Leone SPA
EXPANDER W/TELESCOP. GUIDES 10mm FOR TADS .
30manufacturers in China registered for this device type
441catalogue numbers in this listing
Who Else Makes It
Concentrated in Zhejiang (13), Guangdong (9), Jiangsu (3). 2 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Hangzhou Westlake Biomaterial Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 13 |
| Veden Dental Labs Inc | Zhuhai | Guangdong | Contract manufacturer | 9 |
| Debo Medical Technology (Shijiazhuang) Co., Ltd. | Shijiazhuang | Hebei | Contract manufacturer | 117 |
| 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 |
| Shenzhen Sunmc Dental Technology Co., Ltd. | Shenzhen | Guangdong | Manufacturer | 17 |
| Zhejiang Protect Medical Equipment Co., Ltd. | Anji | Zhejiang | Manufacturer | 16 |
| Guangzhou Cheer-U Material Technology Co., Ltd. | Guangzhou | Guangdong | Manufacturer | 15 |
| Sino Ortho Limited | Hangzhou | Zhejiang | Contract manufacturer | 14 |
| United Dental Changzhou | Changzhou | Jiangsu | Manufacturer | 12 |
Showing 12 of 30. All 30 manufacturers in China registered for Retainer, Screw Expansion, Orthodontic
Record
| Listed by | Leone SPA, Italy |
|---|---|
| FDA product code | DYJ |
| Device type | Retainer, Screw Expansion, Orthodontic |
| Device class | Class 1 |
| Regulation | 21 CFR 872.5410 |
| Establishment | Specification developer, Repacker / relabeller, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2020-04-10 |
| Record revised | 2025-06-20 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number |
| Storage | Special storage condition: Keep dry |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| A4800-12G | In distribution | |
| A0660-95 | In distribution | |
| 201A0621-11 | In distribution | |
| A5310-97 | In distribution | |
| A1621-911D | In distribution | |
| A4801-90 | In distribution | |
| A0640-10D | In distribution | |
| A0620X911 | In distribution | |
| 201A2620-10 | In distribution | |
| A4800-52E | In distribution | |
| A2504-04D | In distribution | |
| A4800-12A | In distribution | |
| A0841-00 | In distribution | |
| R7013-05 | In distribution | |
| A0930-94 | In distribution | |
| A0621P908 | In distribution | |
| A2502-06D | In distribution | |
| A5101-00 | In distribution | |
| A0632-10D | In distribution | |
| A4805-54A | In distribution | |
| R7101-02 | In distribution | |
| 201A1621-13 | In distribution | |
| 201A0620-13 | In distribution | |
| 201-1210-01 | In distribution | |
| A2704-09D | In distribution | |
| A1760-09 | In distribution | |
| A2502-04 | In distribution | |
| A1621P911 | In distribution | |
| A5132-07 | In distribution | |
| A0620X908 | In distribution | |
| A1621-11D | In distribution | |
| A0801-12 | In distribution | |
| A0621-08 | In distribution | |
| A2503-09D | In distribution | |
| A2620-12D | In distribution | |
| A0631-912 | In distribution | |
| R7002-15 | In distribution | |
| A0621-11 | In distribution | |
| F3812-09 | In distribution | |
| A0623-11 | In distribution | |
| A0650-95 | In distribution | |
| A0620-11D | In distribution | |
| A4801-00A | In distribution | |
| A2725G906 | In distribution | |
| A0518-95 | In distribution | |
| A0802-96 | In distribution | |
| A3628-11 | In distribution | |
| A0621-11D | In distribution | |
| R7113-03 | In distribution | |
| A1760-91 | In distribution | |
| A0620X13 | In distribution | |
| A5121-01 | In distribution | |
| A0631-908 | In distribution | |
| R7112-02 | In distribution | |
| A0620D913 | In distribution | |
| A0625-07 | In distribution | |
| A3621-11 | In distribution | |
| A0620-15D | In distribution | |
| A0620W11 | In distribution | |
| R7112-03 | In distribution | |
| R7001-908 | In distribution | |
| A5100P97 | In distribution | |
| A0620W13 | In distribution | |
| A4801-00V | In distribution | |
| A0632-12D | In distribution | |
| R7001-08 | In distribution | |
| A1730-99 | In distribution | |
| A0620A909 | In distribution | |
| A0932-13 | In distribution | |
| M2302-00 | In distribution | |
| A0620X11 | In distribution | |
| F3810-27 | In distribution | |
| A2504-04 | In distribution | |
| A0596-10 | In distribution | |
| A0930-93 | In distribution | |
| A3629-11 | In distribution | |
| A0805-96 | In distribution | |
| A0631-08 | In distribution | |
| A0813-00 | In distribution | |
| A2620-07D | In distribution | |
| 201A0620-11 | In distribution | |
| 201-1006-01 | In distribution | |
| A0650-04 | In distribution | |
| A0671-15 | In distribution | |
| 201A0630-12 | In distribution | |
| R7123-02 | In distribution | |
| A2502G904 | In distribution | |
| A2726-04 | In distribution | |
| A2705-09 | In distribution | |
| R7002-07 | In distribution | |
| A0805-14 | In distribution | |
| A0620L909 | In distribution | |
| A2504-06 | In distribution | |
| A0800-10 | In distribution | |
| A4800-60 | In distribution | |
| A0621-08D | In distribution | |
| 201-1010-01 | In distribution | |
| A0815-95 | In distribution | |
| A0891-95 | In distribution | |
| A5100-07 | In distribution | |
| A0623P911 | In distribution | |
| A0631D10 | In distribution | |
| A1763-00 | In distribution | |
| R7113-02 | In distribution | |
| M2302-02 | In distribution | |
| A1730-05 | In distribution | |
| R7002-20 | In distribution | |
| M2302-01 | In distribution | |
| A5100S97 | In distribution | |
| M2302-91 | In distribution | |
| A5201-00 | In distribution | |
| R7013-08 | In distribution | |
| A5410-95 | In distribution | |
| F3812-04 | In distribution | |
| A2704-06 | In distribution | |
| A0516-14 | In distribution | |
| A1761-09 | In distribution | |
| 201A0620-10 | In distribution | |
| A5310-17 | In distribution | |
| A5310-07 | In distribution | |
| A0650-08 | In distribution | |
| A2706-09D | In distribution | |
| A2704-06D | In distribution | |
| A0621P911 | In distribution | |
| A0671-95 | In distribution | |
| F3836-37 | In distribution | |
| A0623P913D | In distribution | |
| A0630-10 | In distribution | |
| A0665-96 | In distribution | |
| A0631D08 | In distribution | |
| A0801-98 | In distribution | |
| A4800-52A | In distribution | |
| A0630-08 | In distribution | |
| A5220-17 | In distribution | |
| R7002-05 | In distribution | |
| F3822-93 | In distribution | |
| A0802-13 | In distribution | |
| A3620-11 | In distribution | |
| A2504G906 | In distribution | |
| A0620X09 | In distribution | |
| A0630-10D | In distribution | |
| A0623-08 | In distribution | |
| A2726-06 | In distribution | |
| A5133-97 | In distribution | |
| A4805-54E | In distribution | |
| A5101P00 | In distribution | |
| A4805-54R | In distribution | |
| A0650-97 | In distribution | |
| A2502-06 | In distribution | |
| A0660-06 | In distribution | |
| A1763-01 | In distribution | |
| 201-1208-01 | In distribution | |
| A0620D11 | In distribution | |
| A2704-09 | In distribution | |
| A0515-95 | In distribution | |
| A5132-17 | In distribution | |
| 201A1621-11 | In distribution | |
| X0003 | In distribution | |
| A0805-11 | In distribution | |
| A0722-00 | In distribution | |
| A3629-13 | In distribution | |
| A0665-09 | In distribution | |
| A0631D912 | In distribution | |
| A0631D910 | In distribution | |
| A0803-11 | In distribution | |
| A2503G906 | In distribution | |
| A0631-910 | In distribution | |
| A0620G908 | In distribution | |
| A0620-13 | In distribution | |
| A2725-06 | In distribution | |
| A0595-10 | In distribution | |
| A0630-12D | In distribution | |
| A0813-95 | In distribution | |
| R7001-07 | In distribution | |
| A0721-00 | In distribution | |
| A0596-00 | In distribution | |
| A5100-57 | In distribution | |
| A0672-15 | In distribution | |
| A0631-12 | In distribution | |
| R7002-908 | In distribution | |
| A0620D13 | In distribution | |
| F3836-29 | In distribution | |
| A4805-14E | In distribution | |
| A4800-52G | In distribution | |
| R7001-10 | In distribution | |
| R7001-15 | In distribution | |
| A0620D911 | In distribution | |
| A5101-93 | In distribution | |
| A4805-54V | In distribution | |
| A5300-97 | In distribution | |
| A2502-04D | In distribution | |
| A5120-07 | In distribution | |
| A5134-02 | In distribution | |
| A2620-12 | In distribution | |
| A2620-10 | In distribution | |
| A2620-07 | In distribution | |
| A0620A908 | In distribution | |
| R7002-08 | In distribution | |
| A0720-10 | In distribution | |
| A0623P908D | In distribution | |
| A5615-95 | In distribution | |
| A5100-97 | In distribution | |
| A5408-00 | In distribution | |
| A0625-09 | In distribution | |
| A0620W911 | In distribution | |
| A0630-12 | In distribution | |
| A0620D09 | In distribution | |
| A0655-03 | In distribution | |
| A0801-13 | In distribution | |
| A0623P911D | In distribution | |
| R7002-10 | In distribution | |
| A0800-95 | In distribution | |
| A4805-14A | In distribution | |
| 201A0620-15 | In distribution | |
| A0800-12 | In distribution | |
| A2703-06D | In distribution | |
| A2706-06D | In distribution | |
| A0623P908 | In distribution | |
| A4800-12R | In distribution | |
| A1730-02 | In distribution | |
| F3836-33 | In distribution | |
| A0672-95 | In distribution | |
| A2703-06 | In distribution | |
| R7102-03 | In distribution | |
| 201-1206-01 | In distribution | |
| A0620-15 | In distribution | |
| A0840-05 | In distribution | |
| A2705-06D | In distribution | |
| A2703-09 | In distribution | |
| 201A0620-12 | In distribution | |
| A5101-02 | In distribution | |
| A1621-913D | In distribution | |
| 201A0621-08 | In distribution | |
| 201-1006-00 | In distribution | |
| R7111-03 | In distribution | |
| A0931-94 | In distribution | |
| R7200-08 | In distribution | |
| A1621-08 | In distribution | |
| A0803-95 | In distribution | |
| A4801-00R | In distribution | |
| A2503-09 | In distribution | |
| A0930-16 | In distribution | |
| A1730-04 | In distribution | |
| A0801-96 | In distribution | |
| A0631D12 | In distribution | |
| F3822-14 | In distribution | |
| A5300-17 | In distribution | |
| A4805-54G | In distribution | |
| A0805-95 | In distribution | |
| 201-1008-01 | In distribution |
Showing 250 of 300 catalogue numbers.
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Retainer, Screw Expansion, Orthodontic | Dentaurum GmbH & Co. KG | 243 |
| Retainer, Screw Expansion, Orthodontic | Forestadent Bernhard Förster GmbH | 203 |
| Orthosource | Orthosource, Inc. | 110 |
| Hanks Telescoping Herbst | American Orthodontics | 95 |
| palex® | Dentaurum GmbH & Co. KG | 60 |
| Bondable Lingual Retainer | TP Orthodontics, Inc. | 60 |
| Distal Jet | American Orthodontics | 42 |
| Cantilever Bar Offset | American Orthodontics | 38 |
| Miniscope Telescoping Herbst | American Orthodontics | 37 |
| RMO | RMO | 33 |
| Palatal Arches | American Orthodontics | 28 |
| Morelli | Dental Morelli Ltda. | 28 |
Showing 12 of 295. All products under Retainer, Screw Expansion, 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.