510(k) Report

Devices descending from K031915

14 later devices reach Pulpdent Etch-Rite Royale through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K200462EtchPro Etching GelBelport Company, Inc., Gingi-Pak20200—
+1K152110e-1 etchantsE Dental Products20154—
+1K120213Etch-Rite SupremePulpdent Corporation20120—
+1K062409K-Etchant GelKuraray Medical, Inc.20066—
+2K242675FineEtch (FineEtch-10 1.2ml, FineEtch-10 5ml, FineEtch-37 1.2ml FineEtch-37 5ml…Spident Co., Ltd.20241—
+2K172953Acid EtchantAmerican Orthodontics20183—
+2K133078K-Etchant Syringe; Needle Tip (E)Kuraray Noritake Dental, Inc.20130—
+2K080305Nexcomp and Meta EtchantMeta Biomed Co., Ltd.20081—
+2K080265Denfil Etchant-37Vericom Co., Ltd.20080—
+3K260485Any-EtchMediclus Co., Ltd.20260—
+3K214054TP Orthodontics Light-Cure Adhesive System, TP Orthodontics Pre-Applied Adhesive, TP…Tp Orthodontics, Inc.20220—
+3K192273DIAETCH Economic Package Type A, DIATECH Regular Package, DIAETCH Refill Package Type A…DiaDent Group International20201—
+3K181689NexcompMeta Biomed Co., Ltd.20180—
+4K210421Diafil & Diafil CapsuleDiaDent Group International20210—