300 Series Facebow
Facebow Loop Style Short Outer BOW 045 Size 6 118MM
5manufacturers in China registered for this device type
22catalogue 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 | American Orthodontics, United States |
|---|---|
| FDA product code | KCR |
| Device type | Facebow |
| Device class | Class 1 |
| Regulation | 21 CFR 872.3220 |
| Establishment | Contract manufacturer, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2019-09-30 |
| Record revised | 2021-08-20 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number |
| Distribution end date | 2021-08-19 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 852-376 | Withdrawn | |
| 852-347 | Withdrawn | |
| 852-374 | Withdrawn | |
| 852-351 | Withdrawn | |
| 852-304 | Withdrawn | |
| 852-306 | Withdrawn | |
| 852-315 | Withdrawn | |
| 852-345 | Withdrawn | |
| 852-375 | Withdrawn | |
| 852-318 | Withdrawn | |
| 852-349 | Withdrawn | |
| 852-302 | Withdrawn | |
| 852-373 | Withdrawn | |
| 852-325 | Withdrawn | |
| 852-324 | Withdrawn | |
| 852-372 | Withdrawn | |
| 852-305 | Withdrawn | |
| 852-322 | Withdrawn | |
| 852-323 | Withdrawn | |
| 852-326 | Withdrawn | |
| 852-311 | Withdrawn | |
| 852-303 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Facebow | Dentaurum GmbH & Co. KG | 26 |
| 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 |
| 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.