K260460
- 510(k) number
- K260460
- Device name
- Neodent Gold Hue Custom Abutments, Medentika Custom Abutments Gold Hue
- Applicant
- Institut Straumann AG CH
- Product code
- NHA — Abutment, Implant, Dental, Endosseous
- Decision date
- 2026-05-07
- Date received
- 2026-02-11
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Dental
510(k) Summary (official FDA PDF): K260460.pdf
Official FDA record: K260460
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.