ELC
- Product code
- ELC
- Device name
- Scaler, Ultrasonic
- Device class
- Class 2
- 21 CFR
- 21 CFR 872.4850
- Medical specialty
- Dental
- Marketing pathway
- 510(K)
- Flag
- Third-party review eligible
- 510(k) clearances (last 3 years)
- 10
- Summaries archived here
- 8 (direct download)
- 510(k) clearances (all years, FDA)
- 195 (all years; only the last 3 years are listed here)
510(k) clearances, last 3 years (10)
| Number | Decision date | Applicant | Device name | Summary |
|---|---|---|---|---|
| K260773 | 2026-03-10 | Nakanishi, Inc. | Varios Combi Pro2 | |
| K253254 | 2026-01-28 | E.M.S Electro Medical Systems S.A | GBT Machine Airflow Prophylaxis Master | |
| K251689 | 2025-09-19 | Nakanishi, Inc. | VARIOS 170 LUX SCALER SYSTEM (VA170LUXS10); VARIOS 1… | |
| K242317 | 2025-02-13 | Denjoy Dental Co., Ltd. | Integrated Endo System (Meet Endo-II) | FDA |
| K233844 | 2024-08-08 | Odne AG | OdneClean | FDA |
| K240707 | 2024-07-02 | Shenzhen Micro Electric Intelligence C… | Ultrasonic Scaler (WD-JY-B002,WD-JY-W001,WD-JY-R003,… | |
| K240801 | 2024-07-01 | Dent4you AG | BioSonic US200 Ultrasonic Scaler (60034537) | |
| K233922 | 2024-03-11 | Satelec - Acteon Group | SP NEWTRON CAN-A; MODULE NEWTRON CAN-A EMB; SUPPORT … | |
| K223340 | 2023-12-11 | Essential Dental Systems, Inc. | EDS Calculus Softener TURBO CR | |
| K230641 | 2023-11-21 | Guilin Refine Medical Instrument Co., … | Ultrasonic Scaler Tips |
Official FDA classification page: ELC
Classification and pathway per current FDA publications. Data from openFDA (CC0).