DTX Studio Clinic 3.0

K221921

Nobel Biocare AB · cleared 2023-03-28 · product code MYN · Radiology

Premarket evidence — what FDA accepted

Device typesamd
source quote (p.3)
“DTX Studio Clinic is a computer assisted detection (CADe) device that analyses intraoral radiographs to identify and localize dental findings, which include caries, calculus, periapical radiolucency, root canal filling deficiency, discrepancy at margin of an existing restoration and bone loss.”
AlgorithmAI-powered Focus Area Detection algorithm
source quote (p.5)
“DTX Studio Clinic features an Al-powered Focus Area Detection algorithm which analyzes intraoral radiographs for potential dental findings or image artifacts.”
Adaptive (vs locked)FDA source did not state this
PCCPFDA source did not state this
Cybersecurity addressedNo

Validation studies (2)

Standalone

n=452 images

endpoints: overall sensitivity; sensitivity per dental finding type; overall precision; localization accuracy (IoU); Dice score

standards: 21 CFR § 820, ISO 13485:2016, IEC 62304:2006+A1:2015, ISO 14971:2019

Reader study (MRMC)

n=216 images

endpoints: Area Under the Curve (AUC) increase; AUC difference per dental finding; sensitivity on instance level; specificity at image level

standards: 21 CFR § 820, ISO 13485:2016, IEC 62304:2006+A1:2015, ISO 14971:2019

Reported performance (34 observations)

ppvas written: “overall precision”0.45CI [0.40, 0.50]
source quote (p.10)
“Overall precision was found to be 0.45 (with 95% CI [0.40, 0.50]).”
sensitivityas written: “Sensitivity (Caries)”0.7CI [0.65, 0.75]
source quote (p.10)
“0.70 [0.65, 0.75]”
iouas written: “Mean IoU (%) (Caries)”58.6CI [56.2, 60.9]
source quote (p.10)
“58.6 [56.2, 60.9]”
diceas written: “Mean Dice (%) (Caries)”71.9CI [69.9, 74.0]
source quote (p.10)
“71.9 [69.9, 74.0]”
sensitivityas written: “Sensitivity (Periapical Radiolucency)”0.68CI [0.59, 0.77]
source quote (p.10)
“0.68 [0.59, 0.77]”
iouas written: “Mean IoU (%) (Periapical Radiolucency)”48.9CI [44.9, 52.9]
source quote (p.10)
“48.9 [44.9, 52.9]”
diceas written: “Mean Dice (%) (Periapical Radiolucency)”63.7CI [59.9, 67.5]
source quote (p.10)
“63.7 [59.9, 67.5]”
sensitivityas written: “Sensitivity (Root Canal Filling Deficiency)”0.95CI [0.91, 0.99]
source quote (p.11)
“0.95 [0.91, 0.99]”
iouas written: “Mean IoU (%) (Root Canal Filling Deficiency)”51.9CI [49.3, 54.6]
source quote (p.11)
“51.9 [49.3, 54.6]”
diceas written: “Mean Dice (%) (Root Canal Filling Deficiency)”66.9CI [64.3, 69.4]
source quote (p.11)
“66.9 [64.3, 69.4]”
sensitivityas written: “Sensitivity (Discrepancy at Restoration Margin)”0.82CI [0.77, 0.87]
source quote (p.11)
“0.82 [0.77, 0.87]”
iouas written: “Mean IoU (%) (Discrepancy at Restoration Margin)”48.4CI [46.0, 50.7]
source quote (p.11)
“48.4 [46.0, 50.7]”
diceas written: “Mean Dice (%) (Discrepancy at Restoration Margin)”63.5CI [61.3, 65.8]
source quote (p.11)
“63.5 [61.3, 65.8]”
sensitivityas written: “Sensitivity (Bone Loss)”0.78CI [0.75, 0.81]
source quote (p.11)
“0.78 [0.75, 0.81]”
iouas written: “Mean IoU (%) (Bone Loss)”44.8CI [43.4, 46.3]
source quote (p.11)
“44.8 [43.4, 46.3]”
diceas written: “Mean Dice (%) (Bone Loss)”60.1CI [58.7, 61.6]
source quote (p.11)
“60.1 [58.7, 61.6]”
sensitivityas written: “Sensitivity (Calculus)”0.8CI [0.76, 0.84]
source quote (p.11)
“0.80 [0.76, 0.84]”
iouas written: “Mean IoU (%) (Calculus)”55.5CI [53.7, 57.3]
source quote (p.11)
“55.5 [53.7, 57.3]”
diceas written: “Mean Dice (%) (Calculus)”70.1CI [68.4, 71.7]
source quote (p.11)
“70.1 [68.4, 71.7]”
aurocas written: “Increase in AUC for all dental finding types”8.7CI [6.5, 10.9]
source quote (p.11)
“overall increase for all dental finding types together of 8.7% (CI [6.5, 10.9]).”
aurocas written: “Increase in AUC (Root Canal Filling Deficiency)”13.5
source quote (p.11)
“an increase of 13.5% for root canal filling deficiency”
aurocas written: “Increase in AUC (Periapical Radiolucency)”10.2
source quote (p.11)
“10.2% for periapical radiolucency”
aurocas written: “Increase in AUC (Discrepancy at Restoration Margin)”10.1
source quote (p.11)
“10.1% for discrepancy at margin of an existing restoration”
aurocas written: “Increase in AUC (Calculus)”7.2
source quote (p.11)
“7.2% for calculus”
aurocas written: “Increase in AUC (Caries)”6.1
source quote (p.11)
“6.1% for caries”
aurocas written: “Increase in AUC (Bone Loss)”5.6
source quote (p.11)
“5.6% for bone loss”
sensitivityas written: “Increase in sensitivity (overall)”22.4CI [20.1, 24.7]
source quote (p.12)
“overall by 22.4% (with CI [20.1, 24.7])”
sensitivityas written: “Increase in sensitivity (Caries)”19.6
source quote (p.12)
“19.6% for caries”
sensitivityas written: “Increase in sensitivity (Bone Loss)”23.5
source quote (p.12)
“23.5% for bone loss”
sensitivityas written: “Increase in sensitivity (Calculus)”18.1
source quote (p.12)
“18.1% for calculus”
sensitivityas written: “Increase in sensitivity (Discrepancy at Restoration Margin)”28.5
source quote (p.12)
“28.5% for discrepancy at restoration margin”
sensitivityas written: “Increase in sensitivity (Periapical Radiolucency)”20.6
source quote (p.12)
“20.6% for periapical radiolucency”
sensitivityas written: “Increase in sensitivity (Root Canal Filling Deficiency)”27.4
source quote (p.12)
“27.4% for root canal filling deficiency”
specificityas written: “Decrease in specificity (overall)”8.7CI [6.6, 10.7]
source quote (p.12)
“overall by 8.7 % with CI [6.6, 10.7]”

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
1
drift signals on this device
  • re_clearance

    The FDA AI/ML device list shows a newer 510(k) K231898 (decision 2023-12-08) from Nobel Biocare AB for a matching device line ("DTX Studio Clinic (4.0)") — a new clearance for the same line is a change event.

    first seen 2026-07-08 · k_number:K231898

Recall and MAUDE counts are product-code-level (reports aren't reliably attributable to one device). 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).

RIGOR™ Precedent · public FDA/CMS data · descriptive decision-support, not regulatory or reimbursement advice. Share this page: radar.healthai.com/precedent/device/K221921