Reverse Pull Headgear(Face Mask), Middle, Blue
Catalogue number 5268-5002, listed by Astar Orthodontics Inc., China, under Facebow. 5 manufacturers in China are registered for this product code.
5manufacturers in China registered for this device type
1catalogue number
Who Else Makes It
Concentrated in Zhejiang (3), Guangdong (1), Shanghai (1).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Hangzhou Wise Medical Device Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 25 |
| Guangzhou Cheer-U Material Technology Co., Ltd. | Guangzhou | Guangdong | Manufacturer | 15 |
| Astar Orthodontics Inc. | Shanghai | Shanghai | Manufacturer | 12 |
| Hangzhou Pengwu Medical Equipment Co., Ltd. | Hangzhou | Zhejiang | Manufacturer | 9 |
| Zhejiang Risheng Medical Technology Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 8 |
Record
| Listed by | Astar Orthodontics Inc., China |
|---|---|
| FDA product code | KCR |
| Device type | Facebow |
| Device class | Class 1 |
| Regulation | 21 CFR 872.3220 |
| Establishment | Manufacturer, Exporter |
| Premarket notification | Exempt |
| Record published | 2023-12-31 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Label carries | lot or batch number, expiry date, manufacturing date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 5268-5002 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Facebow | Dentaurum GmbH & Co. KG | 26 |
| 300 Series Facebow | American Orthodontics | 22 |
| Morelli | Dental Morelli Ltda. | 17 |
| Facebow | Forestadent Bernhard Förster GmbH | 14 |
| accessory | Amann Girrbach AG | 11 |
| Novo Surgical | Novo Surgical, Inc. | 5 |
| Slidematic Facebow | Whip-MIX Corp. | 4 |
| Hanau Spring Bow Facebow | Whip-MIX Corp. | 2 |
| OneBite™ Facial Axis Recorder | Clinician’S Choice Dental Products, Inc. | 2 |
| UTS 3D/ UTS CAD | Ivoclar Vivadent Aktiengesellschaft | 2 |
| Artex | Amann Girrbach AG | 2 |
| #2240Q ART/#8645 Face BOW IN BOX | Whip-MIX Corp. | 1 |
Showing 12 of 35. All products under Facebow
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.