510(k) Report

Devices descending from K973539

2 later devices reach Roeko Calcium Hydroxide Points through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K032662GuttaflowColtene/Whaledent GmbH & Co. KG20031—
+2K190510GuttaSilMeta Biomed Co., Ltd.20190—