Predicate Devices

Reference Devices

AI/ML (Artificial Intelligence / Machine Learning)

Yes
The summary explicitly states "Artificial Intelligence and Machine Learning (AI/ML)- Enabled Medical Devices: YES".

Therapeutic

No

Explanation: The device is a software that assists in planning treatment devices and designing them, but it does not directly treat or diagnose a disease or condition. It is a tool for dental professionals to create medical devices, not a therapeutic device itself.

Diagnostic

No

The device is described as software for planning patient treatment and designing treatment devices, performing simulations, and utilizing acquired images to create treatment plans and devices. It does not perform diagnosis.

SaMD (Software as a Medical Device)

Yes

The device is explicitly described as "RAYDENT SW is a software" and "RAYDENT is a software". While it utilizes patient images from compatible scanners, the device itself is the software that processes this data and assists in planning and designing treatment devices. The description focuses solely on the software's functions and capabilities.

IVD (In Vitro Diagnostic)

Based on the provided information, no, this device is not an IVD (In Vitro Diagnostic).

Here's why:

Intended Use: The intended use clearly states that RAYDENT SW is designed to assist dental professionals in planning patient treatment devices and designing treatment devices based on patient images and 3D data. This is a planning and design tool for medical devices, not a diagnostic test performed in vitro (outside the body) on biological specimens to determine the presence of a disease or condition.
Device Description: The description reinforces that the software provides tools to simulate treatment plans and design treatment devices. It's about creating physical or virtual models for treatment, not analyzing biological samples for diagnostic purposes.
Input Data: The input data consists of patient images (DICOM, 2D, and 3D mesh data) of anatomical structures (Maxilla, Mandible). IVDs typically analyze biological samples like blood, urine, tissue, etc.
Anatomical Site: The focus is on the anatomical site (Maxilla, Mandible), which is consistent with a device used for planning and designing treatments related to these areas.
Predicate Devices: The predicate devices listed (K180941 Ortho System™, K171122 CEREC Ortho Software, Exemption from Premarket Notification ChairsideCAD) are all software or systems used in dental treatment planning and device design, not IVDs.

In summary, RAYDENT SW is a software tool for dental treatment planning and device design, which falls under the category of medical devices used for treatment or procedural planning, not in vitro diagnostics.

PCCP (Predetermined Change Control Plan) Authorized

No
The provided text does not contain any explicit statement that the FDA has reviewed and approved or cleared a Predetermined Change Control Plan (PCCP) for this specific device.

Overview

Intended Use / Indications for Use

RAYDENT SW is a software designed to assist dental professionals in planning patient 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 practice and receive dedicated training in the use of the software.

Product codes

PNN, NOF

Device Description

RAYDENT is a software that provides tools to simulate treatment plans based on patient images generated by compatible scanners and design treatment devices based on appropriate threedimensional images. It allows dental offices to acquire patient data in conjunction with software on compatible imaging equipment and utilize the acquired images to create treatment plans and devices for skilled dentists and oral and maxillofacial specialists.

Mentions image processing

Acquisition of oral topography image data

Mentions AI, DNN, or ML

YES

Input Imaging Modality

DICOM, 2D and 3D images (PLY, OBJ, STL)

Anatomical Site

Maxilla, Mandible

Indicated Patient Age Range

Not Found

Intended User / Care Setting

dental professionals / dental offices

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

Software, hardware, and integration 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".

The validation suite includes validation of implemented mitigations related to device hazards identified in the risk management procedures.

All test results have been reviewed and approved, showing the RAYDENT SW to be substantially equivalent to the predicate devices.

The documentation level of RAYDENT SW corresponds to basic documentation level based on the intended use, design, and risk of device software functionality.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s)

K180941

Reference Device(s)

K171122

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

Regulation Number and Section

§ 872.5470 Orthodontic plastic bracket.

(a)
Identification. An orthodontic plastic bracket is a plastic device intended to be bonded to a tooth to apply pressure to a tooth from a flexible orthodontic wire to alter its position.(b)
Classification. Class II.

Summary

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Image /page/0/Picture/0 description: The image contains the logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the FDA acronym in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.

May 16, 2024

Huh Soo Ji RA Specialist 1F~3F, 4F(Part), 5F, 265, Daeji-Ro, Suji-gu Yongin-si, Gyeonggi-do 16882 SOUTH KOREA

Re: K233625

Trade/Device Name: Raydent SW Regulation Number: 21 CFR 872.5470 Regulation Name: Orthodontic Plastic Bracket Regulatory Class: Class II Product Code: PNN, NOF Dated: April 19, 2024 Received: April 19, 2024

Dear Huh Soo Ji:

We have reviewed your section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (the Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

1

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

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Sincerely,

Michael E. Adodha -S

Michael E. Adjodha, MChE, RAC, CQIA Assistant Director DHT1B: Division of Dental and ENT Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K233625

Device Name RAYDENT SW

Indications for Use (Describe)

RAYDENT SW is a software designed to assist dental professionals in planning patient 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 practice and receive dedicated training in the use of the software.

Type of Use (Select one or both, as applicable)
☑Prescription Use (Part 21 CFR 801 Subpart D)	☐Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) Summary — K233625

1. 510(k) Summary

The summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR Part 807.92.

2. Date: May 13, 2024

3. Administrative Information

Applicant	Ray Co., Ltd.
Address		1F~3F, 4F(Part), 5F, 265, Daeji-ro, Suji-gu, Yongin-si,
16882, Korea
	Manufacturer	Name	Ray Co., Ltd.
		Address	1F~3F, 4F(Part), 5F, 265, Daeji-ro, Suji-gu, Yongin-si,
16882, Korea
		Tel	+82-31-605-1000
		Fax	+82-2-6280-5534
	Contact Person	Name	Sooji Huh
		Email	sooji.huh@raymedical.co.kr

4. Device Information

Trade/Proprietary Name	RAYDENT SW
Common Name	Orthodontic Software
Device	Orthodontic plastic bracket
Regulation Number	21 CFR 872.5470
Class	2
Product Code	PNN, NOF
Review Panel	Dental

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Parameter	Predicate Device	Reference Device	Reference Device
Device Name	Ortho System™	CEREC Ortho Software	ChairsideCAD
Manufacturer	3Shape A/S	Dentsply Sirona	EXOCAD GMBH
510(K) Number	K180941
Traditional 510k	K171122
Traditional 510k	Exemption from
Premarket Notification
Classification
name	Orthodontic Plastic
Bracket	Orthodontic Plastic
Bracket	System, Optical
Impression, Computer
Assisted Design And
Manufacturing
(Cad/Cam) Of Dental
Restorations
Regulation
number	872.5470	872.5470	872.3661
Primary product
code	PNN(Orthodontic
software)	PNN(Orthodontic
software)	NOF
Parameter	Proposed Device	Predicate Device	Reference Device	Reference Device
Manufacturer	RAY Co., Ltd.	3Shape A/S	Dentsply Sirona	EXOCAD GMBH
Device name	RAYDENT SW	Ortho System™	CEREC Ortho Software	ChairsideCAD
510(K) Number	(Traditional 510K)	K180941
(Traditional 510K)	K171122
(Traditional 510K)	Exemption from Premarket
Notification
Common Name	Orthodontic Software	Orthodontic Software	Orthodontic Software	System, Optical Impression,
Computer Assisted Design And
Manufacturing (Cad/Cam) Of
Dental Restorations
Classification
Product Code	PNN, NOF	PNN	PNN	NOF
Indications
for use	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.	Ortho System™ for dental
retainers and dental cast for
sequential aligners is intended for
use as a medical front-end device
providing tools for management of
orthodontic models, systematic
inspection, detailed analysis,
treatment simulation and virtual
appliance design options based
on 3D models of the patient's
dentition before the start of an
orthodontic treatment.
The use of the Ortho System™
requires the user to have the
necessary training and domain
knowledge in the practice of
orthodontics, as well as to have
received a dedicated training in
the use of the software.	CEREC Ortho Software is
intended for use with image data
acquired from handheld intra oral
3D cameras and desktop
laboratory scanners to create 3D
virtual models to be used for data
acquisition and modeling analysis
for orthodontic patients and
conditions. The CEREC Ortho
Software 3D model data can be
exported to orthodontic design
software to aid in the design of
orthodontic appliances.	ChairsideCAD is a software
device intended to support the
design of dental restorations such
as inlays, onlays, crowns,
copings, veneers, bridges,
pontics, provisionals and bite
splints via a 3D CAD tool. The
design is based on suitable 3D
scans of the patient's dental
anatomy produced by a
compatible scanner. The software
generates geometrical output of
the design for manufacturing on
compatible CAM systems.
ChairsideCAD is intended to be
used by trained professionals in
dental practices and is not to be
used for any purpose other than
the design of dental restorations
or bite splints, nor is it to be used
for designing dental abutments.

5. Predicate device

6. Device Description

RAYDENT is a software that provides tools to simulate treatment plans based on patient images generated by compatible scanners and design treatment devices based on appropriate threedimensional images. It allows dental offices to acquire patient data in conjunction with software on compatible imaging equipment and utilize the acquired images to create treatment plans and devices for skilled dentists and oral and maxillofacial specialists.

7. Indication for use

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.

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8. Comparison with predicate device

The following table provides the summary of the technological characteristics of RAYDENT SW compared to the predicate device

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| Minimum Hardware/
Software
Requirements | CPU : Intel Core i5
RAM : 16GB
GPU : NVIDIA GeForce RTX
2060 6GB
Storage : 1TB SSD
Resolution : 1920 x 1080
LAN : 1Gbps Ethernet
OS : Windows 10 x64 or Windows
11 x64 | CPU : Intel Core i5 or equivalent
RAM : 8GB
GPU : 1GB
Storage : 250GB
Resolution : 1280 x 800 or similar
LAN : Network Internet connection
OS : Windows 7, 8 or 10 64-bit | CPU : Intel QuadCore 1.6 GHz
processor
RAM : 8GB
GPU : NVidia or AMD graphics
card 1 GB
Storage : 250GB hard disk
OS : Windows 7, 64-bit | CPU : Quad-Core
RAM : 4GB
GPU : 1GB
Resolution : 1920 x 1080
OS : Windows 10 64 bit |
|-------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------|
| Support Images | DICOM, 2D and 3D images (PLY,
OBJ, STL) | DICOM, STL, JPG, BMP, PNG | Intra-oral scan data, STL | DICOM, 2D and 3D images(STL,
OFF, OBJ, PLY) |
| Supported anatomic
areas | Maxilla, Mandible | Maxilla, Mandible | Maxilla, Mandible | Maxilla, Mandible |
| Functionality | - Acquisition of oral topography
image data

Creation of virtual 3D virtual
dental models
Alignment of 3D virtual dental
models
Measurement of 3D virtual
dental models
Analysis of 3D virtual dental
models
Orthodontic treatment simulation
Virtual orthodontic appliance
design
Exporting of 3D virtual model,
analysis and treatment case data
Prosthesis design | - Acquisition of oral topography
image data
Creation of virtual 3D virtual
dental models
Alignment of 3D virtual dental
models
Measurement of 3D virtual
dental models
Analysis of 3D virtual dental
models
Orthodontic treatment simulation
Virtual orthodontic appliance
design
Exporting of 3D virtual model,
analysis and treatment case data | - Acquisition of oral topography
image data
Creation of virtual 3D virtual
dental models
Alignment of 3D virtual dental
models
Measurement of 3D virtual
dental models
Analysis of 3D virtual dental
models
Exporting of 3D virtual model
and analysis data | - Design of dental restorations
Geometrical output of the design
for manufacturing on compatible
CAM systems |
| Analysis Features | - Define occlusion
Tooth segmentation
Measure length and angle in the
frontal and lateral direction
Define the tooth and set the
tooth axis
Tooth width measurements
Bolton analysis
IPR | - Occlusal mapping
Tooth and gingiva
separation/segmentation
Definition of dental arch shape
and length
Tooth width measurements
Bolton's analysis
Space analyses | - Occlusal mapping
Tooth and gingiva
separation/segmentation
Definition of dental arch shape
and length
Tooth width measurements
Bolton's analysis
Nance and Moyer space
analyses | N/A |
| Artificial Intelligence
and Machine
Learning (AI/ML)-
Enabled Medical
Devices | YES | N/A | YES | N/A |
| Prosthesis design | Crown | N/A | N/A | Crown |
| | Pontic | | | Pontic |
| | Bridge | | | Bridge |
| | Veneer | | | Veneer |
| | Inlay/Onlay | | | Inlay/Onlay |
| | Temporary Denture | | | Provisional restorations |
| | eModel | | | Bite splints |
| | - | | | Coping |
| | - | | | Abutment |

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The product is principally just the same as in the previous 510(k) #K180941, #K171122 and the ChairsideCAD.

The complete of differences of the subject device to the predicate #K180941 and #K171122 devices are as follows

Minimum Hardware/Software Requirement
Support images
Prosthesis design

The orthodontic treatment simulation and virtual orthodontic appliance design capabilities are the $4.180941. Additionally, the prosthesis design capabilities are the same of the ChairsideCAD.

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9. Performance Testing

Software, hardware, and integration 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".

The validation suite includes validation of implemented mitigations related to device hazards identified in the risk management procedures.

All test results have been reviewed and approved, showing the RAYDENT SW to be substantially equivalent to the predicate devices.

The documentation level of RAYDENT SW corresponds to basic documentation level based on the intended use, design, and risk of device software functionality.

10. Clinical Testing

Clinical testing is not a requirement and has not been performed.

11. Conclusions

In accordance with the Federal Food, Drug and Cosmetic Act, 21 CFR Part 807 and based on the information provided in this premarket notification. Ray Co., Ltd. concludes that the newly RAYDENT SW is substantially equivalent to the predicate device as described herein.