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

Retainer, Screw Expansion, Orthodontic

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

DYJ is the FDA product code for Retainer, Screw Expansion, Orthodontic, a class I device type, regulated under 21 CFR 872.5410. As of , FDA records hold 5 510(k) clearances under this code, the most recent dated , and 6 recalls.

Classification record

Product code
DYJ
Device name
Retainer, Screw Expansion, 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
5
Ingested recalls
6

Clearances, product code DYJ

By decision year
5 clearances under product code DYJ with a decision year between 1984 and 1997, 1984 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code DYJ by decision year
YearClearances
19841
19911
19931
19941
19971

Applicants with the most clearances

Product code DYJ
Applicants holding the most 510(k) clearances under product code DYJ
ApplicantClearances
A Company, Inc.1
American Orthodontics1
Cleft Palate Appliances, Inc.1
Dentauraum, Inc.1
Forestadent1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 117 companies shown, in name order