510(k) Report

Devices descending from K041680

12 later devices reach Orajel Advanced Tooth Desensitizer through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K120109Super Seal Tooth DesensitizerPhoenix Dental, Inc.20126—
+1K082594RemesenseRemedent NV20093—
+1K050486Protect Tooth DesensitizerSunstar Butler200510—
+2K241489ReminGelInter-Med, Inc.20251—
+2K123653Seal Block Pro (Not Finalized), Seal Block Otc (Not Finalized)Bisco, Inc.20130—
+2K122708Remesense for Sensitive TeethSylphar N.V.20131—
+2K120176Senzzzzz AwayCentrix, Inc.20122—
+2K103461Colgate Desensitizing Dental CreamColgate-Palmolive Co.20112—
+3K262243Profisil FreeKettenbach GmbH & Co. KG20260—
+3K140481Colgate Desensitizing Mouthrinse, Colgate Sensitive Pro-Relief MouthwashColgate-Palmolive Company20141—
+3K132426Sylphar Remesense Sensitivity Relief StripsSylphar N.V.20140—
+4K143155LISTERINE Sensitivity Defense MouthrinseJohnson & Johnson Healthcare Products, Division of Mcneil-Pp20150—