K251869 is an FDA 510(k) clearance for the Disposable Prophy Angle (3399-60, 3399-090, 3399-105). This device is classified as a Handpiece, Contra- And Right-angle Attachment, Dental (Class I - General Controls, product code EGS).
Submitted by Premium Plus (Dongguan) Limited (Dongguan, CN). The FDA issued a Cleared decision on September 15, 2025, 89 days after receiving the submission on June 18, 2025.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.4200.
| 510(k) Number | K251869 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 18, 2025 |
| Decision Date | September 15, 2025 |
| Days to Decision | 89 days |
| Submission Type | Traditional |
| Review Panel | Dental (DE) |
| Summary | Summary PDF |
| Product Code | EGS - Handpiece, Contra- And Right-angle Attachment, Dental |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 872.4200 |