enCore Night Guard— 510(k) K252004

Substantially Equivalent

Encore Guards

FDA 510(k) clearance K252004 for enCore Night Guard, Substantially Equivalent on 2025-11-25. Applicant: Encore Guards. Device class: Unclassified.

Clearance details

Applicant: Encore Guards
Product code: Code OBR
Device class: Unclassified
Advisory panel: Unknown
Date received: 2025-06-27
Decision date: 2025-11-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Santa Ana, CA, US

Download summary PDF View on FDA.gov ↗

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More clearances from Encore Guards

K251926 — enCore Impression Material2026-03-17

Data sourced from openFDA. This site is unofficial and independent of the FDA.