Palex®
"palex® click Medium - 10, bent / RPE screw with the “Click” feature to prevent unwanted turning back For effective and reliable rapid palatal expansion by means of fixed appliances. / For…
“palex® click Medium – 10, bent / RPE screw with the “Click” feature to prevent unwanted turning back For effective and reliable rapid palatal expansion by means of fixed appliances. / For further information please visit our website: www.dentaurum.de”
30manufacturers in China registered for this device type
60catalogue 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 | Dentaurum GmbH & Co. KG, Germany |
|---|---|
| FDA product code | DYJ |
| Device type | Retainer, Screw Expansion, Orthodontic |
| Device class | Class 1 |
| Regulation | 21 CFR 872.5410 |
| Establishment | Manufacturer, Exporter |
| Premarket notification | Exempt |
| Record published | 2019-09-18 |
| Record revised | 2021-11-16 (version 5) |
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: No special storage conditions required |
| Distribution end date | 2018-02-03 |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 602-800-33 | 10 | In distribution | |
| 602-832-31 | 10 | In distribution | |
| 602-834-13 | In distribution | ||
| 602-800-11 | In distribution | ||
| 602-810-55 | 50 | In distribution | |
| 602-808-31 | 10 | In distribution | |
| 602-812-31 | 10 | In distribution | |
| 602-808-33 | 10 | In distribution | |
| 602-832-13 | In distribution | ||
| 602-833-55 | 50 | In distribution | |
| 602-832-55 | 50 | In distribution | |
| 602-811-33 | 10 | In distribution | |
| 602-811-13 | In distribution | ||
| 602-808-11 | In distribution | ||
| 602-833-11 | In distribution | ||
| 602-830-13 | In distribution | ||
| 602-800-55 | 50 | In distribution | |
| 602-832-33 | 10 | In distribution | |
| 602-834-33 | 10 | In distribution | |
| 602-830-31 | 10 | In distribution | |
| 602-811-11 | In distribution | ||
| 602-830-33 | 10 | In distribution | |
| 602-811-55 | 50 | In distribution | |
| 602-801-31 | 10 | In distribution | |
| 602-801-55 | 50 | In distribution | |
| 602-835-11 | In distribution | ||
| 602-808-13 | In distribution | ||
| 602-834-31 | 10 | In distribution | |
| 602-810-11 | In distribution | ||
| 602-812-11 | In distribution | ||
| 602-800-13 | In distribution | ||
| 602-800-31 | 10 | In distribution | |
| 602-830-11 | In distribution | ||
| 602-808-55 | 50 | In distribution | |
| 602-810-31 | 10 | In distribution | |
| 602-831-11 | In distribution | ||
| 602-812-55 | 50 | In distribution | |
| 602-832-11 | In distribution | ||
| 602-835-31 | 10 | In distribution | |
| 602-834-11 | In distribution | ||
| 602-831-31 | 10 | In distribution | |
| 602-834-55 | 50 | In distribution | |
| 602-833-31 | 10 | In distribution | |
| 602-830-55 | 50 | In distribution | |
| 602-835-55 | 50 | In distribution | |
| 602-831-55 | 50 | In distribution | |
| 602-811-31 | 10 | In distribution | |
| 602-801-11 | In distribution | ||
| 602-831-01 | Withdrawn | ||
| 602-833-01 | Withdrawn | ||
| 602-801-01 | Withdrawn | ||
| 602-808-01 | Withdrawn | ||
| 602-800-01 | Withdrawn | ||
| 602-812-01 | Withdrawn | ||
| 602-832-01 | Withdrawn | ||
| 602-835-01 | Withdrawn | ||
| 602-810-01 | Withdrawn | ||
| 602-834-01 | Withdrawn | ||
| 602-830-01 | Withdrawn | ||
| 602-811-01 | Withdrawn |
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 |
| 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.