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FDA 510(k)

NobelZygoma TiUltra Implant system

K-Number: K243834 · 2025-08-25

ApplicantNobel Biocare AB
Decision Date2025-08-25
Product CodeDZE
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

NobelZygoma TiUltra Implant system is the device name listed in this FDA 510(k) record. The listed applicant is Nobel Biocare AB. It received FDA 510(k) clearance on 2025-08-25 under 510(k) number K243834. 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 NobelZygoma TiUltra Implant system?

NobelZygoma TiUltra Implant system is a medical device that received FDA 510(k) clearance on 2025-08-25. The listed applicant is Nobel Biocare AB. The 510(k) number is K243834.

When did NobelZygoma TiUltra Implant system receive FDA 510(k) clearance?

NobelZygoma TiUltra Implant system received FDA 510(k) clearance on 2025-08-25, under 510(k) number K243834.

Who is the listed applicant for NobelZygoma TiUltra Implant system?

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

What is the FDA product code for NobelZygoma TiUltra Implant system?

The FDA product code for NobelZygoma TiUltra Implant system is DZE.

Other records listing Nobel Biocare AB as applicant

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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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