510(k) Report

Devices descending from K033630

14 later devices reach Modification of: Sphero Flex, Pivot Flex, and Sphero Block through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K142211OT EquatorRhein'83 Srl201513—
+2K171409OT EquatorRhein'83 Srl20180—
+2K171694s-Clean TiN Coating AbutmentsDentis Co., Ltd.20172—
+2K163060Deep Conical (DC) Implants and AccessoriesSouthern Implants (Pty), Ltd.20177—
+2K160382OT EquatorRhein'83 Srl20160—
+3K230126Dentis s-Clean Regular AbutmentDentis Co., Ltd.20230—
+3K210080Dentis s-Clean s-Line MiniDentis Co., Ltd.20210—
+3K183024Implacil Implant SystemImplacil DE Bortoli Material Odontologico Ltda20202—
+3K180465Provata Implant SystemSouthern Implants (Pty), Ltd.20182—
+3K173706Piccolo Implants and AccessoriesSouthern Implants (Pty), Ltd.20180—
+4K254145Omni-Directional Multi-Unit Abutment System (Trade Name: Omnibut™)Smart Denture Conversions, LLC20260—
+4K222457Provata Implant SystemSouthern Implants (Pty), Ltd.20230—
+4K202832Implacil Implant SystemImplacil DE Bortoli Material Odontologico Ltda20210—
+4K192839DSP Implant SystemD.S.P Industrial Eireli20210—