510(k) Report

Devices descending from K043177

13 later devices reach Cleafil DC Core Automix through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K131432Clearfil SE Bond 2 Kit; Clearfil SE Bond 2 Value Pack; Clearfil SE Bond 2 Trial Pack…Kuraray Noritake Dental, Inc.20131—
+1K111982Clearfil DC Core PlusKuraray America, Inc.20116—
+1K062410Clearfil Esthetic Cement & DC BondKuraray Medical, Inc.200610—
+2K231696Fusion Bond 5, Fusion Bond 7, Fusion Bond DC, Renew MDP, Renew UniversalPrevest Denpro Limited20230—
+2K150704PANAVIA V5: Standard Kit (Universal (A2)), Standard Kit (Clear), Introductory Kit…Kuraray Noritake Dental, Inc.20152—
+2K142623PANAVIA SA Cement Plus HandmixKuraray Noritake Dental, Inc.20150—
+2K142625PANAVIA SA Cement Plus Automix; (Universal (A2), White, Translucent); Value Pack…Kuraray Noritake Dental, Inc.20154—
+2K081583Clearfil SA CementKuraray Medical, Inc.20089—
+3K210504PANAVIA Veneer LCKuraray Noritake Dental, Inc.20210—
+3K191524Visalys Tooth PrimerKettenbach GmbH & Co. KG20190—
+3K183537PANAVIA SA Cement UniversalKuraray Noritake Dental, Inc.20190—
+3K120378Panavia SA Cement Handmix Value Pack (Universal (A2), White) Panavia SA Cement Handmix…Kuraray Medical, Inc.20121—
+3K120379Panavia SA Cement Automix Value Pack (Universal (A2), White) Panavia SA Cement Automix…Kuraray Medical, Inc.20125—