ECM
- Product code
- ECM
- Device name
- Band, Preformed, Orthodontic
- Device class
- Class 1
- 21 CFR
- 21 CFR 872.5410
- Medical specialty
- Dental
- Marketing pathway
- 510(K) Exempt
- 510(k) clearances (all years, FDA)
- 2 (all years; only the last 3 years are listed here)
Official FDA classification page: ECM
Classification and pathway per current FDA publications. Data from openFDA (CC0).