Product Code: KZN FDA class 2 21 CFR 872.3661

Scanner, Color

Dental

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.

510(k)s
2
FEI Numbers
5
Registration Numbers
5
Unique Applicants
2
Years Active
31

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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

GMP Exempt
Implant
Life Sustain/Support
Third Party
Summary Malfunction Reporting

510(k) Clearance History

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Related 510(k) Clearances

This FDA classification is associated with 2 510(k) clearances via K numbers.

K Number Device Name
K072643 CRYSTALEYE SPECTROPHOTOMETER/CRYSTALEYE BASIC SET, MODEL CE100-DC/US
K770667 CHROMASCAN TM

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.