ELC — Scaler, Ultrasonic Class II
FDA product code ELC covers "Scaler, Ultrasonic", a Class II medical device regulated under 21 CFR 872.4850. Submissions are reviewed by the Dental panel. At least 20 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- ELC
- Device Class
- Class II
- Regulation Number
- 872.4850
- Submission Type
- Review Panel
- DE
- Medical Specialty
- Dental
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K260773 | nakanishi | Varios Combi Pro2 | March 10, 2026 |
| K253254 | e.m.s electro medical systems | GBT Machine Airflow Prophylaxis Master | January 28, 2026 |
| K251689 | nakanishi | VARIOS 170 LUX SCALER SYSTEM (VA170LUXS10); VARIOS 170 LUX SCALER SYSTEM (VA170L | September 19, 2025 |
| K242317 | denjoy dental co | Integrated Endo System (Meet Endo-II) | February 13, 2025 |
| K233844 | odne | OdneClean | August 8, 2024 |
| K240707 | shenzhen micro electric intelligence co | Ultrasonic Scaler (WD-JY-B002,WD-JY-W001,WD-JY-R003,WD-JY-G004,WD-JY-B003,WD-JY- | July 2, 2024 |
| K240801 | dent4you | BioSonic US200 Ultrasonic Scaler (60034537) | July 1, 2024 |
| K233922 | satelec - acteon group | SP NEWTRON CAN-A; MODULE NEWTRON CAN-A EMB; SUPPORT XINETIC; NWT CAN SLIM LED CO | March 11, 2024 |
| K223340 | essential dental systems | EDS Calculus Softener TURBO CR | December 11, 2023 |
| K230641 | guilin refine medical instrument co | Ultrasonic Scaler Tips | November 21, 2023 |
| K223173 | w and h dentalwerk buermoss | Proxeo ULTRA (PB-510, PB-520 and PB-530) | July 14, 2023 |
| K231391 | mectron | Combi Touch | May 15, 2023 |
| K222096 | foshan coxo medical instrument co | Endo Ultrasonic Activator | March 23, 2023 |
| K213947 | changzhou bomedent medical technology co | Ultrasonic Endo Activation Device (Model:Actor I pro) | September 8, 2022 |
| K210832 | ttbio | EVOCLEAN CLEANsert Ultrasonic Insert | February 2, 2022 |
| K203615 | guilin woodpecker medical instrument co | Dental Scaler and Air Polisher | December 10, 2021 |
| K202906 | schlumbohm gmbh and co. kg | EndoPilot2 | April 13, 2021 |
| K203302 | sonendo | GentleWave X | February 5, 2021 |
| K201317 | ttbio | TTBIO EVOCLEAN Ultrasonic Scaler | December 4, 2020 |
| K190124 | e.m.s electro medical systems | EMS AIRFLOW Prophylaxis Master, EMS AIRFLOW One | October 20, 2019 |