DYJ
5 FDA 510(k) clearances · Product code
98 daysmedian time to decision
227 days90th percentile
5clearances measured
FDA profile
- Official device name
- Retainer, Screw Expansion, Orthodontic
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 872.5410
- Medical specialty
- Dental
- Adverse events (MAUDE)
- 2004: 1 · 2005: 4 · 2006: 2 · 2007: 6 · 2008: 3 · 2018: 12
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| BILATERAL INFANT CLEFT PALATE ORTHODONTIC APPLIANCE (K970930) | Cleft Palate Appliances, Inc. | 1997-04-23 |
| DENTAURUM EXPANSION SCREWS (K935154) | Dentauraum, Inc. | 1994-02-03 |
| EXPANSION SCREWS (K925088) | Forestadent | 1993-05-22 |
| MOLAR DISTALIZING ASSEMBLY (K912417) | American Orthodontics | 1991-12-20 |
| MANDIBULATOR JAW POSITIONER (K843705) | A Company, Inc. | 1984-11-14 |
Track DYJ automatically
Every clearance here is in the API, with alerts when new ones post.