Implantium II
K-Number: K171126 · 2017-09-07
ApplicantDentium Co., Ltd.
Decision Date2017-09-07
Product CodeDZE
Advisory CommitteeDE
DecisionSubstantially Equivalent
Device Summary
Implantium II is a medical device manufactured by Dentium Co., Ltd.. It received FDA 510(k) clearance on 2017-09-07 under approval number K171126. 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 Implantium II?
Implantium II is a medical device that received FDA 510(k) clearance on 2017-09-07. It is manufactured by Dentium Co., Ltd.. The 510(k) number is K171126.
When was Implantium II approved by the FDA?
Implantium II received FDA 510(k) clearance on 2017-09-07, under approval number K171126.
What company makes Implantium II?
Implantium II is manufactured by Dentium Co., Ltd..
What is the FDA product code for Implantium II?
The FDA product code for Implantium II is DZE.
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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.