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FDA 510(k)

Dentium Implantium & SuperLine Prosthetics

K-Number: K172640 · 2018-05-14

ApplicantDentium Co., Ltd.
Decision Date2018-05-14
Product CodeNHA
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

Dentium Implantium & SuperLine Prosthetics is a medical device manufactured by Dentium Co., Ltd.. It received FDA 510(k) clearance on 2018-05-14 under approval number K172640. 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 Dentium Implantium & SuperLine Prosthetics?

Dentium Implantium & SuperLine Prosthetics is a medical device that received FDA 510(k) clearance on 2018-05-14. It is manufactured by Dentium Co., Ltd.. The 510(k) number is K172640.

When was Dentium Implantium & SuperLine Prosthetics approved by the FDA?

Dentium Implantium & SuperLine Prosthetics received FDA 510(k) clearance on 2018-05-14, under approval number K172640.

What company makes Dentium Implantium & SuperLine Prosthetics?

Dentium Implantium & SuperLine Prosthetics is manufactured by Dentium Co., Ltd..

What is the FDA product code for Dentium Implantium & SuperLine Prosthetics?

The FDA product code for Dentium Implantium & SuperLine Prosthetics is NHA.

Other Devices by Dentium Co., Ltd.

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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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