510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
DZDClass I

Tube, Orthodontic

21 CFR 872.5410 / Dental
FDA source (opens on fda.gov)

DZD is the FDA product code for Tube, Orthodontic, a class I device type, regulated under 21 CFR 872.5410. As of , FDA records hold 8 510(k) clearances under this code, the most recent dated , and 4 recalls.

Classification record

Product code
DZD
Device name
Tube, Orthodontic
Regulation
21 CFR 872.5410
Device class
Class I
Review panel
Dental
Submission type
510(k) exempt
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
8
Ingested recalls
4

Clearances, product code DZD

By decision year
8 clearances under product code DZD with a decision year between 1978 and 1995, 1984 the highest year at 2.
Show the numbers
510(k) clearances under FDA product code DZD by decision year
YearClearances
19781
19842
19901
19911
19942
19951

Applicants with the most clearances

Product code DZD
Applicants holding the most 510(k) clearances under product code DZD
ApplicantClearances
Alexotek Co.2
Aequitron Medical, Inc.1
Dentauraum, Inc.1
Jon-Ko Products, Inc.1
Ortho Specialties1
Percussionaire Corp.1
Rocky Mountain Orthodontics, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 113 companies shown, in name order