510(k) K042823
K042823 is an FDA 510(k) premarket notification submitted by Cosmedent, Inc. for the device "COSMEDENT PIT & FISSURE SEALANT". The FDA issued a decision of Substantially Equivalent on Dec 1, 2004. The device falls under product code EBC (Sealant, Pit And Fissure, And Conditioner), a Class II device regulated under 21 CFR 872.3765. Cosmedent, Inc. has 27 other 510(k) clearances on record.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Dec 1, 2004
- Date Received
- Oct 12, 2004
- 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
- 510(k)