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FDA 510(k)

Implance Dental Implant System, Implance Dental Abutment System

K-Number: K160221 · 2016-09-12

ApplicantAgs Medikal Urunleri Ith. Ihr. Tic. Ltd. Sti.
Decision Date2016-09-12
Product CodeDZE
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

Implance Dental Implant System, Implance Dental Abutment System is the device name listed in this FDA 510(k) record. The listed applicant is Ags Medikal Urunleri Ith. Ihr. Tic. Ltd. Sti.. It received FDA 510(k) clearance on 2016-09-12 under 510(k) number K160221. 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 Implance Dental Implant System, Implance Dental Abutment System?

Implance Dental Implant System, Implance Dental Abutment System is a medical device that received FDA 510(k) clearance on 2016-09-12. The listed applicant is Ags Medikal Urunleri Ith. Ihr. Tic. Ltd. Sti.. The 510(k) number is K160221.

When did Implance Dental Implant System, Implance Dental Abutment System receive FDA 510(k) clearance?

Implance Dental Implant System, Implance Dental Abutment System received FDA 510(k) clearance on 2016-09-12, under 510(k) number K160221.

Who is the listed applicant for Implance Dental Implant System, Implance Dental Abutment System?

The FDA 510(k) record lists Ags Medikal Urunleri Ith. Ihr. Tic. Ltd. Sti. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Implance Dental Implant System, Implance Dental Abutment System?

The FDA product code for Implance Dental Implant System, Implance Dental Abutment System 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.

NCT05122897Investigation of Biofilm Formation on Temporary push-on Rings of Implant CrownsRECRUITINGNCT05883202Effect of the Abutment-Prosthesis Connection on Marginal Bone Loss and Gingival Sealing Around Dental ImplantsSUSPENDEDNCT07246499Multicentre Study on the Impact of Transmucosal Abutment Surface Characteristics on Peri-implant Tissues.COMPLETEDNCT07636265The Effect Of Photobiomodulation On Dental Implant SurvivalCOMPLETEDNCT07638969Occurrence of Peri-Implant Complications: A Multifactorial Cross-Sectional StudyRECRUITINGNCT07687615Cover Screw vs Healing Abutment on OsseointegrationCOMPLETED

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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