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FDA 510(k)

Zeramex(R) XT Dental Implant System, NobelPearl Dental Implant System

K-Number: K180184 · 2018-11-16

ApplicantDentalpoint AG
Decision Date2018-11-16
Product CodeNHA
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

Zeramex(R) XT Dental Implant System, NobelPearl 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 2018-11-16 under 510(k) number K180184. The device is classified under product code NHA. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Zeramex(R) XT Dental Implant System, NobelPearl Dental Implant System?

Zeramex(R) XT Dental Implant System, NobelPearl Dental Implant System is a medical device that received FDA 510(k) clearance on 2018-11-16. The listed applicant is Dentalpoint AG. The 510(k) number is K180184.

When did Zeramex(R) XT Dental Implant System, NobelPearl Dental Implant System receive FDA 510(k) clearance?

Zeramex(R) XT Dental Implant System, NobelPearl Dental Implant System received FDA 510(k) clearance on 2018-11-16, under 510(k) number K180184.

Who is the listed applicant for Zeramex(R) XT Dental Implant System, NobelPearl 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(R) XT Dental Implant System, NobelPearl Dental Implant System?

The FDA product code for Zeramex(R) XT Dental Implant System, NobelPearl Dental Implant System is NHA.

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.

K163043Zeramex P6 Dental Implant SystemK152385Zeramex P6 Dental Implant System

Related Devices (Code: NHA)

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 ScrewNobel Biocare ABK261147Neodent Implant System - NeoConvert FitJJGC Indústria e Comércio de Materiais Dentários S.A.K261122MIST ICImagine Milling Technologies, LLCK260061BioHorizons CEREC Compatible Ti-BasesBioHorizons Implant Systems, Inc.K253922Neodent Scannable Healing AbutmentJJGC Indústria e Comércio de Materiais Dentários S.A.K254145Omni-Directional Multi-Unit Abutment System (Trade Name: Omnibut™)Smart Denture Conversions, LLC

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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