Not Cleared Direct

DEN230035 - DentalMonitoring (FDA 510(k) Clearance)

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

DEN230035 · Dental Monitoring Sas · Dental device
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May 2024
Decision
379d
Days
Class 2
Risk

DEN230035 is an FDA 510(k) submission (not cleared) for the DentalMonitoring. Classified as Dental Image Analyzer (product code SBC), Class II - Special Controls.

Submitted by Dental Monitoring Sas (Paris, FR). The FDA issued a Not Cleared (DENG) decision on May 17, 2024 after a review of 379 days.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.1770 - 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 379 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 Dental Monitoring Sas devices

Submission Details

510(k) Number DEN230035 FDA.gov
FDA Decision Not Cleared Not Substantially Equivalent (DENG)
Date Received May 04, 2023
Decision Date May 17, 2024
Days to Decision 379 days
Submission Type Direct
Review Panel Dental (DE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
252d slower than avg
Panel avg: 127d · This submission: 379d
Pathway characteristics

Device Classification

Product Code SBC Dental Image Analyzer
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.1770
Definition A Dental Image Analyzer Is A Prescription Home Use Device That Uses Software Intended To Collect And Analyze Patient-specific, Optical Camera-based, Intraoral Images. The Analyses Are Provided To Dental Health Care Professionals As An Aid To Diagnosis Of Oral Health Conditions And/or To Monitor Treatment Progress.
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.