Orthosource
Removable Appliance Screw Universal Extra Large Beige 11mm
30manufacturers in China registered for this device type
110catalogue 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 | Orthosource, Inc., United States |
|---|---|
| FDA product code | DYJ |
| Device type | Retainer, Screw Expansion, Orthodontic |
| Device class | Class 1 |
| Regulation | 21 CFR 872.5410 |
| Premarket notification | Exempt |
| Record published | 2022-10-26 |
| Record revised | 2022-11-04 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Label carries | lot or batch number, expiry date |
| Distribution end date | 2022-10-25 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 5005/13 | In distribution | |
| 1006 D-10 | In distribution | |
| 1001 N-12 | In distribution | |
| 1001 N-14A | In distribution | |
| 3009 KG | In distribution | |
| 3040 ZG | In distribution | |
| 1009 KS | In distribution | |
| 810-007 | In distribution | |
| 5005/15 | In distribution | |
| 1110M-22 | In distribution | |
| 1020 ZG | In distribution | |
| 810-001 | In distribution | |
| 4005/13 | In distribution | |
| 1006 B-12 | In distribution | |
| 4009 SO | In distribution | |
| 3016/2 | In distribution | |
| 2009 G | In distribution | |
| 1006 C-14 | In distribution | |
| 1003K-10 | In distribution | |
| 1009 S | In distribution | |
| 810-003 | In distribution | |
| 2004 | In distribution | |
| 3005/7 | In distribution | |
| 1001 N-14B | In distribution | |
| 1041 ZS | In distribution | |
| 3041 ZS | In distribution | |
| 1005/14 | In distribution | |
| 3009 KSO | In distribution | |
| 1016 | In distribution | |
| 1110D-9 | In distribution | |
| 3009 S | In distribution | |
| 0100A-13 | In distribution | |
| 2013 | In distribution | |
| 1006 T-12 | In distribution | |
| 1110E-17 | In distribution | |
| 3009 G | In distribution | |
| 1006 B-14 | In distribution | |
| 1121 | In distribution | |
| 3015/3 | In distribution | |
| 810-006 | In distribution | |
| 1120R | In distribution | |
| 810-156 | In distribution | |
| 4009 G | In distribution | |
| 1122R | In distribution | |
| 2012 | In distribution | |
| 1120 | In distribution | |
| 1005/12 | In distribution | |
| 1003K-14 | In distribution | |
| 1009 KSO | In distribution | |
| 1844 | In distribution | |
| 1006 C-10 | In distribution | |
| 1018FA | In distribution | |
| 1001 N-10 | In distribution | |
| 1110M-15 | In distribution | |
| 1017 | In distribution | |
| 0100B-10 | In distribution | |
| 4016/2 | In distribution | |
| 1009 KG | In distribution | |
| 5005/11 | In distribution | |
| 1006 D-14 | In distribution | |
| 1002K-10 | In distribution | |
| 1110M-17 | In distribution | |
| 3009 KS | In distribution | |
| 3005/12 | In distribution | |
| 3005/14 | In distribution | |
| 1122 | In distribution | |
| 1110C-10 | In distribution | |
| 4005/11 | In distribution | |
| 1110A-15 | In distribution | |
| 2008 | In distribution | |
| 1121R | In distribution | |
| 3020 ZG | In distribution | |
| 1006 D-12 | In distribution | |
| 1040 ZG | In distribution | |
| 2006 | In distribution | |
| 1110B-13 | In distribution | |
| 4015/3 | In distribution | |
| 1845 | In distribution | |
| 4009 S | In distribution | |
| 1005 T-12 | In distribution | |
| 2040 ZG | In distribution | |
| 3021 ZS | In distribution | |
| 3009 SO | In distribution | |
| 810-008 | In distribution | |
| 1005/7 | In distribution | |
| 1009 G | In distribution | |
| 1002K-14 | In distribution | |
| 2005/7 | In distribution | |
| 2009 | In distribution | |
| 1019FA | In distribution | |
| 1214/13 | Withdrawn | |
| 1009 SO | Withdrawn | |
| 820-011 | Withdrawn | |
| 1006 C-15 | Withdrawn | |
| 1009 LSO | Withdrawn | |
| 1006 A-10 | Withdrawn | |
| 810-002 | Withdrawn | |
| 820-007 | Withdrawn | |
| 1021 ZS | Withdrawn | |
| 1006 B-10 | Withdrawn | |
| 820-009 | Withdrawn | |
| 1009 LS | Withdrawn | |
| 1006 A-12 | Withdrawn | |
| 1114/22 | Withdrawn | |
| 1214/15 | Withdrawn | |
| 820-013 | Withdrawn | |
| 810-014 | Withdrawn | |
| 810-011 | Withdrawn | |
| 1006 A-14 | Withdrawn | |
| 1009 LG | 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 |
| 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.