Distal Jet
Fixed Funct Distal JET Wire Standard SS.045 3.5 Inches 10/PKG
30manufacturers in China registered for this device type
42catalogue numbers in this listing
1510(k) clearance
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 | American Orthodontics, United States |
|---|---|
| FDA product code | DYJ |
| Device type | Retainer, Screw Expansion, Orthodontic |
| Device class | Class 1 |
| Regulation | 21 CFR 872.5410 |
| Establishment | Contract manufacturer, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2026-01-28 |
| Record revised | 2025-06-16 (version 7) |
Specifications
| MRI safety | MR Unsafe |
|---|---|
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, manufacturing date |
| Distribution end date | 2025-06-16 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 855-606PK | In distribution | |
| 855-602 | In distribution | |
| 855-511 | In distribution | |
| 855-501 | In distribution | |
| 855-518 | In distribution | |
| 855-509PK | In distribution | |
| 855-607 | In distribution | |
| 855-510 | In distribution | |
| 855-510PK | In distribution | |
| 855-512 | In distribution | |
| 855-500 | In distribution | |
| 855-606 | In distribution | |
| 855-519 | In distribution | |
| 855-505 | In distribution | |
| 855-504 | In distribution | |
| 855-602PK | In distribution | |
| 855-503 | In distribution | |
| 855-608PK | In distribution | |
| 855-505PK | In distribution | |
| 855-509 | In distribution | |
| 855-504PK | In distribution | |
| 855-608 | In distribution | |
| 855-504 | Withdrawn | |
| 855-518 | Withdrawn | |
| 855-504PK | Withdrawn | |
| 855-606 | Withdrawn | |
| 855-608PK | Withdrawn | |
| 855-602PK | Withdrawn | |
| 855-519 | Withdrawn | |
| 855-501 | Withdrawn | |
| 855-512 | Withdrawn | |
| 855-606PK | Withdrawn | |
| 855-602 | Withdrawn | |
| 855-505 | Withdrawn | |
| 855-608 | Withdrawn | |
| 855-607 | Withdrawn | |
| 855-509PK | Withdrawn | |
| 855-503 | Withdrawn | |
| 855-510 | Withdrawn | |
| 855-510PK | Withdrawn | |
| 855-505PK | Withdrawn | |
| 855-511 | 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 |
| palex® | Dentaurum GmbH & Co. KG | 60 |
| Bondable Lingual Retainer | TP Orthodontics, Inc. | 60 |
| 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
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K912417 | 1991-12-20 |
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.