510(k) K140481

COLGATE DESENSITIZING MOUTHRINSE, COLGATE SENSITIVE PRO-RELIEF MOUTHWASH by Colgate-Palmolive Company — Product Code LBH

K140481 is an FDA 510(k) premarket notification submitted by Colgate-Palmolive Company for the device "COLGATE DESENSITIZING MOUTHRINSE, COLGATE SENSITIVE PRO-RELIEF MOUTHWASH". The FDA issued a decision of Substantially Equivalent on June 5, 2014. The device falls under product code LBH (Varnish, Cavity), a Class II device regulated under 21 CFR 872.3260. Colgate-Palmolive Company has at least 4 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 5, 2014
Date Received
February 26, 2014
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