510(k) Report

Devices descending from K021410

24 later devices reach Aquasil Ultra XLV Smart Wetting Impression Material through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K133527Suflex Putty, Suflex Heavy, Suflex Mono, Suflex LightOsstem Germany GmbH201412—
+1K113406Aquasil Ultra Smart Wetting Impression MaterialDentsply International, Inc.20126—
+1K082560Panasil Impression Materials, Including Putty, Binetics, Tray, Monophase and ContactKettenbach GmbH & Co. KG200817—
+2K170736HySil Impression MaterialsOsstem Implant Co., Ltd.201710—
+2K152615Vonflex SVericom Co., Ltd.20162—
+2K152861Aquasil Ultra + Smart Wetting Impression MaterialDentply International, Inc.20162—
+2K151262Hyflex Heavy, Hyflex Mono, Hyflex LightOsstem Implant Co., Ltd.201511—
+2K113279Identium Heavy, Identium Medium, Identium Scan Heavy, Identium Scan Medium, Identium…Kettenbach GmbH & Co. KG20110—
+2K092867Identium Heavy, Medium, Medium Soft, LightKettenbach GmbH & Co. KG20091—
+2K091267Vonflex PuttyVericom Co., Ltd.20090—
+2K083701Panasil Initial Contact and Panasil TrayKettenbach GmbH & Co. KG20092—
+3K233954Chemi-SiL (HB, MB, LB, LBS); Chemi-SiL Bite-BluB&E Korea Co., Ltd.20240—
+3K214086Bright Impress-Light, Bright Impress-Medium, Bright Impress-Heavy, Bright Impress-Bite…Genoss Co., Ltd.20222—
+3K222741DENU Light Body (Regular, Fast), DENU Heavy Body (Regular, Fast), DENU Putty Set…Hdi, Inc.20220—
+3K213890IMICRYL Impression MaterialsImicryl Dis Malzemeleri San. VE Tic. A.S.20220—
+3K220097PRESIDENT The OriginalColtène/Whaledent AG20221—
+3K201184Lascod Impression MaterialsLascod Spa20200—
+3K192941HySil Super Fast Impression MaterialsOsstem Implant Co., Ltd.20202—
+3K181236HySil Impression MaterialsOsstem Implant Co., Ltd.20181—
+4K254152Dia-X Sil Light BodyDiaDent Group International20260—
+4K254142Dia-X Sil Heavy BodyDiaDent Group International20260—
+4K242360Speedex Light Body; Speedex Medium; Speedex Putty; Speedex Putty Soft; Speedex Universal…Dent4you AG20240—
+4K203824VPS Impression MaterialHygedent, Inc.20210—
+4K210041HySil Plus Impression MaterialsOsstem Implant Co., Ltd.20210—