Cleared Traditional

K250743 - Remvia NightGuard

K250743 · Remvia · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 2025
Decision
269d
Days
-
Risk

K250743 is an FDA 510(k) clearance for the Remvia NightGuard. Classified as Mouthguard, Prescription (product code MQC).

Submitted by Remvia (St. Louis, US). The FDA issued a Cleared decision on December 5, 2025 after a review of 269 days - an extended review cycle.

This device falls under the Dental FDA review panel. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Dental review framework, consistent with the majority of Class II 510(k) submissions.

View all Remvia devices

FDA 510(k) Submission Details - K250743

510(k) Number K250743 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 11, 2025
Decision Date December 05, 2025
Days to Decision 269 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
142d slower than avg
Panel avg: 127d · This submission: 269d
Pathway characteristics
Predicate-based equivalence.

MQC Device Classification - Class 0,

Product Code MQC Mouthguard, Prescription
Device Class -

Regulatory Peers - MQC Mouthguard, Prescription

All 42
Devices cleared under the same product code (MQC) and FDA review panel - the closest regulatory comparables to K250743.
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