Bondable Lingual Retainer
Lower Bicuspid to Bicuspid Kit Original Medium Temper Assorted- Size 32, 34, 36, 38 - 3 each,
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 | TP Orthodontics, Inc., United States |
|---|---|
| FDA product code | DYJ |
| Device type | Retainer, Screw Expansion, Orthodontic |
| Device class | Class 1 |
| Regulation | 21 CFR 872.5410 |
| Establishment | Repacker / relabeller, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2021-03-15 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Label carries | lot or batch number, expiry date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 224-335 | In distribution | |
| 224-334 | In distribution | |
| 224-132 | In distribution | |
| 224-034 | In distribution | |
| 224-036 | In distribution | |
| 224-333 | In distribution | |
| 224-050 | In distribution | |
| 224-430 | In distribution | |
| 224-434 | In distribution | |
| 224-119 | In distribution | |
| 224-139 | In distribution | |
| 224-150 | In distribution | |
| 224-330 | In distribution | |
| 224-436 | In distribution | |
| 224-038 | In distribution | |
| 224-220F | In distribution | |
| 224-118 | In distribution | |
| 224-211F | In distribution | |
| 224-331 | In distribution | |
| 224-332 | In distribution | |
| 224-120 | In distribution | |
| 224-336 | In distribution | |
| 224-138 | In distribution | |
| 224-337 | In distribution | |
| 224-444 | In distribution | |
| 224-135 | In distribution | |
| 224-033 | In distribution | |
| 224-322 | In distribution | |
| 224-438 | In distribution | |
| 224-323 | In distribution | |
| 224-134 | In distribution | |
| 224-321 | In distribution | |
| 224-319 | In distribution | |
| 224-137 | In distribution | |
| 224-032 | In distribution | |
| 224-350 | In distribution | |
| 224-136 | In distribution | |
| 224-339 | In distribution | |
| 224-318 | In distribution | |
| 224-320 | In distribution | |
| 224-432 | In distribution | |
| 224-035 | In distribution | |
| 224-210F | In distribution | |
| 224-031 | In distribution | |
| 224-122 | In distribution | |
| 224-338 | In distribution | |
| 224-131 | In distribution | |
| 224-121 | In distribution | |
| 224-133 | In distribution | |
| 224-123 | In distribution | |
| 224-200F | In distribution | |
| 224-460 | In distribution | |
| 224-201F | In distribution | |
| 224-442 | In distribution | |
| 224-440 | In distribution | |
| 224-125 | In distribution | |
| 224-039 | In distribution | |
| 224-030 | In distribution | |
| 224-130 | In distribution | |
| 224-037 | 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 |
| 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.