Not Cleared Direct

DEN240077 - MuReva OM™ (FDA 510(k) Clearance)

Class II Dental device cleared through the Direct 510(k) pathway - typically does not require clinical trials.

DEN240077 · Mureva Phototherapy, Inc. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 2025
Decision
338d
Days
Class 2
Risk

DEN240077 is an FDA 510(k) submission (not cleared) for the MuReva OM™. Classified as Intraoral Phototherapy Device (product code SGQ), Class II - Special Controls.

Submitted by Mureva Phototherapy, Inc. (Strongsville, US). The FDA issued a Not Cleared (DENG) decision on November 26, 2025 after a review of 338 days.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.5595 - the FDA dental device regulatory framework. The Traditional 510(k) pathway requires demonstration of substantial equivalence to a legally marketed predicate device - a standard the FDA determined was not met in this submission.

Device pattern: Regulatory edge-case submission. High predicate equivalence gap. With 338 days under review and no clearance granted, this submission reflects a case where the FDA could not confirm sufficient predicate equivalence - often indicating either a novel device category or unresolved safety and performance questions.

View all Mureva Phototherapy, Inc. devices

Submission Details

510(k) Number DEN240077 FDA.gov
FDA Decision Not Cleared Not Substantially Equivalent (DENG)
Date Received December 23, 2024
Decision Date November 26, 2025
Days to Decision 338 days
Submission Type Direct
Review Panel Dental (DE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
211d slower than avg
Panel avg: 127d · This submission: 338d
Pathway characteristics

Device Classification

Product Code SGQ Intraoral Phototherapy Device
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.5595
Definition An Intraoral Phototherapy Device Is An Intraoral, Non-ionizing, Light-based Device That Is Intended For Non-surgical Treatment Of Oral Conditions Such As Oral Mucositis.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Dental devices follow this clearance model.