Scaler, Ultrasonic
FDA product code ELC · 184 cleared devices
Class 2
Dental
- Regulation
- 21 CFR 872.4850
- Review panel
- DE
- Implant
- No
- Life sustaining
- No
- Third party review
- Yes
- GMP exempt
- No
- Clearance span
- 1976-08-26 – 2026-03-10
ELC
2026-03-10
ELC
2026-01-28
GBT Machine Airflow Prophylaxis Master
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ELC
2025-09-19
VARIOS 170 LUX SCALER SYSTEM (VA170LUXS10); VARIOS 170 LUX SCALER SYSTEM (VA170LUXS11); VARIOS 170 SCALER SYSTEM (VA170S11)
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ELC
2025-02-13
Integrated Endo System (Meet Endo-II)
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ELC
2024-08-08
OdneClean
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ELC
2024-07-02
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)
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ELC
2024-07-01
BioSonic US200 Ultrasonic Scaler (60034537)
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ELC
2024-03-11
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
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ELC
2023-12-11
EDS Calculus Softener TURBO CR
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ELC
2023-11-21
Ultrasonic Scaler Tips
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ELC
2023-07-14
Proxeo ULTRA (PB-510, PB-520 and PB-530)
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ELC
2023-05-15
Combi Touch
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ELC
2023-03-23
Endo Ultrasonic Activator
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ELC
2022-09-08
Ultrasonic Endo Activation Device (Model:Actor I pro)
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ELC
2022-02-02
EVOCLEAN CLEANsert Ultrasonic Insert
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ELC
2021-12-10
Dental Scaler and Air Polisher
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ELC
2021-04-13
EndoPilot2
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ELC
2021-02-05
GentleWave X
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ELC
2020-12-04
TTBIO EVOCLEAN Ultrasonic Scaler
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ELC
2019-10-20
EMS AIRFLOW Prophylaxis Master, EMS AIRFLOW One
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ELC
2019-08-16
Piezon Built-in Kit, Piezon Built-in Kit LED
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ELC
2019-06-07
tün® ultrasonic tips product family
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ELC
2019-03-16
Sonendo GentleWave System
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ELC
2018-03-08
AW-100
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ELC
2017-12-27
COMPACT S, COMPACT S (LED)
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ELC
2017-11-21
Ultrasonic scaler
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ELC
2016-12-22
Y-MIC
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ELC
2016-06-03
Sonendo GentleWave System
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ELC
2016-01-29
Sonendo Gentle Wave System
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ELC
2013-12-06
PIEZON 250
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ELC
2013-11-26
NEWTRON BOOSTER
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ELC
2013-11-22
PIEZON 150
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ELC
2013-10-08
R7
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ELC
2013-08-23
BIOSONIC SUVI PIEZEOELECTRIC SCALER AND POLISHER
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ELC
2013-08-14
AEU-525 TRANSPORT III PORTABLE DENTAL SYSTEM
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ELC
2013-07-23
CAVITRON PROPHY-JET AIR POLISHING PROPHYLAXIS SYSTEM
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ELC
2013-06-11
SONENDO ENDOTHERAPY SYSTEM
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ELC
2013-06-11
ENGLER 25K SERIES ULTRASONIC INSERTS
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ELC
2013-03-29
AEI DR. TERAUCHI ULTRASONIC TIPS
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ELC
2013-03-28
ADVANCED ENDODONTIC SYSTEM- DESIGNER SERIES
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ELC
2013-03-05
ULTRASONIC SCALER
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ELC
2013-01-31
ULTRASONIC SCALER
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ELC
2012-02-23
PROULTRA PIEZO ULTRASONIC
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ELC
2011-04-07
EMS AIR-FLOW MASTER PIEZON
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ELC
2011-03-31
LAKONG ULTRASONIC SCALER
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ELC
2011-01-24
COMPACT PIEZO P2K, POWERCARE
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ELC
2010-09-08
EMS MINIMASTER LED
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ELC
2010-07-30
EMS PIEZON MASTER 700
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ELC
2010-07-09
A-DEC/W&H SYNEA SONIC SCALER HANDPIECE, MODELS ZA-55, ZA-55 L, ZA-55 LM, ZA-55M, SF1LM
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ELC
2010-03-30
SWERV MAGNETOSTRICTIVE ULTRASONIC SCALER SYSTEM
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ELC
2009-12-11
INSIGHT ULTRASONIC INSERTS
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ELC
2009-08-10
SONIC AIR MM1500 + (MID), MODEL 50400014
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ELC
2009-01-30
AIR SONIC SCALER
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ELC
2009-01-29
STER-MATE STERILE LAVAGE KIT
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ELC
2008-09-04
SONICFLEX 2003 AND SONICFLEX LUX 2003 L WITH INSTRUMENT TIPS
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ELC
2008-08-28
BONART ULTRASONIC SCALER, MOEDLS ART-P3II PRO AND ART-MII PRO
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ELC
2008-04-18
VARIOS 75
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ELC
2008-02-14
PERIOSCAN, MODEL: D 3496
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ELC
2007-10-26
BONART MODEL ART-P6 PIEZO ELECTRIC ULTRASONIC SCALER & ACCESSORIES (TIPS)
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ELC
2007-08-24
PMAX NEWTRON XS
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ELC
2007-06-21
SYMMETRY IQ, MODEL 2000 SERIES, 3000 SERIES
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ELC
2007-05-02
STERI -MATE HANDPIECE SLEEVE WITH LED LIGHT
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ELC
2007-05-01
ULTRASONIC SCALER, VARIOS 560
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ELC
2007-04-11
ASC-12 PIEZOELECTRIC SCALER
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ELC
2006-12-11
USI DENTAL SCALER, 25XXX SERIES
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ELC
2006-08-21
ULTRASONIC SCALER, MODELS UDS-N1, UDS-N2. UDS-J, UDS-K, UDS-L
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ELC
2006-08-17
BONART ART-P3II & P4 PIEZO ELECTRIC ULTRASONIC SCALER UNITS WITH ACCESSORIES
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ELC
2006-07-14
SCORPION ULTRASONIC SCALING INSERTS
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ELC
2006-05-03
PIEZOTOME
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ELC
2006-03-29
CLEANSE S+ ULTRASONIC SCALER
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ELC
2006-02-01
SYMMETRY S-SERIES PIEZOELECTRIC SCALING TIPS
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ELC
2005-11-16
PIEZOSURGERY
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ELC
2005-11-07
J. MORITA AZ ULTRASONIC SYSTEM
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ELC
2005-10-28
BONART ART-M3II & M4 ULTRASONIC SCALER UNITS WITH ACCESSORIES (INSERTS)
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ELC
2005-09-02
CAVITRON RF ULTRASONIC SCALER SYSTEM WITH STERIMATE HANDPIECE, MODEL G-131
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ELC
2005-09-02
MAXISONIC FAMILY AND SWIFT ULTRASONIC SCALER
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ELC
2005-07-14
POWERMAX 25, MODEL PM25; POWERMAX 30, MODEL PM30
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ELC
2005-07-13
PROTEGE ULTRASONIC INSERT
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ELC
2005-04-20
SURPASSON P5 NEWTRON
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ELC
2005-03-30
MINIMASTER ULTRASONIC SCALER
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ELC
2005-03-21
PERIOSCAN ULTRASONIC SCALER
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ELC
2005-03-18
XP TECHNOLOGY ULTRASONIC SCALER
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ELC
2004-12-21
DREAM CLEANSE S SCALER, DREAM COMPACT S SCALER
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ELC
2004-09-30
AZ ULTRASONIC SYSTEM
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ELC
2004-04-30
APOZA ULTRASONIC SCALER AND EDODONTICS UNIT, SELECTOR U2
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ELC
2004-04-22
ULTRASONIC SCALER ELEGANCE MS-10 (25K)
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ELC
2004-03-26
ULTRASONIC SCALER, MODELS VARIOS 350 LUX, VARIOS 350 (NO LIGHT), VARIOS 550, VARIOS 150 LUX, VARIOS 150 (NO LIGHT)
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ELC
2004-03-01
SP NEWTRON MODULE
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ELC
2004-01-29
SCALETRON PIEZO ULTRASOUND SCALER
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ELC
2003-12-12
SIROSON L AND SIROSONIC L ULTRASONIC SCALERS
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ELC
2003-12-04
BOBCAT PRO SCALER SYSTEM, MODEL G-130
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ELC
2003-11-20
SSS, MODEL 1072001 (STANDARD 4-HOLE MODEL) & 1072002 (STANDARD 2-HOLE MODEL)
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ELC
2003-08-05
CARRIER TIPS
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ELC
2003-02-07
DIAMONDCOAT ULTRASONIC INSERTS
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ELC
2002-11-06
STERI-MATE STERILIZABLE HANDPIECE
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ELC
2002-08-13
EMS PIEZON MASTER 600
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ELC
2002-07-05
ULTRASONIC TIPS WITH DIAMOND COATING
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ELC
2002-01-24
DELSONIC 2000
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ELC
2001-07-27
MODIFICATION TO:HU-FRIEDY BRAND SATIN SWIVEL ULTRASONIC INSERT
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ELC
2001-06-05
DELDENT ULTRASONIC INSERTS
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