510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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KZNClass II

Scanner, Color

21 CFR 872.3661 / Dental
FDA source (opens on fda.gov)

KZN is the FDA product code for Scanner, Color, a class II device type, regulated under 21 CFR 872.3661. As of , FDA records hold 2 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
KZN
Device name
Scanner, Color
Regulation
21 CFR 872.3661
Device class
Class II
Review panel
Dental
Submission type
510(k) exempt
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
2
Ingested recalls
0

Clearances, product code KZN

By decision year
2 clearances under product code KZN with a decision year between 1977 and 2007, 1977 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code KZN by decision year
YearClearances
19771
20071

Applicants with the most clearances

Product code KZN
Applicants holding the most 510(k) clearances under product code KZN
ApplicantClearances
Olympus Corp.1
Sterndent Corp.1

Companies listing this code with FDA

Companies whose registered establishments list this code