K251294
- 510(k) number
- K251294
- Device name
- Bonafix Implant Abutments
- Applicant
- Zentek Medical, LLC NJ · US
- Product code
- NHA — Abutment, Implant, Dental, Endosseous
- Decision date
- 2025-10-15
- Date received
- 2025-04-25
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Dental
510(k) Summary (official FDA PDF): K251294.pdf
Official FDA record: K251294
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.