510(k) K760768

FLEXIDENT DENTURE by Flexodent Corp. — Product Code EKO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 15, 1976
Date Received
October 4, 1976
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Denture Preformed (Partially Prefabricated Denture)
Device Class
Class II
Regulation Number
872.3600
Review Panel
DE
Submission Type