Accessory
11 catalogue numbers from Tray handle. 5pcs., listed by Amann Girrbach AG, Austria, under Facebow. 5 manufacturers in China are registered for this product code.
5manufacturers in China registered for this device type
11catalogue 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 | Amann Girrbach AG, Austria |
|---|---|
| FDA product code | KCR |
| Device type | Facebow |
| Device class | Class 1 |
| Regulation | 21 CFR 872.3220 |
| Establishment | Private-label distributor, Complaint-file establishment, Manufacturer, Exporter |
| Premarket notification | Exempt |
| Record published | 2022-08-22 |
| Record revised | 2024-09-06 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Prescription | Prescription only |
| Label carries | lot or batch number, serial number |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| Tray handle. 5pcs. | 5 | In distribution | |
| Carrier for facebow cadiax compact, pair | In distribution | ||
| Pours button long / pair | In distribution | ||
| Bite fork partial, 2pcs | In distribution | ||
| Pours button standard/ pair | In distribution | ||
| Axis plane pointer with screw | In distribution | ||
| Leipzig Nasion | In distribution | ||
| Nasion adapter, blue | In distribution | ||
| Bite fork total | In distribution | ||
| Joint support | In distribution | ||
| Nasion vertically adjustable | 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 |
| 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 |
| 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.