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FDA 510(k)

MOR 3.0mm and PUR NP 3.2mm Implant Systems, MOR 2.1x18mm and 2.4x18mm

K-Number: K171728 · 2017-09-28

ApplicantSterngold Dental, LLC
Decision Date2017-09-28
Product CodeDZE
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

MOR 3.0mm and PUR NP 3.2mm Implant Systems, MOR 2.1x18mm and 2.4x18mm is the device name listed in this FDA 510(k) record. The listed applicant is Sterngold Dental, LLC. It received FDA 510(k) clearance on 2017-09-28 under 510(k) number K171728. 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 MOR 3.0mm and PUR NP 3.2mm Implant Systems, MOR 2.1x18mm and 2.4x18mm?

MOR 3.0mm and PUR NP 3.2mm Implant Systems, MOR 2.1x18mm and 2.4x18mm is a medical device that received FDA 510(k) clearance on 2017-09-28. The listed applicant is Sterngold Dental, LLC. The 510(k) number is K171728.

When did MOR 3.0mm and PUR NP 3.2mm Implant Systems, MOR 2.1x18mm and 2.4x18mm receive FDA 510(k) clearance?

MOR 3.0mm and PUR NP 3.2mm Implant Systems, MOR 2.1x18mm and 2.4x18mm received FDA 510(k) clearance on 2017-09-28, under 510(k) number K171728.

Who is the listed applicant for MOR 3.0mm and PUR NP 3.2mm Implant Systems, MOR 2.1x18mm and 2.4x18mm?

The FDA 510(k) record lists Sterngold Dental, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MOR 3.0mm and PUR NP 3.2mm Implant Systems, MOR 2.1x18mm and 2.4x18mm?

The FDA product code for MOR 3.0mm and PUR NP 3.2mm Implant Systems, MOR 2.1x18mm and 2.4x18mm is DZE.

Other records listing Sterngold Dental, LLC 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.

K153173MOR 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

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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