510(k) K182759
K182759 is an FDA 510(k) premarket notification submitted by Montjade Engineering Co., Ltd. for the device "BoniPlus Dental G-Mesh System". The FDA issued a decision of Substantially Equivalent on Jul 29, 2020. The device falls under product code JEY (Plate, Bone), a Class II device regulated under 21 CFR 872.4760.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Jul 29, 2020
- Date Received
- Sep 28, 2018
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Plate, Bone
- Device Class
- Class II
- Regulation Number
- 872.4760
- Review Panel
- DE
- Submission Type
- 510(k)