K240950 is an FDA 510(k) clearance for the Disposable Prophy Angle. This device is classified as a Handpiece, Contra- And Right-angle Attachment, Dental (Class I - General Controls, product code EGS).
Submitted by Pacific Care Limited (N.T., HK). The FDA issued a Cleared decision on May 28, 2025, 415 days after receiving the submission on April 8, 2024.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.4200.
| 510(k) Number | K240950 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 08, 2024 |
| Decision Date | May 28, 2025 |
| Days to Decision | 415 days |
| Submission Type | Abbreviated |
| 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 |