MRI compatibility for existing BioHorizons dental implants and abutments— 510(k) K223697
Substantially EquivalentBioHorizons Implant Systems, Inc.
FDA 510(k) clearance K223697 for MRI compatibility for existing BioHorizons dental implants and abutments, Substantially Equivalent on 2023-10-13. Applicant: BioHorizons Implant Systems, Inc..
Clearance details
- Applicant
- BioHorizons Implant Systems, Inc.
- Product code
- Code DZE
- Advisory panel
- Dental
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Birmingham, AL, US
Adverse events under product code DZE
product code DZE- Death
- 28
- Injury
- 3,367,041
- Malfunction
- 19,958
- Other
- 13
- Total
- 3,387,040
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.