510(k) K241127
K241127 is an FDA 510(k) premarket notification submitted by Cowellmedi Co., Ltd. for the device "INNO SLA Mini Plus® Implant System". The FDA issued a decision of Substantially Equivalent on December 27, 2024. The device falls under product code DZE (Implant, Endosseous, Root-Form), a Class II device regulated under 21 CFR 872.3640. Cowellmedi Co., Ltd. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 27, 2024
- Date Received
- April 23, 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