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FDA 510(k)

Nobel Biocare S Series Implants

K-Number: K252197 · 2026-02-18

ApplicantNobel Biocare AB
Decision Date2026-02-18
Product CodeDZE
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

Nobel Biocare S Series Implants 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 2026-02-18 under 510(k) number K252197. 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 Nobel Biocare S Series Implants?

Nobel Biocare S Series Implants is a medical device that received FDA 510(k) clearance on 2026-02-18. The listed applicant is Nobel Biocare AB. The 510(k) number is K252197.

When did Nobel Biocare S Series Implants receive FDA 510(k) clearance?

Nobel Biocare S Series Implants received FDA 510(k) clearance on 2026-02-18, under 510(k) number K252197.

Who is the listed applicant for Nobel Biocare S Series Implants?

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 Nobel Biocare S Series Implants?

The FDA product code for Nobel Biocare S Series Implants is DZE.

Related Clinical Trials

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.

NCT06086873Investigating Implant Surface Effect on Osseointegration: NGA vs. ModSLARECRUITING

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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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