510(k) Report

Devices descending from K090826

3 later devices reach Monobond Plus through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K242749TopCEM Ceramic Primer Ceramic Coupling AgentRizhao Huge Biomaterials Company, Ltd.20240—
+1K162677L- OVCRhondium, Ltd.20160—
+1K150164Monobond Etch & PrimeIvoclar Vivadent, AG20150—