Facebow
Standard Face Bow mini, with stop loops 97 mm, inner bow ø 1.15 mm
5manufacturers in China registered for this device type
26catalogue 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 | Dentaurum GmbH & Co. KG, Germany |
|---|---|
| FDA product code | KCR |
| Device type | Facebow |
| Device class | Class 1 |
| Regulation | 21 CFR 872.3220 |
| Establishment | Manufacturer, Exporter |
| Premarket notification | Exempt |
| Record published | 2016-09-15 |
| Record revised | 2023-07-24 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number |
| Storage | Special storage condition: No special storage conditions required |
| Distribution end date | 2024-01-25 |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 740-010-00 | In distribution | ||
| 741-050-00 | In distribution | ||
| 740-021-00 | In distribution | ||
| 741-150-00 | In distribution | ||
| 741-055-00 | In distribution | ||
| 607-300-00 | 10 | In distribution | |
| 480-918-02 | 10 | In distribution | |
| 741-045-00 | In distribution | ||
| 741-060-00 | In distribution | ||
| 740-019-00 | In distribution | ||
| 480-914-00 | 100 | In distribution | |
| 741-049-00 | In distribution | ||
| 748-114-00 | In distribution | ||
| 741-040-00 | In distribution | ||
| 740-020-00 | In distribution | ||
| 607-301-00 | 10 | In distribution | |
| 741-255-00 | Withdrawn | ||
| 741-250-00 | Withdrawn | ||
| 741-240-00 | Withdrawn | ||
| 740-220-00 | Withdrawn | ||
| 480-913-00 | 100 | Withdrawn | |
| 748-009-00 | Withdrawn | ||
| 741-245-00 | Withdrawn | ||
| 740-120-00 | Withdrawn | ||
| 740-221-00 | Withdrawn | ||
| 740-219-00 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| 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 |
| 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.