510(k) Report

Devices descending from K030588

7 later devices reach Artegral and Polystar Selection through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K134015M-PM-DiscMerz Dental GmbH20141—
+1K120404Merz Dental GMBH Artegral HD Preformed Plastic Denture TeethMerz Dental GmbH20120—
+1K070591Replica, Ortolux Top, Odipal, Odilux, Odident, Vitacrilic, Nature's Best, Dental Acrylic…Union Dental S.A./Unidesa.Odi20072—
+1K060507Valplast Yamahachi TeethValplast Intl. Corp.20063—
+2K191836Ceramill A-SplintAmann Girrbach AG20190—
+2K122955Dentavit, Monarch, Acrotone, Senator, DentoriumWright Health Group, Ltd.20130—
+2K101029Kaifeng/Crystal, Kaili, Kaijing, Kaiyue, Maist and Kaitong/Royal Synthetic Polymer TeethHuge Dental Material Co., Ltd.20101—