510(k) Report

Devices descending from K972026

21 later devices reach SP4044 & SP4055 Lux Modules through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K033764SP Newtron ModuleSatelec200420—
+2K233922SP Newtron Can-a; Module Newtron Can-a Emb; Support Xinetic; NWT Can Slim Led Cord G3…Satelec - Acteon Group20241—
+2K140990Ems Piezon 707 Bik and Piezon 707 Bik LedE.M.S Electro Medical Systems S.A20150—
+2K102218Compact Piezo P2K, PowercareMectron S.P.A.20113—
+2K053578Scorpion Ultrasonic Scaling InsertsScorpion20060—
+2K050895Surpasson P5 NewtronSatelec200511—
+3K251689Varios 170 Lux Scaler System (VA170LUXS10); Varios 170 Lux Scaler System (VA170LUXS11)…Nakanishi, Inc.20250—
+3K202906EndoPilot2Schlumbohm GmbH & Co. KG20214—
+3K151023Compact Piezo LedMectron S.P.A.20150—
+3K140965Multipiezo Pro, MultipiezoMectron S.P.A.20142—
+3K132322Newtron P5 XS B.LedSatelec - Acteon Group20140—
+3K132267Newtron P5, Newtron P5 B.LedSatelec - Acteon Group20140—
+3K131151EndocenterSatelec - Acteon Group20140—
+3K131997Newtron BoosterSatelec - Acteon Group20130—
+3K071424Pmax Newtron XSSatelec - Acteon Group20072—
+3K060275PiezotomeSatelec20060—
+4K242317Integrated Endo System (Meet Endo-II)Denjoy Dental Co., Ltd.20250—
+4K233865X-Smart Pro; X-Smart Pro+Dentsply Sirona, Inc.20241—
+4K223173Proxeo ULTRA (PB-510, PB-520 and PB-530)W&H Dentalwerk Buermoss GmbH20230—
+4K213947Ultrasonic Endo Activation Device (Model:Actor I pro)Changzhou Bomedent Medical Technology Co.,Ltd20220—
+5K251811Motor and Apex Module (MaAM)Dentsply Sirona, Inc.20250—