510(k) Report

Devices descending from K021416

46 later devices reach Aquasil Ultra Monophase/Heavy/LV Smart Wetting Impression Material through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K113406Aquasil Ultra Smart Wetting Impression MaterialDentsply International, Inc.20126—
+1K103164Vonflex Heavy, Vinflex LightVericom Co., Ltd.201013—
+1K052090Splash! Impression Material DeviceDiscus Dental, Inc.20057—
+1K040053Precision VPS Impression MaterialDiscus Dental, Inc.200425—
+2K191034VPS Impression MaterialHygedent, Inc.20190—
+2K152615Vonflex SVericom Co., Ltd.20162—
+2K152766CharmFlexDentkist, Inc.201612—
+2K152861Aquasil Ultra + Smart Wetting Impression MaterialDentply International, Inc.20162—
+2K134008MD-Flex Heavy BodyMeta Biomed, Inc.20140—
+2K073475System PlusContinental Dental Laboratory20080—
+2K062450D-Spect Cardiac Scanner SystemSpectrum Dynamics, Ltd.200614—
+2K053427Fresh, Dental Impression MaterialExacta Dental Products, Inc.20065—
+3K233954Chemi-SiL (HB, MB, LB, LBS); Chemi-SiL Bite-BluB&E Korea Co., Ltd.20240—
+3K222741DENU Light Body (Regular, Fast), DENU Heavy Body (Regular, Fast), DENU Putty Set…Hdi, Inc.20220—
+3K220097PRESIDENT The OriginalColtène/Whaledent AG20221—
+3K171562Dynax clear, Dynax putty, Dynax heavy body, Dynax light, Dynax monoDreve Dentamid GmbH20184—
+3K170736HySil Impression MaterialsOsstem Implant Co., Ltd.201710—
+3K161774i-SilSpident Co., Ltd.20160—
+3K080124Ventri 1.1Ge Medical Systems F.I. Haifa200822
+3K072468Modification to D-Spect Cardiac Scanner SystemSpectrum Dynamics, Ltd.2007101
+4K242360Speedex Light Body; Speedex Medium; Speedex Putty; Speedex Putty Soft; Speedex Universal…Dent4you AG20240—
+4K214086Bright Impress-Light, Bright Impress-Medium, Bright Impress-Heavy, Bright Impress-Bite…Genoss Co., Ltd.20222—
+4K213244Accusil Dental Impression Materials (Accusil Light Body Regular and Fast Set, Accusil…Prevest Denpro Limited20223—
+4K213890IMICRYL Impression MaterialsImicryl Dis Malzemeleri San. VE Tic. A.S.20220—
+4K212004MyoSPECT, MyoSpect ESGE Healthcare202101
+4K201184Lascod Impression MaterialsLascod Spa20200—
+4K192941HySil Super Fast Impression MaterialsOsstem Implant Co., Ltd.20202—
+4K181236HySil Impression MaterialsOsstem Implant Co., Ltd.20181—
+4K110507Cardiac Scanner and Processing SystemSpectrum Dynamics (Israel), Ltd.20119—
+4K083504GE Discovery NM/CT 570CGe Medical Systems F.I. Haifa200801
+5K254152Dia-X Sil Light BodyDiaDent Group International20260—
+5K254142Dia-X Sil Heavy BodyDiaDent Group International20260—
+5K251926enCore Impression MaterialEncore Guards20260—
+5K251724Remi Impression MaterialGrindguard, Inc.20261—
+5K203824VPS Impression MaterialHygedent, Inc.20210—
+5K210041HySil Plus Impression MaterialsOsstem Implant Co., Ltd.20210—
+5K161740D-SPECT Scanner, D-SPECT L ScannerSpectrum Dynamics Medical, Ltd.20165—
+5K160120D-SPECT Processing and Reviewing WorkstationSpectrum Dynamics, Ltd.20162—
+6K261888ClearClub Impression MaterialClearClub20260—
+6K212230TruSPECT Radiological Image Processing StationSpectrum Dynamics Medical, Ltd.20211—
+6K180514Veriton NMSpectrum Dynamics Medical, Ltd.20184—
+7K253532TruSPECT Processing StationSpectrum Dynamics Medical, Ltd.20250—
+7K182484VERITON CT whole body SPECT/CT systemSpectrum Dynamics Medical, Ltd.20183—
+8K190457VERITON CT whole body SPECT/CT systemSpectrum Dynamics Medical, Ltd.20192—
+9K230600VERITON CT 300 Series Digital SPECT/CT System (VERITON CT 316/364); VERITON CT 400…Spectrum Dynamics Medical, Ltd.20231—
+10K254001VERITON CT 300 Series Digital SPECT/CT System (VERITON CT 316/364); VERITON CT 400…Spectrum Dynamics Medical, Ltd.20260—