510(k) Report

Devices descending from K943574

60 later devices reach Capture Impression Material through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K021416Aquasil Ultra Monophase/Heavy/LV Smart Wetting Impression MaterialDentsply Intl.200246—
+1K973781Aquasil Easy Mix Putty Impression MaterialDentsply Intl.19971—
+1K973782Aquasil XLV Smart Wetting Impression MaterialDentsply Intl.199725—
+1K970433Aquasil Rigid Smart Wetting Impression MaterialDentsply Intl.199728—
+2K113406Aquasil Ultra Smart Wetting Impression MaterialDentsply International, Inc.20126—
+2K103164Vonflex Heavy, Vinflex LightVericom Co., Ltd.201013—
+2K061427Pre-Impression Conditioning SolutionDentsply Intl.20060—
+2K052090Splash! Impression Material DeviceDiscus Dental, Inc.20057—
+2K040053Precision VPS Impression MaterialDiscus Dental, Inc.200425—
+2K021413Aquasil Ultra Rigid Smart Wetting Impression MaterialDentsply Intl.200227—
+2K021410Aquasil Ultra XLV Smart Wetting Impression MaterialDentsply Intl.200224—
+3K191034VPS Impression MaterialHygedent, Inc.20190—
+3K152615Vonflex SVericom Co., Ltd.20162—
+3K152766CharmFlexDentkist, Inc.201612—
+3K152861Aquasil Ultra + Smart Wetting Impression MaterialDentply International, Inc.20162—
+3K134008MD-Flex Heavy BodyMeta Biomed, Inc.20140—
+3K133527Suflex Putty, Suflex Heavy, Suflex Mono, Suflex LightOsstem Germany GmbH201412—
+3K082560Panasil Impression Materials, Including Putty, Binetics, Tray, Monophase and ContactKettenbach GmbH & Co. KG200817—
+3K073475System PlusContinental Dental Laboratory20080—
+3K062450D-Spect Cardiac Scanner SystemSpectrum Dynamics, Ltd.200614—
+3K053427Fresh, Dental Impression MaterialExacta Dental Products, Inc.20065—
+4K233954Chemi-SiL (HB, MB, LB, LBS); Chemi-SiL Bite-BluB&E Korea Co., Ltd.20240—
+4K222741DENU Light Body (Regular, Fast), DENU Heavy Body (Regular, Fast), DENU Putty Set…Hdi, Inc.20220—
+4K220097PRESIDENT The OriginalColtène/Whaledent AG20221—
+4K171562Dynax clear, Dynax putty, Dynax heavy body, Dynax light, Dynax monoDreve Dentamid GmbH20184—
+4K170736HySil Impression MaterialsOsstem Implant Co., Ltd.201710—
+4K161774i-SilSpident Co., Ltd.20160—
+4K151262Hyflex Heavy, Hyflex Mono, Hyflex LightOsstem Implant Co., Ltd.201511—
+4K113279Identium Heavy, Identium Medium, Identium Scan Heavy, Identium Scan Medium, Identium…Kettenbach GmbH & Co. KG20110—
+4K092867Identium Heavy, Medium, Medium Soft, LightKettenbach GmbH & Co. KG20091—
+4K091267Vonflex PuttyVericom Co., Ltd.20090—
+4K083701Panasil Initial Contact and Panasil TrayKettenbach GmbH & Co. KG20092—
+4K080124Ventri 1.1Ge Medical Systems F.I. Haifa200822
+4K072468Modification to D-Spect Cardiac Scanner SystemSpectrum Dynamics, Ltd.2007101
+5K242360Speedex Light Body; Speedex Medium; Speedex Putty; Speedex Putty Soft; Speedex Universal…Dent4you AG20240—
+5K214086Bright Impress-Light, Bright Impress-Medium, Bright Impress-Heavy, Bright Impress-Bite…Genoss Co., Ltd.20222—
+5K213244Accusil Dental Impression Materials (Accusil Light Body Regular and Fast Set, Accusil…Prevest Denpro Limited20223—
+5K213890IMICRYL Impression MaterialsImicryl Dis Malzemeleri San. VE Tic. A.S.20220—
+5K212004MyoSPECT, MyoSpect ESGE Healthcare202101
+5K201184Lascod Impression MaterialsLascod Spa20200—
+5K192941HySil Super Fast Impression MaterialsOsstem Implant Co., Ltd.20202—
+5K181236HySil Impression MaterialsOsstem Implant Co., Ltd.20181—
+5K110507Cardiac Scanner and Processing SystemSpectrum Dynamics (Israel), Ltd.20119—
+5K083504GE Discovery NM/CT 570CGe Medical Systems F.I. Haifa200801
+6K254152Dia-X Sil Light BodyDiaDent Group International20260—
+6K254142Dia-X Sil Heavy BodyDiaDent Group International20260—
+6K251926enCore Impression MaterialEncore Guards20260—
+6K251724Remi Impression MaterialGrindguard, Inc.20261—
+6K203824VPS Impression MaterialHygedent, Inc.20210—
+6K210041HySil Plus Impression MaterialsOsstem Implant Co., Ltd.20210—
+6K161740D-SPECT Scanner, D-SPECT L ScannerSpectrum Dynamics Medical, Ltd.20165—
+6K160120D-SPECT Processing and Reviewing WorkstationSpectrum Dynamics, Ltd.20162—
+7K261888ClearClub Impression MaterialClearClub20260—
+7K212230TruSPECT Radiological Image Processing StationSpectrum Dynamics Medical, Ltd.20211—
+7K180514Veriton NMSpectrum Dynamics Medical, Ltd.20184—
+8K253532TruSPECT Processing StationSpectrum Dynamics Medical, Ltd.20250—
+8K182484VERITON CT whole body SPECT/CT systemSpectrum Dynamics Medical, Ltd.20183—
+9K190457VERITON CT whole body SPECT/CT systemSpectrum Dynamics Medical, Ltd.20192—
+10K230600VERITON CT 300 Series Digital SPECT/CT System (VERITON CT 316/364); VERITON CT 400…Spectrum Dynamics Medical, Ltd.20231—
+11K254001VERITON CT 300 Series Digital SPECT/CT System (VERITON CT 316/364); VERITON CT 400…Spectrum Dynamics Medical, Ltd.20260—