510(k) K112946
K112946 is an FDA 510(k) premarket notification submitted by Pulpdent Corporation for the device "ACTIV VARNISH". The FDA issued a decision of Substantially Equivalent on December 9, 2011. The device falls under product code LBH (Varnish, Cavity), a Class II device regulated under 21 CFR 872.3260. Pulpdent Corporation has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 9, 2011
- Date Received
- October 4, 2011
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Varnish, Cavity
- Device Class
- Class II
- Regulation Number
- 872.3260
- Review Panel
- DE
- Submission Type