EK Implants and Abutments System
K-Number: K203360 · 2022-01-07
ApplicantHiossen, Inc.
Decision Date2022-01-07
Product CodeDZE
Advisory CommitteeDE
DecisionSubstantially Equivalent
Device Summary
EK Implants and Abutments System is a medical device manufactured by Hiossen, Inc.. It received FDA 510(k) clearance on 2022-01-07 under approval number K203360. 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 EK Implants and Abutments System?
EK Implants and Abutments System is a medical device that received FDA 510(k) clearance on 2022-01-07. It is manufactured by Hiossen, Inc.. The 510(k) number is K203360.
When was EK Implants and Abutments System approved by the FDA?
EK Implants and Abutments System received FDA 510(k) clearance on 2022-01-07, under approval number K203360.
What company makes EK Implants and Abutments System?
EK Implants and Abutments System is manufactured by Hiossen, Inc..
What is the FDA product code for EK Implants and Abutments System?
The FDA product code for EK Implants and Abutments System is DZE.
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Other Devices by Hiossen, Inc.
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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.