Teeth, Artificial, Backing And Facing
Backing and Facing Artificial Teeth are dental prosthetic components consisting of a tooth-colored facing material bonded to a metal backing, used in fixed or removable prostheses to restore aesthetics in the anterior region while providing structural support through the metal substrate. They are classified as FDA Class 1 (lowest risk), subject only to general controls. The product code is ELK, regulated under 21 CFR 872.3910 in the Dental (DE) specialty.
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Basic Information
- Product Code
- ELK
- Device Class
- FDA class 1
- Regulation Number
- 872.3910
- 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 2 510(k) clearances via K numbers.
FEI Numbers
This FDA classification entry is associated with 26 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 26 registration numbers. Click on an entry to view related FDA registrations.