FDA product code DYO: Band, Material, Orthodontic
DYO is the FDA product code for band, material, orthodontic. It is a Class I device, regulated under 21 CFR 872.5410 and reviewed by the Dental panel. FDA has cleared 3 510(k) submissions under DYO, from 3 different applicants. The average 510(k) review took 109 days (median 99).
Classification
| Field | Value |
|---|---|
| Device name | Band, Material, Orthodontic |
| Device class | Class I |
| Regulation | 21 CFR 872.5410 |
| Review panel | DE — Dental |
| Medical specialty | Dental |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every DYO clearance
Top DYO applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Dentauraum, Inc. | 1 | 1994-01-31 |
| Ortho Organizers, Inc. | 1 | 1993-09-01 |
| Echo Ultrasound | 1 | 1985-01-23 |
Most recent DYO clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K935152 | Dentauraum, Inc. | DENTAURUM DENTAFORM BANDS, DENTAURUM STANDARD | 1994-01-31 | 95 |
| K931980 | Ortho Organizers, Inc. | STAINLESS STEEL ORTHODONTIC PRODUCTS | 1993-09-01 | 132 |
| K844034 | Echo Ultrasound | SONOCARE | 1985-01-23 | 99 |
Recalls for DYO devices
openFDA lists no recalls for product code DYO.
Frequently asked questions
What is FDA product code DYO?
DYO is the FDA product code for band, material, orthodontic. It is a Class I device, regulated under 21 CFR 872.5410 and reviewed by the Dental panel.
What device class is DYO?
Class I, regulation 21 CFR 872.5410. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code DYO?
Across 3 cleared submissions the average was 109 days from receipt to decision (median 99).
Which companies have the most DYO clearances?
Dentauraum, Inc. (1); Ortho Organizers, Inc. (1); Echo Ultrasound (1).
Next steps
- Run an FDA pathway report with predicate devices for product code DYO
- Run a recall and safety report across every DYO manufacturer
- Watch product code DYO 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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