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FDA 510(k)

Surgikor Fixation One, Abutment Blanks and Abutments

K-Number: K240803 · 2024-09-12

ApplicantSurgikor, LLC
Decision Date2024-09-12
Product CodeDZE
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

Surgikor Fixation One, Abutment Blanks and Abutments is the device name listed in this FDA 510(k) record. The listed applicant is Surgikor, LLC. It received FDA 510(k) clearance on 2024-09-12 under 510(k) number K240803. 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 Surgikor Fixation One, Abutment Blanks and Abutments?

Surgikor Fixation One, Abutment Blanks and Abutments is a medical device that received FDA 510(k) clearance on 2024-09-12. The listed applicant is Surgikor, LLC. The 510(k) number is K240803.

When did Surgikor Fixation One, Abutment Blanks and Abutments receive FDA 510(k) clearance?

Surgikor Fixation One, Abutment Blanks and Abutments received FDA 510(k) clearance on 2024-09-12, under 510(k) number K240803.

Who is the listed applicant for Surgikor Fixation One, Abutment Blanks and Abutments?

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

What is the FDA product code for Surgikor Fixation One, Abutment Blanks and Abutments?

The FDA product code for Surgikor Fixation One, Abutment Blanks and Abutments is DZE.

Other records listing Surgikor, LLC 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.

K182615Surgikor Dental Implant System

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

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

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