ECO
7 FDA 510(k) clearances · Product code
64 daysmedian time to decision
381 days90th percentile
7clearances measured
FDA profile
- Official device name
- Spring, Orthodontic
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 872.5410
- Medical specialty
- Dental
- Adverse events (MAUDE)
- 2002: 1 · 2004: 1
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 |
|---|---|---|
| MAGNEFORCE (K943068) | Ormco Corp. | 1994-08-17 |
| MESIAL LOOP BAR (K933542) | Gac Intl., Inc. | 1994-08-05 |
| ADJUSTABLE BITE CORRECTOR (K942492) | Orthoplus, Inc. | 1994-07-13 |
| ACTIVE VERTICAL CORRECTOR APPLIANCE (K844234) | Active Vertical Correctors, Inc. | 1985-01-04 |
| ORTHOMAG MAGNETIC FORCE SYSTEM (K843550) | Medical Magnetics, Inc. | 1984-12-21 |
| ACTIVE VERTICAL CORRECTOR ACTIVE BITE (K843344) | Active Vertical Correctors, Inc. | 1984-12-03 |
| ISODYNE (K770558) | Hmw Industries | 1977-04-05 |
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Every clearance here is in the API, with alerts when new ones post.