Surgical devices · 21 CFR 872 Subpart E
Ultrasonic Scaler
FDA device type “Scaler, Ultrasonic”.
- Companies listing it
- 9355 makers
- Brands and models
- 781
- 510(k) clearances
- 19516 in five years
- FDA name
- Scaler, Ultrasonic
510(k) clearances per year, 1976–2026
Companies that list ELC
93 companies currently list this device type with FDA.
| Company | Country | Role | Brands and models listed | Clearances | Latest |
|---|---|---|---|---|---|
| Dentsply Sirona, Inc. | United States | Maker | Bobcat PRO Ultrasonic Scaler, · Cavitron JET SPS, · Cavitron SPS, · Focused Spray Inserts, · +11 | 148 | 2026 |
| Nakanishi, Inc. | Japan | Maker | AS2000 B2/3 · AS2000 M4 · DA150SL · E11 · +249 | 37 | 2026 |
| Guilin Woodpecker Medical Instrument Co., Ltd. | China | Maker | Ai-surgery, Surgic smart · Dental Scaler and Air Polisher · Love Hygiene Air · Piezo Bone Surgery · +20 | 12 | 2025 |
| Sybron Dental Specialties | United States | Maker | Ultrasonic Diamond Tip · Ultrasonic Tips | 203 | 2026 |
| Ultradent Products, Inc. | United States | Maker | Ultrawave Bottle cap | 95 | 2026 |
| Foshan COXO Medical Instrument Co., Ltd. | China | Maker | Endo Ultrasonic Activator ; Ultra Smart | 6 | 2025 |
| Cefla S.C. | Italy | Maker | PUMA ELI A R M CART; PUMA ELI A R ORTHO; DAMA AMBIDX · PUMA ELI A R; PUMA ELI A R CP; PUMA ELI A R CART; PUMA ELI A R M; PUMA ELI A R M CP · R7 · R7 CART · +7 | 15 | 2026 |
| Dent4You AG | Switzerland | Maker | BioSonic US200 UltraSonic Scaler | 5 | 2026 |
| Premier Dental Products Company | United States | Maker | Premier Ultrasonic Scaler | 28 | 2026 |
| Young Innovations Inc | United States | Maker | DEL ULTRASONIC TIPS · Diamond Coated Tip · Johnson Promident Ultrasonic Inserts · Kerr Ultrasonic Diamond TIps · +2 | 23 | 2025 |
| Mectron S.P.A. | Italy | Maker | combi touch · COMPACT PIEZO LED · Compact Piezo P2K - Powercare · K10 · +9 | 11 | 2025 |
| Guilin Refine Medical Instrument Co., LTD. | China | Maker | — | 3 | 2026 |
| Parkell, Inc | United States | Maker | — | 58 | 2025 |
| Satelec - Acteon Group | United States | Maker | EDGESURGICALTIP - #1, #2, #3, #4, #5, #6 · EDGETIP - #1, #2, #3, #4, #5, #6, #7, #8 · Endo Tips - ETBD, ET18D, ET20D, ET40D, ET25S, ET25, ET25L · EndoCenter · +23 | 18 | 2024 |
| Dentalez, Inc. | United States | Maker | Titan Blis-sonic Scalers | 9 | 2026 |
| Den-Mat Holdings, LLC | United States | Maker | Pro-Select Platinum | 8 | 2026 |
| Ttbio Corp. | Taiwan | Maker | EVOCLEAN CLEANsert Ultrasonic Insert | 6 | 2023 |
| Lakong Medical Devices Co., Ltd. | China | Maker | Ultrasonic Scaler | 2 | 2026 |
| Coltene/Whaledent AG | Switzerland | Maker | BioSonic S1 Piezo Scaler · BIOSONIC ULTRASONIC SCALER SYSTEM · BioSonic US200 UltraSonic Scaler | 45 | 2022 |
| W&H Dentalwerk Buermoos GmbH | Austria | Maker | — | 17 | 2026 |
| Essential Dental Systems, Inc. | United States | Maker | Turbo-CR | 15 | 2023 |
| KaVo Dental GmbH | Germany | Maker | PIEZO Cem Tip 225 - 107.4027 · PIEZO Endo Tip 220 - 107.4040 · PIEZO Endo Tip 221 - 107.4041 · PIEZO Endo Tip 222 - 107.4043 · +176 | 2 | 2021 |
| ChangZhou BoMedent Medical Technology Co., Ltd | China | Maker | Ultrasonic Endo Activation Device (Model: Actor I pro) | 2 | 2022 |
| Denjoy Dental Co., Ltd. | China | Maker | Integrated Endo System (Meet Endo-II) · JAS Activator · JAS Activator Ultrasonic Tips · JAS Charging Unit · +7 | 1 | 2025 |
| Shenzhen Micro Electric Intelligence Co., Ltd. | China | Maker | Ultrasonic Scaler · WD-JY-A005, WD-JY-H009, WD-JY-10011, WD-JY-K0012, · WD-JY-G004, WD-JY-C006, WD-JY-M0014, WD-JY-N0015, · WD-JY-K0013, WD-JY-K0014, WD-JY-K0015, WD-JY-K0016 · +3 | 1 | 2024 |
| Odne AG | Switzerland | Maker | OdneClean · OdneClean Tip | 1 | 2024 |
| Aseptico, Inc. | United States | Maker | AEU-350 - ASEPTICO GO ULTRA PORTABLE DENTAL SYSTEM · AEU-350-W · AEU-350S - ASEPTICO GO ULTRA PORTABLE DENTAL SYSTEM W/Scaler · AEU-350S-W · +8 | 17 | 2015 |
| Bonart Co., Ltd. | Taiwan | Maker | ART-M1 MAGNET ULTRASONIC SCALER · ART-M3II MAGNET ULTRASONIC SYSTEM · ART-M4 MAGNET ULTRASONIC SYSTEM · ART-P3 PIEZO ELECTRIC SCALER · +3 | 14 | 2017 |
| Sonendo, Inc. | United States | Maker | GentleWave System | 9 | 2021 |
| Hu-Friedy Mfg Co., LLC | United States | Maker | After Five · After Five Plus · Furcation Plus · Hu-Friedy Mfg Co.,LLC · +15 | 8 | 2012 |
| Electro Medical Systems SA | United States | Maker | AIR-FLOW MASTER PIEZON · AIR-FLOW S2 · EMS AIRFLOW Prophylaxis Master, EMS AIRFLOW One · EMS PIEZON 707 BIK · +8 | 5 | 2002 |
| Asi Medical, Inc. | United States | Maker | Advanced Dental System · Advanced Endodontic System · Triton Dental System | 5 | 2013 |
| Rolence Ent., Inc. | Taiwan | Maker | elegance · elitedent · intelligence | 5 | 2009 |
| Apoza Enterprise Co., Ltd. | Taiwan | Maker | PROPHY APII · Selector U2 Plus,with and without Endo;Selector U2, with and without Endo | 5 | 2007 |
| Micron Corporation | Japan | Maker | AW-100 · Micron SSS · SA-100 · TA-100 · +4 | 5 | 2018 |
| DMETEC Co., LTD | South Korea | Maker | CLEANSE S+ ULTRASONIC SCALER · Compact S, Compact S(LED) | 5 | 2017 |
| Dental Technologies, Inc. | United States | Maker | Cavitron Jet with SPS System · Prophy Jet | 2 | 2013 |
| Osada Electric Co., Ltd. | Japan | Maker | OSADA SCALER, ULTRASONIC | 2 | 1994 |
| Nanning Baolai Medical Instrument Co., Ltd. | China | Maker | BD2 · CD1; CD2 ;CD3 · GL5,GL5L · K10 · +5 | 1 | 2015 |
| Schlumbohm GmbH & Co. KG | Germany | Maker | EndoPilot | 1 | 2021 |
| Nanning VV Dental Co., Ltd. | China | Maker | Scaler,ultrasonic E2,P2,SK-E1,SK-D1 · Scaler,ultrasonic VET-1,VET-W3,VET-W3-LED,VET-6,WET-6-LED,VET-W7,WET-W7-LED,VST-1,VST-W3,VST-6,VST-W7 | 1 | 2017 |
| Beyes Dental Inc | Canada | Maker | Beyes Comfort-Sonic Series Ultrasonic Scaler | — | — |
| LM-Instruments Oy | Finland | Maker | — | — | — |
| EMS Electro Medical Systems SA | Switzerland | Maker | AIRFLOW PROPHYLAXIS MASTER, AIRFLOW ONE · GBT Machine Airflow Prophylaxis Master · OSSTEM BIK · PIEZON · +2 | — | — |
| Dental Engineering Laboratories | United States | Maker | TFRK-12 · TFRK-6 · TFRK-S · ZTip-E · +1 | — | — |
| Shenzhen Ainengke Electronics Co., Ltd. | China | Maker | Curwy Moon Electric Teeth Cleaner · RELACS 7000, Plaque remover for teeth, Tartar Remover for Teeth, Teeth Cleaning Kit, 5 Modes with 3 tips, with LED Light · SPARTAN A-10 Plaque Remover for Teeth, Tartar Remover Kit, Dental Cleaning Tools | — | — |
| Dhef Inc. | Taiwan | Maker | ULTRASONIC SCALER | — | — |
| Taiyo Kogyo Co., Ltd. Hanyu Technical Plant | Japan | Maker | VA370 · VA370 Lux · VA370ADNA · VA370LUXADNA · +5 | — | — |
| China Zhong Yan Chang ING International Co, LTD | China | Maker | Ultrasonic Dental Tip | — | — |
| Creanova doo | Serbia | Maker | OdneClean Tip | — | — |
| Dell Dent Ltd. | Israel | Maker | AIRBRUSH | — | — |
| Medidenta | United States | Maker | Autoscaler · Medi-Scaler | — | — |
| Quanzhou Aguru E-commerce Co., Ltd | China | Maker | Plaque Remover for Teeth - Tartar Remover for Teeth, Dental Calculus Remover Teeth Cleaning Kit · Plaque/Tartar Remover for Teeth, Dental Calculus Remover Teeth Cleaning Kit with LED Light & 5 Adjustable Modes | — | — |
| Zibo Dante Co, LTD | China | Maker | Ultrasonic Dental Tip | — | — |
| Creaproduct Srl | Italy | Maker | — | — | — |
| Park Dental Research Corp | United States | Contract manufacturer | NR Piezo | 8 | 2026 |
| A-dec, Inc. | United States | Manufacturer | A-dec/W&H ZA-55 Synea Sonic Scaler · Module Newtron Can-a EMB | 68 | 2022 |
| DCI International LLC | United States | Manufacturer | Acteon® Newtron LED Piezoelectric Scaler · Kit, Ultrasonic Scaler, G139 w/Steri-Mate 360, Cavitron · Ultrasonic Scaler, G139 w/Steri-Mate 360, Cavitron · Ultrasonic Scaler, V6 LED, DTE, Woodpecker | 1 | 2025 |
| Dentamerica | United States | Repacker / relabeler | SCALEX | 4 | 2010 |
| Tpc Advanced Technology, Inc. | United States | Repacker / relabeler | TPC PM25 Scaler | 3 | 2007 |
| Gebr. Brasseler GmbH & Co. KG | Germany | Contract manufacturer | EndoPilot² | 1 | 2007 |
| Engineered Endodontics | United States | Repacker / relabeler | tun ultrasonic tip | 1 | 2019 |
| Vector Research & Development | United States | Repacker / relabeler | Vector | 1 | 2002 |
| Jersey Dental Supplies | United States | Repacker / relabeler | DENTSPLY CAVITRON SPS SCALER SYSTEM | — | — |
| TitanLinks Logistics LLC | United States | Repacker / relabeler | Air polish · dental scaler | — | — |
| Jmu Dental, Inc. | United States | Repacker / relabeler | D1 · D3 · D5 · D6 · +37 | — | — |
| Patterson Companies, Inc. | United States | Foreign exporter | Patterson Ultrasonic Inserts · Scaler, ultrasonic | — | — |
| Soher Med Limited | Hong Kong SAR China | Foreign exporter | Air polish · scaler | — | — |
| HSG-S Corp | United States | Manufacturer | EdgeActivator E70 Tip · EdgePiezo ED3D Endodontic Tip · EdgePiezo Handpiece · EdgePiezo PD3D Subgingival Tip · +2 | — | — |
| Samtrade Supplies Inc. | Canada | Foreign exporter | Cavitron | — | — |
| Nordent MFG., Inc. | United States | Contract manufacturer | AI SURGERY · D600 LED · ultrasonic scaler | — | — |
| GoldenDent | United States | Repacker / relabeler | AP-A · Piezo Implant Motor · PT-A · PT-B · +2 | — | — |
| Flight Dental Systems USA Inc. | United States | Repacker / relabeler | Flight Dental Systems - Ultrasonic Scaler - FMS-2530, BI-2530, N6LED-1902 · FMS-2530R2 | — | — |
| Onvet Medical Canada Inc. | Canada | Manufacturer | AMW-Stronic Series Ultrasonic Scaler | — | — |
| Ads Dental System Inc. | United States | Remanufacturer | D8 LED | — | — |
| Toyo Medical Co. | United States | Repacker / relabeler | Nakanishi Inc · Nakanishi Inc. | — | — |
| W&H Impex Inc. | Canada | Foreign exporter | Foot Control · Instrument changer · Instrument Set BONE · Instrument Set ENDO · +3 | — | — |
| Piezosurgery, Inc DBA Mectron North America | United States | Lister | COMPACT PIEZO LED · MT-Bone · MULTIPIEZO, MULTIPIEZO PRO · Piezosurgery // · +2 | — | — |
| E/T Endodontic Technologies, Ltd. | Canada | Foreign exporter | Acteon IrriSafe Tips | — | — |
| Sanicure BV | Netherlands | Foreign exporter | — | — | — |
| Zapalign LLC | United States | Repacker / relabeler | — | — | — |
| Peter Brasseler Holdings, LLC | United States | Contract manufacturer | — | — | — |
| Zapalign Inc. | South Korea | Foreign exporter | Cavitron | — | — |
| Enova Illumination Inc. | United States | Lister | Piezo Surgery | — | — |
| Kash Sales Inc. | Canada | Foreign exporter | — | — | — |
| Orthodentalusa Corp. | United States | Repacker / relabeler | KASO MEDICAL TECHNOLOGY Co., LTD | — | — |
| 3D Dental Designs and Development LLC | United States | Contract manufacturer | — | — | — |
| Wenzhou Baiyu Glasses Technology Co.,ltd | China | Foreign exporter | Tooth cleaner G68 | — | — |
| Dylan Lucas International Inc | Canada | Foreign exporter | — | — | — |
| Mainline Medical Dental Supply | Canada | Foreign exporter | — | — | — |
| MHM Grupo Diamante, S.A. de C.V. | Mexico | Foreign exporter | — | — | — |
| Oketz Logistics LLC | United States | Repacker / relabeler | — | — | — |
| Veenak International Limited | United Kingdom | Foreign exporter | — | — | — |
510(k) clearances
| Decided | 510(k) | Device | Applicant |
|---|---|---|---|
| 10 Mar 2026 | K260773 | Varios Combi Pro2 | Nakanishi, Inc. |
| 28 Jan 2026 | K253254 | GBT Machine Airflow Prophylaxis Master | E.M.S Electro Medical Systems S.A |
| 19 Sep 2025 | K251689 | VARIOS 170 LUX SCALER SYSTEM (VA170LUXS10); VARIOS 170 LUX SCALER SYSTEM (VA170LUXS11); VARIOS 170 SCALER SYSTEM (VA170S11) | Nakanishi, Inc. |
| 13 Feb 2025 | K242317 | Integrated Endo System (Meet Endo-II) | Denjoy Dental Co., Ltd. |
| 8 Aug 2024 | K233844 | OdneClean | Odne AG |
| 2 Jul 2024 | 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. |
| 1 Jul 2024 | K240801 | BioSonic US200 Ultrasonic Scaler (60034537) | Dent4You AG |
| 11 Mar 2024 | 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 |
| 11 Dec 2023 | K223340 | EDS Calculus Softener TURBO CR | Essential Dental Systems, Inc. |
| 21 Nov 2023 | K230641 | Ultrasonic Scaler Tips | Guilin Refine Medical Instrument Co., LTD. |
| 14 Jul 2023 | K223173 | Proxeo ULTRA (PB-510, PB-520 and PB-530) | W&H Dentalwerk Buermoss GmbH |
| 15 May 2023 | K231391 | Combi Touch | Mectron S.P.A. |
| 23 Mar 2023 | K222096 | Endo Ultrasonic Activator | Foshan COXO Medical Instrument Co., Ltd. |
| 8 Sep 2022 | K213947 | Ultrasonic Endo Activation Device (Model:Actor I pro) | ChangZhou BoMedent Medical Technology Co., Ltd |
| 2 Feb 2022 | K210832 | EVOCLEAN CLEANsert Ultrasonic Insert | Ttbio Corp. |
| 10 Dec 2021 | K203615 | Dental Scaler and Air Polisher | Guilin Woodpecker Medical Instrument Co., Ltd. |
| 13 Apr 2021 | K202906 | EndoPilot2 | Schlumbohm GmbH & Co. KG |
| 5 Feb 2021 | K203302 | GentleWave X | Sonendo, Inc. |
| 4 Dec 2020 | K201317 | TTBIO EVOCLEAN Ultrasonic Scaler | Ttbio Corp. |
| 20 Oct 2019 | K190124 | EMS AIRFLOW Prophylaxis Master, EMS AIRFLOW One | E.M.S Electro Medical Systems S.A |
| 16 Aug 2019 | K191079 | Piezon Built-in Kit, Piezon Built-in Kit LED | E.M.S Electro Medical Systems S.A |
| 7 Jun 2019 | K182145 | tün® ultrasonic tips product family | Engineered Endodontics |
| 16 Mar 2019 | K190359 | Sonendo GentleWave System | Sonendo, Inc. |
| 8 Mar 2018 | K171150 | AW-100 | Micron Corporation |
| 27 Dec 2017 | K170104 | COMPACT S, COMPACT S (LED) | DMETEC Co., LTD |
| 21 Nov 2017 | K163414 | Ultrasonic scaler | Nanning VV Dental Co., Ltd. |
| 22 Dec 2016 | K161639 | Y-MIC | Micron Corporation |
| 3 Jun 2016 | K160905 | Sonendo GentleWave System | Sonendo, Inc. |
| 29 Jan 2016 | K153157 | Sonendo Gentle Wave System | Sonendo, Inc. |
| 5 Aug 2015 | K151023 | COMPACT PIEZO LED | Mectron S.P.A. |
| 16 Jun 2015 | K150535 | Cavitron Touch Ultrasonic Scaling System | Dentsply International, Inc. |
| 1 May 2015 | K143448 | Sonendo GentleWave System | Sonendo, Inc. |
| 6 Apr 2015 | K140233 | ULTRASONIC SCALER | Nanning Baolai Medical Instrument Co., Ltd. |
| 27 Feb 2015 | K140990 | EMS PIEZON 707 BIK AND PIEZON 707 BIK LED | E.M.S Electro Medical Systems S.A |
| 20 Aug 2014 | K140965 | MULTIPIEZO PRO, MULTIPIEZO | Mectron S.P.A. |
| 15 May 2014 | K133752 | SONENDO OMNICLEAN ENDOTHERPAY SYSTEM CONSOLE, SONENDO OMNICLEAN MOLAR PROCEDURE KIT | Sonendo, Inc. |
| 11 Mar 2014 | K132322 | NEWTRON P5 XS B.LED | Satelec - Acteon Group |
| 10 Mar 2014 | K132267 | NEWTRON P5, NEWTRON P5 B.LED | Satelec - Acteon Group |
| 22 Jan 2014 | K132609 | EDS ULTRASONIC TIPS | Essential Dental Systems, Inc. |
| 16 Jan 2014 | K131151 | ENDOCENTER | Satelec - Acteon Group |
| 6 Dec 2013 | K132445 | PIEZON 250 | E.M.S Electro Medical Systems S.A |
| 26 Nov 2013 | K131997 | NEWTRON BOOSTER | Satelec - Acteon Group |
| 22 Nov 2013 | K132443 | PIEZON 150 | E.M.S Electro Medical Systems S.A |
| 8 Oct 2013 | K130834 | R7 | Cefla S.C. |
| 23 Aug 2013 | K130137 | BIOSONIC SUVI PIEZEOELECTRIC SCALER AND POLISHER | Coltene/Whaledent AG |
| 14 Aug 2013 | K130693 | AEU-525 TRANSPORT III PORTABLE DENTAL SYSTEM | Aseptico, Inc. |
| 23 Jul 2013 | K130862 | CAVITRON PROPHY-JET AIR POLISHING PROPHYLAXIS SYSTEM | Dentsply Intl., Inc. |
| 11 Jun 2013 | K130025 | SONENDO ENDOTHERAPY SYSTEM | Sonendo, Inc. |
| 11 Jun 2013 | K122748 | ENGLER 25K SERIES ULTRASONIC INSERTS | Engler Engineering Corp. |
| 29 Mar 2013 | K122501 | AEI DR. TERAUCHI ULTRASONIC TIPS | Young Innovations Inc |
| 28 Mar 2013 | K123139 | ADVANCED ENDODONTIC SYSTEM- DESIGNER SERIES | Asi Medical, Inc. |
| 5 Mar 2013 | K113717 | ULTRASONIC SCALER | Nakanishi, Inc. |
| 31 Jan 2013 | K113530 | ULTRASONIC SCALER | Nakanishi, Inc. |
| 23 Feb 2012 | K113430 | PROULTRA PIEZO ULTRASONIC | Satelec - Acteon Group |
| 7 Apr 2011 | K110173 | EMS AIR-FLOW MASTER PIEZON | E.M.S Electro Medical Systems S.A |
| 31 Mar 2011 | K103498 | LAKONG ULTRASONIC SCALER | Lakong Medical Device Company, Ltd. |
| 24 Jan 2011 | K102218 | COMPACT PIEZO P2K, POWERCARE | Mectron S.P.A. |
| 8 Sep 2010 | K093723 | EMS MINIMASTER LED | E.M.S Electro Medical Systems S.A |
| 30 Jul 2010 | K093000 | EMS PIEZON MASTER 700 | E.M.S Electro Medical Systems S.A |
| 9 Jul 2010 | K100647 | A-DEC/W&H SYNEA SONIC SCALER HANDPIECE, MODELS ZA-55, ZA-55 L, ZA-55 LM, ZA-55M, SF1LM | A-dec, Inc. |
| 30 Mar 2010 | K100401 | SWERV MAGNETOSTRICTIVE ULTRASONIC SCALER SYSTEM | Hu-Friedy Mfg Co., LLC |
| 11 Dec 2009 | K092417 | INSIGHT ULTRASONIC INSERTS | Philips Medical Systems International BV |
| 10 Aug 2009 | K081268 | SONIC AIR MM1500 + (MID), MODEL 50400014 | Micro-Mega Societe Anonyme |
| 30 Jan 2009 | K083059 | AIR SONIC SCALER | Dpm USA Corp. |
| 29 Jan 2009 | K082973 | STER-MATE STERILE LAVAGE KIT | Dentsply Interntional |
| 4 Sep 2008 | K080089 | SONICFLEX 2003 AND SONICFLEX LUX 2003 L WITH INSTRUMENT TIPS | Sybron Dental Specialties |
| 28 Aug 2008 | K081550 | BONART ULTRASONIC SCALER, MOEDLS ART-P3II PRO AND ART-MII PRO | Bonart Co., Ltd. |
| 18 Apr 2008 | K071447 | VARIOS 75 | Nakanishi, Inc. |
| 14 Feb 2008 | K072107 | PERIOSCAN, MODEL: D 3496 | Dentsply Sirona, Inc. |
| 26 Oct 2007 | K071981 | BONART MODEL ART-P6 PIEZO ELECTRIC ULTRASONIC SCALER & ACCESSORIES (TIPS) | Bonart Co., Ltd. |
| 24 Aug 2007 | K071424 | PMAX NEWTRON XS | Satelec - Acteon Group |
| 21 Jun 2007 | K070975 | SYMMETRY IQ, MODEL 2000 SERIES, 3000 SERIES | Hu-Friedy Mfg Co., LLC |
| 2 May 2007 | K070307 | STERI -MATE HANDPIECE SLEEVE WITH LED LIGHT | Dentsply International, Inc. |
| 1 May 2007 | K062731 | ULTRASONIC SCALER, VARIOS 560 | Nakanishi, Inc. |
| 11 Apr 2007 | K070866 | ASC-12 PIEZOELECTRIC SCALER | Aseptico, Inc. |
| 11 Dec 2006 | K062791 | USI DENTAL SCALER, 25XXX SERIES | Ultrasonic Services, Inc. |
| 21 Aug 2006 | K053555 | ULTRASONIC SCALER, MODELS UDS-N1, UDS-N2. UDS-J, UDS-K, UDS-L | Guilin Woodpecker Medical Instrument Co., Ltd. |
| 17 Aug 2006 | K061448 | BONART ART-P3II & P4 PIEZO ELECTRIC ULTRASONIC SCALER UNITS WITH ACCESSORIES | Bonart Co., Ltd. |
| 14 Jul 2006 | K053578 | SCORPION ULTRASONIC SCALING INSERTS | Scorpion |
| 3 May 2006 | K060275 | PIEZOTOME | Satelec |
| 29 Mar 2006 | K060171 | CLEANSE S+ ULTRASONIC SCALER | DMETEC Co., LTD |
| 1 Feb 2006 | K053178 | SYMMETRY S-SERIES PIEZOELECTRIC SCALING TIPS | Hu-Friedy Mfg Co., LLC |
| 16 Nov 2005 | K052518 | PIEZOSURGERY | Piezosurgery S.R.L. |
| 7 Nov 2005 | K053030 | J. MORITA AZ ULTRASONIC SYSTEM | J. Morita USA, Inc. |
| 28 Oct 2005 | K052028 | BONART ART-M3II & M4 ULTRASONIC SCALER UNITS WITH ACCESSORIES (INSERTS) | Bonart Co., Ltd. |
| 2 Sep 2005 | K052334 | CAVITRON RF ULTRASONIC SCALER SYSTEM WITH STERIMATE HANDPIECE, MODEL G-131 | Dentsply Intl., Inc. |
| 2 Sep 2005 | K051910 | MAXISONIC FAMILY AND SWIFT ULTRASONIC SCALER | D.B.I. America Corp. |
| 14 Jul 2005 | K051547 | POWERMAX 25, MODEL PM25; POWERMAX 30, MODEL PM30 | Tpc Advanced Technology, Inc. |
| 13 Jul 2005 | K051776 | PROTEGE ULTRASONIC INSERT | Philips Medical Systems International BV |
| 20 Apr 2005 | K050895 | SURPASSON P5 NEWTRON | Satelec |
| 30 Mar 2005 | K050710 | MINIMASTER ULTRASONIC SCALER | E.M.S Electro Medical Systems S.A |
| 21 Mar 2005 | K050354 | PERIOSCAN ULTRASONIC SCALER | Dentsply Sirona, Inc. |
| 18 Mar 2005 | K042972 | XP TECHNOLOGY ULTRASONIC SCALER | Young Innovations Inc |
| 21 Dec 2004 | K033044 | DREAM CLEANSE S SCALER, DREAM COMPACT S SCALER | American Green Dent. Mfg, Inc. |
| 30 Sep 2004 | K042056 | AZ ULTRASONIC SYSTEM | J. Morita USA, Inc. |
| 30 Apr 2004 | K033198 | APOZA ULTRASONIC SCALER AND EDODONTICS UNIT, SELECTOR U2 | Apoza Enterprise Co., Ltd. |
| 22 Apr 2004 | K040396 | ULTRASONIC SCALER ELEGANCE MS-10 (25K) | Rolence Enteprise, Inc. |
| 26 Mar 2004 | K031421 | ULTRASONIC SCALER, MODELS VARIOS 350 LUX, VARIOS 350 (NO LIGHT), VARIOS 550, VARIOS 150 LUX, VARIOS 150 (NO LIGHT) | Nakanishi, Inc. |
| 1 Mar 2004 | K033764 | SP NEWTRON MODULE | Satelec |
| 29 Jan 2004 | K033120 | SCALETRON PIEZO ULTRASOUND SCALER | Pac-Dent International (Suzhou), Ltd. |
| 12 Dec 2003 | K033640 | SIROSON L AND SIROSONIC L ULTRASONIC SCALERS | Dentsply Sirona, Inc. |
| 4 Dec 2003 | K033705 | BOBCAT PRO SCALER SYSTEM, MODEL G-130 | Dentsply International, Inc. |
| 20 Nov 2003 | K032995 | SSS, MODEL 1072001 (STANDARD 4-HOLE MODEL) & 1072002 (STANDARD 2-HOLE MODEL) | Micron Corporation |
| 5 Aug 2003 | K031461 | CARRIER TIPS | Dentsply Intl., Inc. |
| 7 Feb 2003 | K030111 | DIAMONDCOAT ULTRASONIC INSERTS | Dentsply International, Inc. |
| 6 Nov 2002 | K023697 | STERI-MATE STERILIZABLE HANDPIECE | Dentsply International, Inc. |
| 13 Aug 2002 | K022328 | EMS PIEZON MASTER 600 | Electro Medical Systems SA |
| 5 Jul 2002 | K021253 | ULTRASONIC TIPS WITH DIAMOND COATING | Sybron Endo/Analytic |
| 24 Jan 2002 | K014238 | DELSONIC 2000 | Deldent , Ltd. |
| 27 Jul 2001 | K012060 | MODIFICATION TO:HU-FRIEDY BRAND SATIN SWIVEL ULTRASONIC INSERT | Hu-Friedy Mfg Co., LLC |
| 5 Jun 2001 | K011179 | DELDENT ULTRASONIC INSERTS | Deldent , Ltd. |
| 17 Apr 2001 | K010195 | PREMIER ULTRASONIC SCALER AND INSERTS | Premier Dental Products Company |
| 21 Dec 2000 | K002122 | VECTOR | Duerr Dental SE |
| 4 Dec 2000 | K002753 | SPARTAN A-10 | Spartan Ultrasonics, Inc. |
| 4 Dec 2000 | K000846 | TKD SCALERS | Orasystems |
| 13 Nov 2000 | K002521 | SPARTAN MTS | Spartan Marketing Group |
| 15 May 2000 | K000510 | ART-M1, MODEL M1-1-ART-A1 | Bonart Co., Ltd. |
| 6 Mar 2000 | K994299 | ART-P3, MODEL P3-1-ART-A1 | Bonart Co., Ltd. |
| 6 Mar 2000 | K994203 | ART-M3 25K, MODEL M3-1-ART2-A1; ART-M3 30K, MODEL M3-1-ART3-A1 | Bonart Co., Ltd. |
| 27 Jan 2000 | K992504 | EMS KERMIT | (Ems Sa) Electro Medical Systems |
| 5 Nov 1999 | K990546 | DELSONIC 2000 | Sds Dental, Inc. |
| 18 Oct 1999 | K991239 | VIP 60 (2H), MODEL 115-000-1, VIP 60 (4H), MODEL 115-000-2 | Micron Corporation |
| 30 Jul 1999 | K991874 | EMS SURFACE MOUNT SCALER | (Ems Sa) Electro Medical Systems |
| 23 Jun 1999 | K991021 | SONIC SCALER WITH FIBER OPTIC, MODEL NAS-L, SONIC SCALER WITHOUT FIBER OPTIC, MODEL NAS-NL | Nsk Nakanishi, Inc. |
| 29 Jan 1999 | K983029 | POWER PLUS 25K MODEL, S1000, POWER PLUS 30K MODEL,S1001 | Tpc Advanced Technology, Inc. |
| 20 Jan 1999 | K983727 | BIOSONIC ULTRASONIC SCALER SYSTEM | Coltene/Whaledent AG |
| 28 Oct 1998 | K982793 | PIEZO TRONIC | Advanced Medical Devices, Inc. |
| 9 Jul 1997 | K972026 | SP4044 & SP4055 LUX MODULES | Satelec |
| 22 Apr 1997 | K964596 | PROSELECT 3 PERIDONTAL THERAPY SYSTEM | Professional Dental Mfg., Inc. |
| 11 Apr 1997 | K970123 | DENTSPLY CAVITRON SPS SCALER SYSTEM | Dentsply Intl., Inc. |
| 4 Apr 1997 | K970342 | CAVITRON JET WITH SPS SYSTEM | Dentsply Intl., Inc. |
| 23 Jan 1997 | K964320 | TONY RISO 25/30 MULTIFUNCTION SCALER | Tony Riso Co., Inc. |
| 23 May 1996 | K961158 | SUPRASSON P5 BOOSTER | Satelec |
| 10 May 1996 | K960889 | SAPPHIRE PLUS SCALER MOD. 300114/PLUGGER MOD. 300115/CUTTING MOD. 300116/SPREADER MOD. 300117 TIPS | San Diego Swiss Machining, Inc. |
| 5 Mar 1996 | K943403 | CONDOR ULTRASONIC INSERTS | Condor Products, Inc. |
| 18 Jan 1996 | K954820 | SCALEX 800 | Dentamerica |
| 7 Oct 1995 | K953919 | DENTAL ULTRASONIC SCALER INSERTS | Hu-Friedy Mfg Co., LLC |
| 29 Sep 1995 | K942139 | SUPRASSON P MAX | Satelec |
| 28 Aug 1995 | K953026 | MINIPIEZON | Electro Medical Systems SA |
| 7 Aug 1995 | K942380 | MICRO ICS SONIC SCALER | Micro Motors, Inc. |
| 12 May 1995 | K951272 | RELACS 7000 | Micro-Mega Societe Anonyme |
| 4 Apr 1995 | K950256 | TURBO 25/30 | Parkell, Inc |
| 4 Apr 1995 | K950240 | LE CLEAN MACHINE | Parkell, Inc |
| 23 May 1994 | K941392 | JET UNIT (CJ HANDPIECE) | Dentsply Intl., Inc. |
| 14 Feb 1994 | K934714 | ENDODONTIC PULP CANAL SPREADER | Excellence IN Endodontics, Inc. |
| 20 Oct 1993 | K933547 | INTRA-ORAL IRRIGATOR | Parkell, Inc |
| 20 Oct 1993 | K920328 | AMDENT 2030, POLISHER/SCALER | Amdent AB |
| 22 Jul 1993 | K930698 | THE MODEL 3003 SCALER | Dentsply Intl., Inc. |
| 8 Jul 1993 | K921893 | COLGATE ODONTOSON ULTRASONIC SCALER | Perio-Giene |
| 26 Oct 1992 | K923639 | DIAMOND COATED DENTAL INSERTS | Dentsply Intl., Inc. |
| 16 Apr 1991 | K903298 | DYNASONIC PLAQUE REMOVER & POLISHER DYNATIP | Micro Motors, Inc. |
| 5 Dec 1990 | K904296 | LYSTA HYGIENIST III SCALER | Prodent Intl., Inc. |
| 10 Oct 1990 | K903163 | PERIODONTAL DEBRIDING SOLUTION E | Dentsply Intl., Inc. |
| 31 Aug 1990 | K896749 | PIEZON MASTER 400 | Electro Medical Systems (Ems Sa) |
| 13 Aug 1990 | K902413 | SONIC SCALER | Dentsply Intl., Inc. |
| 15 May 1990 | K901488 | LYNX-SM, SCLAER DENTAL HANDPIECE | CNC Manufacturing, Inc. |
| 18 Apr 1990 | K900709 | AIR FLOW SII | Electro Medical Systems (Ems Sa) |
| 6 Oct 1989 | K894247 | PERIODONTAL IRRIGATING SOLUTION-D | Dentsply Intl., Inc. |
| 17 Mar 1989 | K884221 | ULTRASONIC SCALER COVER | Steri-Shield Products, Inc. |
| 15 Jul 1988 | K880940 | AMDENT MODEL 830 ULTRASONIC SCALER | Pathway Products, Inc. |
| 21 Apr 1988 | K881253 | ROTORY SCALER SWIVEL IMPROVEMENT FEATURE, TITAN SW | Dentalez Group |
| 27 Oct 1987 | K873146 | USI BASIC. AG 1050. AG 1090 | Cranston Ind., Inc. |
| 19 Feb 1987 | K864996 | ULTRASONIC SCALER 3000/ PROPHY-JET 30/ CAVI-JET 30 | Dentsply Intl., Inc. |
| 2 Oct 1986 | K863676 | GENTEEL | Luben Dental Co., Inc. |
| 4 Feb 1986 | K853841 | HARMO SONIC | U.S. Shizai Corp. |
| 30 Jan 1986 | K852525 | SATALEC PIEZOTEC | Spelna, Inc. |
| 1 Jul 1985 | K852540 | ULTRASONIC TOOTH SCALER MODEL DSCIOP | Parkell, Inc |
| 23 Jan 1985 | K844250 | OSADA ENAC | Osada Electric Co., Ltd. |
| 3 Aug 1984 | K842581 | CAVI-MED | Cooper Lasersonics, Inc. |
| 16 Mar 1984 | K840141 | DENTAL ULTRASONIC SCALER/ENDOSONIC | CooperVision, Inc. |
| 16 Mar 1984 | K834283 | DENTSPLY G-106 CAVITRON ULTRASONIC | Coopercare, Inc. |
| 16 Mar 1984 | K832674 | SATELEC PROPHY UNIT PU 2000S | Spelna, Inc. |
| 16 Mar 1984 | K832664 | SATELEC SUPRASSON PIEZOMATIC P2 | Spelna, Inc. |
| 19 Oct 1983 | K832665 | SATELEC SUPRASSON SP 3055 | Spelna, Inc. |
| 12 Sep 1983 | K832443 | ULTRASONIC DENTAL PROPHYLAXIS UNIT | California Technics, Inc. |
| 17 Nov 1982 | K823134 | AIR FLOW II | Healthco, Inc. |
| 6 Jul 1982 | K821810 | PIEZON ULTRASONIC SCALER | Healthco, Inc. |
| 24 Feb 1982 | K820162 | TEC-SON II | California Technics, Inc. |
| 14 Dec 1981 | K812909 | HYGIENTIST; CYCLOSON I & II; RETROFIT | Fibra Sonics, Inc. |
| 26 Jun 1981 | K811396 | SONUS V | California Technics, Inc. |
| 16 Jun 1981 | K811145 | PNEUMATIC DENTAL SCALER | Innovate, Inc. |
| 5 May 1981 | K811023 | ROOT CANAL KIT | Dentsply Intl., Inc. |
| 16 Sep 1980 | K801689 | SONATRON ULTRASONIC DENTAL SCANNER | Simplified Systems, Inc. |
| 26 Oct 1979 | K791704 | MASTERSCALE II | Litton Dental Products |
| 19 Sep 1979 | K791585 | MODEL G-61 ULTRASONIC DENTAL UNIT | Cavitron Corp. |
| 17 Sep 1979 | K791024 | ULTRASONIC DENTAL PROPHYLAXIS UNIT | Litton Dental Products |
| 27 Feb 1979 | K782133 | ODONTOSON 3 | Mdt Corp., Inc. |
| 30 Jun 1978 | K781044 | ULTRASONIC DENTAL PROPHYLAXIS UNIT,SSM | Litton Dental Products |
| 22 Jun 1978 | K780808 | PIEZOMATIC ULTRASONIC SCALER (SYSTEM S) | Dental Ventures of America, Inc. |
| 22 Aug 1977 | K771556 | EXR | Litton Dental Products |
| 19 Aug 1977 | K771557 | ULTRASON 990 | Litton Dental Products |
| 16 Dec 1976 | K761247 | LT:200, LOVING TOUCH | Litton Dental Products |
| 16 Dec 1976 | K761246 | SONUS III | Litton Dental Products |
| 21 Oct 1976 | K760805 | ULTRASONIC DENTAL PROPHYLAXIS DEVICE | Cavitron Corp. |
| 26 Aug 1976 | K760445 | DENTAL PROPHYLAXIS UNIT ULTRASONIC | Branson Ultrasonics Corp. |
Official records: FDA product classification for ELC · 21 CFR 872.4850.
Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026