Generic Buccal Tubes
Nola Hook Great Lakes Ortho Assembly Pack OF 10
45manufacturers in China registered for this device type
1catalogue number
Who Else Makes It
Concentrated in Guangdong (10), Zhejiang (8), Shanghai (6). 8 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Shenzhen Senlede Technologies Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 33 |
| Suzhou Pac-Dent Technology Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 26 |
| Hangzhou Westlake Biomaterial Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 13 |
| Xiamen Yizhou IMP. & EXP. Co., Ltd. | Xiamen | Fujian | Contract manufacturer | 10 |
| Dongguan Junhai Medical Device Co., Ltd. | Dong Guang | Guangdong | Contract manufacturer | 9 |
| Forefront (Xiamen) Medical Devices Co., Ltd. | Xiamen | Fujian | Contract manufacturer | 8 |
| Taizhou Polus Technology Co., Ltd. | Taizhou | Zhejiang | Contract manufacturer | 2 |
| Talent Technology Mould Co., Limited | Shenzhen | Guangdong | Contract manufacturer | 1 |
| Shanghai Medical Instruments (Group) Ltd. Corp. | Shanghai | Shanghai | Contract manufacturer | 235 |
| Xinhua Surgical Instrument Co., Ltd. | Zibo | Shandong | Manufacturer | 222 |
| Debo Medical Technology (Shijiazhuang) Co., Ltd. | Shijiazhuang | Hebei | Contract manufacturer | 117 |
| Hubei Guarddent Medical Technology Co., Ltd. | Wuhan | Hubei | Manufacturer | 60 |
Showing 12 of 45. All 45 manufacturers in China registered for Retractor, All Types
Record
| Listed by | American Orthodontics, United States |
|---|---|
| FDA product code | EIG |
| Device type | Retractor, All Types |
| Device class | Class 1 |
| Regulation | 21 CFR 872.4565 |
| Establishment | Contract manufacturer, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2022-11-03 |
| Record revised | 2025-01-03 (version 3) |
Specifications
| MRI safety | MR Unsafe |
|---|---|
| Prescription | Prescription only |
| Label carries | lot or batch number, manufacturing date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 851-4706 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Surgical Direct | Surgical Direct, Inc. | 340 |
| Retractor, All Types | George Tiemann & Co. | 218 |
| Retractor | KLS-Martin L.P. | 210 |
| Zoll-Dental | Zoll-Dental | 110 |
| BMT Medizintechnik GmbH | BMT Medizintechnik GmbH | 90 |
| ACE | Ace Surgical Supply Co., Inc. | 88 |
| Millennium | Avalign Technologies, Inc. | 86 |
| Helmut Zepf | Helmut Zepf Medizintechnik Gmbh | 83 |
| Retractor, All Types | Biomet Microfixation | 78 |
| HU-Friedy | HU-Friedy MFG Co., LLC | 63 |
| Kohdent | Kohler Medizintechnik GmbH | 61 |
| Power Dental USA | Power Dental U.S.A. Inc. | 59 |
Showing 12 of 336. All products under Retractor, All Types
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.