Atoz Expander
The ATOZ Expander is used to stretch and split the mid-palatal suture and subsequently increase the width of the maxillary arch. For the procedure, the ATOZ Expander is placed under the…
The ATOZ Expander is used to stretch and split the mid-palatal suture and subsequently increase the width of the maxillary arch. For the procedure, the ATOZ Expander is placed under the patient’s palate, and the ATOZ Mini-Screw and the ATOZ Screwdriver, which are registered with the FDA separately from this product, are used to fix the ATOZ Expander. After that, use the ATOZ activation key to expand this product. The patient’s palate is then forcibly opened by the force of the expander. The gap will naturally form bone over time and remain permanently expanded, and the ATOZ Expander and the ATOZ Mini-Screw are removed when the patient’s palate is sufficiently wide. INDICATION FOR USE The ATOZ Expander is used to stretch and split the mid-palatal suture and subsequently increase the width of the maxillary arch Trade Name: ATOZ Expander Model Number: T-UNI-F12
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 | MK medical GmbH, Germany |
|---|---|
| FDA product code | DYJ |
| Device type | Retainer, Screw Expansion, Orthodontic |
| Device class | Class 1 |
| Regulation | 21 CFR 872.5410 |
| Establishment | Contract manufacturer, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2022-01-22 |
Specifications
| MRI safety | MR Unsafe |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| MKE-08-F | In distribution | |
| T-UNI-F12 | In distribution | |
| A-UNI-F08 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Leone SPA | Leone SPA | 441 |
| 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 |
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.