RAYDENT SW

K233625

RAY Co., Ltd. · cleared 2024-05-16 · product code PNN · Dental

Premarket evidence — what FDA accepted

Device typesamd
source quote (p.4)
“RAYDENT SW is a software designed to assist dental professionals in planning patient treatment and designing treatment devices.”
AlgorithmArtificial Intelligence and Machine Learning (AI/ML)-Enabled Medical Device
source quote (p.9)
“Artificial Intelligence and Machine Learning (AI/ML)-Enabled Medical Devices YES”
Adaptive (vs locked)FDA source did not state this
PCCPNo
Cybersecurity addressedYes
source quote (p.10)
“Software, hardware, and integration verification and validation testing was performed in accordance with the FDA Guidance Document "Guidance for the Content of Premarket Submissions for Device Software Functions" and "Guidance for the Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions".”

Validation studies (1)

Bench

sample size not stated

standards: FDA Guidance Document "Guidance for the Content of Premarket Submissions for Device Software Functions", FDA Guidance Document "Guidance for the Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions"

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/K233625