Co., Ltd. | Wuxi | Jiangsu | Private-label distributor | 66 |
| Zhejiang Yamei Medical Equipment Technology Co., Ltd. | Yang Jiao Lang Zin’An Town | Zhejiang | Manufacturer | 39 |
| Henan Baistra Medical Devices Limited | Zhengzhou | Henan | Manufacturer | 34 |
| Hangzhou Wise Medical Device Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 25 |
| Changsha Nice Medical Instrument Limited Company | Changsha | Hunan | Manufacturer | 17 |
| Guangzhou OO Medical Scientific Limited | Guangzhou | Guangdong | Manufacturer | 17 |
| Orthguide Medical Technology (Jiangsu) Co., Ltd. | Wuxi | Jiangsu | Contract manufacturer | 17 |
Showing 12 of 34. All 34 manufacturers in China registered for Tube, Orthodontic
Record
| Listed by | Ormco Corporation, United States |
|---|---|
| FDA product code | DZD |
| Device type | Tube, Orthodontic |
| Device class | Class 1 |
| Regulation | 21 CFR 872.5410 |
| Establishment | Specification developer, Complaint-file establishment, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2022-12-06 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date, manufacturing date |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 340-5202 | Slot size 018, Torque 0, Angulation 0, Rotation 5 | 10 | In distribution |
| 342-4131 | Slot size 022, Torque -27, Angulation 0, Rotation 5 | 10 | In distribution |
| 515-0131 | Slot size 022, Torque -27, Angulation 0, Rotation 5 | 10 | In distribution |
| 340-5114 | Slot size 018, Torque -10, Angulation 0 | 10 | In distribution |
| 515-0115 | Slot size 022, Torque -10, Angulation 0, Rotation 15 | 10 | In distribution |
| 342-5131 | Slot size 022, Torque -27, Angulation 0, Rotation 5 | 10 | In distribution |
| 514-0212 | Slot size 018, Torque -10, Angulation 0, Rotation 5 | 10 | In distribution |
| 340-4232 | Slot size 018, Torque -27, Angulation 0, Rotation 5 | 10 | In distribution |
| 515-0114 | Slot size 018, Torque -10, Angulation 0, Rotation 5 | 10 | In distribution |
| 515-0213 | Slot size 022, Torque -10, Angulation 0, Rotation 5 | 10 | In distribution |
| 340-1232 | Slot size 018, Torque -27, Angulation 0, Rotation 5 | 10 | In distribution |
| 342-5111 | Slot size 022, Torque -10, Angulation 0, Rotation 5 | 10 | In distribution |
| 342-5213 | Slot size 022, Torque -10, Angulation 0, Rotation 5 | 10 | In distribution |
| 340-0236 | Slot size 018, Torque -10, Angulation 0, Rotation 0 | 10 | In distribution |
| 515-0232 | Slot size 018, Torque -27, Angulation 0, Rotation 5 | 10 | In distribution |
| 340-4112 | Slot size 018, Torque -10, Angulation 0, Rotation 5 | 10 | In distribution |
| 514-0231 | Slot size 022, Torque -27, Angulation 0, Rotation 5 | 10 | In distribution |
| 342-5231 | Slot size 022, Torque -27, Angulation 0, Rotation 5 | 10 | In distribution |
| 514-0215 | Slot size 022, Torque -10, Angulation 0, Rotation 15 | 10 | In distribution |
| 342-4111 | Slot size 022, Torque -10, Angulation 0, Rotation 5 | 10 | In distribution |
| 514-0213 | Slot size 022, Torque -10, Angulation 0, Rotation 5 | 10 | In distribution |
| 520-0236 | Slot size 018, Torque -10, Angulation 0, Rotation 0 | 10 | In distribution |
| 340-4202 | Slot size 018, Torque 0, Angulation 0, Rotation 5 | 10 | In distribution |
| 514-0122 | Slot size 018, Torque -22, Angulation 0, Rotation 5 | 10 | In distribution |
| 342-1239 | Slot size 022, Torque -10, Angulation 0 | 10 | In distribution |
| 340-5118 | Slot size 018, Torque -10, Angulation 0 | 10 | In distribution |
| 520-0238 | Slot size 018, Torque -10, Angulation 15 | 10 | In distribution |
| 514-0201 | Slot size 022, Torque 0, Angulation 0, Rotation 5 | 10 | In distribution |
| 521-0232 | Slot size 018, Torque -27, Angulation 0, Rotation 5 | 10 | In distribution |
| 340-5216 | Slot size 018, Torque -10, Angulation 0, Rotation 15 | 10 | In distribution |
| 340-5214 | Slot size 018, Torque -10, Angulation 0, Rotation 5 | 10 | In distribution |
| 342-5211 | Slot size 022, Torque -10, Angulation 0, Rotation 5 | 10 | In distribution |
| 521-0237 | Slot size 022, Torque -10, Angulation 0, Rotation 0 | 10 | In distribution |
| 342-1241 | Slot size 022, Torque -10, Angulation 0 | 10 | In distribution |
| 515-0202 | Slot size 018, Torque 0, Angulation 0, Rotation 5 | 10 | In distribution |
| 514-0121 | Slot size 022, Torque -22, Angulation 0, Rotation 5 | 10 | In distribution |
| 514-0113 | Slot size 022, Torque -10, Angulation 0, Rotation 5 | 10 | In distribution |
| 514-0117 | Slot size 022, Torque -10, Angulation 0, Rotation 0 | 10 | In distribution |
| 342-4117 | Slot size 022, Torque -10, Angulation 0, Rotation 0 | 10 | In distribution |
| 340-4132 | Slot size 018, Torque -27, Angulation 0, Rotation 5 | 10 | In distribution |
| 515-0211 | Slot size 022, Torque -10, Angulation 0, Rotation 5 | 10 | In distribution |
| 515-0111 | Slot size 022, Torque -10, Angulation 0, Rotation 5 | 10 | In distribution |
| 340-5116 | Slot size 018, Torque -10, Angulation 0 | 10 | In distribution |
| 515-0214 | Slot size 018, Torque -10, Angulation 0, Rotation 5 | 10 | In distribution |
| 520-0231 | Slot size 022, Torque -27, Angulation 0, Rotation 5 | 10 | In distribution |
| 514-0112 | Slot size 018, Torque -10, Angulation 0, Rotation 5 | 10 | In distribution |
| 521-0231 | Slot size 022, Torque -27, Angulation 0, Rotation 5 | 10 | In distribution |
| 520-0234 | Slot size 018, Torque -27, Angulation 15 | 10 | In distribution |
| 342-0231 | Slot size 022, Torque -27, Angulation 0 | 10 | In distribution |
| 342-5117 | Slot size 022, Torque -10, Angulation 0, Rotation 0 | 10 | In distribution |
| 340-4122 | Slot size 018, Torque -22, Angulation 0, Rotation 5 | 10 | In distribution |
| 340-4116 | Slot size 018, Torque -10, Angulation 0 | 10 | In distribution |
| 515-0132 | Slot size 018, Torque -27, Angulation 0, Rotation 5 | 10 | In distribution |
| 342-4113 | Slot size 022, Torque -10, Angulation 0 | 10 | In distribution |
| 520-0239 | Slot size 022, Torque -10, Angulation 15 | 10 | In distribution |
| 514-0116 | Slot size 018, Torque -10, Angulation 0, Rotation 15 | 10 | In distribution |
| 340-4214 | Slot size 018, Torque -10, Angulation 0 | 10 | In distribution |
| 515-0215 | Slot size 022, Torque -10, Angulation 0, Rotation 15 | 10 | In distribution |
| 340-5112 | Slot size 018, Torque -10, Angulation 0, Rotation 5 | 10 | In distribution |
| 515-0118 | Slot size 018, Torque -10, Angulation 0, Rotation 0 | 10 | In distribution |
| 521-0239 | Slot size 022, Torque -10, Angulation 15 | 10 | In distribution |
| 342-4121 | Slot size 022, Torque -22, Angulation 0, Rotation 5 | 10 | In distribution |
| 340-1240 | Slot size 018, Torque -10, Angulation 0 | 10 | In distribution |
| 521-0236 | Slot size 018, Torque -10, Angulation 0, Rotation 0 | 10 | In distribution |
| 514-0131 | Slot size 022, Torque -27, Angulation 0, Rotation 5 | 10 | In distribution |
| 521-0234 | Slot size 018, Torque -27, Angulation 15 | 10 | In distribution |
| 340-5212 | Slot size 018, Torque -10, Angulation 0, Rotation 5 | 10 | In distribution |
| 342-4211 | Slot size 022, Torque -10, Angulation 0, Rotation 5 | 10 | In distribution |
| 340-4212 | Slot size 018, Torque -10, Angulation 0, Rotation 5 | 10 | In distribution |
| 340-5122 | Slot size 018, Torque -22, Angulation 0, Rotation 5 | 10 | In distribution |
| 515-0116 | Slot size 018, Torque -10, Angulation 0, Rotation 15 | 10 | In distribution |
| 515-0121 | Slot size 022, Torque -22, Angulation 0, Rotation 5 | 10 | In distribution |
| 521-0238 | Slot size 018, Torque -10, Angulation 15 | 10 | In distribution |
| 342-4115 | Slot size 022, Torque -10, Angulation 0, Rotation 15 | 10 | In distribution |
| 515-0112 | Slot size 018, Torque -10, Angulation 0, Rotation 5 | 10 | In distribution |
| 342-5201 | Slot size 022, Torque 0, Angulation 0, Rotation 5 | 10 | In distribution |
| 342-5121 | Slot size 022, Torque -22, Angulation 0, Rotation 5 | 10 | In distribution |
| 342-4231 | Slot size 022, Torque -27, Angulation 0, Rotation 5 | 10 | In distribution |
| 342-4201 | Slot size 022, Torque 0, Angulation 0, Rotation 5 | 10 | In distribution |
| 514-0202 | Slot size 018, Torque 0, Angulation 0, Rotation 5 | 10 | In distribution |
| 340-0232 | Slot size 018, Torque -27, Angulation 0, Rotation 5 | 10 | In distribution |
| 514-0232 | Slot size 018, Torque -27, Angulation 0, Rotation 5 | 10 | In distribution |
| 514-0132 | Slot size 018, Torque -27, Angulation 0, Rotation 5 | 10 | In distribution |
| 514-0115 | Slot size 022, Torque -10, Angulation 0, Rotation 15 | 10 | In distribution |
| 514-0114 | Slot size 018, Torque -10, Angulation 0, Rotation 5 | 10 | In distribution |
| 514-0214 | Slot size 018, Torque -10, Angulation 0, Rotation 5 | 10 | In distribution |
| 340-4216 | Slot size 018, Torque -10, Angulation 0 | 10 | In distribution |
| 515-0216 | Slot size 018, Torque -10, Angulation 0, Rotation 15 | 10 | In distribution |
| 515-0113 | Slot size 022, Torque -10, Angulation 0, Rotation 5 | 10 | In distribution |
| 514-0111 | Slot size 022, Torque -10, Angulation 0, Rotation 5 | 10 | In distribution |
| 342-5115 | Slot size 022, Torque -10, Angulation 0, Rotation1 5 | 10 | In distribution |
| 342-4213 | Slot size 022, Torque -10, Angulation 0, Rotation 5 | 10 | In distribution |
| 514-0118 | Slot size 018, Torque -10, Angulation 0, Rotation 0 | 10 | In distribution |
| 515-0201 | Slot size 022, Torque 0, Angulation 0, Rotation 5 | 10 | In distribution |
| 340-4118 | Slot size 018, Torque -10, Angulation 0 | 10 | In distribution |
| 340-4114 | Slot size 018, Torque -10, Angulation 0 | 10 | In distribution |
| 340-0240 | Slot size 018, Torque -10, Angulation 0 | 10 | In distribution |
| 520-0237 | Slot size 022, Torque -10, Angulation 0, Rotation 0 | 10 | In distribution |
| 342-1231 | Slot size 022, Torque -27, Angulation 0, Rotation 5 | 10 | In distribution |
| 342-5113 | Slot size 022, Torque -10, Angulation 0 | 10 | In distribution |
| 520-0232 | Slot size 018, Torque -27, Angulation 0, Rotation 5 | 10 | In distribution |
| 515-0122 | Slot size 018, Torque -22, Angulation 0, Rotation 5 | 10 | In distribution |
| 340-5132 | Slot size 018, Torque -27, Angulation 0, Rotation 5 | 10 | In distribution |
| 342-0241 | Slot size 022, Torque -10, Angulation 0 | 10 | In distribution |
| 342-5215 | Slot size 022, Torque -10, Angulation 0, Rotation 15 | 10 | In distribution |
| 515-0117 | Slot size 022, Torque -10, Angulation 0, Rotation 0 | 10 | In distribution |
| 514-0211 | Slot size 022, Torque -10, Angulation 0, Rotation 5 | 10 | In distribution |
| 515-0231 | Slot size 022, Torque -27, Angulation 0, Rotation 5 | 10 | In distribution |
| 340-5232 | Slot size 018, Torque -27, Angulation 0, Rotation 5 | 10 | In distribution |
| 342-4215 | Slot size 022, Torque -10, Angulation 0, Rotation 15 | 10 | In distribution |
| 514-0216 | Slot size 018, Torque -10, Angulation 0, Rotation 15 | 10 | In distribution |
| 515-0212 | Slot size 018, Torque -10, Angulation 0, Rotation 5 | 10 | In distribution |
| 340-1236 | Slot size 018, Torque -10, Angulation 0, Rotation 0 | 10 | In distribution |
| 342-0239 | Slot size 022, Torque -10, Angulation 0 | 10 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Tube, Orthodontic | Forestadent Bernhard Förster GmbH | 2,336 |
| Generic Buccal Tubes | American Orthodontics | 799 |
| Tube, Orthodontic | G & H Wire Company | 758 |
| Leone SPA | Leone SPA | 722 |
| RMO | RMO | 697 |
| Tube, Orthodontic | Dentaurum GmbH & Co. KG | 602 |
| LP Low Profile | American Orthodontics | 506 |
| 3M™ Unitek™ Victory Series™ | 3M Unitek | 434 |
| Buccal Tubes | American Orthodontics | 356 |
| Peerless Buccal Tube | Ormco Corporation | 331 |
| Empower Tube | American Orthodontics | 296 |
| Mini Master Series | American Orthodontics | 289 |
Showing 12 of 333. All products under Tube, 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.