ZENEX FreeMilling & CCM Cast Abutment
K-Number: K231557 · 2023-08-24
ApplicantIzenimplant Co., Ltd.
Decision Date2023-08-24
Product CodeNHA
Advisory CommitteeDE
DecisionSubstantially Equivalent
Device Summary
ZENEX FreeMilling & CCM Cast Abutment is a medical device manufactured by Izenimplant Co., Ltd.. It received FDA 510(k) clearance on 2023-08-24 under approval number K231557. 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 ZENEX FreeMilling & CCM Cast Abutment?
ZENEX FreeMilling & CCM Cast Abutment is a medical device that received FDA 510(k) clearance on 2023-08-24. It is manufactured by Izenimplant Co., Ltd.. The 510(k) number is K231557.
When was ZENEX FreeMilling & CCM Cast Abutment approved by the FDA?
ZENEX FreeMilling & CCM Cast Abutment received FDA 510(k) clearance on 2023-08-24, under approval number K231557.
What company makes ZENEX FreeMilling & CCM Cast Abutment?
ZENEX FreeMilling & CCM Cast Abutment is manufactured by Izenimplant Co., Ltd..
What is the FDA product code for ZENEX FreeMilling & CCM Cast Abutment?
The FDA product code for ZENEX FreeMilling & CCM Cast Abutment is NHA.
Other Devices by Izenimplant Co., Ltd.
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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.