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FDA 510(k)

Zeramex P6 Dental Implant System

K-Number: K163043 · 2016-11-30

ApplicantDentalpoint AG
Decision Date2016-11-30
Product CodeDZE
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

Zeramex P6 Dental Implant System is the device name listed in this FDA 510(k) record. The listed applicant is Dentalpoint AG. It received FDA 510(k) clearance on 2016-11-30 under 510(k) number K163043. 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 Zeramex P6 Dental Implant System?

Zeramex P6 Dental Implant System is a medical device that received FDA 510(k) clearance on 2016-11-30. The listed applicant is Dentalpoint AG. The 510(k) number is K163043.

When did Zeramex P6 Dental Implant System receive FDA 510(k) clearance?

Zeramex P6 Dental Implant System received FDA 510(k) clearance on 2016-11-30, under 510(k) number K163043.

Who is the listed applicant for Zeramex P6 Dental Implant System?

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

What is the FDA product code for Zeramex P6 Dental Implant System?

The FDA product code for Zeramex P6 Dental Implant System is DZE.

Other records listing Dentalpoint 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.

K180184Zeramex(R) XT Dental Implant System, NobelPearl Dental Implant SystemK152385Zeramex P6 Dental Implant System

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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