510(k) K760768
K760768 is an FDA 510(k) premarket notification submitted by Flexodent Corp. for the device "FLEXIDENT DENTURE". The FDA issued a decision of Substantially Equivalent on October 15, 1976. The device falls under product code EKO (Denture Preformed (Partially Prefabricated Denture)), a Class II device regulated under 21 CFR 872.3600.
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