510(k) Report

Devices descending from K093711

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K123215Viscostat ClearUltradent Products, Inc.20136—
+1K113839Retract Gingival Retraction/Hemostatic PasteParkell, Inc.20120—
+2K193389Vista ClearInter-Med/Vista Dental Products20202—
+2K190220Vista FS, Vista FS LiquidInter-Med/Vista Dental Products201911
+2K152064Astringedent ClearUltradent Products, Inc.20152—
+3K211420Stasis GelBelport Company, Inc., Gingi-Pak20220—
+3K211419Gingi-Aid GelBelport Company, Inc., Gingi-Pak20220—
+3K200764StatstixCentrix Incorporated20200—