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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 a medical device manufactured by Surgikor, LLC. It received FDA 510(k) clearance on 2024-09-12 under approval 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. It is manufactured by Surgikor, LLC. The 510(k) number is K240803.

When was Surgikor Fixation One, Abutment Blanks and Abutments approved by the FDA?

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

What company makes Surgikor Fixation One, Abutment Blanks and Abutments?

Surgikor Fixation One, Abutment Blanks and Abutments is manufactured by Surgikor, LLC.

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.

Related Clinical Trials

NCT07246499 Multicentre Study on the Impact of Transmucosal Abutment Surface Characteristics on Peri-implant Tissues. ACTIVE_NOT_RECRUITING NCT05883202 Effect of the Abutment-Prosthesis Connection on Marginal Bone Loss and Gingival Sealing Around Dental Implants SUSPENDED

Other Devices by Surgikor, LLC

K182615Surgikor Dental Implant System

Related Devices (Code: DZE)

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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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