EKK
1 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Spreader, Pulp Canal Filling Material, Endodontic
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 872.4565
- Medical specialty
- Dental
- Adverse events (MAUDE)
- 2000: 1 · 2005: 4 · 2006: 6 · 2007: 14 · 2008: 8
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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| Record | Firm | Date | Builder |
|---|---|---|---|
| ENDODONTIC ELECTRONIC SPREADER HEATER (K853183) | Sturgeon Engineering Co. | 1985-10-16 | + Add |
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