Dental · 510(k) · 2024
RAYDENT SW
RAY Co., Ltd.. Cleared by FDA on 16 May 2024 under submission K233625, product code PNN (orthodontic software). What FDA's record says, in FDA's words.
Device record · K233625
- Device. RAYDENT SWDEVICE
- Company. RAY Co., Ltd. (KR)COMPANY
- Decision. 16 May 2024, 510(k), substantially equivalent (traditional review); received 13 November 2023DECISION
- Panel. DentalPANEL
- Product code. PNN, Orthodontic SoftwareCODE
- Regulation. 21 CFR 872.5470, Class IIREG
- Source. FDA database entry · decision document (10 pages)SOURCE
Retrieved · the fields above are FDA's; the statement below was copied from the decision document on that day.
What FDA cleared it for
The Indications for Use statement, verbatim, from the decision document.
RAYDENT SW is a software designed to assist dental professionals in planning patient treatment and designing treatment devices. The software performs simulations based on patient images, allowing reference to treatment plans, and is used as a tool to design treatment devices based on 3D mesh data. Treatment devices include prosthetic devices (Veneer, Crown, Bridge, In/Onlay) and orthodontic devices (Clear Aligner). To use RAYDENT SW, users must have the necessary education and domain knowledge in orthodontic or prosthodontic practice and receive dedicated training in the use of the software.
The product code's definition, from FDA's classification record. The device is software that is to be used for the diagnosis and treatment planning of orthodontic patients and conditions. It may include orthodontic output devices used for the treatment of orthodontics. The device is intended for prescription use only.
What the statement says
Pattern matches on the Indications for Use text. Each line is a fact that the text contains the words, not a finding about the device.
- Mentionsnone of the tracked terms matched
Adverse-event reports in MAUDE, by product code
As of , MAUDE held 1 report filed against devices carrying product code PNN. That code is shared by every device of this type, not this device alone, and MAUDE reports are submitted by manufacturers, facilities and the public without FDA verification. The latest reports, in the reporter’s words:
29 October 2024 · Malfunction · LIGHTFORCE ORTHODONTIC SYSTEM · LIGHTFORCE ORTHODONTICS · report MW5161850
1. DESCRIPTION: I DON¿T THINK ANY ACTIONS ARE INTENTIONAL. I BELIEVE THEM TO BE DUE TO A MANAGEMENT TEAM WITHOUT SUFFICIENT MEDICAL DEVICE EXPERIENCE. ¿ RECEIVED 510K CLEARANCE FOR CUSTOM CERAMIC DEVICE, BUT POSSIBLY MODIFYING THE DEVICE AFTER RECEIVING CLEARANCE TO TEST NEW PRODUCT FEATURES ON PATIENTS, WHICH MAY EXCEED SCOPE OF CLEARANCE ¿ POSSIBLE USE OF A CUSTOM METAL DEVICE ON A PATIENT BEFORE RECEIVING 510K CLEARANCE ¿ POSSIBLE PROMOTION OR ADVERTISING OF A DEVICE OUTSIDE THE FDA-CLEARED […]
Where this fits
This page is a record, not medical advice and not a safety rating. It copies FDA's fields and FDA's statement, and lists what the statement's text mentions. Read the labeling before relying on any of it.
More devices under product code PNN, in Dental, or cleared in 2024. The whole record is at FDA AI-enabled medical devices.
A device's authorized use is a sentence the record can be read against. What Apodicta does on a medical record is that reading: every line of a note, a claim or a report proved to its source or held, before it renders.