Product Code: ELC FDA class 2 21 CFR 872.4850

Scaler, Ultrasonic

Dental

The Ultrasonic Scaler is a dental device that uses high-frequency ultrasonic vibrations transmitted through a metal tip or insert to remove calculus, biofilm, and stain from tooth surfaces and within periodontal pockets, often combined with a water lavage for cooling and debris removal. It is classified as FDA Class 2 (moderate risk), requiring 510(k) premarket clearance. The product code is ELC, regulated under 21 CFR 872.4850 in the Dental (DE) specialty. This device is eligible for third-party review.

View on FDA

510(k)s

192

FEI Numbers

104

Registration Numbers

104

Unique Applicants

113

Years Active

Basic Information

Product Code: ELC
Device Class: FDA class 2
Regulation Number: 872.4850
Medical Specialty: Dental
Review Panel: DE
Submission Type: 1

Device Characteristics

✗

GMP Exempt

✗

Implant

✗

Life Sustain/Support

✓

Third Party

—

Summary Malfunction Reporting

510(k) Clearance History

Related 510(k) Clearances

This FDA classification is associated with 192 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K242317	Integrated Endo System (Meet Endo-II)	Feb 13, 2025	Substantially Equivalent	Denjoy Dental Co., Ltd.
K233844	OdneClean	Aug 08, 2024	Substantially Equivalent	Odne AG
K240707	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)	Jul 02, 2024	Substantially Equivalent	Shenzhen Micro Electric Intelligence Co., Ltd.
K240801	BioSonic US200 Ultrasonic Scaler (60034537)	Jul 01, 2024	Substantially Equivalent	Dent4You AG
K233922	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	Mar 11, 2024	Substantially Equivalent	SATELEC-ACTEON GROUP
K223340	EDS Calculus Softener TURBO CR	Dec 11, 2023	Substantially Equivalent	Essential Dental Systems Inc.
K230641	Ultrasonic Scaler Tips	Nov 21, 2023	Substantially Equivalent	Guilin Refine Medical Instrument Co., Ltd.
K223173	Proxeo ULTRA (PB-510, PB-520 and PB-530)	Jul 14, 2023	Substantially Equivalent	W&H Dentalwerk Buermoss GmbH
K231391	Combi Touch	May 15, 2023	Substantially Equivalent	Mectron S.p.A.
K222096	Endo Ultrasonic Activator	Mar 23, 2023	Substantially Equivalent	Foshan COXO Medical Instrument Co.,Ltd.
K213947	Ultrasonic Endo Activation Device (Model:Actor I pro)	Sep 08, 2022	Substantially Equivalent	ChangZhou BoMedent Medical Technology Co.,Ltd
K210832	EVOCLEAN CLEANsert Ultrasonic Insert	Feb 02, 2022	Substantially Equivalent	TTBIO CORP.
K203615	Dental Scaler and Air Polisher	Dec 10, 2021	Substantially Equivalent	Guilin Woodpecker Medical Instrument Co., Ltd.
K202906	EndoPilot2	Apr 13, 2021	Substantially Equivalent	Schlumbohm GmbH & Co. KG
K203302	GentleWave X	Feb 05, 2021	Substantially Equivalent	Sonendo, Inc
K201317	TTBIO EVOCLEAN Ultrasonic Scaler	Dec 04, 2020	Substantially Equivalent	TTBIO CORP.
K190124	EMS AIRFLOW Prophylaxis Master, EMS AIRFLOW One	Oct 20, 2019	Substantially Equivalent	E.M.S Electro Medical Systems S.A.
K191079	Piezon Built-in Kit, Piezon Built-in Kit LED	Aug 16, 2019	Substantially Equivalent	E.M.S Electro Medical Systems S.A
K182145	tün® ultrasonic tips product family	Jun 07, 2019	Substantially Equivalent	Engineered Endodontics
K190359	Sonendo GentleWave System	Mar 16, 2019	Substantially Equivalent	Sonendo, Inc.
K171150	AW-100	Mar 08, 2018	Substantially Equivalent	Micron Corporation
K170104	COMPACT S, COMPACT S (LED)	Dec 27, 2017	Substantially Equivalent	DMETEC CO., LTD.
K163414	Ultrasonic scaler	Nov 21, 2017	Substantially Equivalent	NANNING VV DENTAL CO., LTD.
K161639	Y-MIC	Dec 22, 2016	Substantially Equivalent	MICRON CORPORATION
K160905	Sonendo GentleWave System	Jun 03, 2016	Substantially Equivalent	SONENDO, INC.
K153157	Sonendo Gentle Wave System	Jan 29, 2016	Substantially Equivalent	SONENDO, INC.
K151023	COMPACT PIEZO LED	Aug 05, 2015	Substantially Equivalent	MECTRON SPA
K150535	Cavitron Touch Ultrasonic Scaling System	Jun 16, 2015	Substantially Equivalent	DENTSPLY INTERNATIONAL, INC.
K143448	Sonendo GentleWave System	May 01, 2015	Substantially Equivalent	Sonendo, Inc.
K140233	ULTRASONIC SCALER	Apr 06, 2015	Substantially Equivalent	NANNING BAOLAI MEDICAL INSTRUMENT CO., LTD.
K140990	EMS PIEZON 707 BIK AND PIEZON 707 BIK LED	Feb 27, 2015	Substantially Equivalent	E.M.S. ELECTRO MEDICAL SYSTEMS S.A.
K140965	MULTIPIEZO PRO, MULTIPIEZO	Aug 20, 2014	Substantially Equivalent	MECTRON SPA
K133752	SONENDO OMNICLEAN ENDOTHERPAY SYSTEM CONSOLE, SONENDO OMNICLEAN MOLAR PROCEDURE KIT	May 15, 2014	Substantially Equivalent	SONENDO, INC.
K132322	NEWTRON P5 XS B.LED	Mar 11, 2014	Substantially Equivalent	SATELEC-ACTEON GROUP
K132267	NEWTRON P5, NEWTRON P5 B.LED	Mar 10, 2014	Substantially Equivalent	SATELEC-ACTEON GROUP
K132609	EDS ULTRASONIC TIPS	Jan 22, 2014	Substantially Equivalent	ESSENTIAL DENTAL SYSTEMS, INC.
K131151	ENDOCENTER	Jan 16, 2014	Substantially Equivalent	SATELEC-ACTEON GROUP
K132445	PIEZON 250	Dec 06, 2013	Substantially Equivalent	E.M.S. ELECTRO MEDICAL SYSTEMS S.A.
K131997	NEWTRON BOOSTER	Nov 26, 2013	Substantially Equivalent	SATELEC-ACTEON GROUP
K132443	PIEZON 150	Nov 22, 2013	Substantially Equivalent	E.M.S. ELECTRO MEDICAL SYSTEMS S.A.
K130834	R7	Oct 08, 2013	Substantially Equivalent	CEFLA S.C.
K130137	BIOSONIC SUVI PIEZEOELECTRIC SCALER AND POLISHER	Aug 23, 2013	Substantially Equivalent	COLTENE/WHALEDENT
K130693	AEU-525 TRANSPORT III PORTABLE DENTAL SYSTEM	Aug 14, 2013	Substantially Equivalent	ASEPTICO, INC.
K130862	CAVITRON PROPHY-JET AIR POLISHING PROPHYLAXIS SYSTEM	Jul 23, 2013	Substantially Equivalent	DENTSPLY INTL., INC.
K130025	SONENDO ENDOTHERAPY SYSTEM	Jun 11, 2013	Substantially Equivalent	SONENDO, INC.
K122748	ENGLER 25K SERIES ULTRASONIC INSERTS	Jun 11, 2013	Substantially Equivalent	ENGLER ENGINEERING CORP.
K122501	AEI DR. TERAUCHI ULTRASONIC TIPS	Mar 29, 2013	Substantially Equivalent	AMERICAN EAGLE INSTRUMENTS, INC.
K123139	ADVANCED ENDODONTIC SYSTEM- DESIGNER SERIES	Mar 28, 2013	Substantially Equivalent	ASI MEDICAL, INC.
K113717	ULTRASONIC SCALER	Mar 05, 2013	Substantially Equivalent	NAKANISHI, INC.
K113530	ULTRASONIC SCALER	Jan 31, 2013	Substantially Equivalent	NAKANISHI, INC.
K113430	PROULTRA PIEZO ULTRASONIC	Feb 23, 2012	Substantially Equivalent	SATELEC-ACTEON GROUP
K110173	EMS AIR-FLOW MASTER PIEZON	Apr 07, 2011	Substantially Equivalent	EMS ELECTRO MEDICAL SYSTEMS SA
K103498	LAKONG ULTRASONIC SCALER	Mar 31, 2011	Substantially Equivalent	LAKONG MEDICAL DEVICE COMPANY, LTD
K102218	COMPACT PIEZO P2K, POWERCARE	Jan 24, 2011	Substantially Equivalent	MECTRON S.P.A.
K093723	EMS MINIMASTER LED	Sep 08, 2010	Substantially Equivalent	EMS ELECTRO MEDICAL SYSTEMS SA
K093000	EMS PIEZON MASTER 700	Jul 30, 2010	Substantially Equivalent	EMS ELECTRO MEDICAL SYSTEMS SA
K100647	A-DEC/W&H SYNEA SONIC SCALER HANDPIECE, MODELS ZA-55, ZA-55 L, ZA-55 LM, ZA-55M, SF1LM	Jul 09, 2010	Substantially Equivalent	A-DEC, INC.
K100401	SWERV MAGNETOSTRICTIVE ULTRASONIC SCALER SYSTEM	Mar 30, 2010	Substantially Equivalent	HU-FRIEDY MFG. CO., INC
K092417	INSIGHT ULTRASONIC INSERTS	Dec 11, 2009	Substantially Equivalent	DISCUS DENTAL, LLC
K081268	SONIC AIR MM1500 + (MID), MODEL 50400014	Aug 10, 2009	Substantially Equivalent	MICRO-MEGA SOCIETE ANONYME
K083059	AIR SONIC SCALER	Jan 30, 2009	Substantially Equivalent	DPM USA CORP.
K082973	STER-MATE STERILE LAVAGE KIT	Jan 29, 2009	Substantially Equivalent	DENTSPLY INTERNTIONAL
K080089	SONICFLEX 2003 AND SONICFLEX LUX 2003 L WITH INSTRUMENT TIPS	Sep 04, 2008	Substantially Equivalent	SYBRON DENTAL SPECIALTIES, INC.
K081550	BONART ULTRASONIC SCALER, MOEDLS ART-P3II PRO AND ART-MII PRO	Aug 28, 2008	Substantially Equivalent	BONART CO. LTD.
K071447	VARIOS 75	Apr 18, 2008	Substantially Equivalent	NAKANISHI, INC.
K072107	PERIOSCAN, MODEL: D 3496	Feb 14, 2008	Substantially Equivalent	SIRONA DENTAL SYSTEMS GMBH
K071981	BONART MODEL ART-P6 PIEZO ELECTRIC ULTRASONIC SCALER & ACCESSORIES (TIPS)	Oct 26, 2007	Substantially Equivalent	BONART CO. LTD.
K071424	PMAX NEWTRON XS	Aug 24, 2007	Substantially Equivalent	SATELEC-ACTEON GROUP
K070975	SYMMETRY IQ, MODEL 2000 SERIES, 3000 SERIES	Jun 21, 2007	Substantially Equivalent	HU-FRIEDY MFG. CO., INC
K070307	STERI -MATE HANDPIECE SLEEVE WITH LED LIGHT	May 02, 2007	Substantially Equivalent	DENTSPLY INTERNATIONAL, INC.
K062731	ULTRASONIC SCALER, VARIOS 560	May 01, 2007	Substantially Equivalent	NAKANISHI, INC.
K070866	ASC-12 PIEZOELECTRIC SCALER	Apr 11, 2007	Substantially Equivalent	ASEPTICO, INC.
K062791	USI DENTAL SCALER, 25XXX SERIES	Dec 11, 2006	Substantially Equivalent	ULTRASONIC SERVICES INC.
K053555	ULTRASONIC SCALER, MODELS UDS-N1, UDS-N2. UDS-J, UDS-K, UDS-L	Aug 21, 2006	Substantially Equivalent	GUILIN WOODPECKER MEDICAL INSTRUMENT CO., LTD
K061448	BONART ART-P3II & P4 PIEZO ELECTRIC ULTRASONIC SCALER UNITS WITH ACCESSORIES	Aug 17, 2006	Substantially Equivalent	BONART CO. LTD.
K053578	SCORPION ULTRASONIC SCALING INSERTS	Jul 14, 2006	Substantially Equivalent	SCORPION
K060275	PIEZOTOME	May 03, 2006	Substantially Equivalent	SATELEC
K060171	CLEANSE S+ ULTRASONIC SCALER	Mar 29, 2006	Substantially Equivalent	DMETEC CO., LTD.
K053178	SYMMETRY S-SERIES PIEZOELECTRIC SCALING TIPS	Feb 01, 2006	Substantially Equivalent	HU-FRIEDY MFG. CO.,INC.
K052518	PIEZOSURGERY	Nov 16, 2005	Substantially Equivalent	PIEZOSURGERY SRL
K053030	J. MORITA AZ ULTRASONIC SYSTEM	Nov 07, 2005	Substantially Equivalent	J. MORITA USA, INC.
K052028	BONART ART-M3II & M4 ULTRASONIC SCALER UNITS WITH ACCESSORIES (INSERTS)	Oct 28, 2005	Substantially Equivalent	BONART CO. LTD.
K052334	CAVITRON RF ULTRASONIC SCALER SYSTEM WITH STERIMATE HANDPIECE, MODEL G-131	Sep 02, 2005	Substantially Equivalent	DENTSPLY INTL.
K051910	MAXISONIC FAMILY AND SWIFT ULTRASONIC SCALER	Sep 02, 2005	Substantially Equivalent	D.B.I. AMERICA CORP.
K051547	POWERMAX 25, MODEL PM25; POWERMAX 30, MODEL PM30	Jul 14, 2005	Substantially Equivalent	TPC ADVANCED TECHNOLOGY, INC.
K051776	PROTEGE ULTRASONIC INSERT	Jul 13, 2005	Substantially Equivalent	DISCUS DENTAL INC.
K050895	SURPASSON P5 NEWTRON	Apr 20, 2005	Substantially Equivalent	SATELEC
K050710	MINIMASTER ULTRASONIC SCALER	Mar 30, 2005	Substantially Equivalent	E.M.S. ELECTRO MEDICAL SYSTEMS S.A.
K050354	PERIOSCAN ULTRASONIC SCALER	Mar 21, 2005	Substantially Equivalent	SIRONA DENTAL SYSTEMS GMBH
K042972	XP TECHNOLOGY ULTRASONIC SCALER	Mar 18, 2005	Substantially Equivalent	AMERICAN EAGLE INSTRUMENTS, INC.
K033044	DREAM CLEANSE S SCALER, DREAM COMPACT S SCALER	Dec 21, 2004	Substantially Equivalent	AMERICAN GREEN DENT. MFG, INC.
K042056	AZ ULTRASONIC SYSTEM	Sep 30, 2004	Substantially Equivalent	J. MORITA USA, INC.
K033198	APOZA ULTRASONIC SCALER AND EDODONTICS UNIT, SELECTOR U2	Apr 30, 2004	Substantially Equivalent	APOZA ENTERPRISE CO. LTD.
K040396	ULTRASONIC SCALER ELEGANCE MS-10 (25K)	Apr 22, 2004	Substantially Equivalent	ROLENCE ENTEPRISE, INC.
K031421	ULTRASONIC SCALER, MODELS VARIOS 350 LUX, VARIOS 350 (NO LIGHT), VARIOS 550, VARIOS 150 LUX, VARIOS 150 (NO LIGHT)	Mar 26, 2004	Substantially Equivalent	NAKANISHI, INC.
K033764	SP NEWTRON MODULE	Mar 01, 2004	Substantially Equivalent	SATELEC
K033120	SCALETRON PIEZO ULTRASOUND SCALER	Jan 29, 2004	Substantially Equivalent	PAC-DENT INTERNATIONAL (SUZHOU), LTD.
K033640	SIROSON L AND SIROSONIC L ULTRASONIC SCALERS	Dec 12, 2003	Substantially Equivalent	SIRONA DENTAL SYSTEMS GMBH
K033705	BOBCAT PRO SCALER SYSTEM, MODEL G-130	Dec 04, 2003	Substantially Equivalent	DENTSPLY INTERNATIONAL
K032995	SSS, MODEL 1072001 (STANDARD 4-HOLE MODEL) & 1072002 (STANDARD 2-HOLE MODEL)	Nov 20, 2003	Substantially Equivalent	MICRON CORP.
K031461	CARRIER TIPS	Aug 05, 2003	Substantially Equivalent	DENTSPLY INTL.
K030111	DIAMONDCOAT ULTRASONIC INSERTS	Feb 07, 2003	Substantially Equivalent	DENTSPLY INTERNATIONAL
K023697	STERI-MATE STERILIZABLE HANDPIECE	Nov 06, 2002	Substantially Equivalent	DENTSPLY INTERNATIONAL
K022328	EMS PIEZON MASTER 600	Aug 13, 2002	Substantially Equivalent	ELECTRO MEDICAL SYSTEMS SA
K021253	ULTRASONIC TIPS WITH DIAMOND COATING	Jul 05, 2002	Substantially Equivalent	SYBRON ENDO/ANALYTIC
K014238	DELSONIC 2000	Jan 24, 2002	Substantially Equivalent	DELDENT LTD.
K012060	MODIFICATION TO:HU-FRIEDY BRAND SATIN SWIVEL ULTRASONIC INSERT	Jul 27, 2001	Substantially Equivalent	HU-FRIEDY MFG. CO.,INC.
K011179	DELDENT ULTRASONIC INSERTS	Jun 05, 2001	Substantially Equivalent	DELDENT LTD.
K010195	PREMIER ULTRASONIC SCALER AND INSERTS	Apr 17, 2001	Substantially Equivalent	PREMIER DENTAL PRODUCTS CO.
K002122	VECTOR	Dec 21, 2000	Substantially Equivalent	AIR TECHNIQUES, INC.
K002753	SPARTAN A-10	Dec 04, 2000	Substantially Equivalent	SPARTAN ULTRASONICS, INC.
K000846	TKD SCALERS	Dec 04, 2000	Substantially Equivalent	ORASYSTEMS
K002521	SPARTAN MTS	Nov 13, 2000	Substantially Equivalent	SPARTAN MARKETING GROUP
K000510	ART-M1, MODEL M1-1-ART-A1	May 15, 2000	Substantially Equivalent	BONART CO. LTD.
K994299	ART-P3, MODEL P3-1-ART-A1	Mar 06, 2000	Substantially Equivalent	BONART CO. LTD.
K994203	ART-M3 25K, MODEL M3-1-ART2-A1; ART-M3 30K, MODEL M3-1-ART3-A1	Mar 06, 2000	Substantially Equivalent	BONART CO. LTD.
K992504	EMS KERMIT	Jan 27, 2000	Substantially Equivalent	(EMS SA) ELECTRO MEDICAL SYSTEMS
K990546	DELSONIC 2000	Nov 05, 1999	Substantially Equivalent	SDS DENTAL, INC.
K991239	VIP 60 (2H), MODEL 115-000-1, VIP 60 (4H), MODEL 115-000-2	Oct 18, 1999	Substantially Equivalent	MICRON CORP.
K991874	EMS SURFACE MOUNT SCALER	Jul 30, 1999	Substantially Equivalent	(EMS SA) ELECTRO MEDICAL SYSTEMS
K991021	SONIC SCALER WITH FIBER OPTIC, MODEL NAS-L, SONIC SCALER WITHOUT FIBER OPTIC, MODEL NAS-NL	Jun 23, 1999	Substantially Equivalent	NSK NAKANISHI, INC.
K983029	POWER PLUS 25K MODEL, S1000, POWER PLUS 30K MODEL,S1001	Jan 29, 1999	Substantially Equivalent	TPC ADVANCED TECHNOLOGY, INC.
K983727	BIOSONIC ULTRASONIC SCALER SYSTEM	Jan 20, 1999	Substantially Equivalent	COLTENE/WHALEDENT INC.
K982793	PIEZO TRONIC	Oct 28, 1998	Substantially Equivalent	ADVANCED MEDICAL DEVICES, INC.
K972026	SP4044 & SP4055 LUX MODULES	Jul 09, 1997	Substantially Equivalent	SATELEC
K964596	PROSELECT 3 PERIDONTAL THERAPY SYSTEM	Apr 22, 1997	Substantially Equivalent	PROFESSIONAL DENTAL MFG., INC.
K970123	DENTSPLY CAVITRON SPS SCALER SYSTEM	Apr 11, 1997	Substantially Equivalent	DENTSPLY INTL.
K970342	CAVITRON JET WITH SPS SYSTEM	Apr 04, 1997	Substantially Equivalent	DENTSPLY INTL.
K964320	TONY RISO 25/30 MULTIFUNCTION SCALER	Jan 23, 1997	Substantially Equivalent	TONY RISO CO., INC.
K961158	SUPRASSON P5 BOOSTER	May 23, 1996	Substantially Equivalent	SATELEC
K960889	SAPPHIRE PLUS SCALER MOD. 300114/PLUGGER MOD. 300115/CUTTING MOD. 300116/SPREADER MOD. 300117 TIPS	May 10, 1996	Substantially Equivalent	SAN DIEGO SWISS MACHINING, INC.
K943403	CONDOR ULTRASONIC INSERTS	Mar 05, 1996	Substantially Equivalent	CONDOR PRODUCTS, INC.
K954820	SCALEX 800	Jan 18, 1996	Substantially Equivalent	DENTAMERICA
K953919	DENTAL ULTRASONIC SCALER INSERTS	Oct 07, 1995	Substantially Equivalent	HU-FRIEDY MFG. CO.,INC.
K942139	SUPRASSON P MAX	Sep 29, 1995	Substantially Equivalent	SATELEC
K953026	MINIPIEZON	Aug 28, 1995	Substantially Equivalent	ELECTRO MEDICAL SYSTEMS SA
K942380	MICRO ICS SONIC SCALER	Aug 07, 1995	Substantially Equivalent	MICRO MOTORS, INC.
K951272	RELACS 7000	May 12, 1995	Substantially Equivalent	MICRO-MEGA SOCIETE ANONYME
K950256	TURBO 25/30	Apr 04, 1995	Substantially Equivalent	PARKELL, INC.
K950240	LE CLEAN MACHINE	Apr 04, 1995	Substantially Equivalent	PARKELL, INC.
K941392	JET UNIT (CJ HANDPIECE)	May 23, 1994	Substantially Equivalent	DENTSPLY INTL.
K934714	ENDODONTIC PULP CANAL SPREADER	Feb 14, 1994	Substantially Equivalent	EXCELLENCE IN ENDODONTICS, INC.
K933547	INTRA-ORAL IRRIGATOR	Oct 20, 1993	Substantially Equivalent	PARKELL, INC.
K920328	AMDENT 2030, POLISHER/SCALER	Oct 20, 1993	Substantially Equivalent	AMDENT AB
K930698	THE MODEL 3003 SCALER	Jul 22, 1993	Substantially Equivalent	DENTSPLY INTL.
K921893	COLGATE ODONTOSON ULTRASONIC SCALER	Jul 08, 1993	Substantially Equivalent	PERIO-GIENE
K923639	DIAMOND COATED DENTAL INSERTS	Oct 26, 1992	Substantially Equivalent	DENTSPLY INTL.
K903298	DYNASONIC PLAQUE REMOVER & POLISHER DYNATIP	Apr 16, 1991	Substantially Equivalent	MICRO MOTORS, INC.
K904296	LYSTA HYGIENIST III SCALER	Dec 05, 1990	Substantially Equivalent	PRODENT INTL., INC.
K903163	PERIODONTAL DEBRIDING SOLUTION E	Oct 10, 1990	Substantially Equivalent	DENTSPLY INTL.
K896749	PIEZON MASTER 400	Aug 31, 1990	Substantially Equivalent	ELECTRO MEDICAL SYSTEMS (EMS SA)
K902413	SONIC SCALER	Aug 13, 1990	Substantially Equivalent	DENTSPLY INTL.
K901488	LYNX-SM, SCLAER DENTAL HANDPIECE	May 15, 1990	Substantially Equivalent	MTI PRECISION PRODUCTS
K900709	AIR FLOW SII	Apr 18, 1990	Substantially Equivalent	ELECTRO MEDICAL SYSTEMS (EMS SA)
K894247	PERIODONTAL IRRIGATING SOLUTION-D	Oct 06, 1989	Substantially Equivalent	DENTSPLY INTL.
K884221	ULTRASONIC SCALER COVER	Mar 17, 1989	Substantially Equivalent	STERI-SHIELD PRODUCTS, INC.
K880940	AMDENT MODEL 830 ULTRASONIC SCALER	Jul 15, 1988	Substantially Equivalent	PATHWAY PRODUCTS, INC.
K881253	ROTORY SCALER SWIVEL IMPROVEMENT FEATURE, TITAN SW	Apr 21, 1988	Substantially Equivalent	DENTALEZ GROUP
K873146	USI BASIC. AG 1050. AG 1090	Oct 27, 1987	Substantially Equivalent	CRANSTON IND., INC.
K864996	ULTRASONIC SCALER 3000/ PROPHY-JET 30/ CAVI-JET 30	Feb 19, 1987	Substantially Equivalent	DENTSPLY INTL.
K863676	GENTEEL	Oct 02, 1986	Substantially Equivalent	LUBEN DENTAL CO., INC.
K853841	HARMO SONIC	Feb 04, 1986	Substantially Equivalent	U.S. SHIZAI CORP.
K852525	SATALEC PIEZOTEC	Jan 30, 1986	Substantially Equivalent	SPELNA, INC.
K852540	ULTRASONIC TOOTH SCALER MODEL DSCIOP	Jul 01, 1985	Substantially Equivalent	PARKELL, INC.
K844250	OSADA ENAC	Jan 23, 1985	Substantially Equivalent	OSADA ELECTRIC CO., LTD.
K842581	CAVI-MED	Aug 03, 1984	Substantially Equivalent	COOPER LASERSONICS, INC.
K840141	DENTAL ULTRASONIC SCALER/ENDOSONIC	Mar 16, 1984	Substantially Equivalent	COOPERVISION, INC.
K834283	DENTSPLY G-106 CAVITRON ULTRASONIC	Mar 16, 1984	Substantially Equivalent	COOPER CARE, INC.
K832674	SATELEC PROPHY UNIT PU 2000S	Mar 16, 1984	Substantially Equivalent	SPELNA, INC.
K832664	SATELEC SUPRASSON PIEZOMATIC P2	Mar 16, 1984	Substantially Equivalent	SPELNA, INC.
K832665	SATELEC SUPRASSON SP 3055	Oct 19, 1983	Substantially Equivalent	SPELNA, INC.
K832443	ULTRASONIC DENTAL PROPHYLAXIS UNIT	Sep 12, 1983	Substantially Equivalent	CALIFORNIA TECHNICS, INC.
K823134	AIR FLOW II	Nov 17, 1982	Substantially Equivalent	HEALTHCO, INC.
K821810	PIEZON ULTRASONIC SCALER	Jul 06, 1982	Substantially Equivalent	HEALTHCO, INC.
K820162	TEC-SON II	Feb 24, 1982	Substantially Equivalent	CALIFORNIA TECHNICS, INC.
K812909	HYGIENTIST; CYCLOSON I & II; RETROFIT	Dec 14, 1981	Substantially Equivalent	FIBRA SONICS, INC.
K811396	SONUS V	Jun 26, 1981	Substantially Equivalent	CALIFORNIA TECHNICS, INC.
K811145	PNEUMATIC DENTAL SCALER	Jun 16, 1981	Substantially Equivalent	INNOVATE, INC.
K811023	ROOT CANAL KIT	May 05, 1981	Substantially Equivalent	DENTSPLY INTL.
K801689	SONATRON ULTRASONIC DENTAL SCANNER	Sep 16, 1980	Substantially Equivalent	SIMPLIFIED SYSTEMS, INC.
K791704	MASTERSCALE II	Oct 26, 1979	Substantially Equivalent	LITTON DENTAL PRODUCTS
K791585	MODEL G-61 ULTRASONIC DENTAL UNIT	Sep 19, 1979	Substantially Equivalent	CAVITRON CORP.
K791024	ULTRASONIC DENTAL PROPHYLAXIS UNIT	Sep 17, 1979	Substantially Equivalent	LITTON DENTAL PRODUCTS
K782133	ODONTOSON 3	Feb 27, 1979	Substantially Equivalent	MDT CORP., INC.
K781044	ULTRASONIC DENTAL PROPHYLAXIS UNIT,SSM	Jun 30, 1978	Substantially Equivalent	LITTON DENTAL PRODUCTS
K780808	PIEZOMATIC ULTRASONIC SCALER (SYSTEM S)	Jun 22, 1978	Substantially Equivalent	DENTAL VENTURES OF AMERICA, INC.
K771556	EXR	Aug 22, 1977	Substantially Equivalent	LITTON DENTAL PRODUCTS
K771557	ULTRASON 990	Aug 19, 1977	Substantially Equivalent	LITTON DENTAL PRODUCTS
K761247	LT:200, LOVING TOUCH	Dec 16, 1976	Substantially Equivalent	LITTON DENTAL PRODUCTS
K761246	SONUS III	Dec 16, 1976	Substantially Equivalent	LITTON DENTAL PRODUCTS
K760805	ULTRASONIC DENTAL PROPHYLAXIS DEVICE	Oct 21, 1976	Substantially Equivalent	CAVITRON CORP.
K760445	DENTAL PROPHYLAXIS UNIT ULTRASONIC	Aug 26, 1976	Substantially Equivalent	BRANSON ULTRASONICS CORP.

FEI Numbers

This FDA classification entry is associated with 104 FEI numbers. Click on an entry to view related FDA registrations.

1000113887: 7 registrations

1000114111: 152 registrations

1000127001: 19 registrations

1000139790: 57 registrations

1000160293: 2 registrations

1000361261: 1 registration

1000493876: 9 registrations

1000523896: 24 registrations

1000554802: 31 registrations

1032227: 93 registrations

1220477: 911 registrations

1413475: 53 registrations

1416605: 61 registrations

1419489: 66 registrations

1718912: 102 registrations

1941138: 38 registrations

2018957: 98 registrations

2020943: 4 registrations

2024312: 150 registrations

2024949: 20 registrations

2127132: 9 registrations

2183301: 191 registrations

2243757: 23 registrations

2411797: 47 registrations

2416455: 46 registrations

2433629: 27 registrations

2511556: 113 registrations

2520265: 25 registrations

2521453: 53 registrations

2832: 4 registrations

3000205943: 35 registrations

3000219976: 31 registrations

3000719964: 98 registrations

3001708019: 41 registrations

3002088145: 69 registrations

3002772487: 12 registrations

3002806577: 56 registrations

3002806828: 7 registrations

3002806910: 30 registrations

3002807687: 63 registrations

3002820248: 7 registrations

3002948158: 21 registrations

3003120666: 37 registrations

3003215343: 44 registrations

3003637274: 37 registrations

3003719498: 59 registrations

3003755849: 46 registrations

3003933619: 16 registrations

3003934980: 18 registrations

3004096429: 28 registrations

3004193466: 71 registrations

3004417597: 49 registrations

3004536551: 42 registrations

3004569445: 13 registrations

3005282635: 13 registrations

3005344591: 6 registrations

3005581016: 25 registrations

3005972890: 35 registrations

3006066614: 519 registrations

3006610845: 20 registrations

3007279848: 39 registrations

3007962015: 16 registrations

3008559238: 38 registrations

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3008615394: 4 registrations

3008770655: 43 registrations

3008875470: 111 registrations

3008910197: 30 registrations

3008912871: 85 registrations

3008981576: 14 registrations

3009968482: 89 registrations

3010364969: 13 registrations

3010373292: 2 registrations

3010817521: 3 registrations

3010862763: 91 registrations

3011300255: 46 registrations

3011689956: 141 registrations

3011944170: 6 registrations

3012187973: 201 registrations

3012322979: 10 registrations

3012421607: 606 registrations

3012494290: 762 registrations

3012636179: 178 registrations

3013022399: 6 registrations

3013298431: 204 registrations

3013443753: 14 registrations

3014315145: 1 registration

3014683120: 127 registrations

3014953747: 15 registrations

3015729: 45 registrations

3016075921: 6 registrations

3016114530: 4 registrations

3017604: 28 registrations

3017618678: 6 registrations

3018783058: 1 registration

3018975080: 6 registrations

3022516928: 21 registrations

3023861999: 11 registrations

3026297922: 481 registrations

3030126955: 25 registrations

3030405669: 4 registrations

3030508287: 13 registrations

3031700049: 23 registrations

3343: 7 registrations