Atlas FDA

ELC

195 FDA 510(k) clearances · Product code

90 daysmedian time to decision
305 days90th percentile
195clearances measured

FDA profile

Official device name
Scaler, Ultrasonic
Device class
Class II (moderate risk)
Regulation
21 CFR 872.4850
Medical specialty
Dental
Flags
Third-party review eligible
Adverse events (MAUDE)
2021: 166 · 2022: 165 · 2023: 210 · 2024: 219 · 2025: 289 · 2026: 200
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free

RecordFirmDate
Varios Combi Pro2 (K260773)Nakanishi, Inc.2026-03-10
GBT Machine Airflow Prophylaxis Master (K253254)E.M.S Electro Medical Systems S.A2026-01-28
VARIOS 170 LUX SCALER SYSTEM (VA170LUXS10); VARIOS 170 LUX SCALER SYSTEM (VA170LUXS11); VARIOS 170 SCALER SYSTEM (VA170S11) (K251689)Nakanishi, Inc.2025-09-19
Integrated Endo System (Meet Endo-II) (K242317)Denjoy Dental Co., Ltd.2025-02-13
OdneClean (K233844)Odne AG2024-08-08
Ultrasonic 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-N0016,WD-JY-N0017,WD-JY-E007, WD-JY-F008,WD-JY-A005,WD-JY-H009,WD-JY-I0011, WD-JY-K0012,WD-JY-K0013,WD-JY-K0014, WD-JY-L0013,WD-JY-L0014,WD-JY-L0015, WD-JY-L0016,WD-JY-L0017) (K240707)Shenzhen Micro Electric Intelligence Co., Ltd.2024-07-02
BioSonic US200 Ultrasonic Scaler (60034537) (K240801)Dent4you AG2024-07-01
SP NEWTRON CAN-A; MODULE NEWTRON CAN-A EMB; SUPPORT XINETIC; NWT CAN SLIM LED CORD G3 SHORT; NWT CAN SLIM LED CORD G3 LONG (K233922)Satelec - Acteon Group2024-03-11
EDS Calculus Softener TURBO CR (K223340)Essential Dental Systems, Inc.2023-12-11
Ultrasonic Scaler Tips (K230641)Guilin Refine Medical Instrument Co., Ltd.2023-11-21
Proxeo ULTRA (PB-510, PB-520 and PB-530) (K223173)W&H Dentalwerk Buermoss GmbH2023-07-14
Combi Touch (K231391)Mectron S.P.A.2023-05-15
Endo Ultrasonic Activator (K222096)Foshan Coxo Medical Instrument Co., Ltd.2023-03-23
Ultrasonic Endo Activation Device (Model:Actor I pro) (K213947)Changzhou Bomedent Medical Technology Co.,Ltd2022-09-08
EVOCLEAN CLEANsert Ultrasonic Insert (K210832)Ttbio Corp.2022-02-02
Dental Scaler and Air Polisher (K203615)Guilin Woodpecker Medical Instrument Co., Ltd.2021-12-10
EndoPilot2 (K202906)Schlumbohm GmbH & Co. KG2021-04-13
GentleWave X (K203302)Sonendo, Inc.2021-02-05
TTBIO EVOCLEAN Ultrasonic Scaler (K201317)Ttbio Corp.2020-12-04
EMS AIRFLOW Prophylaxis Master, EMS AIRFLOW One (K190124)E.M.S Electro Medical Systems S.A2019-10-20
Piezon Built-in Kit, Piezon Built-in Kit LED (K191079)E.M.S Electro Medical Systems S.A2019-08-16
tün® ultrasonic tips product family (K182145)Engineered Endodontics2019-06-07
Sonendo GentleWave System (K190359)Sonendo, Inc.2019-03-16
AW-100 (K171150)Micron Corporation2018-03-08
COMPACT S, COMPACT S (LED) (K170104)Dmetec.Co., Ltd.2017-12-27
Ultrasonic scaler (K163414)Nanning VV Dental Co., Ltd.2017-11-21
Y-MIC (K161639)Micron Corporation2016-12-22
Sonendo GentleWave System (K160905)Sonendo, Inc.2016-06-03
Sonendo Gentle Wave System (K153157)Sonendo, Inc.2016-01-29
COMPACT PIEZO LED (K151023)Mectron S.P.A.2015-08-05
Cavitron Touch Ultrasonic Scaling System (K150535)Dentsply International, Inc.2015-06-16
Sonendo GentleWave System (K143448)Sonendo, Inc.2015-05-01
ULTRASONIC SCALER (K140233)Nanning Baolai Medical Instrument Co., Ltd.2015-04-06
EMS PIEZON 707 BIK AND PIEZON 707 BIK LED (K140990)E.M.S Electro Medical Systems S.A2015-02-27
MULTIPIEZO PRO, MULTIPIEZO (K140965)Mectron S.P.A.2014-08-20
SONENDO OMNICLEAN ENDOTHERPAY SYSTEM CONSOLE, SONENDO OMNICLEAN MOLAR PROCEDURE KIT (K133752)Sonendo, Inc.2014-05-15
NEWTRON P5 XS B.LED (K132322)Satelec - Acteon Group2014-03-11
NEWTRON P5, NEWTRON P5 B.LED (K132267)Satelec - Acteon Group2014-03-10
EDS ULTRASONIC TIPS (K132609)Essential Dental Systems, Inc.2014-01-22
ENDOCENTER (K131151)Satelec - Acteon Group2014-01-16
PIEZON 250 (K132445)E.M.S Electro Medical Systems S.A2013-12-06
NEWTRON BOOSTER (K131997)Satelec - Acteon Group2013-11-26
PIEZON 150 (K132443)E.M.S Electro Medical Systems S.A2013-11-22
R7 (K130834)Cefla S.C.2013-10-08
BIOSONIC SUVI PIEZEOELECTRIC SCALER AND POLISHER (K130137)Coltene/Whaledent2013-08-23
AEU-525 TRANSPORT III PORTABLE DENTAL SYSTEM (K130693)Aseptico, Inc.2013-08-14
CAVITRON PROPHY-JET AIR POLISHING PROPHYLAXIS SYSTEM (K130862)Dentsply Intl., Inc.2013-07-23
ENGLER 25K SERIES ULTRASONIC INSERTS (K122748)Engler Engineering Corp.2013-06-11
SONENDO ENDOTHERAPY SYSTEM (K130025)Sonendo, Inc.2013-06-11
AEI DR. TERAUCHI ULTRASONIC TIPS (K122501)American Eagle Instruments, Inc.2013-03-29
ADVANCED ENDODONTIC SYSTEM- DESIGNER SERIES (K123139)Asi Medical, Inc.2013-03-28
ULTRASONIC SCALER (K113717)Nakanishi, Inc.2013-03-05
ULTRASONIC SCALER (K113530)Nakanishi, Inc.2013-01-31
PROULTRA PIEZO ULTRASONIC (K113430)Satelec - Acteon Group2012-02-23
EMS AIR-FLOW MASTER PIEZON (K110173)E.M.S Electro Medical Systems S.A2011-04-07
LAKONG ULTRASONIC SCALER (K103498)Lakong Medical Device Company, Ltd.2011-03-31
COMPACT PIEZO P2K, POWERCARE (K102218)Mectron S.P.A.2011-01-24
EMS MINIMASTER LED (K093723)E.M.S Electro Medical Systems S.A2010-09-08
EMS PIEZON MASTER 700 (K093000)E.M.S Electro Medical Systems S.A2010-07-30
A-DEC/W&H SYNEA SONIC SCALER HANDPIECE, MODELS ZA-55, ZA-55 L, ZA-55 LM, ZA-55M, SF1LM (K100647)A-Dec, Inc.2010-07-09
SWERV MAGNETOSTRICTIVE ULTRASONIC SCALER SYSTEM (K100401)Hu-Friedy Mfg. Co., Inc.2010-03-30
INSIGHT ULTRASONIC INSERTS (K092417)Discus Dental, LLC2009-12-11
SONIC AIR MM1500 + (MID), MODEL 50400014 (K081268)Micro-Mega Societe Anonyme2009-08-10
AIR SONIC SCALER (K083059)Dpm USA Corp.2009-01-30
STER-MATE STERILE LAVAGE KIT (K082973)Dentsply Interntional2009-01-29
SONICFLEX 2003 AND SONICFLEX LUX 2003 L WITH INSTRUMENT TIPS (K080089)Sybron Dental Specialties, Inc.2008-09-04
BONART ULTRASONIC SCALER, MOEDLS ART-P3II PRO AND ART-MII PRO (K081550)Bonart Co., Ltd.2008-08-28
VARIOS 75 (K071447)Nakanishi, Inc.2008-04-18
PERIOSCAN, MODEL: D 3496 (K072107)Sirona Dental Systems GmbH2008-02-14
BONART MODEL ART-P6 PIEZO ELECTRIC ULTRASONIC SCALER & ACCESSORIES (TIPS) (K071981)Bonart Co., Ltd.2007-10-26
PMAX NEWTRON XS (K071424)Satelec - Acteon Group2007-08-24
SYMMETRY IQ, MODEL 2000 SERIES, 3000 SERIES (K070975)Hu-Friedy Mfg. Co., Inc.2007-06-21
STERI -MATE HANDPIECE SLEEVE WITH LED LIGHT (K070307)Dentsply International, Inc.2007-05-02
ULTRASONIC SCALER, VARIOS 560 (K062731)Nakanishi, Inc.2007-05-01
ASC-12 PIEZOELECTRIC SCALER (K070866)Aseptico, Inc.2007-04-11
USI DENTAL SCALER, 25XXX SERIES (K062791)Ultrasonic Services, Inc.2006-12-11
ULTRASONIC SCALER, MODELS UDS-N1, UDS-N2. UDS-J, UDS-K, UDS-L (K053555)Guilin Woodpecker Medical Instrument Co., Ltd.2006-08-21
BONART ART-P3II & P4 PIEZO ELECTRIC ULTRASONIC SCALER UNITS WITH ACCESSORIES (K061448)Bonart Co., Ltd.2006-08-17
SCORPION ULTRASONIC SCALING INSERTS (K053578)Scorpion2006-07-14
PIEZOTOME (K060275)Satelec2006-05-03
CLEANSE S+ ULTRASONIC SCALER (K060171)Dmetec.Co., Ltd.2006-03-29
SYMMETRY S-SERIES PIEZOELECTRIC SCALING TIPS (K053178)Hu-Friedy Mfg. Co., Inc.2006-02-01
PIEZOSURGERY (K052518)Piezosurgery S.R.L.2005-11-16
J. MORITA AZ ULTRASONIC SYSTEM (K053030)J. Morita USA, Inc.2005-11-07
BONART ART-M3II & M4 ULTRASONIC SCALER UNITS WITH ACCESSORIES (INSERTS) (K052028)Bonart Co., Ltd.2005-10-28
CAVITRON RF ULTRASONIC SCALER SYSTEM WITH STERIMATE HANDPIECE, MODEL G-131 (K052334)Dentsply Intl.2005-09-02
MAXISONIC FAMILY AND SWIFT ULTRASONIC SCALER (K051910)D.B.I. America Corp.2005-09-02
POWERMAX 25, MODEL PM25; POWERMAX 30, MODEL PM30 (K051547)Tpc Advanced Technology, Inc.2005-07-14
PROTEGE ULTRASONIC INSERT (K051776)Discus Dental, Inc.2005-07-13
SURPASSON P5 NEWTRON (K050895)Satelec2005-04-20
MINIMASTER ULTRASONIC SCALER (K050710)E.M.S Electro Medical Systems S.A2005-03-30
PERIOSCAN ULTRASONIC SCALER (K050354)Sirona Dental Systems GmbH2005-03-21
XP TECHNOLOGY ULTRASONIC SCALER (K042972)American Eagle Instruments, Inc.2005-03-18
DREAM CLEANSE S SCALER, DREAM COMPACT S SCALER (K033044)American Green Dent. Mfg, Inc.2004-12-21
AZ ULTRASONIC SYSTEM (K042056)J. Morita USA, Inc.2004-09-30
APOZA ULTRASONIC SCALER AND EDODONTICS UNIT, SELECTOR U2 (K033198)Apoza Enterprise Co., Ltd.2004-04-30
ULTRASONIC SCALER ELEGANCE MS-10 (25K) (K040396)Rolence Enteprise, Inc.2004-04-22
ULTRASONIC SCALER, MODELS VARIOS 350 LUX, VARIOS 350 (NO LIGHT), VARIOS 550, VARIOS 150 LUX, VARIOS 150 (NO LIGHT) (K031421)Nakanishi, Inc.2004-03-26
SP NEWTRON MODULE (K033764)Satelec2004-03-01
SCALETRON PIEZO ULTRASOUND SCALER (K033120)Pac-Dent International (Suzhou), Ltd.2004-01-29
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