EKO

Denture Preformed (Partially Prefabricated Denture)

Product code: EKO
Device name: Denture Preformed (Partially Prefabricated Denture)
Device class: Class 2
21 CFR: 21 CFR 872.3600
Medical specialty: Dental
Marketing pathway: 510(K) Exempt
510(k) clearances (all years, FDA): 4 (all years; only the last 3 years are listed here)

Official FDA classification page: EKO

Classification and pathway per current FDA publications. Data from openFDA (CC0).