510(k) Report

Devices descending from K010957

8 later devices reach Quell Desensitizer through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K073117Dentin Desensitizer AgentDentsply Intl., Inc.20070—
+1K033295Butler Nucare Root Conditioner with NovaminNovamin Technology, Inc.20036—
+2K072342Sultan Tooth Root DesensitizerDentsply International, Inc.20075—
+3K082198Durashield PlusDentsply Intl., Inc.20084—
+4K103160Nupro Model 13016901CAO Group, Inc.20111—
+4K100540Ascent F-Coat Model: 006-00097CAO Group, Inc.20102—
+4K090519Vanish Varnish, 5% Sodium Fluoride Varnish, Model 12245, Vanish Varnish, 5% Fluoride…3M Company20093—
+5K140349Starbright 5% Sodium Fluoride VarnishNanova Biomaterials, Inc.20140—