K252731

Promimic ZrP Surface Dental Implant; Promimic ZrP + HAnano Surface Dental Implant

510(k) number
K252731
Device name
Promimic ZrP Surface Dental Implant; Promimic ZrP + HAnano Surface Dental Implant
Applicant
Promimic AB SE
Product code
DZE — Implant, Endosseous, Root-Form
Decision date
2026-05-12
Date received
2025-08-28
Decision
Substantially Equivalent
Clearance type
Traditional
Advisory committee
Dental
510(k) Summary (official FDA PDF): K252731.pdf
Official FDA record: K252731
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.