K Number

Device Name

TRUST

Manufacturer

Rgorithm Korea

Date Cleared

2023-07-18

(459 days)

Product Code

PNP

Regulation Number

872.3630

Intended 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 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)

More Information

Contact

Type

Center

Panel

Date Received

Product Code

Subsequent Product Codes

Applicant Name (Manufacturer)

Device Name

Decision

Street 1

Street 2

City

State

Country Code

ZIP

Postal Code

Class Advise Committee

SSP Indicator

Third Party Reviewed

Expedited Review

Predicate Devices

K200100

Reference Devices

K200100

AI/ML (Artificial Intelligence / Machine Learning)

No
The summary describes a software device for designing dental abutments based on pre-defined parameters from cleared systems, with no mention of AI or ML technologies.

Therapeutic

No
TRUST is a software device intended for designing patient-specific components of one-piece type abutments, which are then manufactured into the final device. It is an aid in the restoration of chewing function, but it is not the therapeutic device itself; it is a design tool.

Diagnostic

TRUST is a software device intended for designing patient-specific components of dental abutments, aiding in the restoration of chewing function, not for diagnosing conditions or diseases.

SaMD (Software as a Medical Device)

Yes

The device description explicitly states "TRUST has no patient contact being a software only device. (stand-alone software)".

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

Intended Use: The intended use is to aid in the restoration of chewing function by designing a patient-specific dental implant abutment. This is a mechanical/structural function related to dental prosthetics, not a diagnostic test performed on biological samples.
Device Description: The device is described as software used by dental professionals to design a component of a dental implant system. It does not involve analyzing biological samples or providing diagnostic information about a patient's health status.
Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analysis of biological samples (blood, urine, tissue, etc.)
- Detection or measurement of analytes
- Providing information for diagnosis, monitoring, or prognosis of a disease or condition

The device is clearly focused on the design and manufacturing process of a dental prosthetic component, which falls under the category of medical devices used for restoration and function, not in vitro diagnostics.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

Product codes

PNP

Device Description

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)

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).

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

3D Scan (STL and PLY Only(3D surface data))

Anatomical Site

Mandibles and maxillae (partially edentulous)

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Dental practitioner or dental laboratory staff

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 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.

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

Not Found

Predicate Device(s)

K200100

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

Regulation Number and Section

§ 872.3630 Endosseous dental implant abutment.

(a)
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.(b)
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.)

Summary

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

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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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

Indications for Use

510(k) Number (if known) K221107

Device Name TRUST

Indications for Use (Describe)

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 – 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. +82 2 6264 4688

03. Submission Correspondent

Sanglok. Lee Wise COMPANY Inc. #507, #508, 166 Gasan digital 2-ro, Geumcheon-gu, Seoul, Korea TEL: +82 2 831 3615 Email: info@wisecompany.org

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

06. Device Description

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
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	Abutment Design is
intended as an aid to the
restoration of chewing
function in partially or
fully edentulous
mandibles and maxillae.
Abutment Design is
intended for use by a
dental practitioner or
dental laboratory staff for
designing the patient
specific component of a
two-piece, one-piece, or
hybrid dental implant
abutment. The resulting
abutment design is
intended to be used by	Substantially Equivalent
Discussion - Intended use
of the subject device is a
subset of the predicate
device's Intended use, and
the inclusion of 'fully
edentulous' or not does not
raise any questions of
substantial equivalence.
Discussion - The change in
allowable abutment types
does not raise any
questions of substantial
equivalence.
	endosseous dental
implant abutment to
create the final device.	the manufacturer of an
endosseous dental
implant abutment to
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
Resolution	1920X1080 pixels	1920x1080 pixels	Equivalence
Video Card
Memory	DirectX 11	1GB DirectX 11	Equivalence
Available
HDD Space	500 GB (1TB if used as
a standalone system or
a server with the order
folder)	500 GB (1TB if used as a
standalone system or a
server with the order
folder)	Equivalence
CPU	Intel I3 Dual core	Intel Core i7 or
equivalent	Equivalence or lower
Network	Network Internet
connection	Network Internet
connection	Equivalence
USB ports	Software only	USB 2.0 port for 3Shape
desktop scanner	Not Equivalence
No additional connection
required
Mouse	With the wheel button
support	With the wheel button
support	Equivalence
3D Mouse	Including wheel control
mouse	(Optional) 3DConnexion
SpaceMouse™ Pro	Not Equivalence
It only supports normal
keyboards and mouse.
Feature
Graphical UI	Yes	Yes	Equivalence
Windows OS
platform	Yes	Yes	Equivalence
Uses
standard PC
hardware	Yes	Yes	Equivalence

Digitally
imports
topography
of teeth by
3D Scan	Yes	Yes	Equivalence
Uses 3D
CAD design
tools	Yes	Yes	Equivalence
Patient
specific
abutment
design	Yes	Yes	Equivalence
Implant Bar
design	No	No	Equivalence
Export to
remote
milling
machine by
internet	Yes	Yes	Equivalence
Network
Protocol	Internet/TCP-IP	Internet/TCP-IP	Equivalence
Intended
users	Dental practitioners and
dental
technicians	Dental practitioners and
dental technicians	Equivalence
Output type	The abutment is saved
as a .TMZ file. Digital
encrypted
proprietary .TMZ file only
of the patient specific
abutment component,
not including the
abutment-to implant
connection interface.
Encryption is always
active until the output is
decrypted by our servers
during the ordering
process, when it is sent
to an abutment
manufacturer for
creation of the final	Digital encrypted or non-
encrypted proprietary
or .STL file only of the
patient specific abutment
component, not including
the abutment-to implant
connection interface. If
encryption is active or not
will solely be determined
by the 510(k) clearance
of the abutment system.	Equivalence
	device.
*Device
submission
includes pre-
manufactured
prosthetics	No	No	Equivalence

07. Summary of Technological Characteristics Comparison

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

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

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 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.