Prosthesis, Facial, Mandibular Implant
A mandibular implant is a surgically implanted facial prosthesis used to reconstruct or augment the mandible following trauma, oncological resection, or congenital deficiency, restoring facial contour and jaw function. It is classified as FDA Class 2, indicating moderate risk and requiring 510(k) premarket clearance before marketing. The product code is JAZ, regulated under 21 CFR 874.3695, within the Ear, Nose, Throat medical specialty. This device is an implant.
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Basic Information
- Product Code
- JAZ
- Device Class
- FDA class 2
- Regulation Number
- 874.3695
- Medical Specialty
- Ear, Nose, Throat
- Review Panel
- EN
- Submission Type
- 1
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 2 510(k) clearances via K numbers.
FEI Numbers
This FDA classification entry is associated with 2 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 2 registration numbers. Click on an entry to view related FDA registrations.