510(k) K240950
K240950 is an FDA 510(k) premarket notification submitted by Pacific Care Limited for the device "Disposable Prophy Angle". The FDA issued a decision of Substantially Equivalent on May 28, 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.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 28, 2025
- Date Received
- April 8, 2024
- Clearance Type
- Abbreviated
- 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