510(k) K903672
K903672 is an FDA 510(k) premarket notification submitted by Dirotian Pty. , Ltd. for the device "DENE BRIDGE". The FDA issued a decision of Substantially Equivalent on December 5, 1990. 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
- December 5, 1990
- Date Received
- August 14, 1990
- 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