510(k) Report

Devices descending from K960819

13 later devices reach Heliodent DS through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K083344Heliodent PlusSirona Dental Systems GmbH20089—
+1K042260Phot-X II, Model 303Takara Belmont USA, Inc.20042—
+1K033755MinraySoredex Palodex Group OY20040—
+2K190357Star-X, Intraoral X-ray SystemHdx Will Corp.20190—
+2K141293Phot-X Iis Model 505Takara Belmont Corporation20140—
+2K120318Vivi Ergon-X HFVivi S.R.L.20127—
+3K163519RX DCCefla S.C.20174—
+3K130109Endograph DCVilla Sistemi Medicali S.P.A.20131—
+4K231055x-mind dc (under trademark Acteon), Owandy-RX DC (under trademark OwandyRadiology)De Götzen S.R.L.20230—
+4K182206RiX70 DCTrident S.R.L20183—
+5K232085Dvas (Dvas-M, Dvas-W)Genoray Co., Ltd.20230—
+5K211014PortraySurround Medical Systems20211—
+6K223780Lumos 3DX3Dio20230—