510(k) Report

Devices descending from K982915

9 later devices reach Sci-Pharm DFV Varnish through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K100503Pulpdent Copal Varnish with FluoridePulpdent Corporation20100—
+1K090519Vanish Varnish, 5% Sodium Fluoride Varnish, Model 12245, Vanish Varnish, 5% Fluoride…3M Company20093—
+1K082198Durashield PlusDentsply Intl., Inc.20084—
+1K030488FluorilaqPascal Co., Inc.20032—
+2K113146PCXX VarnishRoss Healthcare, Inc.20120—
+2K103160Nupro Model 13016901CAO Group, Inc.20111—
+2K100540Ascent F-Coat Model: 006-00097CAO Group, Inc.20102—
+2K090597Fluorilaq Sodium Fluoride Cavity VarnishPascal Co., Inc.20090—
+3K140349Starbright 5% Sodium Fluoride VarnishNanova Biomaterials, Inc.20140—