510(k) K252585
K252585 is an FDA 510(k) premarket notification submitted by Izenimplant Co., Ltd. for the device "ZENEX Implant System_R-System". The FDA issued a decision of Substantially Equivalent on January 8, 2026. The device falls under product code DZE (Implant, Endosseous, Root-Form), a Class II device regulated under 21 CFR 872.3640. Izenimplant Co., Ltd. has at least 7 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 8, 2026
- Date Received
- August 15, 2025
- 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