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KZN — Scanner, Color Class II

FDA Device Classification

FDA product code KZN covers "Scanner, Color", a Class II medical device regulated under 21 CFR 872.3661. Submissions are reviewed by the Dental panel. At least 2 recent 510(k) clearances have been granted under this product code.

Classification Details

Product Code
KZN
Device Class
Class II
Regulation Number
872.3661
Submission Type
Review Panel
DE
Medical Specialty
Dental
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K072643olympus corporationCRYSTALEYE SPECTROPHOTOMETER/CRYSTALEYE BASIC SET, MODEL CE100-DC/USNovember 16, 2007
K770667sterndentCHROMASCAN TMApril 20, 1977

FDA data resources