510(k) Report

Devices descending from K161580

2 later devices reach Premier Sealant through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K243254Parkell Pit and Fissure SealantParkell, Inc.20251—
+2K260819Any-Com SealMediclus Co., Ltd.20260—