Smile Dx®

K242437

Cube Click, Inc. · cleared 2025-05-14 · product code MYN · Radiology

Premarket evidence — what FDA accepted

Device typesamd
source quote (p.6)
“Smile Dx® is a computer-assisted detection (CADe) software designed to aid dentists in the review of digital files of bitewing and periapical radiographs of permanent teeth.”
Algorithmcomputer vision machine learning algorithm(s)
source quote (p.13)
“Utilizes computer vision machine learning algorithm(s).”
Adaptive (vs locked)FDA source did not state this
PCCPFDA source did not state this
Cybersecurity addressedFDA source did not state this

Validation studies (4)

Standalone

n=867 cases

endpoints: Caries detection; Periapical radiolucency detection

standards: 2022 FDA Guidance "Computer-Assisted Detection Devices Applied to Radiology Images and Radiology Device Data - Premarket Notification [510(k)] Submissions"

Standalone

n=352 cases

endpoints: Bone Level Detection; Bone Loss Measurement

standards: 2022 FDA Guidance "Computer-Assisted Detection Devices Applied to Radiology Images and Radiology Device Data - Premarket Notification [510(k)] Submissions"

Standalone

n=200 cases

endpoints: Normal anatomy detection; Restoration detection

standards: 2022 FDA Guidance "Computer-Assisted Detection Devices Applied to Radiology Images and Radiology Device Data - Premarket Notification [510(k)] Submissions"

Reader study (MRMC)

n=352 cases

endpoints: wAFROC analysis for caries detection; wAFROC analysis for PARL detection; Sensitivity for caries detections; Specificity for caries detections; Sensitivity for PARL detections; Specificity for PARL detections

standards: 2022 FDA Guidance "Computer-Assisted Detection Devices Applied to Radiology Images and Radiology Device Data - Premarket Notification [510(k)] Submissions"

Reported performance (6 observations)

sensitivity0.839CI 12.8%, 26.4%
source quote (p.18)
“For caries detections, reader sensitivity improved from 64.3% without device to 83.9% with device, an increase of 19.6% [12.8%, 26.4%].”
specificity0.902CI 13.5%, 19.9%
source quote (p.18)
“For caries detections, reader specificity improved from 73.6% without device to 90.2% with device, a difference of 16.7% [13.5%, 19.9%].”
diceas written: “Dice (Caries)”0.74CI [0.72 0.76]
source quote (p.16)
“Dice 0.74 [0.72 0.76]”
diceas written: “Dice (Periapical Radiolucency)”0.77CI [0.74, 0.80]
source quote (p.16)
“0.77 [0.74, 0.80]”
diceas written: “Dice (Normal Anatomy)”0.84CI [0.83, 0.85]
source quote (p.17)
“0.84 [0.83, 0.85]”
diceas written: “Dice (Restorations)”0.87CI [0.85, 0.90]
source quote (p.17)
“0.87 [0.85, 0.90]”

Each value carries its own analysis unit and task — never compare or pool across devices. Source: 510(k) summary PDF.

Predicate network

Postmarket — what happened after clearance

0
recalls in product code, 24mo
0
MAUDE reports in code, 12mo
-100%
vs code's own 3-yr baseline
0
drift signals on this device

Recall and MAUDE counts are product-code-level (reports aren't reliably attributable to one device); a recall is shown as device-attributed only when the recall record itself lists this clearance number. Signals are descriptive observables with sources — never a judgment that the device is unsafe or drifting. Snapshot 2026-07-08.

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 510(k) AI/ML devices in the Radiology 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/K242437