# DEN230035: DentalMonitoring

- Pathway: De Novo (Direct)
- Applicant: Dental Monitoring Sas
- Decided: May 17, 2024 after 379 days
- Product code: SBC (Dental Image Analyzer)
- Device class: 2
- Regulation: 21 CFR 872.1770
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. De Novo decisions do not claim a predicate device.

## Most influential descendants
- K260082: TRIOS Dx (R1) (2026), 0 descendants of its own

## Indications for use
DentalMonitoring is a medical device software using image processing algorithms to analyze pictures of the oral cavity (hereinafter Scans). Scans are taken using the DM App, a smartphone, and the manufacturer’s proprietary hardware products. Scans are taken by the patient, a non-healthcare professional, or a healthcare professional. The Scan is taken in healthcare facilities, such as a dental practice, or in a non-healthcare environment, such as the patient’s own home. For some clinical parameters, DentalMonitoring requires a 3D Model. The product is designed to assist healthcare professionals in remotely monitoring orthodontic treatments and treatment progress. The results of DentalMonitoring are intended to be used as an aid in diagnosis and monitoring, not on a stand-alone basis for clinical decision-making. DentalMonitoring is indicated for use for patients over the age of 6 and reports results solely on permanent teeth. DentalMonitoring can monitor the following clinical parameters: ▪ oral hygiene: dental plaque / food residue; ▪ soft tissue statement: gingival recession, black triangle; ▪ dental statement: closure of extraction space, tooth wear; ▪ alignment: closure of all anterior spaces; and ▪ dental occlusion: o in 2D Monitoring: midline deviation, overbite/open bite, overjet o in 3D Monitoring: canine class, midline deviation, overbite/open bite, overjet Additionally, the following clinical parameters specific to orthodontic treatment types or phases can be monitored using DentalMonitoring: ▪ for aligner treatments: tracking (seat/unseat), attachment loss, button loss; ▪ for braces: bracket debonding, tie loss, self-ligating clips, passive archwire and auxiliaries; and ▪ for thermoformed retainers: tracking (seat/unseat). Based on an initial 3D Model provided by a healthcare professional, DentalMonitoring can also provide healthcare professionals with 3D Models representative of the patient’s dentition and treatment progress. This device is a prescription device and is not intended for over-the-counter use

Source page: https://510kreport.com/device/DEN230035
Methodology: https://510kreport.com/methodology