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

FDA 510(k)

Dentis Dental Implant System

K-Number: K171027 · 2017-09-06

Decision Date2017-09-06
Product CodeDZE
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

Dentis Dental Implant System is a medical device manufactured by Dentis Co., Ltd.. It received FDA 510(k) clearance on 2017-09-06 under approval number K171027. 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 Dentis Dental Implant System?

Dentis Dental Implant System is a medical device that received FDA 510(k) clearance on 2017-09-06. It is manufactured by Dentis Co., Ltd.. The 510(k) number is K171027.

When was Dentis Dental Implant System approved by the FDA?

Dentis Dental Implant System received FDA 510(k) clearance on 2017-09-06, under approval number K171027.

What company makes Dentis Dental Implant System?

Dentis Dental Implant System is manufactured by Dentis Co., Ltd..

What is the FDA product code for Dentis Dental Implant System?

The FDA product code for Dentis Dental Implant System is DZE.

Related Clinical Trials

Related PubMed Literature

Other Devices by Dentis Co., Ltd.

View all 31 devices →

Related Devices (Code: DZE)

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.