URIS Smart Path Implant System & Prosthetic is indicated for use in partially or fully edentulous mandibles and maxillae, in support of single or multiple-unit restorations including; cemented retained, or overdenture restorations, and final or temporary abutment support for fixed bridgework. It is intended for delayed loading.

All digitally designed abutments and/or coping for use with URIS Smart Path Prosthetic abutments are intended to be sent to a TruAbutment-validated milling center for manufacture.

Device Description

URIS Smart Path Implant System fixtures are dental implants made of Unalloyed Titanium, grade 4 (ASTM F67) intended for use in partially or fully edentulous mandibles and maxillae, in support of single or multipleunit restorations. The surface treated is SLA (Sandblasted, Large grit and Acid etched) and is provided sterile. It consists of two implant lines, the Smart Path OMNI Thread and the Smart Path extra aggressive Thread, with corresponding cover screws, healing abutments. The Smart Path implant has a tapered wall with a single thread design. The Smart Path extra aggressive Thread is straight walled with smaller threading at the coronal end, and bigger threading at the apical end.

URIS SP Prosthetic System is made of titanium alloy (Ti-6Al-4V ELI) intended for use as an aid in prosthetic restoration. It consists of SP Healing Abutment, SP Temporary Abutment, SP Multi-Unit Straight Abutment, SP Multi-Unit Angled Abutment, SP T-L Straight Abutment, URIS SP Base, URIS SP DS, SP Abutment Screw.

Cover screw and healing abutment are anodized in yellow or green or purple.

Fixtures and cover screw are provided sterile and other prosthetics are provided non-sterile. All non-sterile products must be sterilized by end users before use.

URIS SP Base consists of a two-piece abutment, where the titanium base is a pre-manufactured abutment that will be used to support a CAD/CAM designed superstructure (the second part of the two-piece abutment) that composes the final abutment. URIS Base is made of titanium alloy conforming to ASTM F136 Standard Specification for Wrought Titanium-6Aluminum-4Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant Applications.

AI/ML Overview

The provided text is a 510(k) Summary for the URIS Smart Path Implant System & Prosthetic. It describes the device, its intended use, and argues for its substantial equivalence to predicate devices based on technological characteristics and non-clinical testing.

However, the document does not contain any information about acceptance criteria or a study that specifically proves the device meets acceptance criteria in the context of clinical performance or diagnostic accuracy, which are typically associated with the questions asked.

The document focuses on non-clinical tests to demonstrate substantial equivalence, as is common for dental implants and prosthetics. These tests are primarily related to material properties, sterilization, packaging, and mechanical fatigue.

Therefore, most of the requested information cannot be extracted from this document, as it pertains to clinical performance/accuracy studies which were explicitly stated as not included: "No clinical data were included in this submission."

Here's a breakdown of what can be extracted and what information is missing:

1. A table of acceptance criteria and the reported device performance

Test Performed	Acceptance Criteria (Explicitly Stated in Document)	Reported Device Performance (as stated in Document)
Bacterial Endotoxin Testing (LAL)	In accordance with USP <85> and USP <161>	"met the standards"
Sterilization Testing	According to ISO 11137-1,-2,-3 and ISO 11737-1,-2	"met the standards"
Shelf Life Testing	According to ISO 11607-1,-2 / ASTM F1980-07, ASTM F88, ASTM F1140, ASTM F1929, ASTM F2096 and sterility testing	"met the standards"
Biocompatibility Testing	Based on ISO 10993-1	Leveraged from predicate and reference devices (K172100 and K200817) and determined to be similar based on similar materials and manufacturing processes.
SEM and EDS analysis for SLA surface treatment	(Implicit: demonstrate identical surface treatment characteristics as predicate/reference)	Leveraged from prior clearance for identical SLA surface treatment and manufacturing.
Human Factors testing (usability evaluation for aseptic presentation)	In line with ISO 11607-1:2019 and FDA guidance "Applying Human Factors and Usability Engineering to Medical Devices."	(Implied: met standards, no specific results reported)
Evaluation of broken tip at various degrees of rotation after removal from packaging	(Implicit: prevention of device damage during removal)	(Implied: met standards, no specific results reported)
Quality System (QS) plan for packaging design	Ensure devices conform with product specifications	(Implied: met standards, no specific results reported)
Fatigue testing (for endosseous dental implants)	According to "Guidance for industry and FDA staff Class II Special Controls Guidance Document Root-form Endosseous Dental Implants and Endosseous Dental Abutment" and ISO 14801:2016 under worst-case scenario.	"met the standards"
MR Environment Condition (Magnetically Induced Displacement Force and Torque on metal alloys)	Based on FDA guidance "Testing and Labeling Medical Devices for Safety in the Magnetic Resonance (MR) Environment"	(Implied: evaluated and deemed safe, no specific results reported)

Missing Information (Not present in the provided document):

Sample sizes used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective): Not applicable, as no clinical studies with test sets were performed. Non-clinical tests typically report sample sizes per test standard, but these are not detailed here beyond stating "worst-case scenario" for fatigue testing.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, as no clinical studies requiring ground truth establishment were performed.
Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable, as no clinical studies requiring adjudication were performed.
If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This device is a dental implant system, not an AI-powered diagnostic tool, and no clinical studies were performed.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an algorithm-only device.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable, as no clinical studies requiring ground truth were performed.
The sample size for the training set: Not applicable, as no AI/machine learning component requiring a training set is described.
How the ground truth for the training set was established: Not applicable, as no AI/machine learning component requiring a training set is described.

Summary

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

December 29, 2023

TruAbutment Inc. Chris Kim Manager 17666 Fitch Irvine. California 92614

Re: K230438

Trade/Device Name: URIS Smart Path Implant System & Prosthetic Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: Class II Product Code: DZE, NHA Dated: October 5, 2023 Received: December 1, 2023

Dear Chris Kim:

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.

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).

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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 OS 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.

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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,

Andrew I. Steen -S

Andrew I. Steen 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) K230438

Device Name

URIS Smart Path Implant System & Prosthetic

Indications for Use (Describe)

All digitally designed abutments and/or coping for use with URIS Smart Path Prosthetic abutments are intended to be sent to a TruAbutment-validated milling center for manufacture.

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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Image /page/4/Picture/0 description: The image shows a logo for "Abutment". The logo is in blue and features the word "Abutment" in a stylized font. The "A" in "Abutment" is larger than the other letters, and the "ru" is written in a cursive style. The logo has a jagged edge on the left side, resembling teeth.

510(k) Summary K230438

Submitter TruAbutment Inc. Ki Yoon Nam 17666 Fitch, Irvine, CA 92614 USA Email: kiyoon.nam@truabutment.com Phone: 1-714-956-1488

Official Correspondent

TruAbutment Inc. Chris Kim 17666 Fitch, Irvine, CA 92614 USA Email: chris.kim(@truabutment.com Phone: 1-714-956-1488

Device Information

Trade Name: URIS Smart Path Implant System & Prosthetic ●
. Common Name: Dental implants
. Classification Name: Endosseous Dental Implant
. Primary Product Code: DZE
Secondary Product Code: NHA ●
. Panel: Dental
Regulation Number: 21 CFR 872.3640
. Device Class: Class II
Date prepared: 12/29/2023

Predicate Devices/ Reference Devices:

The subject device is substantially equivalent to the following predicate and refernce devices:

Primary Predicate:

. URIS OMNI System (K172100) by TruAbutment Korea Co., Ltd.

Reference Devices:

IBS System (K220517) by InnoBioSurg Co., Ltd.
URIS OMNI Narrow System & Prosthetic (K200817) by TruAbutment Korea Co., Ltd.
InCoris Zi (K123664) by Sirona Dental Systems GmbH. ●
RelyX Unicem 2Automix (K100756) by 3M ESPE ●

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Image /page/5/Picture/0 description: The image shows a logo for "Abutment.ru". The logo is in blue and features the word "Abutment" in a stylized font, with the "A" slightly larger than the other letters. Below "Abutment" is ".ru" in a larger, bolder font, also in blue. The left side of the logo has a jagged edge, resembling the profile of a screw thread.

General Description

Cover screw and healing abutment are anodized in yellow or green or purple.

Fixtures and cover screw are provided sterile and other prosthetics are provided non-sterile. All non-sterile products must be sterilized by end users before use.

Raw material blanks

InCoris Zi (ZrO2) by Sirona Dental Systems GmbH, L size blanks, cleared under K123664. ● Cement

. RelyX Unicem 2Automix by 3M ESPE, cleared under K100756.
All zirconia superstructure that composes the final abutment must be designed and milled through the 3 shape CAD/CAM System, by TruAbutment validated milling center, according to the prosthetic planning and patient clinical situation.

Design parameter	Limit (Min.~Max.)
Maximum Angulation	0~15°
Maximum Cuff Height	0.5~5.0 mm
Minimum Diameter	Ø5.0~ Ø8.0
Minimum wall thickness at abutment/implant interface	0.4mm
Minimum and Maximum length of abutment post	4.0~6.0 mm

Design Limitation for Zirconia superstructure

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Image /page/6/Picture/0 description: The image shows a logo with the word "ABUTMENT" in a stylized font. The letters "ru" are written in a large, cursive font, with the "r" appearing to have a jagged edge. The logo is a light blue color, and there is a black line at the bottom of the image.

Indication for Use

URIS Smart Path Implant System & Prosthetic is indicated for use in partially or fully edentulous mandibles and maxillae, in support of single or multiple-unit restorations including; cemented retained, screw retained, or overdenture restorations, and final or temporary abutment support for fixed bridgework. It is intended for delayed loading.

All digitally designed abutments and/or coping for use with URIS OMNI Prosthetic abutments are intended to be sent to a TruAbutment-validated milling center for manufacture.

Summary of Technological Characteristics

The subject device is substantially equivalent to the currently cleared devices. They are substantially equivalent in intended use, material, design, dimension, connection, functions and surface treatments. Comparison demonstrating Substantial Equivalence follows at the end of this section.

URIS SP Fixture

	Subject Device	Predicate Device	Reference Devices
510KNumber	K230438	K172100	K220517
DeviceName	URIS Smart Path ImplantSystem & Prosthetic	URIS OMNI System	IBS System
Manufacturer	TruAbutment Korea Co.,Ltd	TruAbutment Korea Co.,Ltd	InnoBioSurg Co., Ltd.
Indicationsfor Use	URIS Smart Path ImplantSystem & Prosthetic isindicated for use inpartially or fully edentulousmandibles and maxillae, insupport of single ormultiple-unit restorationsincluding; cementedretained, screw retained, oroverdenture restorations,and final or temporaryabutment support for fixedbridgework. It is intendedfor delayed loading.All digitally designedabutments and/or copingfor use with URIS OMNIProsthetic abutments areintended to be sent to aTruAbutment-validatedmilling center for	URIS OMNI System isindicated for use in partiallyor fully edentulousmandibles and maxillae, insupport of single or multiple-unit restorations including;cemented retained, screwretained, or overdenturerestorations, and final ortemporary abutment supportfor fixed bridgework. It isintended for delayed loading.	The IBS System is intendedto replace missing teeth torestore chewing function.The IBS System can beplaced in support of singleor multiple-unit restorationsincluding; cement retained,screw retained, oroverdenture restorations,and terminal or immediateabutment support for fixedbridgework. This system isfor one or two stagesurgical procedures.This system is intended fordelayed loading.
	Subject Device	Predicate Device	Reference Devices
510KNumber	K230438	K172100	K220517
	manufacture.
Design	Image: Subject Device	Image: Predicate Device	Image: Reference Devices
Structure	- Internal - connected- Submerged Fixture	- Internal Hex- connected- Submerged Fixture	- Internal Hex- connected- Non Submerged Fixture
BodyDiameter(D)andLength(mm)	SP OMNI ThreadØ3.5 x 8.5, 10, 11.5, 13, 14.5mm,Ø4.0 x 7, 8.5, 10, 11.5, 13, 14.5mm,Ø4.5 x 7, 8.5, 10, 11.5, 13, 14.5mm,Ø5.0 x 7, 8.5, 10, 11.5, 13, 14.5mm,Ø5.5 x 7, 8.5, 10, 11.5, 13, 14.5mm,Ø6.0 x 7, 8.5, 10mm,Ø6.5 x 7, 8.5, 10mmSP Extra Aggressive ThreadØ3.5 x 7, 8.5, 10, 11.5, 13, 14.5mm,Ø4.0 x 7, 8.5, 10, 11.5, 13, 14.5mm,Ø4.5 x 7, 8.5, 10, 11.5, 13, 14.5mm,Ø5.0 x 7, 8.5, 10, 11.5, 13, 14.5mm,Ø5.5 x 7, 8.5, 10mm,	Ø3.5 x 8.5, 10, 11.5, 13, 14.5mm,Ø4.0 x 7, 8.5, 10, 11.5, 13, 14.5mm,Ø4.5 x 7, 8.5, 10, 11.5, 13, 14.5mm,Ø5.0 x 7, 8.5, 10, 11.5, 13, 14.5mm,Ø5.5 x 7, 8.5, 10, 11.5, 13, 14.5mm,Ø6.0 x 7, 8.5, 10mm,Ø6.5 x 7, 8.5, 10mm	Ø7.0 x 7, 8, 9, 10, 11, 12,13mmØ7.5 x 7, 8, 9, 10, 11, 12,13mmØ8.0 x 7, 8, 9, 10, 11, 12,13mm
Material ofFixture	CP Ti Grade 4 (ASTMF67)	CP Ti Grade 4 (ASTM F67)	Ti-6Al-4V Eli
Surface	Sand-blasted, Large grit,Acid-etched(S.L.A)	Sand-blasted, Large grit,Acid-etched(S.L.A)	Sand-blasted, Large grit,Acid-etched(S.L.A)
Sterilization	Gamma Sterilization	Gamma Sterilization	Gamma Sterilization
Shelf Life	5years	5years	5years
ImplantBodyFeatures	Threaded	Threaded	Threaded
ProductCode	DZE	DZE	DZE
	Subject Device	Predicate Device	Reference Devices
510KNumber	K230438	K172100	K220517
SE	The subject device is substantially equivalent in indications and design principles to theprimary predicate device and the reference devices listed above. Provided tables arecomparing the Indications for Use Statements and the technological characteristics of thesubject device, the primary predicate device, and the reference devices.The Indications for Use Statement (IFUS) for subject device abutment is substantiallyequivalent in intended use to the predicate device K172100. All are intended for usewith endosseous dental implants in the maxilla and mandible to provide functional andesthetic rehabilitation of the edentulous maxilla and mandible.Minor differences in the designs, implant connections, dimensions, or sizes between thesubject device, the predicate device, and the reference devices do not affect substantialequivalence.The implant body dimension of the subject device is the similar included in K172100.URIS SP Extra Aggressive Implant bodies are only available in limited diameters/lengths.Ø3.5 x 7, 8.5, 10, 11.5, 13, 14.5mm,Ø4.5 x 7, 8.5, 10, 11.5, 13, 14.5mm,Ø5.5 x 7, 8.5, 10mmThe subject device and reference device K220517 packaging methods are similar.

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Image /page/7/Picture/0 description: The image contains the word "ABUTMENT" in a stylized font. The letters are in a bright blue color. The bottom of the word is designed to look like a screw.

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Image /page/8/Picture/0 description: The image features a logo with the word "ABUTMENT" in a stylized, sans-serif font. The letters are white against a blue background. The "ru" in "ABUTMENTru" is larger and more prominent, with the "r" extending downwards in a curved shape. The bottom of the "r" has a jagged edge, resembling the threads of a screw or bolt.

URIS SP Abutments

Subject Device	Predicate Device
----------------	------------------

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Image /page/9/Picture/0 description: The image shows the word "ABUTMENT" in a stylized font. The letters are blue and white. Below the word is the number 2.

Part Name	Healing Abutment	Healing Abutment
Design	Image: Healing Abutment Design 1	Image: Healing Abutment Design 2
Applicant	TruAbutment Korea Co., Ltd	TruAbutment Korea Co., Ltd
Trade Name	URIS Smart Path Implant System	URIS OMNI System
510(K) No.	K230438	K172100
ClassificationName	Endosseous Dental ImplantAbutments(872.3630)	Endosseous Dental ImplantAbutments(872.3630)
Product Code	NHA	NHA
Material	Ti-6Al-4V ELI (ASTM F136)	Ti-6Al-4V ELI (ASTM F136)
Description	URIS Smart Path Implant System &Prosthetic is indicated for use inpartially or fully edentulousmandibles and maxillae, in support ofsingle or multiple-unit restorationsincluding; cemented retained, screwretained, or overdenture restorations,and final or temporary abutmentsupport for fixed bridgework. It isintended for delayed loading.	URIS OMNI System is indicated for usein partially or fully edentulous mandiblesand maxillae, in support of single ormultiple-unit restorations including;cemented retained, screw retained, oroverdenture restorations, and final ortemporary abutment support for fixedbridgework. It is intended for delayedloading.
Diameters	4.0/4.5/5.0/6/7mm	4.0/4.5/5.5/6.5/7.5mm
SurfaceTreatment	Anodizing (Yellow, Green)	Anodizing (Yellow, Green)
Sterile	Non-sterile	Non-sterile
SE	The subject device and reference devices (K172100) have the similar intendeduse, have similar technological characteristic, and are made of similar materials.The subject device and reference device have similar physical dimensions,including diameter. Therefore, the subject device is substantially equivalent tothe currently cleared devices.	The subject device and reference devices (K172100) have the similar intendeduse, have similar technological characteristic, and are made of similar materials.including diameter. Therefore, the subject device is substantially equivalent tothe currently cleared devices.

	Subject Device	Reference Device
--	----------------	------------------

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Image /page/10/Picture/0 description: The image shows the word "ABUTMENT" in white letters on a blue background. Below the word is a blue image that looks like a screw. The number 2 is in the bottom right corner of the image.

Part Name	T-L Straight Abutment	T LOC Straight Abutment
Design	Image: T-L Straight Abutment	Image: T LOC Straight Abutment
Applicant	TruAbutment Korea Co., Ltd.	TruAbutment Korea Co., Ltd.
Trade Name	URIS Smart Path Implant System	URIS OMNI Narrow System &Prosthetic
510(K) No.	K230438	K200817
ClassificationName	Endosseous Dental ImplantAbutments(872.3630)	Endosseous Dental ImplantAbutments(872.3630)
Product Code	NHA	NHA
Material	Ti-6Al-4V ELI (ASTM F136)	Ti-6Al-4V ELI (ASTM F136)
Description	T-L Straight Abutment is intendedfor use in conjunction with thefixture in partially or fully edentulousmandibles and maxillae, in support ofmultiple-unit cement retainedrestorations.	T LOC Straight Abutment is intended foruse in conjunction with the fixture inpartially or fully edentulous mandiblesand maxillae, in support of single ormultiple-unit cement retainedrestorations.
Diameters	3.8mm	3.8mm
Lengths	G/H : 1.0/2.0/3.0/4.0/5.0/6.0 mm	G/H : 1.0/2.0/3.0/4.0/5.0/6.0 mm
SurfaceTreatment	None	None
Sterile	Non-sterile	Non-sterile
SE	The subject device (T-L Straight Abutment) is substantially equivalent to the predicate device (TLOC Straight Abutment, K200817). The subject device and the predicate device K200817 have internal connections, are made of Ti-6Al-4V ELI, and are conducted End User Steam Sterilization.

	Subject Device	Reference Device
Part Name	Multi-Unit Straight Abutment	Multi-Unit Straight Abutment

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Image /page/11/Picture/0 description: The image shows a logo for a company called "Abutment". The logo is blue and features the word "Abutment" in a stylized font. The logo also includes a graphic of a screw. There is a number "2" below the logo.

Design	Image: Dental implant	Image: Dental implant
Applicant	TruAbutment Korea Co., Ltd.	TruAbutment Korea Co., Ltd.
Trade Name	URIS Smart Path Implant System	URIS OMNI Narrow System & Prosthetic
510(K) No.	K230438	K200817
Classification Name	Endosseous Dental ImplantAbutments(872.3630)	Endosseous Dental ImplantAbutments(872.3630)
Product Code	NHA	NHA
Material	Ti-6Al-4V ELI (ASTM F136)	Ti-6Al-4V ELI (ASTM F136)
Description	Multi-Unit Straight Abutment isintended for use in conjunction withthe fixture in partially or fullyedentulous mandibles and maxillae, insupport of multiple-unit cementretained restorations.	Multi-Unit Straight Abutment is intendedfor use in conjunction with the fixture inpartially or fully edentulous mandiblesand maxillae, in support of single ormultiple-unit cement retained restorations.
Diameters	5.0mm	5.0mm
Lengths	G/H :1.0/2.0/3.0/4.0/5.0/6.0mm	G/H :1.0/2.0/3.0/4.0/5.0/6.0mm
Angularcorrection	No angular correction allowed	No angular correction allowed
SurfaceTreatment	None	None
Sterile	Non-sterile	Non-sterile
SE	The subject device (Multi-unit Straight Abutment) is substantially equivalent to thepredicate device (Multi Straight Abutment, K172100). The subject device and thepredicate device K172100 have internal implant interface connections, are made ofTi-6Al-4V ELI, and are conducted End User Steam Sterilization. The subjectdevice doesn't include surface treatment. and abutment with a post length of lessthan 4mm is only available for multi-unit cases.

Subject Device	Reference Device
----------------	------------------

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Image /page/12/Picture/0 description: The image shows a logo with the word "ABUTMENT" in white letters on a blue background. The letters are stylized, with the "A" being larger than the other letters. Below the word "ABUTMENT" is a blue image that resembles a screw or bolt. The logo is simple and eye-catching, and the use of blue and white gives it a clean and professional look.

Part Name	Multi-Unit Angled Abutment	Multi-Unit Angled Abutment
Design	Image: Multi-Unit Angled Abutment	Image: Multi-Unit Angled Abutment
Applicant	TruAbutment Korea Co., Ltd	TruAbutment Korea Co., Ltd
Trade Name	URIS Smart Path Implant System	URIS OMNI Narrow System &Prosthetic
510(K) No.	K230438	K200817
ClassificationName	Endosseous Dental ImplantAbutments(872.3630)	Endosseous Dental ImplantAbutments(872.3630)
Product Code	NHA	NHA
Material	Ti-6Al-4V ELI (ASTM F136)	Ti-6Al-4V ELI (ASTM F136)
Description	Multi-Unit Angled Abutment isintended for use in conjunction withthe fixture in partially or fullyedentulous mandibles and maxillae,in support of multiple-unit cementretained restorations.	Multi-Unit Angled Abutment is intendedfor use in conjunction with the fixture inpartially or fully edentulous mandiblesand maxillae, in support of single ormultiple-unit cement retainedrestorations.
Diameters	5.0mm	5.0mm
Lengths	G/H : 3.0/4.0/5.0(17°)G/H : 4.0/5.0/6.0(29.5°)	G/H : 3.0/4.0/5.0(17°)G/H : 4.0/5.0/6.0(29.5°)
Post Angle	17° / 29.5°	17° / 29.5°
SurfaceTreatment	None	None
Sterile	Non-sterile	Non-sterile
SE	The subject device (Multi-unit Angled Abutment) are substantially equivalent tothe predicate device (Multi unit Angled Abutment, K200817). The subject deviceand the predicate device have internal connections, are made of Ti-6Al-4V ELI,and are conducted End User Steam Sterilization.

Subject Device	Predicate Device
----------------	------------------

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Image /page/13/Picture/0 description: The image shows the word "ABUTMENT" in a stylized font. The letters are white and set against a blue background. The bottom of the image has a design that resembles the threads of a screw, also in blue.

Part Name	Temporary Abutment	Temporary Abutment
Design	Image: Temporary Abutment Design 1	Image: Temporary Abutment Design 2
Applicant	TruAbutment Korea Co., Ltd	TruAbutment Korea Co., Ltd.
Trade Name	URIS Smart Path Implant System	URIS OMNI System
510(K) No.	K230438	K172100
ClassificationName	Endosseous Dental ImplantAbutments(872.3630)	Endosseous Dental ImplantAbutments(872.3630)
ProductCode	NHA	NHA
Material	Ti-6Al-4V ELI (ASTM F136)	Ti-6Al-4V ELI (ASTM F136)
Description	URIS Smart Path Implant System isindicated for use in partially or fullyedentulous mandibles and maxillae, insupport of single or multiple-unitrestorations including; cemented retained,screw retained, or overdenture restorations,and final or temporary abutment supportfor fixed bridgework. It is intended fordelayed loading.	URIS OMNI System is indicated for use inpartially or fully edentulous mandibles andmaxillae, in support of single or multiple-unit restorations including; cementedretained, screw retained, or overdenturerestorations, and final or temporaryabutment support for fixed bridgework. Itis intended for delayed loading.
Diameters	3.7 / 4.2 / 4.7mm	3.7 / 4.3mm
Lengths	Height 10mm	Height 10mm
Angularcorrection	Patient-specific customized by hand-milling with no angular correction.	Patient-specific customized by hand-milling with no angular correction.
SurfaceTreatment	None	None
MaximumDuration	Less than 6 months	Less than 6 months
Sterile	Non-sterile	Non-sterile
SE	The subject temporary abutment and reference devices are substantiallyequivalent in intended use, material, surface treatment, design, dimension andmaximum duration of 6 months. K172100 is selected as a predicate device as it isindicated for temporary restorations of single crowns and bridges for up to sixmonths. The diameters of the subject device are slightly different from theReference devices. However, the diameter of 4.7mm is in the range of diametersof predicates and this dimensional difference doesn't affect substantialequivalence.

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Image /page/14/Picture/0 description: The image shows the word "ABUTMENT" in a stylized font. The word is written in all capital letters, with the "A" slightly larger than the other letters. The letters are blue, and the image has a white background. The bottom of the image has a design that looks like the bottom of a screw.

	Subject Device	Reference Device
Part Name	URIS SP DS	URIS DS
Design	Image: URIS SP DS	Image: URIS DS
Applicant	TruAbutment Korea Co., Ltd	TruAbutment Korea Co., Ltd
Trade Name	URIS Smart Path Implant System	URIS OMNI Narrow System & Prosthetic
510(K) No.	K230438	K200817
ClassificationName	Endosseous Dental ImplantAbutments(872.3630)	Endosseous Dental ImplantAbutments(872.3630)
Product Code	NHA	NHA
Material	Ti-6Al-4V ELI (ASTM F136)	Ti-6Al-4V ELI (ASTM F136)
Description	URIS SP DS is a patient-specific CAD/CAMabutment, directly connected to endosseousdental implants and is intended for use as anaid in prosthetic rehabilitation.All digitally designed abutments and/or copingfor use with the URIS SP DS abutments areintended to be sent to a TruAbutment-validatedmilling center for manufacture.	URIS DS is a patient-specific CAD/CAMabutment, directly connected to endosseousdental implants and is intended for use as anaid in prosthetic rehabilitation. It is compatiblewith the following systems:URIS OMNI System Implants(K172100) 3.5, 4.0, 4.5, 5.0, 5.5, 6.0,6.5mmURIS OMNI Narrow System Implants(Proposed) 3.15 mmAll digitally designed abutments and/or copingfor use with the TruAbutment DS abutments areintended to be sent to a TruAbutment-validatedmilling center for manufacture.
CAD DesignLimits	Minimum and Maximum Gingiva Height:0.5~~4mmMinimum and Maximum diameter atabutment/implant interface: Ø3.8~~Ø5.5Minimum and Maximum length ofabutment: 6~~11mmMinimum and Maximum length ofabutment post (length above the abutmentcollar/gingival height): 4~~8mmMinimum wall thickness atabutment/implant interface: 0.4mm	Minimum and Maximum Gingiva Height:0.5~~4mmMinimum and Maximum diameter atabutment/implant interface: Ø3.8~~Ø5.5Minimum and Maximum length ofabutment: 6~~11mmMinimum and Maximum length ofabutment post (length above the abutmentcollar/gingival height): 4~~8mmMinimum wall thickness atabutment/implant interface: 0.4mm
	Minimum and Maximum abutment angle:0~25°	Minimum and Maximum abutment angle:0~25°
SurfaceTreatment	None	None
Sterile	Non-sterile	Non-sterile
SE	The subject device (URIS SP DS) are substantially equivalent to the reference device(URIS DS, K200817). The subject device and the predicate device K200817 have internalconnections, are made of Ti-6Al-4V ELI, and are conducted End User Steam Sterilizationand are similar CAD Design Limits.

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Image /page/15/Picture/0 description: The image shows a logo with the word "ABUTMENT" in a stylized font. The "A" in "ABUTMENT" is larger than the other letters. Below the word "ABUTMENT" is the letter "ru" in a large, stylized font. The logo is blue and white.

	Subject Device	Reference Device
Part Name	URIS Base	URIS Base
Design	Image: URIS Base Subject Device	Image: URIS Base Reference Device
Applicant	TruAbutment Korea Co., Ltd.	TruAbutment Korea Co., Ltd.
Trade Name	URIS Smart Path Implant System	URIS OMNI Narrow System & Prosthetic
510(K) No.	K230438	K200817
Classification Name	Endosseous Dental ImplantAbutments(872.3630)	Endosseous Dental ImplantAbutments(872.3630)
ProductCode	NHA	NHA
Material	Ti-6Al-4V ELI (ASTM F136)	Ti-6Al-4V ELI (ASTM F136)
Description	URIS SP Base is intended for use inconjunction with the fixture in partially orfully edentulous mandibles and maxillae,in support of single or multiple-unitcement retained restorations.All digitally designed zirconiasuperstructures for use with the URIS SPBase are intended to be sent to aTruAbutment-validated milling center formanufacture.	URIS Base is intended for use inconjunction with the fixture in partially orfully edentulous mandibles and maxillae,in support of single or multiple-unitcement retained restorations.All digitally designed zirconia superstructuresfor use with the URIS Base are intended to besent to a TruAbutment-validated milling centerfor manufacture.
Diameters	3.8mm/4.08mm/4.78mm/4.3mm	4.0mm/4.3mm

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Image /page/16/Picture/0 description: The image contains the word "ABUTMENT" in a stylized font. Below the word, there is a graphic that resembles a screw or bolt head, with a series of jagged edges. The letter "ru" is written in a large, stylized font and is placed to the right of the screw graphic. The color of the text and graphic is a bright blue.

	Subject Device	Reference Device
	/4.8mm/5.08mm
Lengths	Cuff Height: 1.0/2.0/3.0/4.0mmPost Height : 3.5/5.5mm	Cuff Height: 1.0/2.0mmPost Height : 3.5/5.5mm
Designparametersof zirconiasuperstruct-ures	Min / Max Angulation 15°Min / Max Cuff Height 0.5~~5mmMin / Max Diameter Ø5.0~~ Ø 8.0mm	Min / Max Angulation 15°Min / Max Cuff Height 0.5~~5mmMin / Max Diameter Ø5.0~~ Ø 8.0mm
superstruct-ures	Minimum Thickness 0.4mmMinimum Post Height 4~6mm	Minimum Thickness 0.4mmMinimum Post Height 4~6mm
SurfaceTreatment	None	None
Sterile	Non-sterile	Non-sterile
SE	The subject device (URIS SP Base) are substantially equivalent to the reference device(URIS Base, K200817). The subject device and the reference device K200817 haveinternal implant interface connections, are made of Ti-6Al-4V ELI, and are conductedEnd User Steam Sterilization. The minor differences between the IFUS for the subjectdevice and the predicate is diameter and Length. The subject device includes diametersize 3.8mm, 4.08mm, 4.3mm, 4.78mm, 4.8mm, 5.08mm and Length range of 3.5mm to5.5mm. The predicate device includes diameter size of 4.0mm, 4.3mm and length rangeof 3.5mm to 5.5mm.

	Subject Device	Predicate Device
Part Name	Abutment Screw	Abutment Screw
Design	Image: Subject Device Design	Image: Predicate Device Design
Applicant	TruAbutment Korea Co., Ltd.	TruAbutment Korea Co., Ltd.
Trade Name	URIS Smart Path Implant System	URIS OMNI System
510(K) No.	K230438	K172100
	Subject Device	Predicate Device
Part Name	Abutment Screw	Abutment Screw
Design	Image: Subject Device Design	Image: Predicate Device Design
ClassificationName	Endosseous Dental ImplantAbutments(872.3630)	Endosseous Dental ImplantAbutments(872.3630)
Product Code	NHA	NHA
Material	Ti-6Al-4V ELI (ASTM F136)	Ti-6Al-4V ELI (ASTM F136)
Description	URIS Smart Path Implant System &Prosthetic is indicated for use in partiallyor fully edentulous mandibles andmaxillae, in support of single or multiple-unit restorations including; cementedretained, screw retained, or overdenturerestorations, and final or temporaryabutment support for fixed bridgework. Itis intended for delayed loading.	URIS OMNI System is indicated for use inpartially or fully edentulous mandibles andmaxillae, in support of single or multiple-unit restorations including; cementedretained, screw retained, or overdenturerestorations, and final or temporaryabutment support for fixed bridgework. It isintended for delayed loading.
Diameters	2.0 / 2.1mm	1.9 / 2.3mm
Lengths	7.7 / 7.9 / 8.2mm	7.2 / 7.7mm
SurfaceTreatment	Anodizing (Yellow, Green, Purple)	None
Sterile	Non-sterile	Non-sterile
SE	The subject device and predicate device (K172100) have the similar intendeduse, have similar technological characteristic, and are made of similar materials.The minor differences between the subject device and the predicate is diameter andLength. The subject device includes diameter size 2.0mm, 2.1mm and Length rangeof 7.7mm to 8.2mm. The predicate device includes diameter size of 1.9mm, 2.3mmand length range of 7.2mm to 7.7mm.The subject device has three color (yellow, green, and purple) anodized treatment onthe surface, while the reference device has no surface treatment. It is the similar asthe anodizing method of the healing abutment included in K172100.However, those differences don't affect substantial equivalence.

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Image /page/17/Picture/0 description: The image shows the word "ABUTMENT" in a stylized font. The letters are blue and the word is written in all caps. The letter "A" is larger than the other letters and is positioned slightly above the rest of the word.

Subject Device implant bodies has similar material, dimensions and indication for use and similar surface treatment, machining/manufacturing, design and technological characteristics as the predicate and reference devices. URIS SP Prosthetic System has similar indication for use and similar manufacturing

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Image /page/18/Picture/0 description: The image is a logo for Abutment. The logo is blue and features the word "Abutment" in a stylized font. The "A" in Abutment is larger than the other letters. Below the word "Abutment" is a stylized image of a screw.

process including raw material, machining, dimensions, angulation, and surface treatment and similar design and technological characteristics as the predicate and reference devices.

The differences between the subject device and predicate and reference devices are detailed shape and detailed dimension of diameter and length.

Any differences between the subject device and predicate and reference devices do not raise new types of substantially equivalent issues.

MR Environment Condition

Non-clinical worst-case MRI review was performed to evaluate the metallic URIS SP Implant system in the MRI environment using scientific rationale and published literature (e.g., Woods, Terry O., Jana G. Delfino, and Sunder Rajan. "Assessment of Magnetically Induced Displacement Force and Torque on Metal Alloys Used in Medical Devices." Journal of Testing and Evaluation 49.2 (2019): 783-795), based on the entire system including all variations (all compatible implant bodies, dental abutments, and fixation screws) and material composition. Rationale addressed parameters per the FDA guidance "Testing and Labeling Medical Devices for Safety in the Magnetic Resonance (MR) Environment," including magnetically induced displacement force and torque.

Non-Clinical Test Data

The following tests were performed for the subject device:

Bacterial Endotoxin Testing (LAL) in accordance with USP <85> and USP <161>
Sterilization Testing according to ISO 11137-1,-2,-3 and ISO 11737-1,-2
Shelf Life Testing according to ISO 11607-1,-2 / ASTM F1980-07, ASTM F88, ASTM F1140, ASTM F1929, ASTM F2096 and sterility testing.

Requirements for biological evaluation of the subject device were based on the ISO 10993-1 "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process. Biocompatibility testing information is also leveraged from predicate and reference device (K172100 and K200817). The Biocompatibility Test was conducted on the predicate and reference devices is leveraged for the subject device because both products are manufactured with similar materials, manufacturer, manufacturing process.

SEM (Scanning electron microscopy) images and EDS (Energy Dispersive X-ray Spectroscopy) analysis were conducted on the predicate and reference devices is leveraged from our own prior clearance for the identical SLA surface treatment and manufacturing.

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Image /page/19/Picture/0 description: The image shows a logo for a company called "Abutment". The logo is blue and features the word "Abutment" in a stylized font. The letter "A" is larger than the other letters and is placed above the rest of the word. Below the word "Abutment" is a graphic that resembles a tooth implant. The logo is simple and modern, and the blue color gives it a professional look.

Below performance testing and information have been provided for subject implant fixture packaging:

· Human Factors testing (A usability evaluation for aseptic presentation of the subject device, in line with ISO 11607-1:2019 and the recommendations of the FDA guidance document, "Applying Human Factors and Usability Engineering to Medical Devices.")
· Low and high magnification images at various degrees of rotation following the removal from the packaging (Evaluation of the broken tip at various degrees rotation at a high magnification and low magnification for damage after removal from the packaging and disconnection of the fixture iig)
Quality System (OS) plan including the method and frequency of acceptance activities to ensure that the devices conform with product specifications with packaging design.

Fatigue testing was conducted according to the "Guidance for industry and FDA staff Class II Special Controls Guidance Document Root-form Endosseous Dental Implants and Endosseous Dental Abutment" and ISO 14801:2016 Dentistry - Fatigue test for endosseous dental implants under the worst-case scenario.

The results of the non-clinical testing demonstrate that the results have met the standards, and the subject device is substantially equivalent to the predicate device.

No clinical data were included in this submission.

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, TruAbutment Korea Co., Ltd. concludes that the URIS Smart Path Implant System & Prosthetic is substantially equivalent to predicate and reference devices as described herein.

Regulation Number and Section

§ 872.3640 Endosseous dental implant.

(a)
Identification. An endosseous dental implant is a prescription device made of a material such as titanium or titanium alloy that is intended to be surgically placed in the bone of the upper or lower jaw arches to provide support for prosthetic devices, such as artificial teeth, in order to restore a patient's chewing function.(b)
Classification. (1) Class II (special controls). The device is classified as class II if it is a root-form endosseous dental implant. The root-form endosseous dental implant is characterized by four geometrically distinct types: Basket, screw, solid cylinder, and hollow cylinder. 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.)(2)
Classification. Class II (special controls). The device is classified as class II if it is a blade-form endosseous dental implant. The special controls for this device are:(i) The design characteristics of the device must ensure that the geometry and material composition are consistent with the intended use;
(ii) Mechanical performance (fatigue) testing under simulated physiological conditions to demonstrate maximum load (endurance limit) when the device is subjected to compressive and shear loads;
(iii) Corrosion testing under simulated physiological conditions to demonstrate corrosion potential of each metal or alloy, couple potential for an assembled dissimilar metal implant system, and corrosion rate for an assembled dissimilar metal implant system;
(iv) The device must be demonstrated to be biocompatible;
(v) Sterility testing must demonstrate the sterility of the device;
(vi) Performance testing to evaluate the compatibility of the device in a magnetic resonance (MR) environment;
(vii) Labeling must include a clear description of the technological features, how the device should be used in patients, detailed surgical protocol and restoration procedures, relevant precautions and warnings based on the clinical use of the device, and qualifications and training requirements for device users including technicians and clinicians;
(viii) Patient labeling must contain a description of how the device works, how the device is placed, how the patient needs to care for the implant, possible adverse events and how to report any complications; and
(ix) Documented clinical experience must demonstrate safe and effective use and capture any adverse events observed during clinical use.