DentalMonitoring

DEN230035

Dental Monitoring SAS · granted 2024-05-17 · product code SBC · Dental

Premarket evidence — what FDA accepted

Device typesamd
source quote (p.1)
“DentalMonitoring is a medical device software using image processing algorithms to analyze pictures of the oral cavity (hereinafter Scans).”
Algorithmartificial intelligence comprising machine learning and locked neural network algorithms
source quote (p.2)
“DentalMonitoring is a standalone software with embedded artificial intelligence comprising machine learning and locked neural network algorithms.”
Adaptive (vs locked)No
source quote (p.2)
“locked neural network algorithms.”
PCCPNo
Cybersecurity addressedYes
source quote (p.4)
“DentalMonitoring approach to cybersecurity aligns with FDA's 2020 guidance titled, "Guidance on Cybersecurity For Medical Devices" The device also conforms to the cybersecurity requirements identified in Section 524B to the FD&C Act.”

Validation studies (5)

Retrospective clinical

n=5,064 cases · 15 site(s)

endpoints: dental plaque / food residue; gingival recession; black triangle; closure of extraction space; closure of all anterior spaces; tracking (seat/unseat); attachment loss; button loss; bracket debonding; tie loss; self-ligating clips

Prospective clinical

n=291 patients · 4 site(s)

endpoints: canine class; midline deviation; overbite/open bite; overjet

standards: EP09c - Third Edition, 2018

Prospective clinical

n=273 patients · 6 site(s)

endpoints: passive archwire and auxiliaries

Prospective clinical

n=250 patients · 7 site(s)

endpoints: Updated 3D Model

Bench

n=80 other · 5 site(s)

endpoints: usability

Reported performance (2 observations)

sensitivity82.5CI 79.9%-84.8%
source quote (p.7)
“Sensitivity 82.5% 95% CI Lower Bound 79.9% 95% CI Upper Bound 84.8%”
specificity83.2CI 80.5%-85.5%
source quote (p.7)
“Specificity 83.2% 95% CI Lower Bound 80.5% 95% CI Upper Bound 85.5%”

Each value carries its own analysis unit and task — never compare or pool across devices. Source: De Novo decision summary PDF.

Predicate network

Postmarket — what happened after clearance

Not yet tracked — the weekly postmarket refresh hasn't snapshotted this device.

Reimbursement — how devices like this got paid

Not yet tracked — no payment pathway indexed for this clearance (the reimbursement corpus is a growing seed set).

Applicable FDA guidance — what the submission is measured against

FDA guidance documents and guiding principles applicable to De Novo AI/ML devices in the Dental panel. A curated reference index, not legal or regulatory advice — each item states its own status, and a draft is never binding.

Applicability is derived from the device's FDA advisory panel and pathway — cross-cutting guidances apply to every AI/ML device; panel-specific ones are flagged. Titles, dates, and links verified against fda.gov as of July 2026.

Constat Precedent · public FDA/CMS data · descriptive decision-support, not regulatory or reimbursement advice. Share this page: constat.dev/precedent/device/DEN230035