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FDA 510(k)

INNO SLA Mini Plus® Implant System

K-Number: K241127 · 2024-12-27

ApplicantCowellmedi Co., Ltd.
Decision Date2024-12-27
Product CodeDZE
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

INNO SLA Mini Plus® Implant System is the device name listed in this FDA 510(k) record. The listed applicant is Cowellmedi Co., Ltd.. It received FDA 510(k) clearance on 2024-12-27 under 510(k) number K241127. 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 INNO SLA Mini Plus® Implant System?

INNO SLA Mini Plus® Implant System is a medical device that received FDA 510(k) clearance on 2024-12-27. The listed applicant is Cowellmedi Co., Ltd.. The 510(k) number is K241127.

When did INNO SLA Mini Plus® Implant System receive FDA 510(k) clearance?

INNO SLA Mini Plus® Implant System received FDA 510(k) clearance on 2024-12-27, under 510(k) number K241127.

Who is the listed applicant for INNO SLA Mini Plus® Implant System?

The FDA 510(k) record lists Cowellmedi Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for INNO SLA Mini Plus® Implant System?

The FDA product code for INNO SLA Mini Plus® Implant System 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.

NCT07744776Effect of Implant Macro-Design and Surface Treatment on Insertion Torque and Early Implant Stability Quotient (ISQ)RECRUITING

Other records listing Cowellmedi Co., Ltd. as applicant

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.

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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.K252731Promimic ZrP Surface Dental Implant; Promimic ZrP + HAnano Surface Dental ImplantPromimic ABK252031Adin Long Dental Implant SystemAdin Dental Implant Systems , 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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