510(k) Report

Devices descending from K974628

4 later devices reach Frialit-2 Protect Abutment through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K050208Friadent EstheticapDentsply International20053—
+2K073073Ankylos Temporary Abutment BalanceDentsply International, Inc.20080—
+2K053099Biohorizons Plastic Temporary AbutmentsBioHorizons Implant Systems, Inc.20061—
+3K122559Biodenta Dental Implant System - AbutmentsBiodenta Swiss AG20130—