CEREC Ortho Software

K171122

Dentsply Sirona · cleared 2018-01-11 · product code PNN · Dental

Premarket evidence — what FDA accepted

Device typesamd
source quote (p.4)
“The CEREC Ortho Software is stand-alone software which utilizes images of the patient's intra-oral anatomy from intra-oral cameras and/or desktop laboratory scanners to create a 3D virtual dental model that can be used in the same manner as a traditional physical dental model.”
AlgorithmThe software facilitates the segmentation and editing of 3D virtual digital models, performs measurement and jaw analysis (including Bolton, Nance, and Moyers analyses), and provides alignment tools.
source quote (p.4)
“The CEREC Ortho Software facilitates the segmentation and editing of the 3D virtual digital model as well as analysis which can be used in secondary orthodontic treatment planning. The software allows for measurement and jaw analysis to be performed – including Bolton, Nance, and Moyers analyses. The models and analysis produced by the proposed CEREC Ortho Software can be exported to an orthodontic laboratory or directly to orthodontic appliance manufacturers for use in orthodontic treatment planning and design of orthodontic appliances.”
Adaptive (vs locked)FDA source did not state this
PCCPFDA source did not state this
Cybersecurity addressedFDA source did not state this

Validation studies (2)

Bench

sample size not stated

endpoints: accuracy of the measurement functions of the CEREC Ortho Software; trueness and precision of optical impressions produced using CEREC optical impression systems and the CEREC Omnicam intra-oral scanner

Standalone

sample size not stated

endpoints: conformity with IEC 62304 (Medical device software - Software lifecycle processes)

standards: IEC 62304

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

0
recalls in product code, 24mo
0
MAUDE reports in code, 12mo
—
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 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/K171122