510(k) K073209
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 29, 2008
- Date Received
- November 14, 2007
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Dental Cement W/Out Zinc-Oxide Eugenol As An Ulcer Covering For Pain Relief
- Device Class
- Class II
- Regulation Number
- 872.3275
- Review Panel
- DE
- Submission Type