510(k) Report

Devices descending from K973876

26 later devices reach Prophyflex 2, Model 2012 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K112673Prophy-Mate NeoNakanishi, Inc.20120—
+1K041141Dentsply Cavitron Jet Wave Air Polishing Prophylaxis System, Model G125Dentsply Intl.20040—
+1K031868ProphypearlsKavo America20030—
+1K991857Airflow HandyElectro Medical Systems, Inc.199923—
+2K022119Ems Air-Flow Handy 2 Dental HandpieceElectro Medical Systems SA200222—
+3K132478Air-Flow Handy 3.0E.M.S Electro Medical Systems S.A20143—
+3K110379Air-N-GOSatelec20113—
+3K092289Ems Air-Flow Handy PerioE.M.S Electro Medical Systems S.A200918—
+3K033675Prosmile Air Polisher and Prophylaxis PowderSirona Dental Systems GmbH20041—
+4K151912AIR-FLOW handy 3.0 PLUSE.M.S Electro Medical Systems S.A20162—
+4K140684Clinpro Prophy Powder3M Deutschland GmbH20141—
+4K130862Cavitron Prophy-Jet Air Polishing Prophylaxis SystemDentsply Intl., Inc.20130—
+4K112869Easyprophy Series Air Polish Devices, Models Easyprophy 200 and Easyprophy 400Beyes Dental Canada, Inc.20110—
+4K110173Ems Air-Flow Master PiezonE.M.S Electro Medical Systems S.A201113—
+4K042872Rondoflex Plus 360Kavo America Corporation20040—
+5K241880Air Powered Tooth Polishing System (Perio-Mate); Air Powered Tooth Polishing System…Nakanishi, Inc.20240—
+5K221548Dental Air Polishing HandpieceGuilin Woodpecker Medical Instrument Co., Ltd.20220—
+5K203615Dental Scaler and Air PolisherGuilin Woodpecker Medical Instrument Co., Ltd.20210—
+5K190124EMS AIRFLOW Prophylaxis Master, EMS AIRFLOW OneE.M.S Electro Medical Systems S.A201943
+5K171189AIR-FLOW PLUS Prophylaxis powderE.M.S Electro Medical Systems S.A20170—
+5K151748Clean & More3M Deutschland GmbH20160—
+5K130137Biosonic Suvi Piezeoelectric Scaler and PolisherColtene/Whaledent20130—
+6K260773Varios Combi Pro2Nakanishi, Inc.20260—
+6K253254GBT Machine Airflow Prophylaxis MasterE.M.S Electro Medical Systems S.A20260—
+6K231391Combi TouchMectron S.P.A.20231—
+7K251425turbodent touchMectron S.P.A.20250—