510(k) K233808
K233808 is an FDA 510(k) premarket notification submitted by Ossvis Co., Ltd. for the device "LW Narrow Implant System". The FDA issued a decision of Substantially Equivalent on July 31, 2024. The device falls under product code DZE (Implant, Endosseous, Root-Form), a Class II device regulated under 21 CFR 872.3640. Ossvis Co., Ltd. has at least 6 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 31, 2024
- Date Received
- November 30, 2023
- 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