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FDA 510(k)

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

K-Number: K252731 · 2026-05-12

ApplicantPromimic AB
Decision Date2026-05-12
Product CodeDZE
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

Promimic ZrP Surface Dental Implant; Promimic ZrP + HAnano Surface Dental Implant is a medical device manufactured by Promimic AB. It received FDA 510(k) clearance on 2026-05-12 under approval number K252731. The device is classified under product code DZE. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Promimic ZrP Surface Dental Implant; Promimic ZrP + HAnano Surface Dental Implant?

Promimic ZrP Surface Dental Implant; Promimic ZrP + HAnano Surface Dental Implant is a medical device that received FDA 510(k) clearance on 2026-05-12. It is manufactured by Promimic AB. The 510(k) number is K252731.

When was Promimic ZrP Surface Dental Implant; Promimic ZrP + HAnano Surface Dental Implant approved by the FDA?

Promimic ZrP Surface Dental Implant; Promimic ZrP + HAnano Surface Dental Implant received FDA 510(k) clearance on 2026-05-12, under approval number K252731.

What company makes Promimic ZrP Surface Dental Implant; Promimic ZrP + HAnano Surface Dental Implant?

Promimic ZrP Surface Dental Implant; Promimic ZrP + HAnano Surface Dental Implant is manufactured by Promimic AB.

What is the FDA product code for Promimic ZrP Surface Dental Implant; Promimic ZrP + HAnano Surface Dental Implant?

The FDA product code for Promimic ZrP Surface Dental Implant; Promimic ZrP + HAnano Surface Dental Implant is DZE.

Related PubMed Literature

PMID: 42181028 Systematic biocompatibility assessment of 4-µm surface silicone implants. Biomaterials and biosystems (2026)

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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