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FDA 510(k)

ET Abutment System

K-Number: K222636 · 2023-04-28

ApplicantHiossen, Inc.
Decision Date2023-04-28
Product CodeNHA
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

ET Abutment System is a medical device manufactured by Hiossen, Inc.. It received FDA 510(k) clearance on 2023-04-28 under approval number K222636. 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 ET Abutment System?

ET Abutment System is a medical device that received FDA 510(k) clearance on 2023-04-28. It is manufactured by Hiossen, Inc.. The 510(k) number is K222636.

When was ET Abutment System approved by the FDA?

ET Abutment System received FDA 510(k) clearance on 2023-04-28, under approval number K222636.

What company makes ET Abutment System?

ET Abutment System is manufactured by Hiossen, Inc..

What is the FDA product code for ET Abutment System?

The FDA product code for ET Abutment System 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.