EAY
18 FDA 510(k) clearances · Product code
53 daysmedian time to decision
74 days90th percentile
18clearances measured
FDA profile
- Official device name
- Light, Fiber Optic, Dental
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 872.4620
- Medical specialty
- Dental
- Adverse events (MAUDE)
- 1997: 1 · 1998: 1 · 2001: 1
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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Every clearance here is in the API, with alerts when new ones post.