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

Maintainer, Space Preformed, Orthodontic

21 CFR 872.5525 / Dental
FDA source (opens on fda.gov)

DYT is the FDA product code for Maintainer, Space Preformed, Orthodontic, a class I device type, regulated under 21 CFR 872.5525. As of , FDA records hold 4 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
DYT
Device name
Maintainer, Space Preformed, Orthodontic
Regulation
21 CFR 872.5525
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
4
Ingested recalls
0

Clearances, product code DYT

By decision year
4 clearances under product code DYT with a decision year between 1978 and 1994, 1978 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code DYT by decision year
YearClearances
19781
19811
19871
19941

Applicants with the most clearances

Product code DYT
Applicants holding the most 510(k) clearances under product code DYT
ApplicantClearances
Dentauraum, Inc.1
Dentec, Inc.1
Northwest Orthodontics, Inc.1
Unitek Corp.1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 90 companies shown, in name order