FDA 510(k) Applications for Medical Device Product Code "ELC"
(Scaler, Ultrasonic)
| FDA 510(k) Number | Applicant | Device Name | Decision Date |
| K992504 | (EMS SA) ELECTRO MEDICAL SYSTEMS | EMS KERMIT | 01/27/2000 |
| K991874 | (EMS SA) ELECTRO MEDICAL SYSTEMS | EMS SURFACE MOUNT SCALER | 07/30/1999 |
| K100647 | A-DEC, INC. | A-DEC/W&H SYNEA SONIC SCALER HANDPIECE, MODELS ZA-55, ZA-55 L, ZA-55 LM, ZA-55M, SF1LM | 07/09/2010 |
| K982793 | ADVANCED MEDICAL DEVICES, INC. | PIEZO TRONIC | 10/28/1998 |
| K002122 | AIR TECHNIQUES, INC. | VECTOR | 12/21/2000 |
| K122501 | AMERICAN EAGLE INSTRUMENTS, INC. | AEI DR. TERAUCHI ULTRASONIC TIPS | 03/29/2013 |
| K042972 | AMERICAN EAGLE INSTRUMENTS, INC. | XP TECHNOLOGY ULTRASONIC SCALER | 03/18/2005 |
| K033044 | AMERICAN GREEN DENT. MFG, INC. | DREAM CLEANSE S SCALER, DREAM COMPACT S SCALER | 12/21/2004 |
| K033198 | APOZA ENTERPRISE CO. LTD. | APOZA ULTRASONIC SCALER AND EDODONTICS UNIT, SELECTOR U2 | 04/30/2004 |
| K130693 | ASEPTICO, INC. | AEU-525 TRANSPORT III PORTABLE DENTAL SYSTEM | 08/14/2013 |
| K070866 | ASEPTICO, INC. | ASC-12 PIEZOELECTRIC SCALER | 04/11/2007 |
| K123139 | ASI MEDICAL, INC. | ADVANCED ENDODONTIC SYSTEM- DESIGNER SERIES | 03/28/2013 |
| K000510 | BONART CO. LTD. | ART-M1, MODEL M1-1-ART-A1 | 05/15/2000 |
| K994203 | BONART CO. LTD. | ART-M3 25K, MODEL M3-1-ART2-A1; ART-M3 30K, MODEL M3-1-ART3-A1 | 03/06/2000 |
| K994299 | BONART CO. LTD. | ART-P3, MODEL P3-1-ART-A1 | 03/06/2000 |
| K052028 | BONART CO. LTD. | BONART ART-M3II & M4 ULTRASONIC SCALER UNITS WITH ACCESSORIES (INSERTS) | 10/28/2005 |
| K061448 | BONART CO. LTD. | BONART ART-P3II & P4 PIEZO ELECTRIC ULTRASONIC SCALER UNITS WITH ACCESSORIES | 08/17/2006 |
| K071981 | BONART CO. LTD. | BONART MODEL ART-P6 PIEZO ELECTRIC ULTRASONIC SCALER & ACCESSORIES (TIPS) | 10/26/2007 |
| K081550 | BONART CO. LTD. | BONART ULTRASONIC SCALER, MOEDLS ART-P3II PRO AND ART-MII PRO | 08/28/2008 |
| K130834 | CEFLA S.C. | R7 | 10/08/2013 |
| K213947 | ChangZhou BoMedent Medical Technology Co.,Ltd | Ultrasonic Endo Activation Device (Model:Actor I pro) | 09/08/2022 |
| K130137 | COLTENE/WHALEDENT | BIOSONIC SUVI PIEZEOELECTRIC SCALER AND POLISHER | 08/23/2013 |
| K983727 | COLTENE/WHALEDENT INC. | BIOSONIC ULTRASONIC SCALER SYSTEM | 01/20/1999 |
| K943403 | CONDOR PRODUCTS, INC. | CONDOR ULTRASONIC INSERTS | 03/05/1996 |
| K051910 | D.B.I. AMERICA CORP. | MAXISONIC FAMILY AND SWIFT ULTRASONIC SCALER | 09/02/2005 |
| K011179 | DELDENT LTD. | DELDENT ULTRASONIC INSERTS | 06/05/2001 |
| K014238 | DELDENT LTD. | DELSONIC 2000 | 01/24/2002 |
| K242317 | Denjoy Dental Co., Ltd. | Integrated Endo System (Meet Endo-II) | 02/13/2025 |
| K240801 | Dent4You AG | BioSonic US200 Ultrasonic Scaler (60034537) | 07/01/2024 |
| K954820 | DENTAMERICA | SCALEX 800 | 01/18/1996 |
| K033705 | DENTSPLY INTERNATIONAL | BOBCAT PRO SCALER SYSTEM, MODEL G-130 | 12/04/2003 |
| K030111 | DENTSPLY INTERNATIONAL | DIAMONDCOAT ULTRASONIC INSERTS | 02/07/2003 |
| K023697 | DENTSPLY INTERNATIONAL | STERI-MATE STERILIZABLE HANDPIECE | 11/06/2002 |
| K150535 | DENTSPLY INTERNATIONAL, INC. | Cavitron Touch Ultrasonic Scaling System | 06/16/2015 |
| K070307 | DENTSPLY INTERNATIONAL, INC. | STERI -MATE HANDPIECE SLEEVE WITH LED LIGHT | 05/02/2007 |
| K082973 | DENTSPLY INTERNTIONAL | STER-MATE STERILE LAVAGE KIT | 01/29/2009 |
| K031461 | DENTSPLY INTL. | CARRIER TIPS | 08/05/2003 |
| K970342 | DENTSPLY INTL. | CAVITRON JET WITH SPS SYSTEM | 04/04/1997 |
| K052334 | DENTSPLY INTL. | CAVITRON RF ULTRASONIC SCALER SYSTEM WITH STERIMATE HANDPIECE, MODEL G-131 | 09/02/2005 |
| K970123 | DENTSPLY INTL. | DENTSPLY CAVITRON SPS SCALER SYSTEM | 04/11/1997 |
| K130862 | DENTSPLY INTL., INC. | CAVITRON PROPHY-JET AIR POLISHING PROPHYLAXIS SYSTEM | 07/23/2013 |
| K051776 | DISCUS DENTAL INC. | PROTEGE ULTRASONIC INSERT | 07/13/2005 |
| K092417 | DISCUS DENTAL, LLC | INSIGHT ULTRASONIC INSERTS | 12/11/2009 |
| K060171 | DMETEC CO., LTD. | CLEANSE S+ ULTRASONIC SCALER | 03/29/2006 |
| K170104 | DMETEC CO., LTD. | COMPACT S, COMPACT S (LED) | 12/27/2017 |
| K083059 | DPM USA CORP. | AIR SONIC SCALER | 01/30/2009 |
| K191079 | E.M.S Electro Medical Systems S.A | Piezon Built-in Kit, Piezon Built-in Kit LED | 08/16/2019 |
| K190124 | E.M.S Electro Medical Systems S.A. | EMS AIRFLOW Prophylaxis Master, EMS AIRFLOW One | 10/20/2019 |
| K140990 | E.M.S. ELECTRO MEDICAL SYSTEMS S.A. | EMS PIEZON 707 BIK AND PIEZON 707 BIK LED | 02/27/2015 |
| K050710 | E.M.S. ELECTRO MEDICAL SYSTEMS S.A. | MINIMASTER ULTRASONIC SCALER | 03/30/2005 |
| K132443 | E.M.S. ELECTRO MEDICAL SYSTEMS S.A. | PIEZON 150 | 11/22/2013 |
| K132445 | E.M.S. ELECTRO MEDICAL SYSTEMS S.A. | PIEZON 250 | 12/06/2013 |
| K022328 | ELECTRO MEDICAL SYSTEMS SA | EMS PIEZON MASTER 600 | 08/13/2002 |
| K110173 | EMS ELECTRO MEDICAL SYSTEMS SA | EMS AIR-FLOW MASTER PIEZON | 04/07/2011 |
| K093723 | EMS ELECTRO MEDICAL SYSTEMS SA | EMS MINIMASTER LED | 09/08/2010 |
| K093000 | EMS ELECTRO MEDICAL SYSTEMS SA | EMS PIEZON MASTER 700 | 07/30/2010 |
| K182145 | Engineered Endodontics | tⁿn« ultrasonic tips product family | 06/07/2019 |
| K122748 | ENGLER ENGINEERING CORP. | ENGLER 25K SERIES ULTRASONIC INSERTS | 06/11/2013 |
| K223340 | Essential Dental Systems Inc. | EDS Calculus Softener TURBO CR | 12/11/2023 |
| K132609 | ESSENTIAL DENTAL SYSTEMS, INC. | EDS ULTRASONIC TIPS | 01/22/2014 |
| K222096 | Foshan COXO Medical Instrument Co.,Ltd. | Endo Ultrasonic Activator | 03/23/2023 |
| K230641 | Guilin Refine Medical Instrument Co., Ltd. | Ultrasonic Scaler Tips | 11/21/2023 |
| K053555 | GUILIN WOODPECKER MEDICAL INSTRUMENT CO., LTD | ULTRASONIC SCALER, MODELS UDS-N1, UDS-N2. UDS-J, UDS-K, UDS-L | 08/21/2006 |
| K203615 | Guilin Woodpecker Medical Instrument Co., Ltd. | Dental Scaler and Air Polisher | 12/10/2021 |
| K100401 | HU-FRIEDY MFG. CO., INC | SWERV MAGNETOSTRICTIVE ULTRASONIC SCALER SYSTEM | 03/30/2010 |
| K070975 | HU-FRIEDY MFG. CO., INC | SYMMETRY IQ, MODEL 2000 SERIES, 3000 SERIES | 06/21/2007 |
| K012060 | HU-FRIEDY MFG. CO.,INC. | MODIFICATION TO:HU-FRIEDY BRAND SATIN SWIVEL ULTRASONIC INSERT | 07/27/2001 |
| K053178 | HU-FRIEDY MFG. CO.,INC. | SYMMETRY S-SERIES PIEZOELECTRIC SCALING TIPS | 02/01/2006 |
| K042056 | J. MORITA USA, INC. | AZ ULTRASONIC SYSTEM | 09/30/2004 |
| K053030 | J. MORITA USA, INC. | J. MORITA AZ ULTRASONIC SYSTEM | 11/07/2005 |
| K103498 | LAKONG MEDICAL DEVICE COMPANY, LTD | LAKONG ULTRASONIC SCALER | 03/31/2011 |
| K231391 | Mectron S.p.A. | Combi Touch | 05/15/2023 |
| K102218 | MECTRON S.P.A. | COMPACT PIEZO P2K, POWERCARE | 01/24/2011 |
| K151023 | MECTRON SPA | COMPACT PIEZO LED | 08/05/2015 |
| K140965 | MECTRON SPA | MULTIPIEZO PRO, MULTIPIEZO | 08/20/2014 |
| K081268 | MICRO-MEGA SOCIETE ANONYME | SONIC AIR MM1500 + (MID), MODEL 50400014 | 08/10/2009 |
| K032995 | MICRON CORP. | SSS, MODEL 1072001 (STANDARD 4-HOLE MODEL) & 1072002 (STANDARD 2-HOLE MODEL) | 11/20/2003 |
| K991239 | MICRON CORP. | VIP 60 (2H), MODEL 115-000-1, VIP 60 (4H), MODEL 115-000-2 | 10/18/1999 |
| K171150 | Micron Corporation | AW-100 | 03/08/2018 |
| K161639 | MICRON CORPORATION | Y-MIC | 12/22/2016 |
| K113530 | NAKANISHI, INC. | ULTRASONIC SCALER | 01/31/2013 |
| K113717 | NAKANISHI, INC. | ULTRASONIC SCALER | 03/05/2013 |
| K031421 | NAKANISHI, INC. | ULTRASONIC SCALER, MODELS VARIOS 350 LUX, VARIOS 350 (NO LIGHT), VARIOS 550, VARIOS 150 LUX, VARIOS 150 (NO LIGHT) | 03/26/2004 |
| K062731 | NAKANISHI, INC. | ULTRASONIC SCALER, VARIOS 560 | 05/01/2007 |
| K071447 | NAKANISHI, INC. | VARIOS 75 | 04/18/2008 |
| K140233 | NANNING BAOLAI MEDICAL INSTRUMENT CO., LTD. | ULTRASONIC SCALER | 04/06/2015 |
| K163414 | NANNING VV DENTAL CO., LTD. | Ultrasonic scaler | 11/21/2017 |
| K991021 | NSK NAKANISHI, INC. | SONIC SCALER WITH FIBER OPTIC, MODEL NAS-L, SONIC SCALER WITHOUT FIBER OPTIC, MODEL NAS-NL | 06/23/1999 |
| K233844 | Odne AG | OdneClean | 08/08/2024 |
| K000846 | ORASYSTEMS | TKD SCALERS | 12/04/2000 |
| K033120 | PAC-DENT INTERNATIONAL (SUZHOU), LTD. | SCALETRON PIEZO ULTRASOUND SCALER | 01/29/2004 |
| K052518 | PIEZOSURGERY SRL | PIEZOSURGERY | 11/16/2005 |
| K010195 | PREMIER DENTAL PRODUCTS CO. | PREMIER ULTRASONIC SCALER AND INSERTS | 04/17/2001 |
| K964596 | PROFESSIONAL DENTAL MFG., INC. | PROSELECT 3 PERIDONTAL THERAPY SYSTEM | 04/22/1997 |
| K040396 | ROLENCE ENTEPRISE, INC. | ULTRASONIC SCALER ELEGANCE MS-10 (25K) | 04/22/2004 |
| K960889 | SAN DIEGO SWISS MACHINING, INC. | SAPPHIRE PLUS SCALER MOD. 300114/PLUGGER MOD. 300115/CUTTING MOD. 300116/SPREADER MOD. 300117 TIPS | 05/10/1996 |
| K060275 | SATELEC | PIEZOTOME | 05/03/2006 |
| K033764 | SATELEC | SP NEWTRON MODULE | 03/01/2004 |
| K972026 | SATELEC | SP4044 & SP4055 LUX MODULES | 07/09/1997 |
| K961158 | SATELEC | SUPRASSON P5 BOOSTER | 05/23/1996 |
| K050895 | SATELEC | SURPASSON P5 NEWTRON | 04/20/2005 |
| K131151 | SATELEC-ACTEON GROUP | ENDOCENTER | 01/16/2014 |
| K131997 | SATELEC-ACTEON GROUP | NEWTRON BOOSTER | 11/26/2013 |
| K132322 | SATELEC-ACTEON GROUP | NEWTRON P5 XS B.LED | 03/11/2014 |
| K132267 | SATELEC-ACTEON GROUP | NEWTRON P5, NEWTRON P5 B.LED | 03/10/2014 |
| K071424 | SATELEC-ACTEON GROUP | PMAX NEWTRON XS | 08/24/2007 |
| K113430 | SATELEC-ACTEON GROUP | PROULTRA PIEZO ULTRASONIC | 02/23/2012 |
| K233922 | SATELEC-ACTEON GROUP | 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 | 03/11/2024 |
| K202906 | Schlumbohm GmbH & Co. KG | EndoPilot2 | 04/13/2021 |
| K053578 | SCORPION | SCORPION ULTRASONIC SCALING INSERTS | 07/14/2006 |
| K990546 | SDS DENTAL, INC. | DELSONIC 2000 | 11/05/1999 |
| K240707 | Shenzhen Micro Electric Intelligence Co., Ltd. | 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 | 07/02/2024 |
| K050354 | SIRONA DENTAL SYSTEMS GMBH | PERIOSCAN ULTRASONIC SCALER | 03/21/2005 |
| K072107 | SIRONA DENTAL SYSTEMS GMBH | PERIOSCAN, MODEL: D 3496 | 02/14/2008 |
| K033640 | SIRONA DENTAL SYSTEMS GMBH | SIROSON L AND SIROSONIC L ULTRASONIC SCALERS | 12/12/2003 |
| K203302 | Sonendo, Inc | GentleWave X | 02/05/2021 |
| K130025 | SONENDO, INC. | SONENDO ENDOTHERAPY SYSTEM | 06/11/2013 |
| K153157 | SONENDO, INC. | Sonendo Gentle Wave System | 01/29/2016 |
| K190359 | Sonendo, Inc. | Sonendo GentleWave System | 03/16/2019 |
| K143448 | Sonendo, Inc. | Sonendo GentleWave System | 05/01/2015 |
| K160905 | SONENDO, INC. | Sonendo GentleWave System | 06/03/2016 |
| K133752 | SONENDO, INC. | SONENDO OMNICLEAN ENDOTHERPAY SYSTEM CONSOLE, SONENDO OMNICLEAN MOLAR PROCEDURE KIT | 05/15/2014 |
| K002521 | SPARTAN MARKETING GROUP | SPARTAN MTS | 11/13/2000 |
| K002753 | SPARTAN ULTRASONICS, INC. | SPARTAN A-10 | 12/04/2000 |
| K080089 | SYBRON DENTAL SPECIALTIES, INC. | SONICFLEX 2003 AND SONICFLEX LUX 2003 L WITH INSTRUMENT TIPS | 09/04/2008 |
| K021253 | SYBRON ENDO/ANALYTIC | ULTRASONIC TIPS WITH DIAMOND COATING | 07/05/2002 |
| K964320 | TONY RISO CO., INC. | TONY RISO 25/30 MULTIFUNCTION SCALER | 01/23/1997 |
| K983029 | TPC ADVANCED TECHNOLOGY, INC. | POWER PLUS 25K MODEL, S1000, POWER PLUS 30K MODEL,S1001 | 01/29/1999 |
| K051547 | TPC ADVANCED TECHNOLOGY, INC. | POWERMAX 25, MODEL PM25; POWERMAX 30, MODEL PM30 | 07/14/2005 |
| K210832 | TTBIO CORP. | EVOCLEAN CLEANsert Ultrasonic Insert | 02/02/2022 |
| K201317 | TTBIO CORP. | TTBIO EVOCLEAN Ultrasonic Scaler | 12/04/2020 |
| K062791 | ULTRASONIC SERVICES INC. | USI DENTAL SCALER, 25XXX SERIES | 12/11/2006 |
| K223173 | W&H Dentalwerk Buermoss GmbH | Proxeo ULTRA (PB-510, PB-520 and PB-530) | 07/14/2023 |
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