K240531
- 510(k) number
- K240531
- Device name
- SmartShape Healing Abutment; Wide Custom Milled Ti-Blank Abutment
- Applicant
- BioHorizons Implant Systems, Inc. AL · US
- Product code
- NHA — Abutment, Implant, Dental, Endosseous
- Decision date
- 2024-07-30
- Date received
- 2024-02-23
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Dental
510(k) Summary (official FDA PDF): K240531.pdf
Official FDA record: K240531
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.