Dentium CAD/CAM Abutments
K-Number: K161713 · 2016-12-16
ApplicantDentium Co., Ltd.
Decision Date2016-12-16
Product CodeNHA
Advisory CommitteeDE
DecisionSubstantially Equivalent
Device Summary
Dentium CAD/CAM Abutments is a medical device manufactured by Dentium Co., Ltd.. It received FDA 510(k) clearance on 2016-12-16 under approval number K161713. 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 CAD/CAM Abutments?
Dentium CAD/CAM Abutments is a medical device that received FDA 510(k) clearance on 2016-12-16. It is manufactured by Dentium Co., Ltd.. The 510(k) number is K161713.
When was Dentium CAD/CAM Abutments approved by the FDA?
Dentium CAD/CAM Abutments received FDA 510(k) clearance on 2016-12-16, under approval number K161713.
What company makes Dentium CAD/CAM Abutments?
Dentium CAD/CAM Abutments is manufactured by Dentium Co., Ltd..
What is the FDA product code for Dentium CAD/CAM Abutments?
The FDA product code for Dentium CAD/CAM Abutments is NHA.
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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.