Scanner, Color
The Dental Color Scanner is a device used in dentistry to capture and digitally analyze the shade of natural teeth or dental restorations, providing objective color matching data to guide the fabrication of prosthetic crowns, veneers, and other restorations. It is classified as FDA Class 2, indicating moderate risk, and does not require a premarket submission under the submission type assigned to this category. The product code is KZN, regulated under 21 CFR 872.3661, in the Dental medical specialty. No special flags apply to this device.
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Basic Information
- Product Code
- KZN
- Device Class
- FDA class 2
- Regulation Number
- 872.3661
- 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 5 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 5 registration numbers. Click on an entry to view related FDA registrations.