EK Digital Abutments
K-Number: K233389 · 2024-05-29
ApplicantHiossen, Inc.
Decision Date2024-05-29
Product CodeNHA
Advisory CommitteeDE
DecisionSubstantially Equivalent
Device Summary
EK Digital Abutments is a medical device manufactured by Hiossen, Inc.. It received FDA 510(k) clearance on 2024-05-29 under approval number K233389. 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 EK Digital Abutments?
EK Digital Abutments is a medical device that received FDA 510(k) clearance on 2024-05-29. It is manufactured by Hiossen, Inc.. The 510(k) number is K233389.
When was EK Digital Abutments approved by the FDA?
EK Digital Abutments received FDA 510(k) clearance on 2024-05-29, under approval number K233389.
What company makes EK Digital Abutments?
EK Digital Abutments is manufactured by Hiossen, Inc..
What is the FDA product code for EK Digital Abutments?
The FDA product code for EK Digital 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.