K242064
- 510(k) number
- K242064
- Device name
- Omni-Directional Multi-unit Abutment System (Trade Name: Omnibut)
- Applicant
- Smart Denture Conversions, LLC NC · US
- Product code
- NHA — Abutment, Implant, Dental, Endosseous
- Decision date
- 2025-01-17
- Date received
- 2024-07-15
- Decision
- Substantially Equivalent
- Clearance type
- Abbreviated
- Advisory committee
- Dental
510(k) Summary (official FDA PDF): K242064.pdf
Official FDA record: K242064
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.