Elite® Band Assemblies
022 Elite® LR6 Conv Sgl BT -25T/0A/+4Off Tempra - Cleat 37.5
27manufacturers in China registered for this device type
924catalogue 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 | 2021-09-13 |
| Record revised | 2025-12-30 (version 5) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, manufacturing date |
| Distribution end date | 2026-01-30 |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 900-124083E-3 | In distribution | |
| 06E-3 | In distribution | |
| 900-107086E-3 | In distribution | |
| 900-11006E-3 | In distribution | |
| 900-127081E-3 | In distribution | |
| 900-122086E | In distribution | |
| 900-131072E-3 | In distribution | |
| 900-144081E | In distribution | |
| 900-104081E-34.5 | In distribution | |
| 900-103081E-44 | In distribution | |
| 900-001081E | In distribution | |
| 900-02008E | In distribution | |
| 900-04306E-3 | In distribution | |
| 900-122066E | In distribution | |
| 900-111072E-3 | In distribution | |
| 900-121081E-30 | In distribution | |
| 900-03107E | In distribution | |
| 900-103081E-43 | In distribution | |
| 900-002081E | In distribution | |
| 900-11308E | In distribution | |
| 900-133083E | In distribution | |
| 900-021083E | In distribution | |
| 902-101086E-3 | In distribution | |
| 902-14408E-3 | In distribution | |
| 900-004081E | In distribution | |
| 900-121081E-37.5 | In distribution | |
| 950-13407E-3 | In distribution | |
| 900-101066E-3 | In distribution | |
| 900-132072E | In distribution | |
| 900-12708E | In distribution | |
| 900-031071E | In distribution | |
| 900-121081E-33 | In distribution | |
| 900-118066E | In distribution | |
| 902-109061E-3 | In distribution | |
| 902-154081E-3 | In distribution | |
| 900-108081E-40.5 | In distribution | |
| 902-11106E-3 | In distribution | |
| 900-12008E | In distribution | |
| 900-133063E | In distribution | |
| 900-123062E-3 | In distribution | |
| 902-10308E-3 | In distribution | |
| 900-124081E-44 | In distribution | |
| 902-104081E-3 | In distribution | |
| 900-04606E-3 | In distribution | |
| 900-11109E-3 | In distribution | |
| 900-103081E-32.5 | In distribution | |
| 902-146086E-3 | In distribution | |
| 900-109066E-3 | In distribution | |
| 900-14308E-3 | In distribution | |
| 900-122063E-3 | In distribution | |
| 902-146081E-3 | In distribution | |
| 900-124081E-39.5 | In distribution | |
| 900-044086E | In distribution | |
| 900-10306E-3 | In distribution | |
| 900-004063E | In distribution | |
| 900-005081E-3 | In distribution | |
| 900-145086E-3 | In distribution | |
| 900-11708E-3 | In distribution | |
| 900-145061E-3 | In distribution | |
| 900-121082E | In distribution | |
| 902-143083E-3 | In distribution | |
| 900-123062E | In distribution | |
| 902-15206E-3 | In distribution | |
| 900-123086E | In distribution | |
| 900-102062E | In distribution | |
| 900-04606E | In distribution | |
| 900-124062E | In distribution | |
| 900-122081E-38 | In distribution | |
| 900-122081E-43 | In distribution | |
| 900-14508E-3 | In distribution | |
| 900-022081E-3 | In distribution | |
| 900-11408E-3 | In distribution | |
| 900-11908E-3 | In distribution | |
| 900-12106E-3 | In distribution | |
| 900-124086E-3 | In distribution | |
| 900-003061E | In distribution | |
| 900-107061E | In distribution | |
| 900-10606E | In distribution | |
| 900-107062E | In distribution | |
| 900-10208E-3 | In distribution | |
| 900-101061E | In distribution | |
| 900-104081E-42.5 | In distribution | |
| 900-103081E-39 | In distribution | |
| 900-004063E-3 | In distribution | |
| 900-10508E-3 | In distribution | |
| 900-124062E-3 | In distribution | |
| 902-114061E-3 | In distribution | |
| 900-104081E-43.5 | In distribution | |
| 900-108081E-37.5 | In distribution | |
| 900-108082E-3 | In distribution | |
| 900-13109E-3 | In distribution | |
| 900-123081E-43.5 | In distribution | |
| 900-10908E-3 | In distribution | |
| 900-133083E-3 | In distribution | |
| 900-012092E | In distribution | |
| 902-104086E-3 | In distribution | |
| 900-103081E-37 | In distribution | |
| 900-121081E-34.5 | In distribution | |
| 900-123081E-39 | In distribution | |
| 900-105082E | In distribution | |
| 900-01006E-3 | In distribution | |
| 900-023061E | In distribution | |
| 900-101062E | In distribution | |
| 902-15608E-3 | In distribution | |
| 900-122062E-3 | In distribution | |
| 900-10508E | In distribution | |
| 900-032071E-3 | In distribution | |
| 902-156086E-3 | In distribution | |
| 900-104081E-33 | In distribution | |
| 900-104081E-38.5 | In distribution | |
| 950-15409E-3 | In distribution | |
| 900-10906E-3 | In distribution | |
| 902-111061E-3 | In distribution | |
| 900-12706E | In distribution | |
| 900-023066E-3 | In distribution | |
| 900-023063E-3 | In distribution | |
| 900-022081E | In distribution | |
| 900-024061E-3 | In distribution | |
| 900-107081E-39 | In distribution | |
| 900-146063E | In distribution | |
| 900-12806E | In distribution | |
| 900-107062E-3 | In distribution | |
| 900-12706E-3 | In distribution | |
| 900-124081E-39 | In distribution | |
| 900-00806E-3 | In distribution | |
| 900-107081E-38 | In distribution | |
| 900-121081E-31.5 | In distribution | |
| 900-13408E | In distribution | |
| 902-14508E-3 | In distribution | |
| 900-132072E-3 | In distribution | |
| 900-107082E | In distribution | |
| 900-122081E-30.5 | In distribution | |
| 900-143066E | In distribution | |
| 900-122081E-37.5 | In distribution | |
| 900-145081E | In distribution | |
| 900-107081E-37 | In distribution | |
| 900-123081E-31 | In distribution | |
| 900-107082E-3 | In distribution | |
| 900-10908E | In distribution | |
| 900-13207E | In distribution | |
| 900-103081E-35.5 | In distribution | |
| 900-143061E-3 | In distribution | |
| 900-02308E | In distribution | |
| 900-104081E-43 | In distribution | |
| 900-12708E-3 | In distribution | |
| 900-11409E-3 | In distribution | |
| 900-005081E | In distribution | |
| 900-107081E-29.5 | In distribution | |
| 900-003082E | In distribution | |
| 900-124061E | In distribution | |
| 900-104081E-31.5 | In distribution | |
| 902-10306E-3 | In distribution | |
| 900-04506E | In distribution | |
| 900-12308E | In distribution | |
| 900-102081E-3 | In distribution | |
| 900-105061E-3 | In distribution | |
| 900-122081E-36 | In distribution | |
| 900-108081E-42 | In distribution | |
| 900-143066E-3 | In distribution | |
| 950-13307E-3 | In distribution | |
| 900-023081E-3 | In distribution | |
| 900-007086E-3 | In distribution | |
| 902-153081E-3 | In distribution | |
| 900-103081E-3 | In distribution | |
| 900-102066E | In distribution | |
| 900-034082E-3 | In distribution | |
| 900-110061E-3 | In distribution | |
| 900-128061E | In distribution | |
| 902-14506E-3 | In distribution | |
| 900-11006E | In distribution | |
| 900-124081E-31 | In distribution | |
| 900-021061E | In distribution | |
| 900-124081E-36 | In distribution | |
| 900-123081E-31.5 | In distribution | |
| 900-122081E-44 | In distribution | |
| 902-145086E-3 | In distribution | |
| 900-108061E | In distribution | |
| 900-102086E-3 | In distribution | |
| 900-122081E-35.5 | In distribution | |
| 902-103083E-3 | In distribution | |
| 950-133091E-3 | In distribution | |
| 900-127061E-3 | In distribution | |
| 902-112061E-3 | In distribution | |
| 900-02106E | In distribution | |
| 900-105081E-3 | In distribution | |
| 900-02106E-3 | In distribution | |
| 900-008061E | In distribution | |
| 900-121086E | In distribution | |
| 900-124081E-29.5 | In distribution | |
| 902-11108E-3 | In distribution | |
| 900-145061E | In distribution | |
| 902-10106E-3 | In distribution | |
| 900-123081E-35.5 | In distribution | |
| 900-104081E-36 | In distribution | |
| 900-146063E-3 | In distribution | |
| 902-14308E-3 | In distribution | |
| 900-104081E-41 | In distribution | |
| 900-12008E-3 | In distribution | |
| 900-123081E-29.5 | In distribution | |
| 902-15106E-3 | In distribution | |
| 900-104081E-35 | In distribution | |
| 900-104061E | In distribution | |
| 902-102081E-3 | In distribution | |
| 900-024066E-3 | In distribution | |
| 900-121081E-37 | In distribution | |
| 900-14406E | In distribution | |
| 900-006081E | In distribution | |
| 900-133061E-3 | In distribution | |
| 900-123081E-30 | In distribution | |
| 900-127086E-3 | In distribution | |
| 950-153091E-3 | In distribution | |
| 900-02208E | In distribution | |
| 902-10108E-3 | In distribution | |
| 900-108081E-43 | In distribution | |
| 900-123061E-3 | In distribution | |
| 900-144066E | In distribution | |
| 900-023061E-3 | In distribution | |
| 900-118066E-3 | In distribution | |
| 900-145063E-3 | In distribution | |
| 900-12406E | In distribution | |
| 900-122081E-38.5 | In distribution | |
| 902-113061E-3 | In distribution | |
| 900-122061E | In distribution | |
| 900-10308E-3 | In distribution | |
| 900-13406E-3 | In distribution | |
| 900-108081E-29.5 | In distribution | |
| 900-007086E | In distribution | |
| 900-018081E-3 | In distribution | |
| 900-001081E-3 | In distribution | |
| 902-143082E-3 | In distribution | |
| 900-121081E-44 | In distribution | |
| 900-104081E-3 | In distribution | |
| 900-121081E-43.5 | In distribution | |
| 902-14106E-3 | In distribution | |
| 900-122081E-32.5 | In distribution | |
| 900-13209E-3 | In distribution | |
| 900-124081E-32.5 | In distribution | |
| 900-106061E | In distribution | |
| 900-012092E-3 | In distribution | |
| 900-00706E-3 | In distribution | |
| 900-121081E-41 | In distribution | |
| 900-122081E-42 | In distribution | |
| 950-15507E-3 | In distribution | |
| 900-106062E-3 | In distribution | |
| 900-00708E | In distribution | |
| 900-145086E | In distribution | |
| 900-128086E-3 | In distribution | |
| 900-043086E-3 | In distribution | |
| 900-102061E | In distribution | |
| 902-14606E-3 | 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 |
| Band Assemblies | Ortho Organizers, Inc. | 1,642 |
| 3M™ Victory Series™ | 3M Unitek | 1,388 |
| The Orthodontic Store | Young Innovations Inc. | 925 |
| 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.