510(k) Report

Devices descending from K003995

15 later devices reach Speculite/Orallite through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K060920VelscopeLed Medical Diagnostics, Inc.200612—
+1K041614Microlux DLAddent, Inc.20050—
+1K033033Vizilite-Blue Oral Exam KitTrylon Corp.20049—
+2K082668Bio-ScreenAddent, Inc.20090—
+2K082603Trimira Ocs 3000Remicalm, LLC20088—
+2K070523Modification to: VelscopeLed Dental, Inc.200710—
+3K102083Velscope VXLed Dental, Inc.20102—
+3K101140Dentlight Oral Exam Light KitDentlight, Inc.20105—
+3K090135Trimira Identafi 3000Remicalm, LLC20097—
+4K210550VALO Grand Corded and Accessory LensesUltradent Products, Inc.20213—
+4K151630G.o.c.c.l.e.s.Pierrel Pharma S.R.L.20150—
+4K123169OralidForward Science, LLC20130—
+5K220471VALO X, VALO X Accessory LensesUltradent Products, Inc.20222—
+6K253461Demi ProMeta Systems Co., Ltd.20250—
+6K243921LED Curing Lights (DB686 HALO)Foshan Coxo Medical Instrument Co., Ltd.20250—