510(k) Report

Devices descending from K063626

5 later devices reach Duraflex through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K250489FP3DKeystone Industries20251—
+1K172407DuracetalThe Myerson Company Limited20170—
+1K123396I.Flex by TCSThermoplastic Comfort Systems, Inc.20130—
+1K111709Foundation Dental ResinUnix-Japan Co., Ltd.20110—
+2K253365LuxCreo Flexible Partial Denture ResinLuxCreo, Inc.20250—