510(k) K080266
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 6, 2008
- Date Received
- February 1, 2008
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- Yes
Device Classification
- Device Name
- Resin, Root Canal Filling
- Device Class
- Class II
- Regulation Number
- 872.3820
- Review Panel
- DE
- Submission Type