ClearanceBrief
Panels › Dental › Product code ELC · Class 2

Scaler, Ultrasonic

Regulation 872.4850

2510(k)s in 12 months (195 all time)
0recalls in 12 months (10 all time)
10recalls that name a 510(k)
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Top companies in ELC

Decided510(k)Device and applicantCode
Mar 10, 2026K260773Varios Combi Pro2
Nakanishi, Inc., JP
ELC
Jan 28, 2026K253254GBT Machine Airflow Prophylaxis Master
E.M.S Electro Medical Systems S.A, CH
ELC
Sep 19, 2025K251689VARIOS 170 LUX SCALER SYSTEM (VA170LUXS10); VARIOS 170 LUX SCALER SYSTEM (VA170LUXS11); VARIOS 170 SCALER SYSTEM (VA170S
Nakanishi, Inc., JP
ELC
Feb 13, 2025K242317Integrated Endo System (Meet Endo-II)
Denjoy Dental Co., Ltd., CN
ELC
Aug 8, 2024K233844OdneClean
Odne AG, CH
ELC
Jul 2, 2024K240707Ultrasonic Scaler (WD-JY-B002,WD-JY-W001,WD-JY-R003,WD-JY-G004,WD-JY-B003,WD-JY-C006,WD-JY-M0014, WD-JY-N0015,WD-JY-N001
Shenzhen Micro Electric Intelligence Co., Ltd., CN
ELC
Jul 1, 2024K240801BioSonic US200 Ultrasonic Scaler (60034537)
Dent4you AG, CH
ELC
Mar 11, 2024K233922SP NEWTRON CAN-A; MODULE NEWTRON CAN-A EMB; SUPPORT XINETIC; NWT CAN SLIM LED CORD G3 SHORT; NWT CAN SLIM LED CORD G3 LO
Satelec - Acteon Group, FR
ELC
Dec 11, 2023K223340EDS Calculus Softener TURBO CR
Essential Dental Systems, Inc.
ELC
Nov 21, 2023K230641Ultrasonic Scaler Tips
Guilin Refine Medical Instrument Co., Ltd., CN
ELC
Jul 14, 2023K223173Proxeo ULTRA (PB-510, PB-520 and PB-530)
W&H Dentalwerk Buermoss GmbH, AT
ELC
May 15, 2023K231391Combi Touch
Mectron S.P.A., IT
ELC
Mar 23, 2023K222096Endo Ultrasonic Activator
Foshan Coxo Medical Instrument Co., Ltd., CN
ELC
Sep 8, 2022K213947Ultrasonic Endo Activation Device (Model:Actor I pro)
Changzhou Bomedent Medical Technology Co.,Ltd, CN
ELC
Feb 2, 2022K210832EVOCLEAN CLEANsert Ultrasonic Insert
Ttbio Corp., TW
ELC
Dec 10, 2021K203615Dental Scaler and Air Polisher
Guilin Woodpecker Medical Instrument Co., Ltd., CN
ELC
Apr 13, 2021K202906EndoPilot2
Schlumbohm GmbH & Co. KG, DE
ELC
Feb 5, 2021K203302GentleWave X
Sonendo, Inc.
ELC
Dec 4, 2020K201317TTBIO EVOCLEAN Ultrasonic Scaler
Ttbio Corp., TW
ELC
Oct 20, 2019K190124EMS AIRFLOW Prophylaxis Master, EMS AIRFLOW One
E.M.S Electro Medical Systems S.A, CH
ELC
Aug 16, 2019K191079Piezon Built-in Kit, Piezon Built-in Kit LED
E.M.S Electro Medical Systems S.A, CH
ELC
Jun 7, 2019K182145tün® ultrasonic tips product family
Engineered Endodontics
ELC
Mar 16, 2019K190359Sonendo GentleWave System
Sonendo, Inc.
ELC
Mar 8, 2018K171150AW-100
Micron Corporation, JP
ELC
Dec 27, 2017K170104COMPACT S, COMPACT S (LED)
Dmetec.Co., Ltd., KR
ELC
Nov 21, 2017K163414Ultrasonic scaler
Nanning VV Dental Co., Ltd., CN
ELC
Dec 22, 2016K161639Y-MIC
Micron Corporation, JP
ELC
Jun 3, 2016K160905Sonendo GentleWave System
Sonendo, Inc.
ELC
Jan 29, 2016K153157Sonendo Gentle Wave System
Sonendo, Inc.
ELC
Aug 5, 2015K151023COMPACT PIEZO LED
Mectron S.P.A., IT
ELC
Jun 16, 2015K150535Cavitron Touch Ultrasonic Scaling System
Dentsply International, Inc.
ELC
May 1, 2015K143448Sonendo GentleWave System
Sonendo, Inc.
ELC
Apr 6, 2015K140233ULTRASONIC SCALER
Nanning Baolai Medical Instrument Co., Ltd., CN
ELC
Feb 27, 2015K140990EMS PIEZON 707 BIK AND PIEZON 707 BIK LED
E.M.S Electro Medical Systems S.A
ELC
Aug 20, 2014K140965MULTIPIEZO PRO, MULTIPIEZO
Mectron S.P.A., IT
ELC
May 15, 2014K133752SONENDO OMNICLEAN ENDOTHERPAY SYSTEM CONSOLE, SONENDO OMNICLEAN MOLAR PROCEDURE KIT
Sonendo, Inc.
ELC
Mar 11, 2014K132322NEWTRON P5 XS B.LED
Satelec - Acteon Group
ELC
Mar 10, 2014K132267NEWTRON P5, NEWTRON P5 B.LED
Satelec - Acteon Group
ELC
Jan 22, 2014K132609EDS ULTRASONIC TIPS
Essential Dental Systems, Inc.
ELC
Jan 16, 2014K131151ENDOCENTER
Satelec - Acteon Group
ELC
Dec 6, 2013K132445PIEZON 250
E.M.S Electro Medical Systems S.A
ELC
Nov 26, 2013K131997NEWTRON BOOSTER
Satelec - Acteon Group
ELC
Nov 22, 2013K132443PIEZON 150
E.M.S Electro Medical Systems S.A
ELC
Oct 8, 2013K130834R7
Cefla S.C.
ELC
Aug 23, 2013K130137BIOSONIC SUVI PIEZEOELECTRIC SCALER AND POLISHER
Coltene/Whaledent
ELC
Aug 14, 2013K130693AEU-525 TRANSPORT III PORTABLE DENTAL SYSTEM
Aseptico, Inc.
ELC
Jul 23, 2013K130862CAVITRON PROPHY-JET AIR POLISHING PROPHYLAXIS SYSTEM
Dentsply Intl., Inc.
ELC
Jun 11, 2013K130025SONENDO ENDOTHERAPY SYSTEM
Sonendo, Inc.
ELC
Jun 11, 2013K122748ENGLER 25K SERIES ULTRASONIC INSERTS
Engler Engineering Corp.
ELC
Mar 29, 2013K122501AEI DR. TERAUCHI ULTRASONIC TIPS
American Eagle Instruments, Inc.
ELC

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