Promimic ZrP Surface Dental Implant; Promimic ZrP + HAnano Surface Dental Implant— 510(k) K252731

Substantially Equivalent

Promimic AB

FDA 510(k) clearance K252731 for Promimic ZrP Surface Dental Implant; Promimic ZrP + HAnano Surface Dental Implant, Substantially Equivalent on 2026-05-12. Applicant: Promimic AB.

Clearance details

Applicant: Promimic AB
Product code: Code DZE
Advisory panel: Dental
Date received: 2025-08-28
Decision date: 2026-05-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mölndal, SE

Download summary PDF View on FDA.gov ↗

Adverse events under product code DZE

product code DZE

Death: 28
Injury: 3,367,041
Malfunction: 19,958
Other: 13
Total: 3,387,040

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.