510(k) Report

Devices descending from K040053

25 later devices reach Precision VPS Impression Material through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K191034VPS Impression MaterialHygedent, Inc.20190—
+1K134008MD-Flex Heavy BodyMeta Biomed, Inc.20140—
+1K062450D-Spect Cardiac Scanner SystemSpectrum Dynamics, Ltd.200614—
+1K052090Splash! Impression Material DeviceDiscus Dental, Inc.20057—
+2K073475System PlusContinental Dental Laboratory20080—
+2K080124Ventri 1.1Ge Medical Systems F.I. Haifa200822
+2K072468Modification to D-Spect Cardiac Scanner SystemSpectrum Dynamics, Ltd.2007101
+2K053427Fresh, Dental Impression MaterialExacta Dental Products, Inc.20065—
+3K212004MyoSPECT, MyoSpect ESGE Healthcare202101
+3K171562Dynax clear, Dynax putty, Dynax heavy body, Dynax light, Dynax monoDreve Dentamid GmbH20184—
+3K110507Cardiac Scanner and Processing SystemSpectrum Dynamics (Israel), Ltd.20119—
+3K083504GE Discovery NM/CT 570CGe Medical Systems F.I. Haifa200801
+4K213244Accusil Dental Impression Materials (Accusil Light Body Regular and Fast Set, Accusil…Prevest Denpro Limited20223—
+4K161740D-SPECT Scanner, D-SPECT L ScannerSpectrum Dynamics Medical, Ltd.20165—
+4K160120D-SPECT Processing and Reviewing WorkstationSpectrum Dynamics, Ltd.20162—
+5K251926enCore Impression MaterialEncore Guards20260—
+5K251724Remi Impression MaterialGrindguard, Inc.20261—
+5K212230TruSPECT Radiological Image Processing StationSpectrum Dynamics Medical, Ltd.20211—
+5K180514Veriton NMSpectrum Dynamics Medical, Ltd.20184—
+6K261888ClearClub Impression MaterialClearClub20260—
+6K253532TruSPECT Processing StationSpectrum Dynamics Medical, Ltd.20250—
+6K182484VERITON CT whole body SPECT/CT systemSpectrum Dynamics Medical, Ltd.20183—
+7K190457VERITON CT whole body SPECT/CT systemSpectrum Dynamics Medical, Ltd.20192—
+8K230600VERITON CT 300 Series Digital SPECT/CT System (VERITON CT 316/364); VERITON CT 400…Spectrum Dynamics Medical, Ltd.20231—
+9K254001VERITON CT 300 Series Digital SPECT/CT System (VERITON CT 316/364); VERITON CT 400…Spectrum Dynamics Medical, Ltd.20260—