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

Wire, Fixation, Intraosseous

21 CFR 872.4880 / Dental
FDA source (opens on fda.gov)

DZK is the FDA product code for Wire, Fixation, Intraosseous, a class II device type, regulated under 21 CFR 872.4880. As of , FDA records hold 2 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
DZK
Device name
Wire, Fixation, Intraosseous
Regulation
21 CFR 872.4880
Device class
Class II
Review panel
Dental
Submission type
510(k)
Implant
Yes
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
2
Ingested recalls
0

Clearances, product code DZK

By decision year
2 clearances under product code DZK with a decision year between 2002 and 2010, 2002 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code DZK by decision year
YearClearances
20021
20101

Applicants with the most clearances

Product code DZK
Applicants holding the most 510(k) clearances under product code DZK
ApplicantClearances
Ideatrics, Inc.1
Russell B. Walther1

Companies listing this code with FDA

Companies whose registered establishments list this code