K-number	K252004
Device name	enCore Night Guard
Applicant	Encore Guards
Product code	OBR
Device class	Class U
Decision date	Nov 25, 2025
Decision	Substantially Equivalent
Regulation	—

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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enCore Night Guard

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