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.. Device class: 2.
Clearance details
- Applicant
- BioHorizons Implant Systems, Inc.
- Product code
- Code DZE
- Device class
- Class 2
- Regulation
- 21 CFR 872.3640
- Advisory panel
- Dental
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Birmingham, AL, US
Recent devices under product code DZE
view allMore clearances from BioHorizons Implant Systems, Inc.
view allAdverse 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 →
Recalls naming K223697
K-number listed on FDA's recall recordMatched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K223697.
Data sourced from openFDA. This site is unofficial and independent of the FDA.