510(k) Report

Devices descending from K983477

9 later devices reach Super Seal through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K123653Seal Block Pro (Not Finalized), Seal Block Otc (Not Finalized)Bisco, Inc.20130—
+1K122421Teethmate Desensitzer Set Teethmate Desensitizer Powder Teethmate Desensitizer LiquidKuraray Noritake Dental, Inc.20122—
+1K120176Senzzzzz AwayCentrix, Inc.20122—
+1K082594RemesenseRemedent NV20093—
+1K033521BisblockBisco, Inc.20044—
+2K131068Teethmate Desensitizer Set; Teethmate Desensitizer Powder; Teethmate Desensitizer LiquidKuraray Noritake Dental, Inc.20131—
+2K122708Remesense for Sensitive TeethSylphar N.V.20131—
+3K191103Parkell Desensitizer GelParkell, Inc.20190—
+3K132426Sylphar Remesense Sensitivity Relief StripsSylphar N.V.20140—