Remi Custom Night Guard— 510(k) K251778

Substantially Equivalent

Remi

FDA 510(k) clearance K251778 for Remi Custom Night Guard, Substantially Equivalent on 2025-10-17. Applicant: Remi. Device class: Unclassified.

Clearance details

Applicant: Remi
Product code: Code OBR
Device class: Unclassified
Advisory panel: Unknown
Date received: 2025-06-10
Decision date: 2025-10-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Francisco, CA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code OBR

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K253641 — Owl Night Guard2026-02-26
K252004 — enCore Night Guard2025-11-25
K250456 — Dentemp Pro-Comfort Dental Guard2025-05-19

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