ELC — Scaler, Ultrasonic Class II
FDA Device Classification
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 |