Product code KCR
- Device name
- Facebow
- Medical specialty
- Dental
- Device class
- 1
- Regulation number
- 872.3220
- Review panel
- DE
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- Y
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K830775 | FACEBOW FOR BALANCE ARTICULATOR | Almore Intl., Inc. | 1983-04-28 |
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| 06973329326080 | Reverse Pull Headgear(Face Mask), Middle, Orange | Astar Orthodontics Inc. | 2023-12-31 |
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| E1996625211 | CRS Set 15 | Candulor AG | 2023-11-16 |
| 07895742167462 | Morelli | Dental Morelli Ltda | 2021-04-30 |
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| J011480914000 | N.A. | DENTAURUM GmbH & Co.KG | 2016-09-15 |