Hanau Spring Bow Facebow
2 catalogue numbers from 010328-000, listed by Whip-MIX Corp., United States, under Facebow. 5 manufacturers in China are registered for this product code.
5manufacturers in China registered for this device type
2catalogue numbers in this listing
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 | Whip-MIX Corp., United States |
|---|---|
| FDA product code | KCR |
| Device type | Facebow |
| Device class | Class 1 |
| Regulation | 21 CFR 872.3220 |
| Establishment | Specification developer, Repacker / relabeller, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2020-09-22 |
| Record revised | 2025-09-01 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Label carries | lot or batch number, manufacturing date |
| Distribution end date | 2025-08-29 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 010328-000 | In distribution | |
| 010351-000 | Withdrawn |
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 |
| 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 |
| Noninium® | Dentaurum GmbH & Co. KG | 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.