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

Drill, Bone, Powered

21 CFR 872.4120 / Dental
FDA source (opens on fda.gov)

DZI is the FDA product code for Drill, Bone, Powered, a class II device type, regulated under 21 CFR 872.4120. As of , FDA records hold 50 510(k) clearances under this code, the most recent dated , and 20 recalls.

Classification record

Product code
DZI
Device name
Drill, Bone, Powered
Regulation
21 CFR 872.4120
Device class
Class II
Review panel
Dental
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
Yes
Ingested clearances
50
Ingested recalls
20

Clearances, product code DZI

By decision year
50 clearances under product code DZI with a decision year between 1979 and 2026, 2009 the highest year at 5.
Show the numbers
510(k) clearances under FDA product code DZI by decision year
YearClearances
19791
19814
19872
19961
19992
20032
20041
20051
20062
20072
20084
20095
20112
20124
20141
20153
20161
20183
20203
20231
20242
20251
20262

Applicants with the most clearances

Product code DZI
Applicants holding the most 510(k) clearances under product code DZI
ApplicantClearances
Mectron S.p.A.5
JEDMED Instrument Company4
Satelec3
Stryker Corp.3
Bonart Co. Ltd.2
Dmetec.Co., Ltd.2
Dong IL Technology, Ltd.2
Implant Direct Sybron Manufacturing LLC2
Linvatec Corporation2
Nakanishi Inc.2

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 75 companies shown, in name order