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

Headgear, Extraoral, Orthodontic

21 CFR 872.5500 / Dental
FDA source (opens on fda.gov)

DZB is the FDA product code for Headgear, Extraoral, Orthodontic, a class II device type, regulated under 21 CFR 872.5500. As of , FDA records hold 36 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
DZB
Device name
Headgear, Extraoral, Orthodontic
Regulation
21 CFR 872.5500
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
36
Ingested recalls
0

Clearances, product code DZB

By decision year
36 clearances under product code DZB with a decision year between 1977 and 2021, 1998 the highest year at 5.
Show the numbers
510(k) clearances under FDA product code DZB by decision year
YearClearances
19772
19781
19791
19801
19851
19862
19903
19911
19922
19932
19942
19951
19962
19985
20002
20031
20041
20052
20112
20171
20211

Applicants with the most clearances

Product code DZB
Applicants holding the most 510(k) clearances under product code DZB
ApplicantClearances
Ortho Kinetics Corp.6
Northwest Orthodontics, Inc.5
Ormco Corp.4
Great Lakes Orthodontics, Ltd.2
Ortho Technology2
A Company, Inc.1
Clp Products1
Dentauraum, Inc.1
Dontech Products B.V.1
Forestadent Bernhard Forster GmbH1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 27 companies shown, in name order