510(k) K201621
K201621 is an FDA 510(k) premarket notification submitted by Innobiosurg Co., Ltd. for the device "Magicore II System". The FDA issued a decision of Substantially Equivalent on Jul 15, 2020. The device falls under product code NHA (Abutment, Implant, Dental, Endosseous), a Class II device regulated under 21 CFR 872.3630. Innobiosurg Co., Ltd. has 14 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Jul 15, 2020
- Date Received
- Jun 15, 2020
- Clearance Type
- Special
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Abutment, Implant, Dental, Endosseous
- Device Class
- Class II
- Regulation Number
- 872.3630
- Review Panel
- DE
- Submission Type
- 510(k)
To be used in conjunction with an endosseous dental implant fixture to aid in prosthetic rehabilitation.