DTX Studio Clinic (4.0)
K231898Nobel Biocare AB · cleared 2023-12-08 · product code LLZ · Radiology
Premarket evidence — what FDA accepted
source quote (p.4)
“DTX Studio™™™ Clinic is a software interface for dental/medical practitioners used to analyze 2D and 3D imaging data, in a timely fashion, for the treatment of dental, craniomaxillofacial and related conditions.”
source quote (p.4)
“DTX Studio Clinic features an Al-powered Focus Area Detection algorithm which analyzes 2D intraoral radiographs for potential dental findings or image artifacts. The detected focus areas can be converted afterwards to diagnostic findings after approval by the user. ... Algorithm: Supervised machine learning”
source quote (p.6)
“The first functionality concerns the unchanged Focus Area detection, an Al-powered Focus Area Detection algorithm which analyzes intraoral radiographs for potential dental findings or image artifacts, and which was cleared in primary predicate K221921. There are no functional or technical differences between the Focus Area detection in DTX Studio Clinic 3.0 (primary predicate - K221921) and the current subject device.”
Validation studies (3)
Bench
sample size not stated
endpoints: demonstrates that the requirements for the features have been met
standards: ISO 13485:2016 Standards, IEC 62304:2006/Amd 1:2015 standard, ISO 14971:2019
Standalone
sample size not stated
endpoints: the focus area detection is executed, and the same number of focus areas were detected compared to the predicate device. All detected bounding boxes were identical and the acceptance criteria was met.
Standalone
sample size not stated
endpoints: the surgical template file created in DTX Studio Clinic 4.0 has the same fitting surface and sleeve hole design as in DTX Studio Implant for the same implant plan parameters.
Reported performance (0 observations)
FDA source did not state a quantitative performance metric — non-reporting is itself the signal.
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
- adverse_event_inflection
MAUDE adverse-event reports for product code LLZ: 295 in the 12 months ending 2026-06, vs a 37.7/12mo average over the prior 3 windows (+683%). Code-level count — reports are not attributed to this specific device.
first seen 2026-07-08 · openFDA /device/event.json count=date_received product_code=LLZ
- recall_reason_pattern
Software/algorithm-related recall in product code LLZ (GE Medical Systems SCS, initiated 2026-05-08): "GE HealthCare has become aware of a context synchronization issue in AW Server 3.2 ext. 6.5. When a user selects a patient or exam in the AW Server Web Client worklist and launches" Recalling firm is another firm in the same product code.
first seen 2026-07-08 · recall res_event_number:99042
- recall_reason_pattern
Software/algorithm-related recall in product code LLZ (PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Veenpluis 4-6 Best Netherlands, initiated 2026-03-05): "Potential that mis-ordered frames in Vue Motion during dynamic cine runs may cause images frames to display out of sequence." Recalling firm is another firm in the same product code.
first seen 2026-07-08 · recall res_event_number:98520
- recall_reason_pattern
Software/algorithm-related recall in product code LLZ (GE Medical Systems, LLC, initiated 2026-01-30): "There is a potential cybersecurity vulnerability affecting certain versions of Centricity Universal Viewer. User login credentials may be exposed on the local client workstation, w" Recalling firm is another firm in the same product code.
first seen 2026-07-08 · recall res_event_number:98428
- recall_reason_pattern
Software/algorithm-related recall in product code LLZ (Focalyx Technologies, LLC., initiated 2025-12-23): "Software device that is an accessory for image-guided interventional and diagnostic procedures involving prostate has accessories that may not function properly with Windows 10, wh" Recalling firm is another firm in the same product code.
first seen 2026-07-08 · recall res_event_number:98137
- recall_reason_pattern
Software/algorithm-related recall in product code LLZ (DICOM Grid, Inc., initiated 2025-11-18): "Software intended to aid in diagnosing conditions, planning treatments, visualizing anatomical structures has a bug that, if all of following are met: Viewing images in InteleShare" Recalling firm is another firm in the same product code.
first seen 2026-07-08 · recall res_event_number:97993
- …and 20 more.
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).