ELA
- Product code
- ELA
- Device name
- Instrument, Hand, Calculus Removal
- Device class
- Class 1
- 21 CFR
- 21 CFR 872.4565
- Medical specialty
- Dental
- Marketing pathway
- 510(K) Exempt
- 510(k) clearances (last 3 years)
- 4
Official FDA classification page: ELA
Classification and pathway per current FDA publications. Data from openFDA (CC0).