Dental

ELC · Scaler, Ultrasonic

Dental · 21 CFR 872.4850 · Class 2

Overview

Product CodeELC
Device NameScaler, Ultrasonic
Regulation21 CFR 872.4850
Device ClassClass 2
Review PanelDental
3rd-Party ReviewableYes

Identification

An ultrasonic scaler is a device intended for use during dental cleaning and periodontal (gum) therapy to remove calculus deposits from teeth by application of an ultrasonic vibrating scaler tip to the teeth.

Classification Rationale

Class II.

Cleared Devices (195)

RecordDevice NameApplicantDecision DateDecision
K260773Varios Combi Pro2Nakanishi, Inc.Mar 10, 2026SESE
K253254GBT Machine Airflow Prophylaxis MasterE.M.S Electro Medical Systems S.AJan 28, 2026SESE
K251689VARIOS 170 LUX SCALER SYSTEM (VA170LUXS10); VARIOS 170 LUX SCALER SYSTEM (VA170LUXS11); VARIOS 170 SCALER SYSTEM (VA170S11)Nakanishi, Inc.Sep 19, 2025SESE
K242317Integrated Endo System (Meet Endo-II)Denjoy Dental Co., Ltd.Feb 13, 2025SESE
K233844OdneCleanOdne AGAug 8, 2024SESE
K240707Ultrasonic 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)Shenzhen Micro Electric Intelligence Co., Ltd.Jul 2, 2024SESE
K240801BioSonic US200 Ultrasonic Scaler (60034537)Dent4you AGJul 1, 2024SESE
K233922SP NEWTRON CAN-A; MODULE NEWTRON CAN-A EMB; SUPPORT XINETIC; NWT CAN SLIM LED CORD G3 SHORT; NWT CAN SLIM LED CORD G3 LONGSatelec - Acteon GroupMar 11, 2024SESE
K223340EDS Calculus Softener TURBO CREssential Dental Systems, Inc.Dec 11, 2023SESE
K230641Ultrasonic Scaler TipsGuilin Refine Medical Instrument Co., Ltd.Nov 21, 2023SESE
K223173Proxeo ULTRA (PB-510, PB-520 and PB-530)W&H Dentalwerk Buermoss GmbHJul 14, 2023SESE
K231391Combi TouchMectron S.P.A.May 15, 2023SESE
K222096Endo Ultrasonic ActivatorFoshan Coxo Medical Instrument Co., Ltd.Mar 23, 2023SESE
K213947Ultrasonic Endo Activation Device (Model:Actor I pro)Changzhou Bomedent Medical Technology Co.,LtdSep 8, 2022SESE
K210832EVOCLEAN CLEANsert Ultrasonic InsertTtbio Corp.Feb 2, 2022SESE
K203615Dental Scaler and Air PolisherGuilin Woodpecker Medical Instrument Co., Ltd.Dec 10, 2021SESE
K202906EndoPilot2Schlumbohm GmbH & Co. KGApr 13, 2021SESE
K203302GentleWave XSonendo, Inc.Feb 5, 2021SESE
K201317TTBIO EVOCLEAN Ultrasonic ScalerTtbio Corp.Dec 4, 2020SESE
K190124EMS AIRFLOW Prophylaxis Master, EMS AIRFLOW OneE.M.S Electro Medical Systems S.AOct 20, 2019SESE
K191079Piezon Built-in Kit, Piezon Built-in Kit LEDE.M.S Electro Medical Systems S.AAug 16, 2019SESE
K182145tün® ultrasonic tips product familyEngineered EndodonticsJun 7, 2019SESE
K190359Sonendo GentleWave SystemSonendo, Inc.Mar 16, 2019SESE
K171150AW-100Micron CorporationMar 8, 2018SESE
K170104COMPACT S, COMPACT S (LED)Dmetec.Co., Ltd.Dec 27, 2017SESE
K163414Ultrasonic scalerNanning VV Dental Co., Ltd.Nov 21, 2017SESE
K161639Y-MICMicron CorporationDec 22, 2016SESE
K160905Sonendo GentleWave SystemSonendo, Inc.Jun 3, 2016SESE
K153157Sonendo Gentle Wave SystemSonendo, Inc.Jan 29, 2016SESE
K151023COMPACT PIEZO LEDMectron S.P.A.Aug 5, 2015SESE
K150535Cavitron Touch Ultrasonic Scaling SystemDentsply International, Inc.Jun 16, 2015SESE
K143448Sonendo GentleWave SystemSonendo, Inc.May 1, 2015SESE
K140233ULTRASONIC SCALERNanning Baolai Medical Instrument Co., Ltd.Apr 6, 2015SESE
K140990EMS PIEZON 707 BIK AND PIEZON 707 BIK LEDE.M.S Electro Medical Systems S.AFeb 27, 2015SESE
K140965MULTIPIEZO PRO, MULTIPIEZOMectron S.P.A.Aug 20, 2014SESE
K133752SONENDO OMNICLEAN ENDOTHERPAY SYSTEM CONSOLE, SONENDO OMNICLEAN MOLAR PROCEDURE KITSonendo, Inc.May 15, 2014SESE
K132322NEWTRON P5 XS B.LEDSatelec - Acteon GroupMar 11, 2014SESE
K132267NEWTRON P5, NEWTRON P5 B.LEDSatelec - Acteon GroupMar 10, 2014SESE
K132609EDS ULTRASONIC TIPSEssential Dental Systems, Inc.Jan 22, 2014SESE
K131151ENDOCENTERSatelec - Acteon GroupJan 16, 2014SESE
K132445PIEZON 250E.M.S Electro Medical Systems S.ADec 6, 2013SESE
K131997NEWTRON BOOSTERSatelec - Acteon GroupNov 26, 2013SESE
K132443PIEZON 150E.M.S Electro Medical Systems S.ANov 22, 2013SESE
K130834R7Cefla S.C.Oct 8, 2013SESE
K130137BIOSONIC SUVI PIEZEOELECTRIC SCALER AND POLISHERColtene/WhaledentAug 23, 2013SESE
K130693AEU-525 TRANSPORT III PORTABLE DENTAL SYSTEMAseptico, Inc.Aug 14, 2013SESE
K130862CAVITRON PROPHY-JET AIR POLISHING PROPHYLAXIS SYSTEMDentsply Intl., Inc.Jul 23, 2013SESE
K130025SONENDO ENDOTHERAPY SYSTEMSonendo, Inc.Jun 11, 2013SESE
K122748ENGLER 25K SERIES ULTRASONIC INSERTSEngler Engineering Corp.Jun 11, 2013SESE
K122501AEI DR. TERAUCHI ULTRASONIC TIPSAmerican Eagle Instruments, Inc.Mar 29, 2013SESE
K123139ADVANCED ENDODONTIC SYSTEM- DESIGNER SERIESAsi Medical, Inc.Mar 28, 2013SESE
K113717ULTRASONIC SCALERNakanishi, Inc.Mar 5, 2013SESE
K113530ULTRASONIC SCALERNakanishi, Inc.Jan 31, 2013SESE
K113430PROULTRA PIEZO ULTRASONICSatelec - Acteon GroupFeb 23, 2012SESE
K110173EMS AIR-FLOW MASTER PIEZONE.M.S Electro Medical Systems S.AApr 7, 2011SESE
K103498LAKONG ULTRASONIC SCALERLakong Medical Device Company, Ltd.Mar 31, 2011SESE
K102218COMPACT PIEZO P2K, POWERCAREMectron S.P.A.Jan 24, 2011SESE
K093723EMS MINIMASTER LEDE.M.S Electro Medical Systems S.ASep 8, 2010SESE
K093000EMS PIEZON MASTER 700E.M.S Electro Medical Systems S.AJul 30, 2010SESE
K100647A-DEC/W&H SYNEA SONIC SCALER HANDPIECE, MODELS ZA-55, ZA-55 L, ZA-55 LM, ZA-55M, SF1LMA-Dec, Inc.Jul 9, 2010SESE
K100401SWERV MAGNETOSTRICTIVE ULTRASONIC SCALER SYSTEMHu-Friedy Mfg. Co., Inc.Mar 30, 2010SESE
K092417INSIGHT ULTRASONIC INSERTSDiscus Dental, LLCDec 11, 2009SESE
K081268SONIC AIR MM1500 + (MID), MODEL 50400014Micro-Mega Societe AnonymeAug 10, 2009SESE
K083059AIR SONIC SCALERDpm USA Corp.Jan 30, 2009SESE
K082973STER-MATE STERILE LAVAGE KITDentsply InterntionalJan 29, 2009SESE
K080089SONICFLEX 2003 AND SONICFLEX LUX 2003 L WITH INSTRUMENT TIPSSybron Dental Specialties, Inc.Sep 4, 2008SESE
K081550BONART ULTRASONIC SCALER, MOEDLS ART-P3II PRO AND ART-MII PROBonart Co., Ltd.Aug 28, 2008SESE
K071447VARIOS 75Nakanishi, Inc.Apr 18, 2008SESE
K072107PERIOSCAN, MODEL: D 3496Sirona Dental Systems GmbHFeb 14, 2008SESE
K071981BONART MODEL ART-P6 PIEZO ELECTRIC ULTRASONIC SCALER & ACCESSORIES (TIPS)Bonart Co., Ltd.Oct 26, 2007SESE
K071424PMAX NEWTRON XSSatelec - Acteon GroupAug 24, 2007SESE
K070975SYMMETRY IQ, MODEL 2000 SERIES, 3000 SERIESHu-Friedy Mfg. Co., Inc.Jun 21, 2007SESE
K070307STERI -MATE HANDPIECE SLEEVE WITH LED LIGHTDentsply International, Inc.May 2, 2007SESE
K062731ULTRASONIC SCALER, VARIOS 560Nakanishi, Inc.May 1, 2007SESE
K070866ASC-12 PIEZOELECTRIC SCALERAseptico, Inc.Apr 11, 2007SESE
K062791USI DENTAL SCALER, 25XXX SERIESUltrasonic Services, Inc.Dec 11, 2006SESE
K053555ULTRASONIC SCALER, MODELS UDS-N1, UDS-N2. UDS-J, UDS-K, UDS-LGuilin Woodpecker Medical Instrument Co., Ltd.Aug 21, 2006SESE
K061448BONART ART-P3II & P4 PIEZO ELECTRIC ULTRASONIC SCALER UNITS WITH ACCESSORIESBonart Co., Ltd.Aug 17, 2006SESE
K053578SCORPION ULTRASONIC SCALING INSERTSScorpionJul 14, 2006SESE
K060275PIEZOTOMESatelecMay 3, 2006SESE
K060171CLEANSE S+ ULTRASONIC SCALERDmetec.Co., Ltd.Mar 29, 2006SESE
K053178SYMMETRY S-SERIES PIEZOELECTRIC SCALING TIPSHu-Friedy Mfg. Co., Inc.Feb 1, 2006SESE
K052518PIEZOSURGERYPiezosurgery S.R.L.Nov 16, 2005SESE
K053030J. MORITA AZ ULTRASONIC SYSTEMJ. Morita USA, Inc.Nov 7, 2005SESE
K052028BONART ART-M3II & M4 ULTRASONIC SCALER UNITS WITH ACCESSORIES (INSERTS)Bonart Co., Ltd.Oct 28, 2005SESE
K052334CAVITRON RF ULTRASONIC SCALER SYSTEM WITH STERIMATE HANDPIECE, MODEL G-131Dentsply Intl.Sep 2, 2005SESE
K051910MAXISONIC FAMILY AND SWIFT ULTRASONIC SCALERD.B.I. America Corp.Sep 2, 2005SESE
K051547POWERMAX 25, MODEL PM25; POWERMAX 30, MODEL PM30Tpc Advanced Technology, Inc.Jul 14, 2005SESE
K051776PROTEGE ULTRASONIC INSERTDiscus Dental, Inc.Jul 13, 2005SESE
K050895SURPASSON P5 NEWTRONSatelecApr 20, 2005SESE
K050710MINIMASTER ULTRASONIC SCALERE.M.S Electro Medical Systems S.AMar 30, 2005SESE
K050354PERIOSCAN ULTRASONIC SCALERSirona Dental Systems GmbHMar 21, 2005SESE
K042972XP TECHNOLOGY ULTRASONIC SCALERAmerican Eagle Instruments, Inc.Mar 18, 2005SESE
K033044DREAM CLEANSE S SCALER, DREAM COMPACT S SCALERAmerican Green Dent. Mfg, Inc.Dec 21, 2004SESE
K042056AZ ULTRASONIC SYSTEMJ. Morita USA, Inc.Sep 30, 2004SESE
K033198APOZA ULTRASONIC SCALER AND EDODONTICS UNIT, SELECTOR U2Apoza Enterprise Co., Ltd.Apr 30, 2004SESE
K040396ULTRASONIC SCALER ELEGANCE MS-10 (25K)Rolence Enteprise, Inc.Apr 22, 2004SESE
K031421ULTRASONIC SCALER, MODELS VARIOS 350 LUX, VARIOS 350 (NO LIGHT), VARIOS 550, VARIOS 150 LUX, VARIOS 150 (NO LIGHT)Nakanishi, Inc.Mar 26, 2004SESE
K033764SP NEWTRON MODULESatelecMar 1, 2004SESE
K033120SCALETRON PIEZO ULTRASOUND SCALERPac-Dent International (Suzhou), Ltd.Jan 29, 2004SESE
K033640SIROSON L AND SIROSONIC L ULTRASONIC SCALERSSirona Dental Systems GmbHDec 12, 2003SESE
K033705BOBCAT PRO SCALER SYSTEM, MODEL G-130Dentsply InternationalDec 4, 2003SESE
K032995SSS, MODEL 1072001 (STANDARD 4-HOLE MODEL) & 1072002 (STANDARD 2-HOLE MODEL)Micron Corp.Nov 20, 2003SESE
K031461CARRIER TIPSDentsply Intl.Aug 5, 2003SESE
K030111DIAMONDCOAT ULTRASONIC INSERTSDentsply InternationalFeb 7, 2003SESE
K023697STERI-MATE STERILIZABLE HANDPIECEDentsply InternationalNov 6, 2002SESE
K022328EMS PIEZON MASTER 600Electro Medical Systems SAAug 13, 2002SESE
K021253ULTRASONIC TIPS WITH DIAMOND COATINGSybron Endo/AnalyticJul 5, 2002SESE
K014238DELSONIC 2000Deldent , Ltd.Jan 24, 2002SESE
K012060MODIFICATION TO:HU-FRIEDY BRAND SATIN SWIVEL ULTRASONIC INSERTHu-Friedy Mfg. Co., Inc.Jul 27, 2001SESE
K011179DELDENT ULTRASONIC INSERTSDeldent , Ltd.Jun 5, 2001SESE
K010195PREMIER ULTRASONIC SCALER AND INSERTSPremier Dental Products Co.Apr 17, 2001SESE
K002122VECTORAir Techniques, Inc.Dec 21, 2000SESE
K002753SPARTAN A-10Spartan Ultrasonics, Inc.Dec 4, 2000SESE
K000846TKD SCALERSOrasystemsDec 4, 2000SESE
K002521SPARTAN MTSSpartan Marketing GroupNov 13, 2000SESE
K000510ART-M1, MODEL M1-1-ART-A1Bonart Co., Ltd.May 15, 2000SESE
K994299ART-P3, MODEL P3-1-ART-A1Bonart Co., Ltd.Mar 6, 2000SESE
K994203ART-M3 25K, MODEL M3-1-ART2-A1; ART-M3 30K, MODEL M3-1-ART3-A1Bonart Co., Ltd.Mar 6, 2000SESE
K992504EMS KERMIT(Ems Sa) Electro Medical SystemsJan 27, 2000SESE
K990546DELSONIC 2000Sds Dental, Inc.Nov 5, 1999SESE
K991239VIP 60 (2H), MODEL 115-000-1, VIP 60 (4H), MODEL 115-000-2Micron Corp.Oct 18, 1999SESE
K991874EMS SURFACE MOUNT SCALER(Ems Sa) Electro Medical SystemsJul 30, 1999SESE
K991021SONIC SCALER WITH FIBER OPTIC, MODEL NAS-L, SONIC SCALER WITHOUT FIBER OPTIC, MODEL NAS-NLNsk Nakanishi, Inc.Jun 23, 1999SESE
K983029POWER PLUS 25K MODEL, S1000, POWER PLUS 30K MODEL,S1001Tpc Advanced Technology, Inc.Jan 29, 1999SESE
K983727BIOSONIC ULTRASONIC SCALER SYSTEMColtene/Whaledent, Inc.Jan 20, 1999SESE
K982793PIEZO TRONICAdvanced Medical Devices, Inc.Oct 28, 1998SESE
K972026SP4044 & SP4055 LUX MODULESSatelecJul 9, 1997SESE
K964596PROSELECT 3 PERIDONTAL THERAPY SYSTEMProfessional Dental Mfg., Inc.Apr 22, 1997SESE
K970123DENTSPLY CAVITRON SPS SCALER SYSTEMDentsply Intl.Apr 11, 1997SESE
K970342CAVITRON JET WITH SPS SYSTEMDentsply Intl.Apr 4, 1997SESE
K964320TONY RISO 25/30 MULTIFUNCTION SCALERTony Riso Co., Inc.Jan 23, 1997SESE
K961158SUPRASSON P5 BOOSTERSatelecMay 23, 1996SESE
K960889SAPPHIRE PLUS SCALER MOD. 300114/PLUGGER MOD. 300115/CUTTING MOD. 300116/SPREADER MOD. 300117 TIPSSan Diego Swiss Machining, Inc.May 10, 1996SESE
K943403CONDOR ULTRASONIC INSERTSCondor Products, Inc.Mar 5, 1996SESE
K954820SCALEX 800DentamericaJan 18, 1996SESE
K953919DENTAL ULTRASONIC SCALER INSERTSHu-Friedy Mfg. Co., Inc.Oct 7, 1995SESE
K942139SUPRASSON P MAXSatelecSep 29, 1995SESE
K953026MINIPIEZONElectro Medical Systems SAAug 28, 1995SESE
K942380MICRO ICS SONIC SCALERMicro Motors, Inc.Aug 7, 1995SESE
K951272RELACS 7000Micro-Mega Societe AnonymeMay 12, 1995SESE
K950256TURBO 25/30Parkell, Inc.Apr 4, 1995SESE
K950240LE CLEAN MACHINEParkell, Inc.Apr 4, 1995SESE
K941392JET UNIT (CJ HANDPIECE)Dentsply Intl.May 23, 1994SESE
K934714ENDODONTIC PULP CANAL SPREADERExcellence IN Endodontics, Inc.Feb 14, 1994SESE
K933547INTRA-ORAL IRRIGATORParkell, Inc.Oct 20, 1993SESE
K920328AMDENT 2030, POLISHER/SCALERAmdent ABOct 20, 1993SESE
K930698THE MODEL 3003 SCALERDentsply Intl.Jul 22, 1993SESE
K921893COLGATE ODONTOSON ULTRASONIC SCALERPerio-GieneJul 8, 1993SESE
K923639DIAMOND COATED DENTAL INSERTSDentsply Intl.Oct 26, 1992SESE
K903298DYNASONIC PLAQUE REMOVER & POLISHER DYNATIPMicro Motors, Inc.Apr 16, 1991SESE
K904296LYSTA HYGIENIST III SCALERProdent Intl., Inc.Dec 5, 1990SESE
K903163PERIODONTAL DEBRIDING SOLUTION EDentsply Intl.Oct 10, 1990SESE
K896749PIEZON MASTER 400Electro Medical Systems (Ems Sa)Aug 31, 1990SESE
K902413SONIC SCALERDentsply Intl.Aug 13, 1990SESE
K901488LYNX-SM, SCLAER DENTAL HANDPIECEMti Precision ProductsMay 15, 1990SESE
K900709AIR FLOW SIIElectro Medical Systems (Ems Sa)Apr 18, 1990SESE
K894247PERIODONTAL IRRIGATING SOLUTION-DDentsply Intl.Oct 6, 1989SESE
K884221ULTRASONIC SCALER COVERSteri-Shield Products, Inc.Mar 17, 1989SESE
K880940AMDENT MODEL 830 ULTRASONIC SCALERPathway Products, Inc.Jul 15, 1988SESE
K881253ROTORY SCALER SWIVEL IMPROVEMENT FEATURE, TITAN SWDentalez GroupApr 21, 1988SESE
K873146USI BASIC. AG 1050. AG 1090Cranston Ind., Inc.Oct 27, 1987SESE
K864996ULTRASONIC SCALER 3000/ PROPHY-JET 30/ CAVI-JET 30Dentsply Intl.Feb 19, 1987SESE
K863676GENTEELLuben Dental Co., Inc.Oct 2, 1986SESE
K853841HARMO SONICU.S. Shizai Corp.Feb 4, 1986SESE
K852525SATALEC PIEZOTECSpelna, Inc.Jan 30, 1986SESE
K852540ULTRASONIC TOOTH SCALER MODEL DSCIOPParkell, Inc.Jul 1, 1985SESE
K844250OSADA ENACOsada Electric Co., Ltd.Jan 23, 1985SESE
K842581CAVI-MEDCooper Lasersonics, Inc.Aug 3, 1984SESE
K840141DENTAL ULTRASONIC SCALER/ENDOSONICCooperVision, Inc.Mar 16, 1984SESE
K834283DENTSPLY G-106 CAVITRON ULTRASONICCoopercare, Inc.Mar 16, 1984SESE
K832674SATELEC PROPHY UNIT PU 2000SSpelna, Inc.Mar 16, 1984SESE
K832664SATELEC SUPRASSON PIEZOMATIC P2Spelna, Inc.Mar 16, 1984SESE
K832665SATELEC SUPRASSON SP 3055Spelna, Inc.Oct 19, 1983SESE
K832443ULTRASONIC DENTAL PROPHYLAXIS UNITCalifornia Technics, Inc.Sep 12, 1983SESE
K823134AIR FLOW IIHealthco, Inc.Nov 17, 1982SESE
K821810PIEZON ULTRASONIC SCALERHealthco, Inc.Jul 6, 1982SESE
K820162TEC-SON IICalifornia Technics, Inc.Feb 24, 1982SESE
K812909HYGIENTIST; CYCLOSON I & II; RETROFITFibra Sonics, Inc.Dec 14, 1981SESE
K811396SONUS VCalifornia Technics, Inc.Jun 26, 1981SESE
K811145PNEUMATIC DENTAL SCALERInnovate, Inc.Jun 16, 1981SESE
K811023ROOT CANAL KITDentsply Intl.May 5, 1981SESE
K801689SONATRON ULTRASONIC DENTAL SCANNERSimplified Systems, Inc.Sep 16, 1980SESE
K791704MASTERSCALE IILitton Dental ProductsOct 26, 1979SESE
K791585MODEL G-61 ULTRASONIC DENTAL UNITCavitron Corp.Sep 19, 1979SESE
K791024ULTRASONIC DENTAL PROPHYLAXIS UNITLitton Dental ProductsSep 17, 1979SESE
K782133ODONTOSON 3Mdt Corp., Inc.Feb 27, 1979SESE
K781044ULTRASONIC DENTAL PROPHYLAXIS UNIT,SSMLitton Dental ProductsJun 30, 1978SESE
K780808PIEZOMATIC ULTRASONIC SCALER (SYSTEM S)Dental Ventures of America, Inc.Jun 22, 1978SESE
K771556EXRLitton Dental ProductsAug 22, 1977SESE
K771557ULTRASON 990Litton Dental ProductsAug 19, 1977SESE
K761247LT:200, LOVING TOUCHLitton Dental ProductsDec 16, 1976SESE
K761246SONUS IIILitton Dental ProductsDec 16, 1976SESE
K760805ULTRASONIC DENTAL PROPHYLAXIS DEVICECavitron Corp.Oct 21, 1976SESE
K760445DENTAL PROPHYLAXIS UNIT ULTRASONICBranson Ultrasonics Corp.Aug 26, 1976SESE

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