De Novo · Granted

Granted

DentalMonitoring

DEN230035De NovoGranted May 17, 2024379-day reviewClass II21 CFR 872.1770

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Dental Monitoring Sas · SBC Dental Image Analyzer

Granted on May 17, 2024 as a new device type through De Novo after a 379-day review. 1 later device descends from it.

Decided: May 17, 2024
Review: 379 days
Class: Class II
Product code: SBC
Recalls: None

1 later device descends from it, 1 citing it directly.

This deviceDEN230035 DentalMonitoringDental Monitoring Sas · 2024
Descendant · cites it directly · 0 of its ownK260082 TRIOS Dx (R1)3Shape TRIOS A/S · 2026

Most influential descendants

Showing 1 of 1 · See all

K260082TRIOS Dx (R1)3Shape TRIOS A/S · 2026 · cites it directly0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	DEN230035	DentalMonitoring	Dental Monitoring Sas	2024	—
+1	K260082	TRIOS Dx (R1)	3Shape TRIOS A/S	2026	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2026	1	0

FIG. 1 — Lineage of DEN230035, 2024–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Sources: FDA De Novo database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in SBC? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Candidate predicates for a device like this, rankedin the report
Recall history across each candidate’s familyin the report

Get a 510(k) Report

Does it have a predicate?

De Novo decisions do not claim a predicate device.

What descends from it? (1)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K260082	TRIOS Dx (R1)	3Shape TRIOS A/S	2026	0

Has anything in its family been recalled? (0 Class I)

No FDA recall names this device.

No ancestor or descendant has a Class I recall.

What does this lineage say?

Of its descendants, K260082 (3Shape TRIOS A/S, 2026) has gone furthest, with 0 descendants of its own.

How does its category compare?

All SBC devices

SBC Dental Image Analyzer: FDA decisions, review times, recalls and adverse event reports over 20 years. 2024, this device’s year, is highlighted.

FDA decisions per year · SBC

1in 2024

2007high 1 (2024) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · SBC

Too few SBC 510(k)s in any year since 2007 to give a median.

Recalls per year · SBC

No recall names SBC since 2007.

Adverse event reports per year · SBC

No MAUDE report names SBC since 2007.

View these four charts as a table

Year	Decisions	Median 510(k) review, days	MAUDE reports
2007	0	—	0
2008	0	—	0
2009	0	—	0
2010	0	—	0
2011	0	—	0
2012	0	—	0
2013	0	—	0
2014	0	—	0
2015	0	—	0
2016	0	—	0
2017	0	—	0
2018	0	—	0
2019	0	—	0
2020	0	—	0
2021	0	—	0
2022	0	—	0
2023	0	—	0
2024	1	—	0
2025	0	—	0
2026	0	—	—

What is it indicated for?

Read the full statement (289 words)

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

Indications for use as stated in the FDA summary.

https://510kreport.com/device/DEN230035 · printed Nov 6, 2026

Cite this page

510(k) Report. “DEN230035: DentalMonitoring.” Lineage record from FDA De Novo data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/DEN230035

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Record history

FDA decision record loaded May 2, 2026
Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026