510(k) K251869
K251869 is an FDA 510(k) premarket notification submitted by Premium Plus (Dongguan) Limited for the device "Disposable Prophy Angle (3399-60, 3399-090, 3399-105)". The FDA issued a decision of Substantially Equivalent on September 15, 2025. The device falls under product code EGS (Handpiece, Contra- And Right-Angle Attachment, Dental), a Class I device regulated under 21 CFR 872.4200. Premium Plus (Dongguan) Limited has at least 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 15, 2025
- Date Received
- June 18, 2025
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Handpiece, Contra- And Right-Angle Attachment, Dental
- Device Class
- Class I
- Regulation Number
- 872.4200
- Review Panel
- DE
- Submission Type