510(k) Report

Devices descending from K063237

18 later devices reach Theracal LC through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K2302703M™ VitCal Liner/Base3M Espe Dental Products20231—
+1K202413LC ResinCal PCS&C Polymer Silicon- Und Composite Spezialitaten GmbH20200—
+1K143292TheraCal DCBisco, Inc.20152—
+1K113568Mta-FillapexPaxmed International201212—
+2K261728One-Fil LCMediclus Co., Ltd.20260—
+2K180344TheraCal DCBisco, Inc.20181—
+2K170175Endoseal MtaMaruchi20188—
+2K140247Mta FillapexAngelus Industria DE Productos Odontologicos SA20142—
+3K231480Bright MTA Sealer PlusGenoss Co., Ltd.20230—
+3K221811Vista BC SealerInter-Med, Inc.20220—
+3K212563CalApex Calplus, Cerafill RCS, Endoseal, Nanoseal S, Zical Ultra Paste, Zical Ultra…Prevest Denpro Limited20220—
+3K211905UltraCal XSUltradent Products, Inc.20210—
+3K202015White ENDOSEAL MTAMaruchi20211—
+3K201799CleaniCalMaruchi20212—
+3K172701Bio-C SealerAngelus Industria DE Produtos Odontologicos S/A20181—
+4K212475Prevest Denpro Cavity Liners (Apacal ART, Cal LC, Calcigel, CalUltra)Prevest Denpro Limited20220—
+4K212229White Endoseal MTAMaruchi20210—
+4K190537BIO-C Sealer Ion+Angelus Industria DE Produtos Odontologicos S/A20190—