510(k) Report

Devices descending from K012070

11 later devices reach Orallite Comprehensive Exam Tray through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K041614Microlux DLAddent, Inc.20050—
+1K033033Vizilite-Blue Oral Exam KitTrylon Corp.20049—
+2K082603Trimira Ocs 3000Remicalm, LLC20088—
+3K090135Trimira Identafi 3000Remicalm, LLC20097—
+4K151630G.o.c.c.l.e.s.Pierrel Pharma S.R.L.20150—
+4K101140Dentlight Oral Exam Light KitDentlight, Inc.20105—
+5K210550VALO Grand Corded and Accessory LensesUltradent Products, Inc.20213—
+5K123169OralidForward Science, LLC20130—
+6K220471VALO X, VALO X Accessory LensesUltradent Products, Inc.20222—
+7K253461Demi ProMeta Systems Co., Ltd.20250—
+7K243921LED Curing Lights (DB686 HALO)Foshan Coxo Medical Instrument Co., Ltd.20250—