SFIT Abutment
K-Number: K242287 · 2025-09-16
ApplicantCowellmedi Co., Ltd.
Decision Date2025-09-16
Product CodeNHA
Advisory CommitteeDE
DecisionSubstantially Equivalent
Device Summary
SFIT Abutment is a medical device manufactured by Cowellmedi Co., Ltd.. It received FDA 510(k) clearance on 2025-09-16 under approval number K242287. 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 SFIT Abutment?
SFIT Abutment is a medical device that received FDA 510(k) clearance on 2025-09-16. It is manufactured by Cowellmedi Co., Ltd.. The 510(k) number is K242287.
When was SFIT Abutment approved by the FDA?
SFIT Abutment received FDA 510(k) clearance on 2025-09-16, under approval number K242287.
What company makes SFIT Abutment?
SFIT Abutment is manufactured by Cowellmedi Co., Ltd..
What is the FDA product code for SFIT Abutment?
The FDA product code for SFIT Abutment is NHA.
Other Devices by Cowellmedi 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.