510(k) K223697
K223697 is an FDA 510(k) premarket notification submitted by BioHorizons Implant Systems, Inc. for the device "MRI compatibility for existing BioHorizons dental implants and abutments". The FDA issued a decision of Substantially Equivalent on October 13, 2023. The device falls under product code DZE (Implant, Endosseous, Root-Form), a Class II device regulated under 21 CFR 872.3640. BioHorizons Implant Systems, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 13, 2023
- Date Received
- December 9, 2022
- 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