510(k) K110058
K110058 is an FDA 510(k) premarket notification submitted by Novocol Inc. Dba Septodont and Confi-Dental Produc for the device "BPA-FREE PIT AND FISSURE SEALANT". The FDA issued a decision of Substantially Equivalent on March 31, 2011. The device falls under product code EBC (Sealant, Pit And Fissure, And Conditioner), a Class II device regulated under 21 CFR 872.3765. Novocol Inc. Dba Septodont and Confi-Dental Produc has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 31, 2011
- Date Received
- January 10, 2011
- Clearance Type
- Abbreviated
- 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