510(k) K243731
K243731 is an FDA 510(k) premarket notification submitted by P&A USA for the device "HEXIM Implant; Samwon General Abutments". The FDA issued a decision of Substantially Equivalent on July 9, 2025. The device falls under product code DZE (Implant, Endosseous, Root-Form), a Class II device regulated under 21 CFR 872.3640.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 9, 2025
- Date Received
- December 4, 2024
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Implant, Endosseous, Root-Form
- Device Class
- Class II
- Regulation Number
- 872.3640
- Review Panel
- DE
- Submission Type