Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

Nucleoss Tpure Implant System

K-Number: K160850 · 2017-08-04

ApplicantSanlilar Tibbi Cihazlar Med. Kim.San.Tic.Ltd.Sti
Decision Date2017-08-04
Product CodeDZE
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

Nucleoss Tpure Implant System is the device name listed in this FDA 510(k) record. The listed applicant is Sanlilar Tibbi Cihazlar Med. Kim.San.Tic.Ltd.Sti. It received FDA 510(k) clearance on 2017-08-04 under 510(k) number K160850. 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 Nucleoss Tpure Implant System?

Nucleoss Tpure Implant System is a medical device that received FDA 510(k) clearance on 2017-08-04. The listed applicant is Sanlilar Tibbi Cihazlar Med. Kim.San.Tic.Ltd.Sti. The 510(k) number is K160850.

When did Nucleoss Tpure Implant System receive FDA 510(k) clearance?

Nucleoss Tpure Implant System received FDA 510(k) clearance on 2017-08-04, under 510(k) number K160850.

Who is the listed applicant for Nucleoss Tpure Implant System?

The FDA 510(k) record lists Sanlilar Tibbi Cihazlar Med. Kim.San.Tic.Ltd.Sti as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Nucleoss Tpure Implant System?

The FDA product code for Nucleoss Tpure Implant System is DZE.

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.

↑