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FDA 510(k)

N1 TiUltra TCC Implant System

K-Number: K211109 · 2021-12-21

ApplicantNobel Biocare Services AG
Decision Date2021-12-21
Product CodeDZE
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

N1 TiUltra TCC Implant System is the device name listed in this FDA 510(k) record. The listed applicant is Nobel Biocare Services AG. It received FDA 510(k) clearance on 2021-12-21 under 510(k) number K211109. 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 N1 TiUltra TCC Implant System?

N1 TiUltra TCC Implant System is a medical device that received FDA 510(k) clearance on 2021-12-21. The listed applicant is Nobel Biocare Services AG. The 510(k) number is K211109.

When did N1 TiUltra TCC Implant System receive FDA 510(k) clearance?

N1 TiUltra TCC Implant System received FDA 510(k) clearance on 2021-12-21, under 510(k) number K211109.

Who is the listed applicant for N1 TiUltra TCC Implant System?

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

What is the FDA product code for N1 TiUltra TCC Implant System?

The FDA product code for N1 TiUltra TCC Implant System is DZE.

Other records listing Nobel Biocare Services AG 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.

K231219NobelZygoma PureSet™ TrayK220339Esthetic Abutments Nobel Biocare N1K220048NobelProcera Zirconia N1 BaseK212932Nobel Biocare NobelSpeedy Groovy / Branemark System Mk III TiUnite / Replace Select TC PureSet Tray

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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