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

Ink, Arch Tracing

21 CFR 872.3150 / Dental
FDA source (opens on fda.gov)

KZO is the FDA product code for Ink, Arch Tracing, a class I device type, regulated under 21 CFR 872.3150. As of , FDA records hold 2 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
KZO
Device name
Ink, Arch Tracing
Regulation
21 CFR 872.3150
Device class
Class I
Review panel
Dental
Submission type
510(k) exempt
Implant
No
Life sustaining or supporting
No
GMP exempt
Yes
Third party review eligible
No
Ingested clearances
2
Ingested recalls
0

Clearances, product code KZO

By decision year
2 clearances under product code KZO with a decision year between 1977 and 1981, 1977 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code KZO by decision year
YearClearances
19771
19811

Applicants with the most clearances

Product code KZO
Applicants holding the most 510(k) clearances under product code KZO
ApplicantClearances
Bauer, Cheng & Associates, Inc.1
Dentsply Intl.1

Companies listing this code with FDA

Companies whose registered establishments list this code