510(k) K100290
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 17, 2010
- Date Received
- February 2, 2010
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- Yes
Device Classification
- Device Name
- Cement, Dental
- Device Class
- Class II
- Regulation Number
- 872.3275
- Review Panel
- DE
- Submission Type