Ultrasonic scalers: manufacturers and brands
55 companies make or specify ultrasonic scalers among the 93 that list one with FDA, under 781 brand and model names. FDA has issued 195 510(k) clearances in this category, 16 of them in the last five years.
510(k) clearances per year, 1976–2026
Ultrasonic scaler manufacturers
Makers first, then the most recently active. “Maker” means the company manufactures the device or owns its specifications; a “lister” repacks, relabels, imports or distributes it.
| 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 | — | — | — |
Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026
Where ultrasonic scalers are made
Number of makers in this category with a manufacturing establishment in the country.
FDA device types in this category
| Device type | Class | Regulation | Makers | Clearances |
|---|---|---|---|---|
| Ultrasonic ScalerELC | 2 | 872.4850 | 55 | 195 |
Recent clearances
| Decided | 510(k) | Device | Applicant | Device type |
|---|---|---|---|---|
| 10 Mar 2026 | K260773 | Varios Combi Pro2 | Nakanishi, Inc. | ELC Ultrasonic Scaler |
| 28 Jan 2026 | K253254 | GBT Machine Airflow Prophylaxis Master | E.M.S Electro Medical Systems S.A | ELC Ultrasonic Scaler |
| 19 Sep 2025 | K251689 | VARIOS 170 LUX SCALER SYSTEM (VA170LUXS10); VARIOS 170 LUX SCALER SYSTEM (VA170LUXS11); VARIOS 170 SCALER SYSTEM (VA170S11) | Nakanishi, Inc. | ELC Ultrasonic Scaler |
| 13 Feb 2025 | K242317 | Integrated Endo System (Meet Endo-II) | Denjoy Dental Co., Ltd. | ELC Ultrasonic Scaler |
| 8 Aug 2024 | K233844 | OdneClean | Odne AG | ELC Ultrasonic Scaler |
| 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. | ELC Ultrasonic Scaler |
| 1 Jul 2024 | K240801 | BioSonic US200 Ultrasonic Scaler (60034537) | Dent4You AG | ELC Ultrasonic Scaler |
| 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 | ELC Ultrasonic Scaler |
| 11 Dec 2023 | K223340 | EDS Calculus Softener TURBO CR | Essential Dental Systems, Inc. | ELC Ultrasonic Scaler |
| 21 Nov 2023 | K230641 | Ultrasonic Scaler Tips | Guilin Refine Medical Instrument Co., LTD. | ELC Ultrasonic Scaler |
| 14 Jul 2023 | K223173 | Proxeo ULTRA (PB-510, PB-520 and PB-530) | W&H Dentalwerk Buermoss GmbH | ELC Ultrasonic Scaler |
| 15 May 2023 | K231391 | Combi Touch | Mectron S.P.A. | ELC Ultrasonic Scaler |
| 23 Mar 2023 | K222096 | Endo Ultrasonic Activator | Foshan COXO Medical Instrument Co., Ltd. | ELC Ultrasonic Scaler |
| 8 Sep 2022 | K213947 | Ultrasonic Endo Activation Device (Model:Actor I pro) | ChangZhou BoMedent Medical Technology Co., Ltd | ELC Ultrasonic Scaler |
| 2 Feb 2022 | K210832 | EVOCLEAN CLEANsert Ultrasonic Insert | Ttbio Corp. | ELC Ultrasonic Scaler |
| 10 Dec 2021 | K203615 | Dental Scaler and Air Polisher | Guilin Woodpecker Medical Instrument Co., Ltd. | ELC Ultrasonic Scaler |
| 13 Apr 2021 | K202906 | EndoPilot2 | Schlumbohm GmbH & Co. KG | ELC Ultrasonic Scaler |
| 5 Feb 2021 | K203302 | GentleWave X | Sonendo, Inc. | ELC Ultrasonic Scaler |
| 4 Dec 2020 | K201317 | TTBIO EVOCLEAN Ultrasonic Scaler | Ttbio Corp. | ELC Ultrasonic Scaler |
| 20 Oct 2019 | K190124 | EMS AIRFLOW Prophylaxis Master, EMS AIRFLOW One | E.M.S Electro Medical Systems S.A | ELC Ultrasonic Scaler |
| 16 Aug 2019 | K191079 | Piezon Built-in Kit, Piezon Built-in Kit LED | E.M.S Electro Medical Systems S.A | ELC Ultrasonic Scaler |
| 7 Jun 2019 | K182145 | tün® ultrasonic tips product family | Engineered Endodontics | ELC Ultrasonic Scaler |
| 16 Mar 2019 | K190359 | Sonendo GentleWave System | Sonendo, Inc. | ELC Ultrasonic Scaler |
| 8 Mar 2018 | K171150 | AW-100 | Micron Corporation | ELC Ultrasonic Scaler |
| 27 Dec 2017 | K170104 | COMPACT S, COMPACT S (LED) | DMETEC Co., LTD | ELC Ultrasonic Scaler |
| 21 Nov 2017 | K163414 | Ultrasonic scaler | Nanning VV Dental Co., Ltd. | ELC Ultrasonic Scaler |
| 22 Dec 2016 | K161639 | Y-MIC | Micron Corporation | ELC Ultrasonic Scaler |
| 3 Jun 2016 | K160905 | Sonendo GentleWave System | Sonendo, Inc. | ELC Ultrasonic Scaler |
| 29 Jan 2016 | K153157 | Sonendo Gentle Wave System | Sonendo, Inc. | ELC Ultrasonic Scaler |
| 5 Aug 2015 | K151023 | COMPACT PIEZO LED | Mectron S.P.A. | ELC Ultrasonic Scaler |
| 16 Jun 2015 | K150535 | Cavitron Touch Ultrasonic Scaling System | Dentsply International, Inc. | ELC Ultrasonic Scaler |
| 1 May 2015 | K143448 | Sonendo GentleWave System | Sonendo, Inc. | ELC Ultrasonic Scaler |
| 6 Apr 2015 | K140233 | ULTRASONIC SCALER | Nanning Baolai Medical Instrument Co., Ltd. | ELC Ultrasonic Scaler |
| 27 Feb 2015 | K140990 | EMS PIEZON 707 BIK AND PIEZON 707 BIK LED | E.M.S Electro Medical Systems S.A | ELC Ultrasonic Scaler |
| 20 Aug 2014 | K140965 | MULTIPIEZO PRO, MULTIPIEZO | Mectron S.P.A. | ELC Ultrasonic Scaler |
| 15 May 2014 | K133752 | SONENDO OMNICLEAN ENDOTHERPAY SYSTEM CONSOLE, SONENDO OMNICLEAN MOLAR PROCEDURE KIT | Sonendo, Inc. | ELC Ultrasonic Scaler |
| 11 Mar 2014 | K132322 | NEWTRON P5 XS B.LED | Satelec - Acteon Group | ELC Ultrasonic Scaler |
| 10 Mar 2014 | K132267 | NEWTRON P5, NEWTRON P5 B.LED | Satelec - Acteon Group | ELC Ultrasonic Scaler |
| 22 Jan 2014 | K132609 | EDS ULTRASONIC TIPS | Essential Dental Systems, Inc. | ELC Ultrasonic Scaler |
| 16 Jan 2014 | K131151 | ENDOCENTER | Satelec - Acteon Group | ELC Ultrasonic Scaler |