Phoenix Stainless Steel
OPT 1 Molar Band UP Right 6/7 Size 35.5 PK5
27manufacturers in China registered for this device type
120catalogue 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 | Phoenix Orthodontics Inc, United States |
|---|---|
| FDA product code | ECM |
| Device type | Band, Preformed, Orthodontic |
| Device class | Class 1 |
| Regulation | 21 CFR 872.5410 |
| Establishment | Repacker / relabeller |
| Premarket notification | Exempt |
| Record published | 2020-08-17 |
| Record revised | 2024-08-15 (version 3) |
Specifications
| MRI safety | MR Conditional |
|---|---|
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Distribution end date | 2024-09-03 |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| S-1B67-UR355 | 5 | Withdrawn | |
| S-1B6-LR41 | 5 | Withdrawn | |
| S-1B67-UR42 | 5 | Withdrawn | |
| S-1B67-UR315 | 5 | Withdrawn | |
| S-1B6-LR40 | 5 | Withdrawn | |
| S-1B67-UL355 | 5 | Withdrawn | |
| S-1B67-UL31 | 5 | Withdrawn | |
| S-1B6-LL335 | 5 | Withdrawn | |
| S-1B6-LR42 | 5 | Withdrawn | |
| S-1B67-UR30 | 5 | Withdrawn | |
| S-1B67-UL295 | 5 | Withdrawn | |
| S-1B6-LL315 | 5 | Withdrawn | |
| S-1B6-LR315 | 5 | Withdrawn | |
| S-1B6-LR38 | 5 | Withdrawn | |
| S-1B67-UL32 | 5 | Withdrawn | |
| S-1B6-LR425 | 5 | Withdrawn | |
| S-1B67-UR405 | 5 | Withdrawn | |
| S-1B6-LL35 | 5 | Withdrawn | |
| S-1B67-UL44 | 5 | Withdrawn | |
| S-1B67-UR40 | 5 | Withdrawn | |
| S-1B6-LL325 | 5 | Withdrawn | |
| S-1B6-LL295 | 5 | Withdrawn | |
| S-1B6-LR644 | 5 | Withdrawn | |
| S-1B67-UR38 | 5 | Withdrawn | |
| S-1B67-UL43 | 5 | Withdrawn | |
| S-1B67-UL34 | 5 | Withdrawn | |
| S-1B67-UR295 | 5 | Withdrawn | |
| S-1B6-LR295 | 5 | Withdrawn | |
| S-1B67-UL345 | 5 | Withdrawn | |
| S-1B6-LR30 | 5 | Withdrawn | |
| S-1B67-UL35 | 5 | Withdrawn | |
| S-1B67-UR335 | 5 | Withdrawn | |
| S-1B6-LR305 | 5 | Withdrawn | |
| S-1B67-UL30 | 5 | Withdrawn | |
| S-1B67-UL315 | 5 | Withdrawn | |
| S-1B6-LL30 | 5 | Withdrawn | |
| S-1B6-LR34 | 5 | Withdrawn | |
| S-1B67-UL425 | 5 | Withdrawn | |
| S-1B67-UL37 | 5 | Withdrawn | |
| S-1B6-LL395 | 5 | Withdrawn | |
| S-1B6-LR345 | 5 | Withdrawn | |
| S-1B67-UR33 | 5 | Withdrawn | |
| S-1B67-UR39 | 5 | Withdrawn | |
| S-1B6-LL375 | 5 | Withdrawn | |
| S-1B67-UL385 | 5 | Withdrawn | |
| S-1B67-UR345 | 5 | Withdrawn | |
| S-1B67-UL42 | 5 | Withdrawn | |
| S-1B67-UL39 | 5 | Withdrawn | |
| S-1B67-UR305 | 5 | Withdrawn | |
| S-1B6-LL31 | 5 | Withdrawn | |
| S-1B6-LL36 | 5 | Withdrawn | |
| S-1B6-LL41 | 5 | Withdrawn | |
| S-1B6-LR415 | 5 | Withdrawn | |
| S-1B67-UR36 | 5 | Withdrawn | |
| S-1B6-LR31 | 5 | Withdrawn | |
| S-1B67-UL305 | 5 | Withdrawn | |
| S-1B6-LR32 | 5 | Withdrawn | |
| S-1B67-UR325 | 5 | Withdrawn | |
| S-1B67-UR365 | 5 | Withdrawn | |
| S-1B6-LR375 | 5 | Withdrawn | |
| S-1B6-LR43 | 5 | Withdrawn | |
| S-1B6-LL405 | 5 | Withdrawn | |
| S-1B6-LL435 | 5 | Withdrawn | |
| S-1B67-UR35 | 5 | Withdrawn | |
| S-1B67-UL41 | 5 | Withdrawn | |
| S-1B67-UL40 | 5 | Withdrawn | |
| S-1B6-LR325 | 5 | Withdrawn | |
| S-1B67-UR32 | 5 | Withdrawn | |
| S-1B6-LR435 | 5 | Withdrawn | |
| S-1B6-LL415 | 5 | Withdrawn | |
| S-1B6-LR37 | 5 | Withdrawn | |
| S-1B6-LL345 | 5 | Withdrawn | |
| S-1B6-LL32 | 5 | Withdrawn | |
| S-1B67-UL36 | 5 | Withdrawn | |
| S-1B6-LL42 | 5 | Withdrawn | |
| S-1B67-UR395 | 5 | Withdrawn | |
| S-1B67-UR37 | 5 | Withdrawn | |
| S-1B6-LL305 | 5 | Withdrawn | |
| S-1B67-UL325 | 5 | Withdrawn | |
| S-1B6-LL37 | 5 | Withdrawn | |
| S-1B6-LL40 | 5 | Withdrawn | |
| S-1B67-UL33 | 5 | Withdrawn | |
| S-1B6-LL355 | 5 | Withdrawn | |
| S-1B67-UL365 | 5 | Withdrawn | |
| S-1B6-LL34 | 5 | Withdrawn | |
| S-1B6-LL44 | 5 | Withdrawn | |
| S-1B67-UR425 | 5 | Withdrawn | |
| S-1B67-UR41 | 5 | Withdrawn | |
| S-1B67-UR385 | 5 | Withdrawn | |
| S-1B6-LR385 | 5 | Withdrawn | |
| S-1B6-LR39 | 5 | Withdrawn | |
| S-1B6-LL425 | 5 | Withdrawn | |
| S-1B6-LR405 | 5 | Withdrawn | |
| S-1B6-LL33 | 5 | Withdrawn | |
| S-1B6-LL365 | 5 | Withdrawn | |
| S-1B67-UR415 | 5 | Withdrawn | |
| S-1B67-UL435 | 5 | Withdrawn | |
| S-1B6-LR33 | 5 | Withdrawn | |
| S-1B6-LR35 | 5 | Withdrawn | |
| S-1B6-LR355 | 5 | Withdrawn | |
| S-1B6-LR335 | 5 | Withdrawn | |
| S-1B6-LR365 | 5 | Withdrawn | |
| S-1B67-UL335 | 5 | Withdrawn | |
| S-1B67-UR44 | 5 | Withdrawn | |
| S-1B6-LR395 | 5 | Withdrawn | |
| S-1B6-LL385 | 5 | Withdrawn | |
| S-1B6-LL38 | 5 | Withdrawn | |
| S-1B67-UL405 | 5 | Withdrawn | |
| S-1B6-LL39 | 5 | Withdrawn | |
| S-1B6-LL43 | 5 | Withdrawn | |
| S-1B67-UR375 | 5 | Withdrawn | |
| S-1B67-UR31 | 5 | Withdrawn | |
| S-1B67-UR34 | 5 | Withdrawn | |
| S-1B67-UL38 | 5 | Withdrawn | |
| S-1B67-UL415 | 5 | Withdrawn | |
| S-1B67-UL375 | 5 | Withdrawn | |
| S-1B67-UR435 | 5 | Withdrawn | |
| S-1B67-UR43 | 5 | Withdrawn | |
| S-1B6-LR36 | 5 | Withdrawn | |
| S-1B67-UL395 | 5 | Withdrawn |
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.