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 |
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 |
K132609 |
ESSENTIAL DENTAL SYSTEMS, INC. |
EDS ULTRASONIC TIPS |
01/22/2014 |
K222096 |
Foshan COXO Medical Instrument Co.,Ltd. |
Endo Ultrasonic Activator |
03/23/2023 |
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 |
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 |
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 |
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 |