510(k) Report

Devices descending from K000213

5 later devices reach Jeldent Basic Line through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K033628ARTICHeraeus Kulzer, Inc.20044—
+2K070591Replica, Ortolux Top, Odipal, Odilux, Odident, Vitacrilic, Nature's Best, Dental Acrylic…Union Dental S.A./Unidesa.Odi20072—
+2K060507Valplast Yamahachi TeethValplast Intl. Corp.20063—
+3K122955Dentavit, Monarch, Acrotone, Senator, DentoriumWright Health Group, Ltd.20130—
+3K101029Kaifeng/Crystal, Kaili, Kaijing, Kaiyue, Maist and Kaitong/Royal Synthetic Polymer TeethHuge Dental Material Co., Ltd.20101—