RAYDENT SW

K233625 · Ray Co., Ltd. · PNN · May 16, 2024 · Dental

Device Facts

• Record ID: K233625
• Device Name: RAYDENT SW
• Applicant: Ray Co., Ltd.
• Product Code: PNN · Dental
• Decision Date: May 16, 2024
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.5470
• Device Class: Class 2
• Attributes: AI/ML, Software as a Medical Device

Intended 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.

Device Story

RAYDENT SW is a dental software tool for treatment planning and device design. It accepts 2D and 3D patient images (DICOM, PLY, OBJ, STL) from compatible scanners. The software enables virtual 3D dental model creation, alignment, measurement, and analysis (e.g., tooth segmentation, Bolton analysis, IPR). It supports orthodontic treatment simulation and virtual appliance design, as well as prosthetic design (Crown, Bridge, Veneer, In/Onlay). Used in dental clinics by trained dentists and oral/maxillofacial specialists, the software outputs digital designs for manufacturing. It assists clinicians in visualizing treatment outcomes and designing custom dental devices, potentially improving treatment precision and patient outcomes.

Clinical Evidence

No clinical data. Bench testing only, including software, hardware, and integration validation performed in accordance with FDA guidance documents for device software functions and cybersecurity.

Technological Characteristics

Software-based dental design tool. Operates on Windows 10/11 x64. Hardware requirements: Intel Core i5, 16GB RAM, NVIDIA GeForce RTX 2060 6GB, 1TB SSD. Supports DICOM, PLY, OBJ, STL formats. Features AI/ML-enabled functionality for dental analysis and design. Connectivity via 1Gbps Ethernet. Documentation level: basic.

Indications for Use

Indicated for dental professionals to assist in planning patient treatment and designing prosthetic (Veneer, Crown, Bridge, In/Onlay) and orthodontic (Clear Aligner) devices. Requires users to have orthodontic or prosthodontic domain knowledge and dedicated software training.

Regulatory Classification

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.

Predicate Devices

• Ortho System™ (K180941)
• CEREC Ortho Software (K171122)

Reference Devices

• ChairsideCAD

Submission Summary (Full Text)

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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.

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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 ([e-mail]) or phone [phone] 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) | |
|---------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------|
| <div style="display:flex; align-items:center;"><div><span style="font-size: 2em;">☑</span></div><div>Prescription Use (Part 21 CFR 801 Subpart D)</div></div> | <div style="display:flex; align-items:center;"><div><span>☐</span></div><div>Over-The-Counter Use (21 CFR 801 Subpart C)</div></div> |

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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,<br>16882, Korea | |
| | Manufacturer | Name | Ray Co., Ltd. |
| | | Address | 1F~3F, 4F(Part), 5F, 265, Daeji-ro, Suji-gu, Yongin-si,<br>16882, Korea |
| | | Tel | [phone] |
| | | Fax | [phone] |
| | Contact Person | Name | Sooji Huh |
| | | Email | [e-mail] |

# 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<br>Traditional 510k | K171122<br>Traditional 510k | Exemption from<br>Premarket Notification | |
| Classification<br>name | Orthodontic Plastic<br>Bracket | Orthodontic Plastic<br>Bracket | System, Optical<br>Impression, Computer<br>Assisted Design And<br>Manufacturing<br>(Cad/Cam) Of Dental<br>Restorations | |
| Regulation<br>number | 872.5470 | 872.5470 | 872.3661 | |
| Primary product<br>code | PNN(Orthodontic<br>software) | PNN(Orthodontic<br>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<br>(Traditional 510K) | K171122<br>(Traditional 510K) | Exemption from Premarket<br>Notification |
| Common Name | Orthodontic Software | Orthodontic Software | Orthodontic Software | System, Optical Impression,<br>Computer Assisted Design And<br>Manufacturing (Cad/Cam) Of<br>Dental Restorations |
| Classification<br>Product Code | PNN, NOF | PNN | PNN | NOF |
| Indications<br>for use | RAYDENT SW is a software<br>designed to assist dental<br>professionals in planning patient<br>treatment and designing treatment<br>devices. The software performs<br>simulations based on patient<br>images, allowing reference to<br>treatment plans, and is used as a<br>tool to design treatment devices<br>based on 3D mesh data.<br>Treatment devices include<br>prosthetic devices (Veneer,<br>Crown, Bridge, In/Onlay) and<br>orthodontic devices (Clear<br>Aligner).<br>To use RAYDENT SW, users<br>must have the necessary<br>education and domain knowledge<br>in orthodontic or prosthodontic<br>practice and receive dedicated<br>training in the use of the software. | Ortho System™ for dental<br>retainers and dental cast for<br>sequential aligners is intended for<br>use as a medical front-end device<br>providing tools for management of<br>orthodontic models, systematic<br>inspection, detailed analysis,<br>treatment simulation and virtual<br>appliance design options based<br>on 3D models of the patient's<br>dentition before the start of an<br>orthodontic treatment.<br>The use of the Ortho System™<br>requires the user to have the<br>necessary training and domain<br>knowledge in the practice of<br>orthodontics, as well as to have<br>received a dedicated training in<br>the use of the software. | CEREC Ortho Software is<br>intended for use with image data<br>acquired from handheld intra oral<br>3D cameras and desktop<br>laboratory scanners to create 3D<br>virtual models to be used for data<br>acquisition and modeling analysis<br>for orthodontic patients and<br>conditions. The CEREC Ortho<br>Software 3D model data can be<br>exported to orthodontic design<br>software to aid in the design of<br>orthodontic appliances. | ChairsideCAD is a software<br>device intended to support the<br>design of dental restorations such<br>as inlays, onlays, crowns,<br>copings, veneers, bridges,<br>pontics, provisionals and bite<br>splints via a 3D CAD tool. The<br>design is based on suitable 3D<br>scans of the patient's dental<br>anatomy produced by a<br>compatible scanner. The software<br>generates geometrical output of<br>the design for manufacturing on<br>compatible CAM systems.<br>ChairsideCAD is intended to be<br>used by trained professionals in<br>dental practices and is not to be<br>used for any purpose other than<br>the design of dental restorations<br>or bite splints, nor is it to be used<br>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/<br>Software<br>Requirements | CPU : Intel Core i5<br>RAM : 16GB<br>GPU : NVIDIA GeForce RTX<br>2060 6GB<br>Storage : 1TB SSD<br>Resolution : 1920 x 1080<br>LAN : 1Gbps Ethernet<br>OS : Windows 10 x64 or Windows<br>11 x64 | CPU : Intel Core i5 or equivalent<br>RAM : 8GB<br>GPU : 1GB<br>Storage : 250GB<br>Resolution : 1280 x 800 or similar<br>LAN : Network Internet connection<br>OS : Windows 7, 8 or 10 64-bit | CPU : Intel QuadCore 1.6 GHz<br>processor<br>RAM : 8GB<br>GPU : NVidia or AMD graphics<br>card 1 GB<br>Storage : 250GB hard disk<br>OS : Windows 7, 64-bit | CPU : Quad-Core<br>RAM : 4GB<br>GPU : 1GB<br>Resolution : 1920 x 1080<br>OS : Windows 10 64 bit |
|-------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------|
| Support Images | DICOM, 2D and 3D images (PLY,<br>OBJ, STL) | DICOM, STL, JPG, BMP, PNG | Intra-oral scan data, STL | DICOM, 2D and 3D images(STL,<br>OFF, OBJ, PLY) |
| Supported anatomic<br>areas | Maxilla, Mandible | Maxilla, Mandible | Maxilla, Mandible | Maxilla, Mandible |
| Functionality | - Acquisition of oral topography<br>image data<br>- Creation of virtual 3D virtual<br>dental models<br>- Alignment of 3D virtual dental<br>models<br>- Measurement of 3D virtual<br>dental models<br>- Analysis of 3D virtual dental<br>models<br>- Orthodontic treatment simulation<br>- Virtual orthodontic appliance<br>design<br>- Exporting of 3D virtual model,<br>analysis and treatment case data<br>- Prosthesis design | - Acquisition of oral topography<br>image data<br>- Creation of virtual 3D virtual<br>dental models<br>- Alignment of 3D virtual dental<br>models<br>- Measurement of 3D virtual<br>dental models<br>- Analysis of 3D virtual dental<br>models<br>- Orthodontic treatment simulation<br>- Virtual orthodontic appliance<br>design<br>- Exporting of 3D virtual model,<br>analysis and treatment case data | - Acquisition of oral topography<br>image data<br>- Creation of virtual 3D virtual<br>dental models<br>- Alignment of 3D virtual dental<br>models<br>- Measurement of 3D virtual<br>dental models<br>- Analysis of 3D virtual dental<br>models<br>- Exporting of 3D virtual model<br>and analysis data | - Design of dental restorations<br>- Geometrical output of the design<br>for manufacturing on compatible<br>CAM systems |
| Analysis Features | - Define occlusion<br>- Tooth segmentation<br>- Measure length and angle in the<br>frontal and lateral direction<br>- Define the tooth and set the<br>tooth axis<br>- Tooth width measurements<br>- Bolton analysis<br>- IPR | - Occlusal mapping<br>- Tooth and gingiva<br>separation/segmentation<br>- Definition of dental arch shape<br>and length<br>- Tooth width measurements<br>- Bolton's analysis<br>- Space analyses | - Occlusal mapping<br>- Tooth and gingiva<br>separation/segmentation<br>- Definition of dental arch shape<br>and length<br>- Tooth width measurements<br>- Bolton's analysis<br>- Nance and Moyer space<br>analyses | N/A |
| Artificial Intelligence<br>and Machine<br>Learning (AI/ML)-<br>Enabled Medical<br>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.