510(k) K103461
K103461 is an FDA 510(k) premarket notification submitted by Colgate-Palmolive Co. for the device "COLGATE DESENSITIZING DENTAL CREAM". The FDA issued a decision of Substantially Equivalent on September 13, 2011. The device falls under product code LBH (Varnish, Cavity), a Class II device regulated under 21 CFR 872.3260. Colgate-Palmolive Co. has at least 4 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 13, 2011
- Date Received
- November 24, 2010
- 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