510(k) K213677
K213677 is an FDA 510(k) premarket notification submitted by Zentek Medical, LLC for the device "Bonafix 2 Plus". The FDA issued a decision of Substantially Equivalent on Dec 20, 2022. The device falls under product code DZE (Implant, Endosseous, Root-Form), a Class II device regulated under 21 CFR 872.3640. Zentek Medical, LLC has at least 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Dec 20, 2022
- Date Received
- Nov 22, 2021
- 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