Impla-NX (Model: ISE-270M)
K-Number: K201192 · 2021-05-21
ApplicantMicro-Nx Co., Ltd.
Decision Date2021-05-21
Product CodeEBW
Advisory CommitteeDE
DecisionSubstantially Equivalent
Device Summary
Impla-NX (Model: ISE-270M) is a medical device manufactured by Micro-Nx Co., Ltd.. It received FDA 510(k) clearance on 2021-05-21 under approval number K201192. The device is classified under product code EBW. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Impla-NX (Model: ISE-270M)?
Impla-NX (Model: ISE-270M) is a medical device that received FDA 510(k) clearance on 2021-05-21. It is manufactured by Micro-Nx Co., Ltd.. The 510(k) number is K201192.
When was Impla-NX (Model: ISE-270M) approved by the FDA?
Impla-NX (Model: ISE-270M) received FDA 510(k) clearance on 2021-05-21, under approval number K201192.
What company makes Impla-NX (Model: ISE-270M)?
Impla-NX (Model: ISE-270M) is manufactured by Micro-Nx Co., Ltd..
What is the FDA product code for Impla-NX (Model: ISE-270M)?
The FDA product code for Impla-NX (Model: ISE-270M) is EBW.
Other Devices by Micro-Nx Co., Ltd.
Related Devices (Code: EBW)
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.