FDA product code DYT: Maintainer, Space Preformed, Orthodontic
DYT is the FDA product code for maintainer, space preformed, orthodontic. It is a Class I device, regulated under 21 CFR 872.5525 and reviewed by the Dental panel. FDA has cleared 4 510(k) submissions under DYT, from 4 different applicants. The average 510(k) review took 94 days (median 92).
Classification
| Field | Value |
|---|---|
| Device name | Maintainer, Space Preformed, Orthodontic |
| Device class | Class I |
| Regulation | 21 CFR 872.5525 |
| Review panel | DE — Dental |
| Medical specialty | Dental |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every DYT clearance
Top DYT applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Dentauraum, Inc. | 1 | 1994-04-28 |
| Dentec, Inc. | 1 | 1987-04-07 |
| Unitek Corp. | 1 | 1981-09-21 |
| Northwest Orthodontics, Inc. | 1 | 1978-06-30 |
Most recent DYT clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K935856 | Dentauraum, Inc. | DENTAURUM SPACE MAINTAINER | 1994-04-28 | 141 |
| K864376 | Dentec, Inc. | FIBERBOND | 1987-04-07 | 153 |
| K812239 | Unitek Corp. | UNITEK PALATAL BAR | 1981-09-21 | 41 |
| K780814 | Northwest Orthodontics, Inc. | SAFETY STOP NECKSTRAP | 1978-06-30 | 43 |
Recalls for DYT devices
openFDA lists no recalls for product code DYT.
Frequently asked questions
What is FDA product code DYT?
DYT is the FDA product code for maintainer, space preformed, orthodontic. It is a Class I device, regulated under 21 CFR 872.5525 and reviewed by the Dental panel.
What device class is DYT?
Class I, regulation 21 CFR 872.5525. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code DYT?
Across 4 cleared submissions the average was 94 days from receipt to decision (median 92).
Which companies have the most DYT clearances?
Dentauraum, Inc. (1); Dentec, Inc. (1); Unitek Corp. (1); Northwest Orthodontics, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code DYT
- Run a recall and safety report across every DYT manufacturer
- Watch product code DYT for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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