Scan Abutments and Comfort Caps
K-Number: K191634 · 2019-11-04
ApplicantDentium Co., Ltd.
Decision Date2019-11-04
Product CodeNHA
Advisory CommitteeDE
DecisionSubstantially Equivalent
Device Summary
Scan Abutments and Comfort Caps is a medical device manufactured by Dentium Co., Ltd.. It received FDA 510(k) clearance on 2019-11-04 under approval number K191634. 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 Scan Abutments and Comfort Caps?
Scan Abutments and Comfort Caps is a medical device that received FDA 510(k) clearance on 2019-11-04. It is manufactured by Dentium Co., Ltd.. The 510(k) number is K191634.
When was Scan Abutments and Comfort Caps approved by the FDA?
Scan Abutments and Comfort Caps received FDA 510(k) clearance on 2019-11-04, under approval number K191634.
What company makes Scan Abutments and Comfort Caps?
Scan Abutments and Comfort Caps is manufactured by Dentium Co., Ltd..
What is the FDA product code for Scan Abutments and Comfort Caps?
The FDA product code for Scan Abutments and Comfort Caps 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.