K251869
- 510(k) number
- K251869
- Device name
- Disposable Prophy Angle (3399-60, 3399-090, 3399-105)
- Applicant
- Premium Plus (Dongguan) Limited CN
- Product code
- EGS — Handpiece, Contra- And Right-Angle Attachment, Denta
- Decision date
- 2025-09-15
- Date received
- 2025-06-18
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Dental
510(k) Summary (official FDA PDF): K251869.pdf
Official FDA record: K251869
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.