Dental · De Novo · 2024
DentalMonitoring
Dental Monitoring SAS. Granted by FDA on 17 May 2024 under submission DEN230035, product code SBC (dental image analyzer). What FDA's record says, in FDA's words.
Device record · DEN230035
- Device. DentalMonitoringDEVICE
- Company. Dental Monitoring SASCOMPANY
- Decision. 17 May 2024, De NovoDECISION
- Panel. DentalPANEL
- Product code. SBC, Dental Image AnalyzerCODE
- Regulation. 21 CFR 872.1770, Class IIREG
- Source. FDA database entry · decision document (44 pages)SOURCE
Retrieved · the fields above are FDA's; the statement below was copied from the decision document on that day.
What FDA granted it for
The Indications for Use statement, verbatim, from the decision document.
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 […]
The product code's definition, from FDA's classification record. 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 the statement says
Pattern matches on the Indications for Use text. Each line is a fact that the text contains the words, not a finding about the device.
- Mentionsa diagnostic claim
Adverse-event reports in MAUDE, by product code
As of , MAUDE held 0 reports filed against devices carrying product code SBC. That code is shared by every device of this type, not this device alone, and MAUDE reports are submitted by manufacturers, facilities and the public without FDA verification.
Where this fits
This page is a record, not medical advice and not a safety rating. It copies FDA's fields and FDA's statement, and lists what the statement's text mentions. Read the labeling before relying on any of it.
More devices under product code SBC, in Dental, or granted in 2024. The whole record is at FDA AI-enabled medical devices.
A device's authorized use is a sentence the record can be read against. What Apodicta does on a medical record is that reading: every line of a note, a claim or a report proved to its source or held, before it renders.