TRUST

K221107 · Rgorithm Korea · PNP · Jul 18, 2023 · Dental

Device Facts

• Record ID: K221107
• Device Name: TRUST
• Applicant: Rgorithm Korea
• Product Code: PNP · Dental
• Decision Date: Jul 18, 2023
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3630
• Device Class: Class 2
• Attributes: Software as a Medical Device

Indications for Use

TRUST is intended as an aid to the restoration of chewing function in partially edentulous mandibles and maxillae. TRUST is a software device intended to be used by a dental practitioner or dental laboratory staff for designing the patient specific component of one-piece type abutment. The design result is intended to be used by the manufacturer of an endosseous dental implant abutment to create the final device.

Device Story

TRUST is a standalone CAD software for designing patient-specific one-piece dental implant abutments. Input: 3D surface data (STL/PLY files) representing patient oral topography. Operation: User utilizes digital design tools to create abutment geometry based on parameters (e.g., post height, angulation, gingival margin) provided by cleared implant system manufacturers via a secure server. Output: Encrypted proprietary .TMZ file containing the abutment design, excluding the implant connection interface. Context: Used in dental clinics or laboratories by practitioners/technicians on standard Windows PCs. The design file is transmitted to a manufacturer for final device fabrication. Benefit: Enables customized abutment design to restore chewing function.

Clinical Evidence

No clinical data. Bench testing only, including software validation, hardware integration testing, and cybersecurity analysis performed per FDA guidance.

Technological Characteristics

Standalone CAD software; Windows 7/8/10 (64-bit) platform; 16GB RAM; 1920x1080 resolution; Internet/TCP-IP connectivity for design parameter retrieval and file export; proprietary .TMZ encrypted output format; web-based license management.

Indications for Use

Indicated for dental practitioners or laboratory staff to design patient-specific components for one-piece endosseous dental implant abutments to aid in restoring chewing function in partially edentulous mandibles and maxillae.

Regulatory Classification

Identification

An endosseous dental implant abutment is a premanufactured prosthetic component directly connected to the endosseous dental implant and is intended for use as an aid in prosthetic rehabilitation.

Special Controls

*Classification.* Class II (special controls). The guidance document entitled “Class II Special Controls Guidance Document: Root-Form Endosseous Dental Implants and Endosseous Dental Implant Abutments” will serve as the special control. (See § 872.1(e) for the availability of this guidance document.)

Predicate Devices

• Abutment Design (K200100)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image contains two logos. On the left is the Department of Health & Human Services logo. On the right is the FDA logo, which is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.

7/18/2023

Rgorithm Korea % Sanglok Lee Manager Wise Company Inc. #507, #508, 166 Gasan digital 2-ro Geumcheon-gu, Seoul 08503 Korea, South

Re: K221107

Trade/Device Name: TRUST Regulation Number: 21 CFR 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: Class II Product Code: PNP Dated: June 29, 2023 Received: June 30, 2023

# Dear Sanglok Lee:

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 (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 located 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

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Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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 803) for devices or postmarketing safety reporting (21 CFR 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 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 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 medical devices and radiation-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).

Sincerely,

Sherrill Lathrop Blitzer

Andrew Steen for 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

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# Indications for Use

510(k) Number (if known) K221107

Device Name TRUST

#### Indications for Use (Describe)

TRUST is intended as an aid to the restoration of chewing function in partially edentulous mandibles and maxillae. TRUST is a software device intended to be used by a dental practitioner or dental laboratory staff for designing the patient specific component of one-piece type abutment. The design result is intended to be used by the manufacturer of an endosseous dental implant abutment to create the final device.

Type of Use (Select one or both, as applicable)

| <span style="font-size:12px">☑ Prescription Use (Part 21 CFR 801 Subpart D)</span> |
|------------------------------------------------------------------------------------|
| <span style="font-size:12px">☐ Over-The-Counter Use (21 CFR 801 Subpart C)</span> |

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# 510(k) Summary – Traditional 510(K)

## The assigned 510(k) Number: K221107

## 01. Date of Submission: July 17, 2023

## 02. Applicant / Submitter

Roorithm Korea A-1502, 606 Seobusaet-gil, Geumcheon-gu, Seoul, 08504, Republic of Korea Tel. [phone]

## 03. Submission Correspondent

Sanglok. Lee Wise COMPANY Inc. #507, #508, 166 Gasan digital 2-ro, Geumcheon-gu, Seoul, Korea TEL: [phone] Email: [e-mail]

## 04. Proposed Device Identification

Device Identification and Regulatory information Proprietary Name: TRUST Common Name: Dental Abutment Design Software For Dental Laboratory Device Class: Class II Regulation Number: 21 CFR 872.3630 Regulation Name: Endosseous dental implant abutment Product Code: PNP

Indication for use: TRUST is intended as an aid to the restoration of chewing function in partially edentulous mandibles and maxillae. TRUST is a software device intended to be used by a dental practitioner or dental laboratory staff for designing the patient specific component of one-piece type abutment. The design result is intended to be used by the manufacturer of an endosseous dental implant abutment to create the final device.

#### 05. Predicate Device Identification

- Predicate device 510(k) Number: K200100 Device Name: Abutment Design Manufacturer: 3Shape A/S

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# 06. Device Description

TRUST is intended as an aid to the restoration of chewing function in partially edentulous mandibles and maxilla. TRUST is a software device intended to be used by a dental practitioner or dental laboratory staff for designing the patient specific component of one-piece type abutment. The design result is intended to be used by the manufacturer of an endosseous dental implant abutment to create the final device.

TRUST is restricted to be used with 510(k) cleared abutment systems, and the design output from TRUST (the patient specific part of the abutment) must be manufactured according to the instruction of the selected Implant system.

TRUST includes design parameters from the 510(k) cleared abutment systems such as implant type, maximum and minimum dimensions (e.g., abutment post height, angulation, gingival marqin diameter, wall thickness). The design parameters, provided by abutment system manufacturers(Truabutment), for an abutment system are available via a Trust server when documentation of the 510(k) clearance of said implant system is confirmed by Rgorithm.

TRUST has no patient contact being a software only device. (stand-alone software)

#### Scientific Concept

The underlying scientific concept of TRUST is to apply digital imaging tools for computer aided design(CAD) of abutments.

The system supports the following types of digital data: STL and PLY Only(3D surface data)

| | Subject Device | Predicate Device | Substantial Equivalence |
|-----------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Name | TRUST | Abutment Design | - |
| 510K number | | K200100 | - |
| Classification | Class 2 | Class 2 | Equivalent |
| Intended use | TRUST is intended as<br>an aid to the restoration<br>of chewing function in<br>partially edentulous<br>mandibles and maxillae.<br>TRUST is a software<br>device intended to be<br>used by a dental<br>practitioner or dental<br>laboratory staff for<br>designing the patient<br>specific component of<br>one-piece type<br>abutment. The design<br>result is intended to be<br>used by the<br>manufacturer of an | Abutment Design is<br>intended as an aid to the<br>restoration of chewing<br>function in partially or<br>fully edentulous<br>mandibles and maxillae.<br>Abutment Design is<br>intended for use by a<br>dental practitioner or<br>dental laboratory staff for<br>designing the patient<br>specific component of a<br>two-piece, one-piece, or<br>hybrid dental implant<br>abutment. The resulting<br>abutment design is<br>intended to be used by | Substantially Equivalent<br>Discussion - Intended use<br>of the subject device is a<br>subset of the predicate<br>device's Intended use, and<br>the inclusion of 'fully<br>edentulous' or not does not<br>raise any questions of<br>substantial equivalence.<br>Discussion - The change in<br>allowable abutment types<br>does not raise any<br>questions of substantial<br>equivalence. |
| | endosseous dental<br>implant abutment to<br>create the final device. | the manufacturer of an<br>endosseous dental<br>implant abutment to<br>create the final device | |
| Hardware requirements | | | |
| OS | Windows 7, 8, 10 (64-bit) | Windows 7, 8, 8.1 or 10 (64-bit) | Equivalence |
| RAM | 16GB | 8 GB | Equivalence or higher |
| Monitor<br>Resolution | 1920X1080 pixels | 1920x1080 pixels | Equivalence |
| Video Card<br>Memory | DirectX 11 | 1GB DirectX 11 | Equivalence |
| Available<br>HDD Space | 500 GB (1TB if used as<br>a standalone system or<br>a server with the order<br>folder) | 500 GB (1TB if used as a<br>standalone system or a<br>server with the order<br>folder) | Equivalence |
| CPU | Intel I3 Dual core | Intel Core i7 or<br>equivalent | Equivalence or lower |
| Network | Network Internet<br>connection | Network Internet<br>connection | Equivalence |
| USB ports | Software only | USB 2.0 port for 3Shape<br>desktop scanner | Not Equivalence<br>No additional connection<br>required |
| Mouse | With the wheel button<br>support | With the wheel button<br>support | Equivalence |
| 3D Mouse | Including wheel control<br>mouse | (Optional) 3DConnexion<br>SpaceMouse™ Pro | Not Equivalence<br>It only supports normal<br>keyboards and mouse. |
| Feature | | | |
| Graphical UI | Yes | Yes | Equivalence |
| Windows OS<br>platform | Yes | Yes | Equivalence |
| Uses<br>standard PC<br>hardware | Yes | Yes | Equivalence |
| | | | |
| Digitally<br>imports<br>topography<br>of teeth by<br>3D Scan | Yes | Yes | Equivalence |
| Uses 3D<br>CAD design<br>tools | Yes | Yes | Equivalence |
| Patient<br>specific<br>abutment<br>design | Yes | Yes | Equivalence |
| Implant Bar<br>design | No | No | Equivalence |
| Export to<br>remote<br>milling<br>machine by<br>internet | Yes | Yes | Equivalence |
| Network<br>Protocol | Internet/TCP-IP | Internet/TCP-IP | Equivalence |
| Intended<br>users | Dental practitioners and<br>dental<br>technicians | Dental practitioners and<br>dental technicians | Equivalence |
| Output type | The abutment is saved<br>as a .TMZ file. Digital<br>encrypted<br>proprietary .TMZ file only<br>of the patient specific<br>abutment component,<br>not including the<br>abutment-to implant<br>connection interface.<br>Encryption is always<br>active until the output is<br>decrypted by our servers<br>during the ordering<br>process, when it is sent<br>to an abutment<br>manufacturer for<br>creation of the final | Digital encrypted or non-<br>encrypted proprietary<br>or .STL file only of the<br>patient specific abutment<br>component, not including<br>the abutment-to implant<br>connection interface. If<br>encryption is active or not<br>will solely be determined<br>by the 510(k) clearance<br>of the abutment system. | Equivalence |
| | device. | | |
| *Device<br>submission<br>includes pre-<br>manufactured<br>prosthetics | No | No | Equivalence |

#### 07. Summary of Technological Characteristics Comparison

TRUST has the same intended uses, principle of operation and similar technical characteristics and

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Abutment Design (K200100) is bundled with Intra-oral Scanner or model scanner. Trust is stand-alone and Web distribution S/W. Abutment Design(K200100) manages licenses in a USB dongle, while Trust manages licenses in the web.

The difference in use of a USB dongle compared to the subject license management in the web is addressed by cybersecurity measures which use the IP address to verify user's ID and password.

# 08. Non clinical Testing Data

Software, hardware, and integration and validation testing was performed in accordance with the FDA Guidance Document "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices", issued on May 11, 2005.

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

The cybersecurity analysis was performed in accordance with the FDA Guidance Document "Content of Premarket Submissions for Management of Cybersecurity in Medical Devices", issued on October 02, 2014.

All test results have been reviewed and approved, showing the TRUST to be substantially equivalent to the primary predicate device.

#### 09. Clinical Testing

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

# 10. Substantial Equivalence Conclusion

Based on the results of software validation and the information provided herein, we conclude that the proposed device is substantially equivalent to the predicate devices.