Browse hierarchy: [Dental (DE)](/submissions/DE) → [Subpart E — Surgical Devices](/submissions/DE/subpart-e%E2%80%94surgical-devices) → [21 CFR 872.4850](/submissions/DE/subpart-e%E2%80%94surgical-devices/872.4850) → ELC — Scaler, Ultrasonic # ELC · Scaler, Ultrasonic _Dental · 21 CFR 872.4850 · Class 2_ **Canonical URL:** https://fda.innolitics.com/submissions/DE/subpart-e%E2%80%94surgical-devices/ELC ## Overview - **Product Code:** ELC - **Device Name:** Scaler, Ultrasonic - **Regulation:** [21 CFR 872.4850](/submissions/DE/subpart-e%E2%80%94surgical-devices/872.4850) - **Device Class:** 2 - **Review Panel:** [Dental](/submissions/DE) - **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](https://fda.innolitics.com/submissions/DE/subpart-e%E2%80%94surgical-devices/ELC/K260773.md) | Varios Combi Pro2 | Nakanishi, Inc. | Mar 10, 2026 | SESE | | [K253254](https://fda.innolitics.com/submissions/DE/subpart-e%E2%80%94surgical-devices/ELC/K253254.md) | GBT Machine Airflow Prophylaxis Master | E.M.S Electro Medical Systems S.A | Jan 28, 2026 | SESE | | [K251689](https://fda.innolitics.com/submissions/DE/subpart-e%E2%80%94surgical-devices/ELC/K251689.md) | VARIOS 170 LUX SCALER SYSTEM (VA170LUXS10); VARIOS 170 LUX SCALER SYSTEM (VA170LUXS11); VARIOS 170 SCALER SYSTEM (VA170S11) | Nakanishi, Inc. | Sep 19, 2025 | SESE | | [K242317](https://fda.innolitics.com/submissions/DE/subpart-e%E2%80%94surgical-devices/ELC/K242317.md) | Integrated Endo System (Meet Endo-II) | Denjoy Dental Co., Ltd. | Feb 13, 2025 | SESE | | [K233844](https://fda.innolitics.com/submissions/DE/subpart-e%E2%80%94surgical-devices/ELC/K233844.md) | OdneClean | Odne AG | Aug 8, 2024 | SESE | | [K240707](https://fda.innolitics.com/submissions/DE/subpart-e%E2%80%94surgical-devices/ELC/K240707.md) | 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](https://fda.innolitics.com/submissions/DE/subpart-e%E2%80%94surgical-devices/ELC/K240801.md) | BioSonic US200 Ultrasonic Scaler (60034537) | Dent4you AG | Jul 1, 2024 | SESE | | [K233922](https://fda.innolitics.com/submissions/DE/subpart-e%E2%80%94surgical-devices/ELC/K233922.md) | 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](https://fda.innolitics.com/submissions/DE/subpart-e%E2%80%94surgical-devices/ELC/K223340.md) | EDS Calculus Softener TURBO CR | Essential Dental Systems, Inc. | Dec 11, 2023 | SESE | | [K230641](https://fda.innolitics.com/submissions/DE/subpart-e%E2%80%94surgical-devices/ELC/K230641.md) | Ultrasonic Scaler Tips | Guilin Refine Medical Instrument Co., Ltd. | Nov 21, 2023 | SESE | | [K223173](https://fda.innolitics.com/submissions/DE/subpart-e%E2%80%94surgical-devices/ELC/K223173.md) | Proxeo ULTRA (PB-510, PB-520 and PB-530) | W&H Dentalwerk Buermoss GmbH | Jul 14, 2023 | SESE | | [K231391](https://fda.innolitics.com/submissions/DE/subpart-e%E2%80%94surgical-devices/ELC/K231391.md) | Combi Touch | Mectron S.P.A. | May 15, 2023 | SESE | | [K222096](https://fda.innolitics.com/submissions/DE/subpart-e%E2%80%94surgical-devices/ELC/K222096.md) | Endo Ultrasonic Activator | Foshan Coxo Medical Instrument Co., Ltd. | Mar 23, 2023 | SESE | | [K213947](https://fda.innolitics.com/submissions/DE/subpart-e%E2%80%94surgical-devices/ELC/K213947.md) | Ultrasonic Endo Activation Device (Model:Actor I pro) | Changzhou Bomedent Medical Technology Co.,Ltd | Sep 8, 2022 | SESE | | [K210832](https://fda.innolitics.com/submissions/DE/subpart-e%E2%80%94surgical-devices/ELC/K210832.md) | EVOCLEAN CLEANsert Ultrasonic Insert | Ttbio Corp. | Feb 2, 2022 | SESE | | [K203615](https://fda.innolitics.com/submissions/DE/subpart-e%E2%80%94surgical-devices/ELC/K203615.md) | Dental Scaler and Air Polisher | Guilin Woodpecker Medical Instrument Co., Ltd. | Dec 10, 2021 | SESE | | [K202906](https://fda.innolitics.com/submissions/DE/subpart-e%E2%80%94surgical-devices/ELC/K202906.md) | EndoPilot2 | Schlumbohm GmbH & Co. KG | Apr 13, 2021 | SESE | | [K203302](https://fda.innolitics.com/submissions/DE/subpart-e%E2%80%94surgical-devices/ELC/K203302.md) | GentleWave X | Sonendo, Inc. | Feb 5, 2021 | SESE | | [K201317](https://fda.innolitics.com/submissions/DE/subpart-e%E2%80%94surgical-devices/ELC/K201317.md) | TTBIO EVOCLEAN Ultrasonic Scaler | Ttbio Corp. | Dec 4, 2020 | SESE | | [K190124](https://fda.innolitics.com/submissions/DE/subpart-e%E2%80%94surgical-devices/ELC/K190124.md) | 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 - Bonart Co., Ltd. — 7 clearances - Litton Dental Products — 7 clearances - Nakanishi, Inc. — 7 clearances --- **Source:** [https://fda.innolitics.com/submissions/DE/subpart-e%E2%80%94surgical-devices/ELC](https://fda.innolitics.com/submissions/DE/subpart-e%E2%80%94surgical-devices/ELC) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. 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