ELC · Scaler, Ultrasonic
Dental · 21 CFR 872.4850 · Class 2
Overview
| Product Code | ELC |
|---|---|
| Device Name | Scaler, Ultrasonic |
| Regulation | 21 CFR 872.4850 |
| Device Class | Class 2 |
| Review Panel | Dental |
| 3rd-Party Reviewable | Yes |
Identification
An ultrasonic scaler is a device intended for use during dental cleaning and periodontal (gum) therapy to remove calculus deposits from teeth by application of an ultrasonic vibrating scaler tip to the teeth.
Classification Rationale
Class II.
Recent Cleared Devices (20 of 195)
Showing 20 most recent of 195 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K260773 | Varios Combi Pro2 | Nakanishi, Inc. | Mar 10, 2026 | SESE |
| K253254 | GBT Machine Airflow Prophylaxis Master | E.M.S Electro Medical Systems S.A | Jan 28, 2026 | SESE |
| K251689 | VARIOS 170 LUX SCALER SYSTEM (VA170LUXS10); VARIOS 170 LUX SCALER SYSTEM (VA170LUXS11); VARIOS 170 SCALER SYSTEM (VA170S11) | Nakanishi, Inc. | Sep 19, 2025 | SESE |
| K242317 | Integrated Endo System (Meet Endo-II) | Denjoy Dental Co., Ltd. | Feb 13, 2025 | SESE |
| K233844 | OdneClean | Odne AG | Aug 8, 2024 | SESE |
| 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. | Jul 2, 2024 | SESE |
| K240801 | BioSonic US200 Ultrasonic Scaler (60034537) | Dent4you AG | Jul 1, 2024 | SESE |
| 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 | Mar 11, 2024 | SESE |
| K223340 | EDS Calculus Softener TURBO CR | Essential Dental Systems, Inc. | Dec 11, 2023 | SESE |
| K230641 | Ultrasonic Scaler Tips | Guilin Refine Medical Instrument Co., Ltd. | Nov 21, 2023 | SESE |
| K223173 | Proxeo ULTRA (PB-510, PB-520 and PB-530) | W&H Dentalwerk Buermoss GmbH | Jul 14, 2023 | SESE |
| K231391 | Combi Touch | Mectron S.P.A. | May 15, 2023 | SESE |
| K222096 | Endo Ultrasonic Activator | Foshan Coxo Medical Instrument Co., Ltd. | Mar 23, 2023 | SESE |
| K213947 | Ultrasonic Endo Activation Device (Model:Actor I pro) | Changzhou Bomedent Medical Technology Co.,Ltd | Sep 8, 2022 | SESE |
| K210832 | EVOCLEAN CLEANsert Ultrasonic Insert | Ttbio Corp. | Feb 2, 2022 | SESE |
| K203615 | Dental Scaler and Air Polisher | Guilin Woodpecker Medical Instrument Co., Ltd. | Dec 10, 2021 | SESE |
| K202906 | EndoPilot2 | Schlumbohm GmbH & Co. KG | Apr 13, 2021 | SESE |
| K203302 | GentleWave X | Sonendo, Inc. | Feb 5, 2021 | SESE |
| K201317 | TTBIO EVOCLEAN Ultrasonic Scaler | Ttbio Corp. | Dec 4, 2020 | SESE |
| K190124 | EMS AIRFLOW Prophylaxis Master, EMS AIRFLOW One | E.M.S Electro Medical Systems S.A | Oct 20, 2019 | SESE |
Top Applicants
- Dentsply Intl. — 12 clearances
- E.M.S Electro Medical Systems S.A — 10 clearances
- Sonendo, Inc. — 7 clearances
- Satelec - Acteon Group — 7 clearances
- Nakanishi, Inc. — 7 clearances
