510(k) Report

Devices descending from K031968

3 later devices reach Cerabien ZR through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K133078K-Etchant Syringe; Needle Tip (E)Kuraray Noritake Dental, Inc.20130—
+1K051249ZIROXWieland Dental + Technik GmbH & Co. KG20051—
+2K103773Zenoflex DimensionWieland Dental + Technik GmbH & Co. KG20110—