ELC
Sonendo GentleWave System
- Advisory panel
- Dental
- Total cleared
- 195
Adverse events under product code ELC
product code ELC- Malfunction
- 1,255
- Total
- 1,255
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Recent clearances under product code ELC
1–100 of 195- K260773 — Varios Combi Pro2
- K253254 — GBT Machine Airflow Prophylaxis Master
- K251689 — VARIOS 170 LUX SCALER SYSTEM (VA170LUXS10); VARIOS 170 LUX SCALER SYSTEM (VA170LUXS11); VARIOS 170 SCALER SYSTEM (VA170S11)
- K242317 — Integrated Endo System (Meet Endo-II)
- K233844 — OdneClean
- 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)
- K240801 — BioSonic US200 Ultrasonic Scaler (60034537)
- 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
- K223340 — EDS Calculus Softener TURBO CR
- K230641 — Ultrasonic Scaler Tips
- K223173 — Proxeo ULTRA (PB-510, PB-520 and PB-530)
- K231391 — Combi Touch
- K222096 — Endo Ultrasonic Activator
- K213947 — Ultrasonic Endo Activation Device (Model:Actor I pro)
- K210832 — EVOCLEAN CLEANsert Ultrasonic Insert
- K203615 — Dental Scaler and Air Polisher
- K202906 — EndoPilot2
- K203302 — GentleWave X
- K201317 — TTBIO EVOCLEAN Ultrasonic Scaler
- K190124 — EMS AIRFLOW Prophylaxis Master, EMS AIRFLOW One
- K191079 — Piezon Built-in Kit, Piezon Built-in Kit LED
- K182145 — tün® ultrasonic tips product family
- K190359 — Sonendo GentleWave System
- K171150 — AW-100
- K170104 — COMPACT S, COMPACT S (LED)
- K163414 — Ultrasonic scaler
- K161639 — Y-MIC
- K160905 — Sonendo GentleWave System
- K153157 — Sonendo Gentle Wave System
- K151023 — COMPACT PIEZO LED
- K150535 — Cavitron Touch Ultrasonic Scaling System
- K143448 — Sonendo GentleWave System
- K140233 — ULTRASONIC SCALER
- K140990 — EMS PIEZON 707 BIK AND PIEZON 707 BIK LED
- K140965 — MULTIPIEZO PRO, MULTIPIEZO
- K133752 — SONENDO OMNICLEAN ENDOTHERPAY SYSTEM CONSOLE, SONENDO OMNICLEAN MOLAR PROCEDURE KIT
- K132322 — NEWTRON P5 XS B.LED
- K132267 — NEWTRON P5, NEWTRON P5 B.LED
- K132609 — EDS ULTRASONIC TIPS
- K131151 — ENDOCENTER
- K132445 — PIEZON 250
- K131997 — NEWTRON BOOSTER
- K132443 — PIEZON 150
- K130834 — R7
- K130137 — BIOSONIC SUVI PIEZEOELECTRIC SCALER AND POLISHER
- K130693 — AEU-525 TRANSPORT III PORTABLE DENTAL SYSTEM
- K130862 — CAVITRON PROPHY-JET AIR POLISHING PROPHYLAXIS SYSTEM
- K122748 — ENGLER 25K SERIES ULTRASONIC INSERTS
- K130025 — SONENDO ENDOTHERAPY SYSTEM
- K122501 — AEI DR. TERAUCHI ULTRASONIC TIPS
- K123139 — ADVANCED ENDODONTIC SYSTEM- DESIGNER SERIES
- K113717 — ULTRASONIC SCALER
- K113530 — ULTRASONIC SCALER
- K113430 — PROULTRA PIEZO ULTRASONIC
- K110173 — EMS AIR-FLOW MASTER PIEZON
- K103498 — LAKONG ULTRASONIC SCALER
- K102218 — COMPACT PIEZO P2K, POWERCARE
- K093723 — EMS MINIMASTER LED
- K093000 — EMS PIEZON MASTER 700
- K100647 — A-DEC/W&H SYNEA SONIC SCALER HANDPIECE, MODELS ZA-55, ZA-55 L, ZA-55 LM, ZA-55M, SF1LM
- K100401 — SWERV MAGNETOSTRICTIVE ULTRASONIC SCALER SYSTEM
- K092417 — INSIGHT ULTRASONIC INSERTS
- K081268 — SONIC AIR MM1500 + (MID), MODEL 50400014
- K083059 — AIR SONIC SCALER
- K082973 — STER-MATE STERILE LAVAGE KIT
- K080089 — SONICFLEX 2003 AND SONICFLEX LUX 2003 L WITH INSTRUMENT TIPS
- K081550 — BONART ULTRASONIC SCALER, MOEDLS ART-P3II PRO AND ART-MII PRO
- K071447 — VARIOS 75
- K072107 — PERIOSCAN, MODEL: D 3496
- K071981 — BONART MODEL ART-P6 PIEZO ELECTRIC ULTRASONIC SCALER & ACCESSORIES (TIPS)
- K071424 — PMAX NEWTRON XS
- K070975 — SYMMETRY IQ, MODEL 2000 SERIES, 3000 SERIES
- K070307 — STERI -MATE HANDPIECE SLEEVE WITH LED LIGHT
- K062731 — ULTRASONIC SCALER, VARIOS 560
- K070866 — ASC-12 PIEZOELECTRIC SCALER
- K062791 — USI DENTAL SCALER, 25XXX SERIES
- K053555 — ULTRASONIC SCALER, MODELS UDS-N1, UDS-N2. UDS-J, UDS-K, UDS-L
- K061448 — BONART ART-P3II & P4 PIEZO ELECTRIC ULTRASONIC SCALER UNITS WITH ACCESSORIES
- K053578 — SCORPION ULTRASONIC SCALING INSERTS
- K060275 — PIEZOTOME
- K060171 — CLEANSE S+ ULTRASONIC SCALER
- K053178 — SYMMETRY S-SERIES PIEZOELECTRIC SCALING TIPS
- K052518 — PIEZOSURGERY
- K053030 — J. MORITA AZ ULTRASONIC SYSTEM
- K052028 — BONART ART-M3II & M4 ULTRASONIC SCALER UNITS WITH ACCESSORIES (INSERTS)
- K051910 — MAXISONIC FAMILY AND SWIFT ULTRASONIC SCALER
- K052334 — CAVITRON RF ULTRASONIC SCALER SYSTEM WITH STERIMATE HANDPIECE, MODEL G-131
- K051547 — POWERMAX 25, MODEL PM25; POWERMAX 30, MODEL PM30
- K051776 — PROTEGE ULTRASONIC INSERT
- K050895 — SURPASSON P5 NEWTRON
- K050710 — MINIMASTER ULTRASONIC SCALER
- K050354 — PERIOSCAN ULTRASONIC SCALER
- K042972 — XP TECHNOLOGY ULTRASONIC SCALER
- K033044 — DREAM CLEANSE S SCALER, DREAM COMPACT S SCALER
- K042056 — AZ ULTRASONIC SYSTEM
- K033198 — APOZA ULTRASONIC SCALER AND EDODONTICS UNIT, SELECTOR U2
- K040396 — ULTRASONIC SCALER ELEGANCE MS-10 (25K)
- K031421 — ULTRASONIC SCALER, MODELS VARIOS 350 LUX, VARIOS 350 (NO LIGHT), VARIOS 550, VARIOS 150 LUX, VARIOS 150 (NO LIGHT)
- K033764 — SP NEWTRON MODULE
- K033120 — SCALETRON PIEZO ULTRASOUND SCALER
Data sourced from openFDA. This site is unofficial and independent of the FDA.