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FDA 510(k)

TiUltra Implants and Xeal Abutments

K-Number: K202344 · 2020-11-16

ApplicantNobel Biocare AB
Decision Date2020-11-16
Product CodeDZE
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

TiUltra Implants and Xeal Abutments 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 2020-11-16 under 510(k) number K202344. 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 TiUltra Implants and Xeal Abutments?

TiUltra Implants and Xeal Abutments is a medical device that received FDA 510(k) clearance on 2020-11-16. The listed applicant is Nobel Biocare AB. The 510(k) number is K202344.

When did TiUltra Implants and Xeal Abutments receive FDA 510(k) clearance?

TiUltra Implants and Xeal Abutments received FDA 510(k) clearance on 2020-11-16, under 510(k) number K202344.

Who is the listed applicant for TiUltra Implants and Xeal Abutments?

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 TiUltra Implants and Xeal Abutments?

The FDA product code for TiUltra Implants and Xeal Abutments is DZE.

Other records listing Nobel Biocare AB 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.

K253999Universal Base ASC Engaging; Universal Base ASC Non-Engaging; Universal Base MUA ASC; Temporary Abutment Engaging and Non-Engaging; Healing Abutment Conical Connection; Omnigrip Clinical Screw Titanium; Omnigrip Prosthetic ScrewK252197Nobel Biocare S Series ImplantsK243834NobelZygoma TiUltra Implant systemK240346NobelProcera Zirconia Implant BridgeK233208NobelProcera Titanium ASC Abutment, Omnigrip Clinical Screw TitaniumK231898DTX Studio Clinic (4.0)

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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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