K-number	K254112
Device name	Dia-X Sil Bite
Applicant	DiaDent Group International
Product code	ELW
Device class	Class II
Decision date	Mar 19, 2026
Decision	Substantially Equivalent
Regulation	872.3660

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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Dia-X Sil Bite

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