Facebow
A facebow is a dental measurement device used to register and transfer the spatial relationship of the maxillary teeth to the temporomandibular joint and the axis of mandibular rotation, enabling accurate mounting of dental casts on an articulator for the fabrication of prostheses or occlusal adjustments. It is classified as an FDA Class 1 device, the lowest risk category, subject only to general controls. Product code KCR is regulated under 21 CFR 872.3220 in the Dental medical specialty. This device is GMP exempt, meaning it is not subject to full Quality System Regulation requirements.
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Basic Information
- Product Code
- KCR
- Device Class
- FDA class 1
- Regulation Number
- 872.3220
- Medical Specialty
- Dental
- Review Panel
- DE
- Submission Type
- 4
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 1 510(k) clearance via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K830775 | FACEBOW FOR BALANCE ARTICULATOR | Apr 28, 1983 | Substantially Equivalent | Almore Intl., Inc. |
FEI Numbers
This FDA classification entry is associated with 46 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 46 registration numbers. Click on an entry to view related FDA registrations.