FDA product code DYJ: Retainer, Screw Expansion, Orthodontic
DYJ is the FDA product code for retainer, screw expansion, orthodontic. It is a Class I device, regulated under 21 CFR 872.5410 and reviewed by the Dental panel. FDA has cleared 5 510(k) submissions under DYJ, from 5 different applicants. The average 510(k) review took 125 days (median 98). FDA has posted 6 recalls for DYJ devices, 3 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Retainer, Screw Expansion, 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 DYJ clearance
Top DYJ applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Cleft Palate Appliances, Inc. | 1 | 1997-04-23 |
| Dentauraum, Inc. | 1 | 1994-02-03 |
| Forestadent | 1 | 1993-05-22 |
| American Orthodontics | 1 | 1991-12-20 |
| A Company, Inc. | 1 | 1984-11-14 |
Most recent DYJ clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K970930 | Cleft Palate Appliances, Inc. | BILATERAL INFANT CLEFT PALATE ORTHODONTIC APPLIANCE | 1997-04-23 | 41 |
| K935154 | Dentauraum, Inc. | DENTAURUM EXPANSION SCREWS | 1994-02-03 | 98 |
| K925088 | Forestadent | EXPANSION SCREWS | 1993-05-22 | 227 |
| K912417 | American Orthodontics | MOLAR DISTALIZING ASSEMBLY | 1991-12-20 | 203 |
| K843705 | A Company, Inc. | MANDIBULATOR JAW POSITIONER | 1984-11-14 | 54 |
Recalls for DYJ devices
6 product recalls in 4 recall events; 3 initiated in the last five years and 0 still open. Most recent: 2022-02-07.
| Year | Recalls |
|---|---|
| 2022 | 3 |
Frequently asked questions
What is FDA product code DYJ?
DYJ is the FDA product code for retainer, screw expansion, orthodontic. It is a Class I device, regulated under 21 CFR 872.5410 and reviewed by the Dental panel.
What device class is DYJ?
Class I, regulation 21 CFR 872.5410. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code DYJ?
Across 5 cleared submissions the average was 125 days from receipt to decision (median 98).
Which companies have the most DYJ clearances?
Cleft Palate Appliances, Inc. (1); Dentauraum, Inc. (1); Forestadent (1); American Orthodontics (1); A Company, Inc. (1).
Have DYJ devices been recalled?
Yes: 6 product recalls across 4 recall events; the most recent began 2022-02-07.
Next steps
- Run an FDA pathway report with predicate devices for product code DYJ
- Run a recall and safety report across every DYJ manufacturer
- Watch product code DYJ 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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