Band Assemblies
Maxillary Primary Molar Band Lingual Sheaths - Horizontal HK-UL
27manufacturers in China registered for this device type
1,642catalogue 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 | Ortho Organizers, Inc., United States |
|---|---|
| FDA product code | ECM |
| Device type | Band, Preformed, Orthodontic |
| Device class | Class 1 |
| Regulation | 21 CFR 872.5410 |
| Establishment | Specification developer, Repacker / relabeller, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2025-07-07 |
| Record revised | 2025-12-30 (version 4) |
Specifications
| MRI safety | MR Unsafe |
|---|---|
| Single use | Yes |
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Label carries | lot or batch number, manufacturing date |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 902-102086E-29.5 | In distribution | |
| 900-123061E-4 | In distribution | |
| 900-123082E-34 | In distribution | |
| 902-102086E-40 | In distribution | |
| 902-101086E-40 | In distribution | |
| 950-13309E | In distribution | |
| 900-108061E-20 | In distribution | |
| 900-124086E-39.5 | In distribution | |
| 900-104061E-3 | In distribution | |
| 911-312071E-19 | In distribution | |
| 900-108061E-5 | In distribution | |
| 900-12208E-34.5 | In distribution | |
| 902-102086E-30.5 | In distribution | |
| 052 | In distribution | |
| 900-124082E-40.5 | In distribution | |
| 902-11108E-37.5 | In distribution | |
| 950-155071E-26 | In distribution | |
| 900-146081E-31 | In distribution | |
| 902-141086E-40.5 | In distribution | |
| 950-156071E-6 | In distribution | |
| 902-101086E-32.5 | In distribution | |
| 900-118086E-30 | In distribution | |
| 900-122061E-11 | In distribution | |
| 900-12306E-16 | In distribution | |
| 900-104061E-16 | In distribution | |
| 902-101086E-32 | In distribution | |
| 900-122061E-19 | In distribution | |
| 911-362071E-22 | In distribution | |
| 900-124086E-34.5 | In distribution | |
| 902-101086E-34 | In distribution | |
| 902-35108E-34 | In distribution | |
| 902-152083E | In distribution | |
| 900-108061E-7 | In distribution | |
| 900-104061E-4 | In distribution | |
| 900-117086E-40.5 | In distribution | |
| 900-103061E-15 | In distribution | |
| 902-11106E-14 | In distribution | |
| 900-107061E-11 | In distribution | |
| 911-311071E-17 | In distribution | |
| 902-30308E-33.5 | In distribution | |
| 950-156071E-23 | In distribution | |
| 900-110081E-31.5 | In distribution | |
| 950-155071E-25 | In distribution | |
| 900-117086E-42 | In distribution | |
| 900-107061E-6 | In distribution | |
| 902-11206E-14 | In distribution | |
| 902-142086E-37.5 | In distribution | |
| 088VE | In distribution | |
| 900-123086E-33.5 | In distribution | |
| 902-35108E-36.5 | In distribution | |
| 900-109081E-33.5 | In distribution | |
| 950-156071E-24 | In distribution | |
| 950-155071E-6 | In distribution | |
| 900-10708E-40.5 | In distribution | |
| 900-110086E-38 | In distribution | |
| 902-141086E | In distribution | |
| 911-311071E-13 | In distribution | |
| 900-11008E-34 | In distribution | |
| 900-123081E-44 | In distribution | |
| 902-145061E | In distribution | |
| 900-110066E-17CW | In distribution | |
| 902-101086E-33 | In distribution | |
| 911-362071E-7 | In distribution | |
| 900-12306E-11 | In distribution | |
| 900-117086E-32.5 | In distribution | |
| 0133 | In distribution | |
| 073E | In distribution | |
| 900-10108E-35.5 | In distribution | |
| 900-117086E-41.5 | In distribution | |
| 900-107061E-36 | In distribution | |
| 900-109066E-25CW | In distribution | |
| 900-12306E-24 | In distribution | |
| 900-124086E-33.5 | In distribution | |
| 900-110066E-12CW | In distribution | |
| 902-155066E | In distribution | |
| 900-10808E-36 | In distribution | |
| 902-35208E-33 | In distribution | |
| 900-107061E-26 | In distribution | |
| 900-10708E-38 | In distribution | |
| 900-12108E-43 | In distribution | |
| 900-123082E-38 | In distribution | |
| 900-121061E-12 | In distribution | |
| 902-101086E-37.5 | In distribution | |
| 902-142086E-43.5 | In distribution | |
| 091E | In distribution | |
| 900-109066E-7CW | In distribution | |
| 902-30408E-38 | In distribution | |
| 902-141086E-43 | In distribution | |
| 902-30408E-37.5 | In distribution | |
| 900-12208E-29.5 | In distribution | |
| 902-35208E-30 | In distribution | |
| 902-11208E-33.5 | In distribution | |
| 900-110086E-40 | In distribution | |
| 900-104061E-19 | In distribution | |
| 900-10208E-41.5 | In distribution | |
| 902-101086E-39.5 | In distribution | |
| 902-142086E-42 | In distribution | |
| 900-146081E-37.5 | In distribution | |
| 900-10908E-41.5 | In distribution | |
| 900-124061E-34 | In distribution | |
| 900-11008E-35.5 | In distribution | |
| 900-104061E-35 | In distribution | |
| 950-155071E-03 | In distribution | |
| 900-10908E-41 | In distribution | |
| 900-123061E-19 | In distribution | |
| 902-102086E-38.5 | In distribution | |
| 900-10908E-34 | In distribution | |
| 900-10908E-36.5 | In distribution | |
| 900-123086E-39 | In distribution | |
| 902-11108E-34 | In distribution | |
| 902-14108E-38 | In distribution | |
| 902-30408E-40.5 | In distribution | |
| 900-104061E-14 | In distribution | |
| 900-10208E-40.5 | In distribution | |
| 900-123086E-38.5 | In distribution | |
| 900-10808E-41 | In distribution | |
| 900-118086E-37.5 | In distribution | |
| 900-123061E-7 | In distribution | |
| 073 | In distribution | |
| 900-109086E-38.5 | In distribution | |
| 900-123082E-38.5 | In distribution | |
| 902-30408E-29.5 | In distribution | |
| 900-122061E-8 | In distribution | |
| 902-11306E | In distribution | |
| 911-361071E-24 | In distribution | |
| 900-110081E-36.5 | In distribution | |
| 900-103061E-33 | In distribution | |
| 902-101061E | In distribution | |
| 902-11208E-35 | In distribution | |
| 900-118086E-31.5 | In distribution | |
| 082E | In distribution | |
| 900-11008E-38.5 | In distribution | |
| 900-124061E-36 | In distribution | |
| 900-12208E-36.5 | In distribution | |
| 900-146081E-33.5 | In distribution | |
| 902-11108E-31 | In distribution | |
| 902-106081E | In distribution | |
| 900-10808E-32.5 | In distribution | |
| 900-124061E-24 | In distribution | |
| 900-117086E-36 | In distribution | |
| 900-12308E-30.5 | In distribution | |
| 900-103061E-9 | In distribution | |
| 902-102086E-37.5 | In distribution | |
| 064 | In distribution | |
| 900-122061E-18 | In distribution | |
| 902-102086E-38 | In distribution | |
| 900-107061E-12 | In distribution | |
| 911-311071E-9 | In distribution | |
| 950-156071E-27 | In distribution | |
| 900-12408E-33 | In distribution | |
| 900-124082E-41 | In distribution | |
| 900-12308E-34 | In distribution | |
| 902-30408E-38.5 | In distribution | |
| 911-361071E-16 | In distribution | |
| 902-30408E-39.5 | In distribution | |
| 900-12408E-42 | In distribution | |
| 902-102086E-39 | In distribution | |
| 900-104061E-36 | In distribution | |
| 902-11108E-33.5 | In distribution | |
| 902-30408E-40 | In distribution | |
| 902-14306E | In distribution | |
| 950-13407E | In distribution | |
| 950-155071E-11 | In distribution | |
| 900-107061E-8 | In distribution | |
| 900-109066E-10CW | In distribution | |
| 900-121061E-30 | In distribution | |
| 900-104061E-21 | In distribution | |
| 061 | In distribution | |
| 900-145081E-35.5 | In distribution | |
| 911-362071E-19 | In distribution | |
| 093E | In distribution | |
| 902-102086E-37 | In distribution | |
| 900-10108E-37.5 | In distribution | |
| 911-362071E-21 | In distribution | |
| 900-121061E-28 | In distribution | |
| 900-10708E-43.5 | In distribution | |
| 902-142086E-40 | In distribution | |
| 902-109081E | In distribution | |
| 900-109066E-29CW | In distribution | |
| 900-109066E-21CW | In distribution | |
| 900-12108E-34 | In distribution | |
| 911-311071E-29 | In distribution | |
| 902-11208E-37 | In distribution | |
| 950-155071E-23 | In distribution | |
| 902-30408E-33 | In distribution | |
| 902-142086E-30.5 | In distribution | |
| 902-11106E-16 | In distribution | |
| 900-110081E-31 | In distribution | |
| 900-122061E-9 | In distribution | |
| 900-10708E-39.5 | In distribution | |
| 902-35108E-33.5 | In distribution | |
| 900-12408E-35 | In distribution | |
| 900-124082E-35 | In distribution | |
| 902-115086E | In distribution | |
| 902-102086E-35.5 | In distribution | |
| 902-102086E-31.5 | In distribution | |
| 900-107061E-35 | In distribution | |
| 902-30408E-35 | In distribution | |
| 902-10708E | In distribution | |
| 900-10808E-35 | In distribution | |
| 900-110066E-35CW | In distribution | |
| 900-12408E-30.5 | In distribution | |
| 900-10208E-40 | In distribution | |
| 900-10908E-33.5 | In distribution | |
| 900-10708E-43 | In distribution | |
| 902-11108E-41 | In distribution | |
| 911-362071E-31 | In distribution | |
| 900-12208E-30.5 | In distribution | |
| 900-123082E-40.5 | In distribution | |
| 900-124086E-43 | In distribution | |
| 900-109086E-35.5 | In distribution | |
| 902-144061E | In distribution | |
| 900-107061E-30 | In distribution | |
| 900-10108E-38 | In distribution | |
| 902-146086E | In distribution | |
| 900-10808E-42 | In distribution | |
| 902-101086E-43.5 | In distribution | |
| 0255 | In distribution | |
| 900-121061E-23 | In distribution | |
| 900-10708E-42.5 | In distribution | |
| 062 | In distribution | |
| 900-10108E-42 | In distribution | |
| 902-102086E-42 | In distribution | |
| 902-141086E-32.5 | In distribution | |
| 900-108061E-16 | In distribution | |
| 900-103061E-24 | In distribution | |
| 900-123086E-32.5 | In distribution | |
| 911-362071E-29 | In distribution | |
| 900-12408E-30 | In distribution | |
| 950-133091E | In distribution | |
| 900-146081E-31.5 | In distribution | |
| 900-10108E-34 | In distribution | |
| 902-102086E-34 | In distribution | |
| 900-109086E-37.5 | In distribution | |
| 900-110086E-37.5 | In distribution | |
| 902-110086E | In distribution | |
| 900-145081E-31 | In distribution | |
| 902-141086E-31.5 | In distribution | |
| 900-10908E-37.5 | In distribution | |
| 900-104061E-32 | In distribution | |
| 911-362071E-24 | In distribution | |
| 900-12208E-32 | In distribution | |
| 900-117086E-42.5 | In distribution | |
| 950-156071E-9 | In distribution | |
| 900-123082E-33.5 | In distribution | |
| 902-10608E | In distribution | |
| 900-110086E-31 | In distribution | |
| 900-123082E-41.5 | In distribution | |
| 900-12406E-28 | In distribution | |
| 900-117086E-31.5 | In distribution |
Showing 250 of 300 catalogue numbers.
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 |
| 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 |
| Rollo Bands | American Orthodontics | 660 |
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.