510(k) K052281
K052281 is an FDA 510(k) premarket notification submitted by Pulpdent Corporation for the device "EMBRACE WETBOND CLEAR SEALANT". The FDA issued a decision of Substantially Equivalent on February 8, 2006. The device falls under product code EBC (Sealant, Pit And Fissure, And Conditioner), a Class II device regulated under 21 CFR 872.3765. Pulpdent Corporation has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 8, 2006
- Date Received
- August 22, 2005
- 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