K242317
- 510(k) number
- K242317
- Device name
- Integrated Endo System (Meet Endo-II)
- Applicant
- Denjoy Dental Co., Ltd. CN
- Product code
- ELC — Scaler, Ultrasonic
- Decision date
- 2025-02-13
- Date received
- 2024-08-05
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Dental
510(k) Summary (official FDA PDF): K242317.pdf
Official FDA record: K242317
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.