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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 the device name listed in this FDA 510(k) record. The listed applicant is Promimic AB. It received FDA 510(k) clearance on 2026-05-12 under 510(k) 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. The listed applicant is Promimic AB. The 510(k) number is K252731.

When did Promimic ZrP Surface Dental Implant; Promimic ZrP + HAnano Surface Dental Implant receive FDA 510(k) clearance?

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

Who is the listed applicant for Promimic ZrP Surface Dental Implant; Promimic ZrP + HAnano Surface Dental Implant?

The FDA 510(k) record lists Promimic AB as the applicant. This does not by itself establish the device manufacturer.

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 Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT06086873Investigating Implant Surface Effect on Osseointegration: NGA vs. ModSLARECRUITINGNCT06849856Evaluation of the Efficacy of Different Non-Surgical Peri-implantitis Treatment ApproachesCOMPLETEDNCT07212855Use of Glycine Powder and an Angled Implant Brush in Oral Hygiene Procedures in Patients Rehabilitated With Columbus Bridge ProtocolCOMPLETEDNCT07246499Multicentre Study on the Impact of Transmucosal Abutment Surface Characteristics on Peri-implant Tissues.COMPLETEDNCT07529444Microbiological Evaluation of the Effectiveness of Different Surface Decontamination Protocols for Dental ImplantsRECRUITINGNCT07636265The Effect Of Photobiomodulation On Dental Implant SurvivalCOMPLETED

Related Devices (Code: DZE)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K251188UNIQA® Dental Implants SystemUniqa Dental, Ltd.K251232MegaGen Zygoma Dental Implant SystemMegagen Implant Co., Ltd.K250806Dental Implant SystemA.B. Dental Devices , Ltd.K260006INOSS SystemInosys, Inc.K252031Adin Long Dental Implant SystemAdin Dental Implant Systems , Ltd.K253334ZENEX Implant System_Short (R-System)Izenimplant Co., Ltd.

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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