Colgate Desensitizing Dental Cream
FDA 510(k) K103461 · Colgate-Palmolive Co.
510(k) numberK103461
Submission
- Device name
- Colgate Desensitizing Dental Cream
- Applicant
- Colgate-Palmolive Co.
Piscataway, NJ, US - Received
- November 24, 2010
- Decision date
- September 13, 2011
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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| K242913 | Jasmate® ToothpasteLBH · Traditional | Jasberry Healthcare Private Limited | 11/22/2024SE |
More from Jasberry Healthcare Private Limited
| 510(k) | Device | Decision |
|---|---|---|
| K140481 | Colgate Desensitizing Mouthrinse, Colgate Sensitive Pro-Relief MouthwashLBH · Traditional | 06/05/2014SE |
| K944886 | Colgate Precision Mint Wzxed Dental FlossJES · Traditional | 04/27/1995SE |
| K901955 | Periogard(R) PeriopenEFS · Traditional | 04/15/1991SE |
| K883335 | Colgate Dental FlossJES · Traditional | 08/26/1988SE |
Questions and answers
When was Colgate Desensitizing Dental Cream cleared by the FDA?
Colgate Desensitizing Dental Cream (K103461) received a 510(k) decision of Substantially Equivalent on September 13, 2011, 293 days after the submission was received.
What is the product code of K103461?
The FDA product code is LBH – Varnish, Cavity, a Class II (moderate risk) device regulated under 21 CFR 872.3260.