510(k) K111782
K111782 is an FDA 510(k) premarket notification submitted by Shofu Dental Corporation for the device "BEAUTISEALANT". The FDA issued a decision of Substantially Equivalent on September 16, 2011. The device falls under product code EBC (Sealant, Pit And Fissure, And Conditioner), a Class II device regulated under 21 CFR 872.3765. Shofu Dental Corporation has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 16, 2011
- Date Received
- June 24, 2011
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Sealant, Pit And Fissure, And Conditioner
- Device Class
- Class II
- Regulation Number
- 872.3765
- Review Panel
- DE
- Submission Type