Elite® Bondable Buccal Tubes
Elite®.022/045 U6R CBT/NC -14T 10 OFF DB
34manufacturers in China registered for this device type
166catalogue numbers in this listing
1recall
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 | Ortho Organizers, Inc., United States |
|---|---|
| FDA product code | DZD |
| Device type | Tube, Orthodontic |
| Device class | Class 1 |
| Regulation | 21 CFR 872.5410 |
| Establishment | Specification developer, Repacker / relabeller, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2020-07-13 |
| Record revised | 2025-12-30 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number |
| Distribution end date | 2023-07-27 |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 901-012-10 | In distribution | |
| 901-112-10 | In distribution | |
| 901-111-5 | In distribution | |
| 902-046DB-10 | In distribution | |
| 901-008-10 | In distribution | |
| 901-113-5 | In distribution | |
| 901-120-10 | In distribution | |
| 901-121-5 | In distribution | |
| 902-057DB-10 | In distribution | |
| 902-158DB-10 | In distribution | |
| 902-055DB-10 | In distribution | |
| 901-125-10 | In distribution | |
| 902-144DB-5 | In distribution | |
| 901-004-10 | In distribution | |
| 902-001DB-10 | In distribution | |
| 901-133-10 | In distribution | |
| 902-106DB-10 | In distribution | |
| 901-017-10 | In distribution | |
| 901-034-10 | In distribution | |
| 901-011-10 | In distribution | |
| 902-151DB-10 | In distribution | |
| 901-002-10 | In distribution | |
| 901-108-5 | In distribution | |
| 902-113DB-10 | In distribution | |
| 901-150-10 | In distribution | |
| 902-152DB-10 | In distribution | |
| 937-095DB-10 | In distribution | |
| 901-104-10 | In distribution | |
| 901-149-10 | In distribution | |
| 902-018DB-10 | In distribution | |
| 902-013DB-10 | In distribution | |
| 901-024-10 | In distribution | |
| 901-018-10 | In distribution | |
| 902-142DB-10 | In distribution | |
| 901-108-10 | In distribution | |
| 901-044-10 | In distribution | |
| 901-113-10 | In distribution | |
| 902-006DB-10 | In distribution | |
| 902-004DB-10 | In distribution | |
| 902-154DB-10 | In distribution | |
| 901-106-10 | In distribution | |
| 902-058DB-10 | In distribution | |
| 902-105DB-10 | In distribution | |
| 902-107DB-10 | In distribution | |
| 902-159DB-10 | In distribution | |
| 902-002DB-10 | In distribution | |
| 902-156DB-10 | In distribution | |
| 902-009DB-10 | In distribution | |
| 901-132-5 | In distribution | |
| 902-146DB-10 | In distribution | |
| 901-041-10 | In distribution | |
| 901-132-10 | In distribution | |
| 901-151-10 | In distribution | |
| 901-001-10 | In distribution | |
| 901-052-10 | In distribution | |
| 902-101DB-10 | In distribution | |
| 902-010DB-10 | In distribution | |
| 902-041DB-10 | In distribution | |
| 902-144DB-10 | In distribution | |
| 901-045-10 | In distribution | |
| 901-107-5 | In distribution | |
| 902-121DB-10 | In distribution | |
| 902-017DB-10 | In distribution | |
| 902-162DB-10 | In distribution | |
| 902-143DB-10 | In distribution | |
| 901-112-5 | In distribution | |
| 902-153DB-10 | In distribution | |
| 901-006-10 | In distribution | |
| 902-122DB-10 | In distribution | |
| 937-092DB-10 | In distribution | |
| 901-028-10 | In distribution | |
| 901-134-10 | In distribution | |
| 901-014-10 | In distribution | |
| 902-157DB-10 | In distribution | |
| 902-143DB-5 | In distribution | |
| 901-143-10 | In distribution | |
| 902-116DB-10 | In distribution | |
| 901-111-10 | In distribution | |
| 902-059DB-10 | In distribution | |
| 901-022-10 | In distribution | |
| 937-091DB-10 | In distribution | |
| 902-118DB-10 | In distribution | |
| 902-104DB-10 | In distribution | |
| 902-114DB-10 | In distribution | |
| 937-097DB-10 | In distribution | |
| 902-042DB-10 | In distribution | |
| 901-025-10 | In distribution | |
| 902-014DB-10 | In distribution | |
| 901-124-10 | In distribution | |
| 902-016DB-10 | In distribution | |
| 901-026-10 | In distribution | |
| 901-102-10 | In distribution | |
| 902-149DB-10 | In distribution | |
| 902-062DB-10 | In distribution | |
| 901-122-5 | In distribution | |
| 901-032-10 | In distribution | |
| 901-122-10 | In distribution | |
| 901-040-10 | In distribution | |
| 901-114-5 | In distribution | |
| 902-061DB-10 | In distribution | |
| 902-052DB-10 | In distribution | |
| 901-003-10 | In distribution | |
| 902-060DB-10 | In distribution | |
| 902-108DB-10 | In distribution | |
| 901-107-10 | In distribution | |
| 901-131-10 | In distribution | |
| 901-146-10 | In distribution | |
| 937-094DB-10 | In distribution | |
| 902-150DB-10 | In distribution | |
| 901-023-10 | In distribution | |
| 901-105-10 | In distribution | |
| 902-117DB-10 | In distribution | |
| 901-013-10 | In distribution | |
| 901-020-10 | In distribution | |
| 937-093DB-10 | In distribution | |
| 901-031-10 | In distribution | |
| 901-019-10 | In distribution | |
| 902-056DB-10 | In distribution | |
| 902-003DB-10 | In distribution | |
| 901-033-10 | In distribution | |
| 902-103DB-10 | In distribution | |
| 901-123-10 | In distribution | |
| 901-109-10 | In distribution | |
| 902-051DB-10 | In distribution | |
| 901-005-10 | In distribution | |
| 901-117-10 | In distribution | |
| 901-110-10 | In distribution | |
| 902-145DB-10 | In distribution | |
| 901-118-10 | In distribution | |
| 901-119-10 | In distribution | |
| 901-043-10 | In distribution | |
| 901-126-10 | In distribution | |
| 902-045DB-10 | In distribution | |
| 902-111DB-10 | In distribution | |
| 901-007-10 | In distribution | |
| 902-109DB-10 | In distribution | |
| 901-144-10 | In distribution | |
| 901-152-10 | In distribution | |
| 902-141DB-10 | In distribution | |
| 901-101-10 | In distribution | |
| 901-027-10 | In distribution | |
| 937-096DB-10 | In distribution | |
| 901-050-10 | In distribution | |
| 902-115DB-10 | In distribution | |
| 901-131-5 | In distribution | |
| 901-114-10 | In distribution | |
| 902-164DB-10 | In distribution | |
| 901-121-10 | In distribution | |
| 902-112DB-10 | In distribution | |
| 902-163DB-10 | In distribution | |
| 901-046-10 | In distribution | |
| 902-110DB-10 | In distribution | |
| 902-161DB-10 | In distribution | |
| 902-015DB-10 | In distribution | |
| 901-103-10 | In distribution | |
| 901-145-10 | In distribution | |
| 901-140-10 | In distribution | |
| 902-155DB-10 | In distribution | |
| 901-021-10 | In distribution | |
| 902-160DB-10 | In distribution | |
| 902-053DB-10 | In distribution | |
| 902-119DB-10 | In distribution | |
| 902-102DB-10 | In distribution | |
| 937-098DB-10 | In distribution | |
| 901-127-10 | Withdrawn | |
| 901-141-10 | Withdrawn |
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
Recalls
The FDA has not published a severity grade for these. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2010-11-01 | Not classified | Pending | Products were mis-labeled as nickel free. | 1300 | 2011-04-27 |
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.