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

Screw, Fixation, Intraosseous

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

DZL is the FDA product code for Screw, Fixation, Intraosseous, a class II device type, regulated under 21 CFR 872.4880. As of , FDA records hold 81 510(k) clearances under this code, the most recent dated , and 8 recalls.

Classification record

Product code
DZL
Device name
Screw, 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
81
Ingested recalls
8

Clearances, product code DZL

By decision year
81 clearances under product code DZL with a decision year between 1976 and 2026, 1998 the highest year at 9.
Show the numbers
510(k) clearances under FDA product code DZL by decision year
YearClearances
19761
19771
19913
19952
19964
19976
19989
19996
20003
20014
20024
20031
20042
20054
20071
20082
20092
20103
20112
20131
20142
20151
20161
20173
20192
20201
20211
20232
20242
20254
20261

Applicants with the most clearances

Product code DZL
Applicants holding the most 510(k) clearances under product code DZL
ApplicantClearances
Synthes (USA) Products LLC13
Hager & Meisinger GmbH5
Osteomed5
KLS-Martin L.P.4
BioHorizons Implant Systems Inc3
Zimmer GmbH3
Mitek Products3
OSSTEM Implant Co., Ltd.3
Salvin Dental Specialties, LLC3
Doctor'S Research Group, Inc.2

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 65 companies shown, in name order