Promimic ZrP Surface Dental Implant; Promimic ZrP + HAnano Surface Dental Implant— 510(k) K252731
Substantially EquivalentPromimic 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. Device class: 2.
Summary
Promimic's record covers two dental implants, the Promimic ZrP Surface Dental Implant and the Promimic ZrP + HAnano Surface Dental Implant. The product code is DZE, root-form endosseous implants.
Class II, 21 CFR 872.3640. Dental is both the classification panel and the review panel, and it was a Traditional 510(k).
Promimic filed from Mölndal, Sweden. The decision came 257 calendar days after receipt (August 28, 2025 to May 12, 2026).
Clearance details
- Applicant
- Promimic AB
- Product code
- Product code DZE
- Device class
- Class 2
- Regulation
- 21 CFR 872.3640
- Advisory panel
- Dental
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Mölndal, SE
Recent devices under product code DZE
view allMore clearances from Promimic AB
view allAdverse 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, through . 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.