FDA Product Code
FDA Product Code ELC — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Dental
- 21 CFR Citation
- 872.4850
510(k) Clearances — 195 records · page 1 of 2
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K260773 | Varios Combi Pro2 | Nakanishi, Inc. | 2026-03-10 | Traditional | PDF ↗ |
| K253254 | GBT Machine Airflow Prophylaxis Master | E.M.S Electro Medical Systems S.A | 2026-01-28 | Traditional | PDF ↗ |
| K251689 | VARIOS 170 LUX SCALER SYSTEM (VA170LUXS10); VARIOS 170 LUX SCALER SYSTEM (VA170LUXS11); VARIOS 170 SCALER SYSTEM (VA170S11) | Nakanishi, Inc. | 2025-09-19 | Traditional | PDF ↗ |
| K242317 | Integrated Endo System (Meet Endo-II) | Denjoy Dental Co., Ltd. | 2025-02-13 | Traditional | PDF ↗ |
| K233844 | OdneClean | Odne AG | 2024-08-08 | Traditional | PDF ↗ |
| 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) | Shenzhen Micro Electric Intelligence Co., Ltd. | 2024-07-02 | Traditional | PDF ↗ |
| K240801 | BioSonic US200 Ultrasonic Scaler (60034537) | Dent4you AG | 2024-07-01 | Traditional | PDF ↗ |
| 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 | Satelec - Acteon Group | 2024-03-11 | Traditional | PDF ↗ |
| K223340 | EDS Calculus Softener TURBO CR | Essential Dental Systems, Inc. | 2023-12-11 | Traditional | PDF ↗ |
| K230641 | Ultrasonic Scaler Tips | Guilin Refine Medical Instrument Co., Ltd. | 2023-11-21 | Traditional | PDF ↗ |
| K223173 | Proxeo ULTRA (PB-510, PB-520 and PB-530) | W&H Dentalwerk Buermoss GmbH | 2023-07-14 | Traditional | PDF ↗ |
| K231391 | Combi Touch | Mectron S.P.A. | 2023-05-15 | Traditional | PDF ↗ |
| K222096 | Endo Ultrasonic Activator | Foshan Coxo Medical Instrument Co., Ltd. | 2023-03-23 | Traditional | PDF ↗ |
| K213947 | Ultrasonic Endo Activation Device (Model:Actor I pro) | Changzhou Bomedent Medical Technology Co.,Ltd | 2022-09-08 | Traditional | PDF ↗ |
| K210832 | EVOCLEAN CLEANsert Ultrasonic Insert | Ttbio Corp. | 2022-02-02 | Traditional | PDF ↗ |
| K203615 | Dental Scaler and Air Polisher | Guilin Woodpecker Medical Instrument Co., Ltd. | 2021-12-10 | Traditional | PDF ↗ |
| K202906 | EndoPilot2 | Schlumbohm GmbH & Co. KG | 2021-04-13 | Traditional | PDF ↗ |
| K203302 | GentleWave X | Sonendo, Inc. | 2021-02-05 | Traditional | PDF ↗ |
| K201317 | TTBIO EVOCLEAN Ultrasonic Scaler | Ttbio Corp. | 2020-12-04 | Traditional | PDF ↗ |
| K190124 | EMS AIRFLOW Prophylaxis Master, EMS AIRFLOW One | E.M.S Electro Medical Systems S.A | 2019-10-20 | Traditional | PDF ↗ |
| K191079 | Piezon Built-in Kit, Piezon Built-in Kit LED | E.M.S Electro Medical Systems S.A | 2019-08-16 | Traditional | PDF ↗ |
| K182145 | tün® ultrasonic tips product family | Engineered Endodontics | 2019-06-07 | Traditional | PDF ↗ |
| K190359 | Sonendo GentleWave System | Sonendo, Inc. | 2019-03-16 | Special | PDF ↗ |
| K171150 | AW-100 | Micron Corporation | 2018-03-08 | Traditional | PDF ↗ |
| K170104 | COMPACT S, COMPACT S (LED) | Dmetec.Co., Ltd. | 2017-12-27 | Traditional | PDF ↗ |
| K163414 | Ultrasonic scaler | Nanning VV Dental Co., Ltd. | 2017-11-21 | Traditional | PDF ↗ |
| K161639 | Y-MIC | Micron Corporation | 2016-12-22 | Traditional | PDF ↗ |
| K160905 | Sonendo GentleWave System | Sonendo, Inc. | 2016-06-03 | Special | PDF ↗ |
| K153157 | Sonendo Gentle Wave System | Sonendo, Inc. | 2016-01-29 | Special | PDF ↗ |
| K151023 | COMPACT PIEZO LED | Mectron S.P.A. | 2015-08-05 | Traditional | PDF ↗ |
| K150535 | Cavitron Touch Ultrasonic Scaling System | Dentsply International, Inc. | 2015-06-16 | Traditional | PDF ↗ |
| K143448 | Sonendo GentleWave System | Sonendo, Inc. | 2015-05-01 | Traditional | PDF ↗ |
| K140233 | ULTRASONIC SCALER | Nanning Baolai Medical Instrument Co., Ltd. | 2015-04-06 | Traditional | PDF ↗ |
| K140990 | EMS PIEZON 707 BIK AND PIEZON 707 BIK LED | E.M.S Electro Medical Systems S.A | 2015-02-27 | Traditional | PDF ↗ |
| K140965 | MULTIPIEZO PRO, MULTIPIEZO | Mectron S.P.A. | 2014-08-20 | Traditional | PDF ↗ |
| K133752 | SONENDO OMNICLEAN ENDOTHERPAY SYSTEM CONSOLE, SONENDO OMNICLEAN MOLAR PROCEDURE KIT | Sonendo, Inc. | 2014-05-15 | Traditional | PDF ↗ |
| K132322 | NEWTRON P5 XS B.LED | Satelec - Acteon Group | 2014-03-11 | Traditional | PDF ↗ |
| K132267 | NEWTRON P5, NEWTRON P5 B.LED | Satelec - Acteon Group | 2014-03-10 | Traditional | PDF ↗ |
| K132609 | EDS ULTRASONIC TIPS | Essential Dental Systems, Inc. | 2014-01-22 | Traditional | PDF ↗ |
| K131151 | ENDOCENTER | Satelec - Acteon Group | 2014-01-16 | Traditional | PDF ↗ |
| K132445 | PIEZON 250 | E.M.S Electro Medical Systems S.A | 2013-12-06 | Special | PDF ↗ |
| K131997 | NEWTRON BOOSTER | Satelec - Acteon Group | 2013-11-26 | Traditional | PDF ↗ |
| K132443 | PIEZON 150 | E.M.S Electro Medical Systems S.A | 2013-11-22 | Special | PDF ↗ |
| K130834 | R7 | Cefla S.C. | 2013-10-08 | Traditional | PDF ↗ |
| K130137 | BIOSONIC SUVI PIEZEOELECTRIC SCALER AND POLISHER | Coltene/Whaledent | 2013-08-23 | Traditional | PDF ↗ |
| K130693 | AEU-525 TRANSPORT III PORTABLE DENTAL SYSTEM | Aseptico, Inc. | 2013-08-14 | Traditional | PDF ↗ |
| K130862 | CAVITRON PROPHY-JET AIR POLISHING PROPHYLAXIS SYSTEM | Dentsply Intl., Inc. | 2013-07-23 | Traditional | PDF ↗ |
| K122748 | ENGLER 25K SERIES ULTRASONIC INSERTS | Engler Engineering Corp. | 2013-06-11 | Traditional | PDF ↗ |
| K130025 | SONENDO ENDOTHERAPY SYSTEM | Sonendo, Inc. | 2013-06-11 | Traditional | PDF ↗ |
| K122501 | AEI DR. TERAUCHI ULTRASONIC TIPS | American Eagle Instruments, Inc. | 2013-03-29 | Traditional | PDF ↗ |
| K123139 | ADVANCED ENDODONTIC SYSTEM- DESIGNER SERIES | Asi Medical, Inc. | 2013-03-28 | Traditional | PDF ↗ |
| K113717 | ULTRASONIC SCALER | Nakanishi, Inc. | 2013-03-05 | Traditional | PDF ↗ |
| K113530 | ULTRASONIC SCALER | Nakanishi, Inc. | 2013-01-31 | Traditional | PDF ↗ |
| K113430 | PROULTRA PIEZO ULTRASONIC | Satelec - Acteon Group | 2012-02-23 | Traditional | PDF ↗ |
| K110173 | EMS AIR-FLOW MASTER PIEZON | E.M.S Electro Medical Systems S.A | 2011-04-07 | Traditional | PDF ↗ |
| K103498 | LAKONG ULTRASONIC SCALER | Lakong Medical Device Company, Ltd. | 2011-03-31 | Traditional | PDF ↗ |
| K102218 | COMPACT PIEZO P2K, POWERCARE | Mectron S.P.A. | 2011-01-24 | Traditional | PDF ↗ |
| K093723 | EMS MINIMASTER LED | E.M.S Electro Medical Systems S.A | 2010-09-08 | Traditional | PDF ↗ |
| K093000 | EMS PIEZON MASTER 700 | E.M.S Electro Medical Systems S.A | 2010-07-30 | Traditional | PDF ↗ |
| K100647 | A-DEC/W&H SYNEA SONIC SCALER HANDPIECE, MODELS ZA-55, ZA-55 L, ZA-55 LM, ZA-55M, SF1LM | A-Dec, Inc. | 2010-07-09 | Traditional | PDF ↗ |
| K100401 | SWERV MAGNETOSTRICTIVE ULTRASONIC SCALER SYSTEM | Hu-Friedy Mfg. Co., Inc. | 2010-03-30 | Traditional | PDF ↗ |
| K092417 | INSIGHT ULTRASONIC INSERTS | Discus Dental, LLC | 2009-12-11 | Traditional | PDF ↗ |
| K081268 | SONIC AIR MM1500 + (MID), MODEL 50400014 | Micro-Mega Societe Anonyme | 2009-08-10 | Traditional | PDF ↗ |
| K083059 | AIR SONIC SCALER | Dpm USA Corp. | 2009-01-30 | Traditional | PDF ↗ |
| K082973 | STER-MATE STERILE LAVAGE KIT | Dentsply Interntional | 2009-01-29 | Traditional | PDF ↗ |
| K080089 | SONICFLEX 2003 AND SONICFLEX LUX 2003 L WITH INSTRUMENT TIPS | Sybron Dental Specialties, Inc. | 2008-09-04 | Traditional | PDF ↗ |
| K081550 | BONART ULTRASONIC SCALER, MOEDLS ART-P3II PRO AND ART-MII PRO | Bonart Co., Ltd. | 2008-08-28 | Traditional | PDF ↗ |
| K071447 | VARIOS 75 | Nakanishi, Inc. | 2008-04-18 | Traditional | PDF ↗ |
| K072107 | PERIOSCAN, MODEL: D 3496 | Sirona Dental Systems GmbH | 2008-02-14 | Traditional | PDF ↗ |
| K071981 | BONART MODEL ART-P6 PIEZO ELECTRIC ULTRASONIC SCALER & ACCESSORIES (TIPS) | Bonart Co., Ltd. | 2007-10-26 | Traditional | PDF ↗ |
| K071424 | PMAX NEWTRON XS | Satelec - Acteon Group | 2007-08-24 | Traditional | PDF ↗ |
| K070975 | SYMMETRY IQ, MODEL 2000 SERIES, 3000 SERIES | Hu-Friedy Mfg. Co., Inc. | 2007-06-21 | Traditional | PDF ↗ |
| K070307 | STERI -MATE HANDPIECE SLEEVE WITH LED LIGHT | Dentsply International, Inc. | 2007-05-02 | Traditional | PDF ↗ |
| K062731 | ULTRASONIC SCALER, VARIOS 560 | Nakanishi, Inc. | 2007-05-01 | Traditional | PDF ↗ |
| K070866 | ASC-12 PIEZOELECTRIC SCALER | Aseptico, Inc. | 2007-04-11 | Traditional | PDF ↗ |
| K062791 | USI DENTAL SCALER, 25XXX SERIES | Ultrasonic Services, Inc. | 2006-12-11 | Traditional | PDF ↗ |
| K053555 | ULTRASONIC SCALER, MODELS UDS-N1, UDS-N2. UDS-J, UDS-K, UDS-L | Guilin Woodpecker Medical Instrument Co., Ltd. | 2006-08-21 | Traditional | PDF ↗ |
| K061448 | BONART ART-P3II & P4 PIEZO ELECTRIC ULTRASONIC SCALER UNITS WITH ACCESSORIES | Bonart Co., Ltd. | 2006-08-17 | Traditional | PDF ↗ |
| K053578 | SCORPION ULTRASONIC SCALING INSERTS | Scorpion | 2006-07-14 | Traditional | PDF ↗ |
| K060275 | PIEZOTOME | Satelec | 2006-05-03 | Traditional | PDF ↗ |
| K060171 | CLEANSE S+ ULTRASONIC SCALER | Dmetec.Co., Ltd. | 2006-03-29 | Traditional | PDF ↗ |
| K053178 | SYMMETRY S-SERIES PIEZOELECTRIC SCALING TIPS | Hu-Friedy Mfg. Co., Inc. | 2006-02-01 | Traditional | PDF ↗ |
| K052518 | PIEZOSURGERY | Piezosurgery S.R.L. | 2005-11-16 | Traditional | PDF ↗ |
| K053030 | J. MORITA AZ ULTRASONIC SYSTEM | J. Morita USA, Inc. | 2005-11-07 | Traditional | PDF ↗ |
| K052028 | BONART ART-M3II & M4 ULTRASONIC SCALER UNITS WITH ACCESSORIES (INSERTS) | Bonart Co., Ltd. | 2005-10-28 | Traditional | PDF ↗ |
| K052334 | CAVITRON RF ULTRASONIC SCALER SYSTEM WITH STERIMATE HANDPIECE, MODEL G-131 | Dentsply Intl. | 2005-09-02 | Special | PDF ↗ |
| K051910 | MAXISONIC FAMILY AND SWIFT ULTRASONIC SCALER | D.B.I. America Corp. | 2005-09-02 | Traditional | PDF ↗ |
| K051547 | POWERMAX 25, MODEL PM25; POWERMAX 30, MODEL PM30 | Tpc Advanced Technology, Inc. | 2005-07-14 | Special | PDF ↗ |
| K051776 | PROTEGE ULTRASONIC INSERT | Discus Dental, Inc. | 2005-07-13 | Traditional | PDF ↗ |
| K050895 | SURPASSON P5 NEWTRON | Satelec | 2005-04-20 | Traditional | PDF ↗ |
| K050710 | MINIMASTER ULTRASONIC SCALER | E.M.S Electro Medical Systems S.A | 2005-03-30 | Special | PDF ↗ |
| K050354 | PERIOSCAN ULTRASONIC SCALER | Sirona Dental Systems GmbH | 2005-03-21 | Traditional | PDF ↗ |
| K042972 | XP TECHNOLOGY ULTRASONIC SCALER | American Eagle Instruments, Inc. | 2005-03-18 | Traditional | PDF ↗ |
| K033044 | DREAM CLEANSE S SCALER, DREAM COMPACT S SCALER | American Green Dent. Mfg, Inc. | 2004-12-21 | Traditional | PDF ↗ |
| K042056 | AZ ULTRASONIC SYSTEM | J. Morita USA, Inc. | 2004-09-30 | Traditional | PDF ↗ |
| K033198 | APOZA ULTRASONIC SCALER AND EDODONTICS UNIT, SELECTOR U2 | Apoza Enterprise Co., Ltd. | 2004-04-30 | Traditional | PDF ↗ |
| K040396 | ULTRASONIC SCALER ELEGANCE MS-10 (25K) | Rolence Enteprise, Inc. | 2004-04-22 | Traditional | PDF ↗ |
| K031421 | ULTRASONIC SCALER, MODELS VARIOS 350 LUX, VARIOS 350 (NO LIGHT), VARIOS 550, VARIOS 150 LUX, VARIOS 150 (NO LIGHT) | Nakanishi, Inc. | 2004-03-26 | Traditional | PDF ↗ |
| K033764 | SP NEWTRON MODULE | Satelec | 2004-03-01 | Traditional | PDF ↗ |
| K033120 | SCALETRON PIEZO ULTRASOUND SCALER | Pac-Dent International (Suzhou), Ltd. | 2004-01-29 | Traditional | PDF ↗ |
Product code ELC · Class II · Dental. Data: openFDA.