K223697
- 510(k) number
- K223697
- Device name
- MRI compatibility for existing BioHorizons dental implants and abutments
- Applicant
- BioHorizons Implant Systems, Inc. AL · US
- Product code
- DZE — Implant, Endosseous, Root-Form
- Decision date
- 2023-10-13
- Date received
- 2022-12-09
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Dental
This submission filed a 510(k) Statement rather than a Summary; no public summary is available from FDA.
Official FDA record: K223697
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.