The following data is part of a premarket notification filed by Colgate-palmolive Co. with the FDA for Colgate Desensitizing Dental Cream.
Device ID | K103461 |
510k Number | K103461 |
Device Name: | COLGATE DESENSITIZING DENTAL CREAM |
Classification | Varnish, Cavity |
Applicant | COLGATE-PALMOLIVE CO. 909 RIVER RD. Piscataway, NJ 08855 -1343 |
Contact | Charles P Ireland |
Correspondent | Charles P Ireland COLGATE-PALMOLIVE CO. 909 RIVER RD. Piscataway, NJ 08855 -1343 |
Product Code | LBH |
CFR Regulation Number | 872.3260 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2010-11-24 |
Decision Date | 2011-09-13 |
Summary: | summary |