510(k) Report

Devices descending from K982394

22 later devices reach Prime & Bond NT Dual Cure Universal Dental Adhesive System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K122522Dentoetch Quickbond Bond ActivatorItena Clinical20130—
+1K070413Ascent Universal Adhesive, Model 006-00028CAO Group, Inc.20071—
+1K041343Xeno NM Light Cured Dental AdhesiveDentsply International20042—
+1K023842Clearfil SE Bond PlusKuraray Medical, Inc.20033—
+1K023776Xeno Iii Dental AdhesiveDentsply Intl.20033—
+1K012082Optibond Solo Plus ActivatorSybron Dental Specialties, Inc.20011—
+1K992822Seal & Protect Protective Sealant for Exposed DentineDentsply Intl.19999—
+1K992518Prime & Bond NT Dual Cure Universal Dental Adhesive SystemDentsply Intl.19990—
+2K183391Novidia Universal BondNobio, Ltd.20190—
+2K092616Ascent Bond Universal Adhesive System, Models 006-00029, 006-00030, 006-00044, 006-00045CAO Group, Inc.20090—
+2K070956SEA2 Self Etch Adhesive3M Espe Dental Products20070—
+2K061427Pre-Impression Conditioning SolutionDentsply Intl.20060—
+2K051463Xeno Adhesive with ActivatorDentsply Intl.20051—
+2K041960Composite/Compomer Repair KitDmg USA, Inc.20041—
+2K040952PreludeDanville Materials, Inc.20040—
+2K021805Seal & Protect Protective SealantDentsply Intl.20024—
+2K003482Proclude-SensitiveOrtek Therapeutics, Inc.20013—
+3K151619Prime&Bond Elect Universal Dental AdhesiveDentsply International, Inc.20150—
+3K103461Colgate Desensitizing Dental CreamColgate-Palmolive Co.20112—
+3K063444Total Etch Bonding AgentDmg USA, Inc.20070—
+4K140481Colgate Desensitizing Mouthrinse, Colgate Sensitive Pro-Relief MouthwashColgate-Palmolive Company20141—
+5K143155LISTERINE Sensitivity Defense MouthrinseJohnson & Johnson Healthcare Products, Division of Mcneil-Pp20150—