K-number	K242287
Device name	SFIT Abutment
Applicant	Cowellmedi Co., Ltd.
Product code	NHA
Device class	Class II
Decision date	Sep 16, 2025
Decision	Substantially Equivalent
Regulation	872.3630

AI Summary

The FDA summary PDF for this submission is not available in machine-readable form — common for older clearances. View on FDA's site →

Source

View the full FDA submission: accessdata.fda.gov

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SFIT Abutment

Everything you need for a 510(k) submission. Nothing you don't.