URIS OMNI System 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.

Device Description

URIS OMNI 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 multiple-unit restorations. The surface is SLA (Sandblasted, Large grit and Acid etched) treated and is provided sterile. It consists of two implant lines, the OMNI and the OMNI Tapered, with corresponding cover screws, healing abutments and prosthetic abutments. The OMN Tapered implant has a tapered wall with a single thread design. The OMN is straight walled with smaller threading at the coronal end, and bigger threading at the apical end. Both implant lines have two platform sizes, Narrow (Ø 3.5 mm) and Regular (Ø 4.0 - Ø 6.5 mm). Both implant lines share the following diameters and lengths:

Ø 3.5 x 8.5, 10, 11.5, 13, 14.5mm (L) Ø 4.0 x 7. 8.5. 10. 11.5. 13. 14.5mm (L) Ø 4.5 x 7, 8.5, 10, 11.5, 13, 14.5mm (L) Ø 5.0 x 7, 8.5, 10, 11.5, 13, 14.5mm (L) Ø 5.5 x 7. 8.5. 10. 11.5. 13. 14.5mm (L) Ø 6.0 x 7, 8.5, 10mm (L) Ø 6.5 x 7, 8.5, 10mm (L).

URIS Prosthetic System is made of titanium alloy (Ti-6Al-4V ELI) intended for use as an aid in prosthetic restoration. It consists of Cover screw, Healing abutment-direct type, D-basis abutmentcemented type, Angled abutment, Milling abutment, Temporary abutment screw. The surface of cover screw and healing abutment are anodized in yellow and green.

AI/ML Overview

The provided text is a 510(k) Summary for the URIS OMNI System, a dental implant device. It primarily focuses on demonstrating substantial equivalence to predicate devices based on technological characteristics and non-clinical test data for mechanical properties and biocompatibility.

Crucially, this document explicitly states: "No clinical data were included in this submission."

Therefore, the information required to answer your request regarding acceptance criteria and a study proving the device meets those criteria, specifically concerning human performance with or without AI, multi-reader multi-case studies, standalone algorithm performance, or ground truth derived from expert consensus, pathology, or outcomes data, cannot be found in this document.

The acceptance criteria mentioned in this 510(k) summary are for non-clinical tests to demonstrate the device's physical and biological properties.

Here's the relevant information that can be extracted, interpreting "acceptance criteria" in the context of this regulatory submission:

Acceptance Criteria and Device Performance (Non-Clinical)

The "acceptance criteria" for this submission are not expressed as performance metrics for an AI/CADe device, but rather as meeting established standards for dental implants and abutments. The "reported device performance" is a statement that the device met these criteria.

Acceptance Criteria (Stated Purpose)	Reported Device Performance (Conclusion)
Biocompatibility: In accordance with ISO 10993 series (e.g., ISO 10993-5:2009 for cytotoxicity, -10:2010 for irritation/sensitization, -11:2006 for systemic toxicity, -3:2014 for genotoxicity, -6:2007 for implantation).	"Biocompatibility testing has been completed." and "The results of the non-clinical testing demonstrate that the results have met the criteria of the standards, and the subject device is substantially equivalent to the predicate device." (This implies all specified biocompatibility tests were performed and passed.)
Sterilization: In accordance with ISO 11137-1,-2,-3 and ISO 11737-1,-2 (for manufacturer sterilization) and ISO 17665-1,-2 (for end-user sterilization).	"Sterilization Testing according to ISO 11137-1,-2,-3 and ISO 11737-1,-2" and "End user sterilization Testing according to ISO 17665-1,-2" were performed. The conclusion states: "The results of the non-clinical testing demonstrate that the results have met the criteria of the standards..." (Indicating successful sterilization validation).
Shelf Life: In accordance with ISO 11607-1,-2 / ASTM F1980-07, ASTM F88, ASTM F1140, ASTM F1929, ASTM F2096, and sterility testing.	"Shelf Life Testing according to ISO 11607-1,-2 / ASTM F1980-07, ASTM F88, ASTM F1140, ASTM F1929, ASTM F2096 and sterility testing" were performed. The conclusion states: "The results of the non-clinical testing demonstrate that the results have met the criteria of the standards..." (Indicating successful shelf life validation, supporting the claimed 5-year shelf life for fixtures).
Fatigue Testing: In accordance with ISO 14801:2016 and FDA guidance "Guidance for industry and FDA staff Class II Special Controls Guidance Document Root-form Endosseous Dental Implants and Endosseous Dental Abutment" under worst-case scenario.	"Fatigue testing was conducted according to... ISO 14801:2016 Dentistry - Fatigue test for endosseous dental implants under the worst-case scenario." The conclusion states: "The results of the non-clinical testing demonstrate that the results have met the criteria of the standards..." (Indicating the device passed the specified fatigue tests for mechanical durability).
Product Characterization (SEM, EDS): Imaging and elemental analysis to characterize the material and surface.	"SEM (Scanning electron microscopy) images and EDS (Energy Dispersive X-ray Spectroscopy) analysis" were performed. While not explicitly stated as "passed," these are typically done for characterization to support the material and surface claims, which are deemed "substantially equivalent" to predicates. The overall conclusion supports this: "The results of the non-clinical testing demonstrate that the results have met the criteria of the standards, and the subject device is substantially equivalent to the predicate device."

Since "No clinical data were included in this submission," the following requested information cannot be provided from this document:

Sample sizes used for the test set and the data provenance: Not applicable, as no clinical test data is provided.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
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.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable to device performance in a clinical context.
The sample size for the training set: Not applicable (refers to AI/machine learning data, not present here).
How the ground truth for the training set was established: Not applicable.

Summary

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

May 4, 2018

TruAbutment Inc. c/o April Lee Consultant Withus Group Inc. 106 Superior Irvine, California 92620

Re: K172100

Trade/Device Name: URIS OMNI System Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: Class II Product Code: DZE, NHA Dated: April 3, 2018 Received: April 5, 2018

Dear April 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. 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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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); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/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

for Tina Kiang, Ph.D. Acting Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below.

510(k) Number (if known) K172100

Device Name URIS OMNI System

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)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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510(k) Summary

This 510(k) Summary is being submitted in accordance with requirement of 21 CFR part 807.92

Submitter:

TruAbutment Inc. Brandon Kim 17742 Cowan, Irvine CA 92614 USA Email: brandon.kim@urisimplants.com Phone: 1-714-956-1488

Device Information:

Device Name: URIS OMNI System Classification Name: Endosseous Dental Implant Classification: Class II Primary Product Code: DZE Secondary Product Code: NHA Regulation number: 21 CFR 872.3640 Date Prepared: 05/04/2018

Official Correspondent

Withus Group Inc. April Lee 106 Superior, Irvine, CA 92620 USA Email: withus6664@gmail.com Phone: 1-909-274-9971 Fax: 1-909-460-8122

Predicate Device

· Primary Predicate Device:
- TS Fixture System (K121995) by Osstem Implant Co., Ltd. –
· Reference Devices:
- -CMI Implant IS II active (K120503) by Neobiotech Co., Ltd.
- -Oneplant Dental Implant System (K081748) by Warantec Co., Ltd.
- -IH Implant System (K153521) by Sewon Medix Inc.
- -HU/HS/HG Prosthetic System(K081575) by Osstem Implant Co., Ltd.
- -OSSTEM Implant System - Abutment (K161689) by Osstem Implant Co., Ltd.
- -Transfer & Angled Abutment (K153015) by Osstem Implant Co., Ltd.
- -Straumann RC Temporary Abutments (K093027) by Straumann USA

Device Description

Device Component	Diameters (Ø)	Lengths	Angulation
Cover Screw	2.78/3.48mm	4.875/5.375mm	-
Healing Abutments	4.0/4.5/5.5/6.5/7.5mm	Cuff Height: 1.0mm~5.0mm	-

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D-Basis Abutment-direct type	4.0/4.5/5.5/6.5mm	Cuff Height: 1.0mm~6.0mm	-
D-basis abutment-cemented type	4.0/4.5/5.5/6.5mm	Cuff Height: 1.0mm~6.0mm	-
Angled abutment	4.0/ 4.5/5.5mm	Cuff Height: 2.0mm~5.0mm	17°
Milling abutment	4.0/5.0/6.0/7.0mm	Hex Type: 14.1/14.85mmNon-Hex Type: 13.9/14.85mm	-
Temporary abutment	3.7 / 4.3mm	Cuff Height: 1.0mm~3.0mm	-
Abutment screw	1.9/2.3mm	7.2/7.7mm	-

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

Indication for Use

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, functions and surface treatments. Comparison demonstrating Substantial Equivalence follows at the end of this section.

URIS Fixture

	Subject Device	PrimaryPredicate Device	Reference Devices
510KNumber	K172100	K121995	K120503	K081748
DeviceName	URIS OMNI System	TS Fixture System	CMI Implant IS IIactive	Oneplant DentalImplant System
Manufacturer	TruAbutment Co.,Ltd.	OSSTEM ImplantCo., Ltd.	Neobiotech Co., Ltd.	WARANTEC Co.,Ltd.
Indicationsfor Use	URIS OMNI Systemis indicated for use inpartially or fullyedentulousmandibles andmaxillae, in supportof single or multiple-unit restorationsincluding; cementedretained, screwretained, oroverdenturerestorations, andfinal or temporaryabutment support forfixed bridgework. Itis intended fordelayed loading.	The TS FixtureSystem is indicatedfor use in partially orfully edentulousmandibles andmaxillae, in supportof single or multiple-unit restorationsincluding; cementedretained, screwretained, oroverdenturerestorations, andfinal or temporaryabutment support forfixed bridgework. Itis intended fordelayed loading. TSFixture System iscompatible withabutment in theET/SS ImplantSystem.	The CMI Implant ISII active is intendedto be surgicallyplaced in the bone ofthe upper or lowerjaw arches to providesupport forprosthetics devices,such as artificialteeth, and to restorethe patient's chewingfunction. It isintended forimmediate loadingwhen good primarystability is achievedand with appropriateocclusal loading.	ONEPLANT isdesigned for use indental implantSurgery. These areintended for use inpartially or fullyedentulousmandibles andmaxillae to supportfor single ormultiple-unitrestorations such ascemented retained,screw retained, orover denturerestorations andterminal orintermediateabutment support forfixed bridgework.

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Design	Image: Implant	Image: Implant	Image: Implant	Image: Implant
Structure	- Internal Hex-connected- Submerged Fixture	- Internal Hex-connected- Submerged Fixture- Tapered bodyshape and straightbody shape- 4-sided cuttingedge with self-tapping	N/A	- Internal Connection- Morse Taper- Internal Octagon
BodyDiameter(D)	3.5, 4.0, 4.5, 5.0, 5.5,6.0, 6.5mm	TSII SA Fixture: 3.5,4.2, 4.4, 4.9TSIII SA Fixture:3.75, 3.77, 4.2, 4.25,4.6, 4.63, 4.65, 5.05,5.08, 5.1	3.5/4.0/4.5/5.0/5.5/6.0/7.0/8.0mm	3.3, 3.6,4.3, 5.3mm
Length(mm)	7, 8.5, 10, 11.5, 13,14.5mm	7.0~15mm	7.0/7.3/8.5/10.0/11.5/13.0/15.0mm	8.5, 10, 11.5, 13,15mm
Material ofFixture	CP Ti Grade 4(ASTM F67)	CP Ti Grade 4(ASTM F67)	CP Ti Grade 4(ASTM F67)	CP Ti Grade 4(ASTM F67)
Surface	Sand-blasted, Largegrit, Acid-etched(S.L.A)	SA (Sandblastingand Acid etching)	Sand-blasted, Largegrit, Acid-etched(S.L.A)	N/A
Sterilization	Gamma Sterilization	Radiation Sterile	Gamma Sterilization	Gamma Sterilization
Shelf Life	5years	8years	N/A	N/A
ImplantBodyFeatures	Threaded	Threaded	Threaded	Threaded
ProductCode	DZE	DZE	DZE	DZE
SE	The subject device is substantially equivalent to the currently cleared devices. They aresubstantially equivalent in intended use, material, design, dimension, connection,functions and surface treatments. The URIS Implant system is similar in fundamentalscientific technology to the predicate device in that they all have been designed,manufactured and tested in compliance with FDA's Class II special controls guidancedocument root-food endosseous dental implants and endosseous dental implantabutments.Any differences in technology characteristics are accompanied by information thatdemonstrated the device is substantially equivalent as the predicate and do not raisedifferent questions of safety and effectiveness than the predicate.

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URIS Abutments

	Subject Device	Reference Devices
Part Name	Healing Abutment	Healing Abutment	Healing Abutment
Design
Applicant	TruAbutment Korea Co.,Ltd.	Sewon Medix Inc.	OSSTEM Implant Co., Ltd.
Trade Name	URIS OMNI System	IH Prosthetic System	HU/HS/HG ProstheticSystem
510(K) No.	K172100	K153521	K081575
ClassificationName	Endosseous Dental ImplantAbutments(872.3630)	Endosseous Dental ImplantAbutments(872.3630)	Endosseous Dental ImplantAbutments(872.3630)
Product Code	NHA	NHA	NHA
Material	Ti-6A1-4V ELI (ASTMF136)	Ti-6A1-4V ELI (ASTMF136)	Ti-6A1-4V ELI (ASTMF136)
URIS OMNI System isindicated for use in partiallyor fully edentulousmandibles and maxillae, insupport of single ormultiple-unit restorationsincluding; cementedretained, screw retained, orIndicationsoverdenture restorations,For Use/and final or temporaryIntended Useabutment support for fixedbridgework. It is intendedfor delayed loading.		IH Implant System is devicemade of titanium andtitanium alloy indicated forin partially or fullyedentulous mandibles andmaxillae, in support ofsingle or multiple-unitrestorations including;cemented retained or screwretained restorations andterminal or internalabutment support for fixedbridgework. IH ImplantSystem is for single and twostage surgical procedures. Itis intended for delayedloading.	HU/HS/HG ProstheticSystem is intended for usewith a dental implant toprovide supportfor prosthetic restorationssuch as crowns, bridges, oroverdentures.
Diameters	4.0/4.5/5.5/6.5/7.5mm	4.0/4.5/5.0/5.5/6.0/6.5mm	N/A
SurfaceTreatment	Anodizing (Yellow, Green)	None	N/A
Sterile	Non-sterile	Non-sterile	Non-sterile
SE	The subject device and reference devices (K153521, K081575) have the sameintended use, have similar technological characteristic, and are made of similarmaterials. The subject device and predicate devices have similar physicaldimensions, including diameter. Therefore, the subject device is substantiallyequivalent to the currently cleared devices.
	Subject Device	Reference Devices
Part Name	D Basis Abutment -Direct Type	Solid Abutment	Rigid Abutment
Design	Image: D Basis Abutment	Image: Solid Abutment	Image: Rigid Abutment
Applicant	TruAbutment Korea Co.,Ltd.	Sewon Medix Inc.	OSSTEM Implant Co., Ltd.
Trade Name	URIS OMNI System	IH Prosthetic System	OSSTEM Implant System -Abutment
510(K) No.	K172100	K153521	K161689
ClassificationName	Endosseous Dental ImplantAbutments(872.3630)	Endosseous Dental ImplantAbutments(872.3630)	Endosseous Dental ImplantAbutments(872.3630)
Product Code	NHA	NHA	NHA
Material	Ti-6Al-4V ELI (ASTMF136)	Ti-6Al-4V ELI (ASTMF136)	Ti-6Al-4V ELI (ASTMF136)
IndicationsFor Use/Intended Use	URIS OMNI System isindicated for use in partiallyor 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.	IH Implant System is devicemade of titanium andtitanium alloy indicated forin partially or fullyedentulous mandibles andmaxillae, in support ofsingle or multiple-unitrestorations including;cemented retained or screwretained restorations andterminal or internalabutment support for fixedbridgework. IH ImplantSystem is for single and twostage surgical procedures. Itis intended for delayedloading.	The OSSTEM ImplantSystem - Abutment isintended for use with adental implant toprovide support forprosthetic restorations suchas crowns, bridges, oroverdentures.
Diameters	4.0/4.5/5.5/6.5mm	4.0/4.5/5.0/5.5/6.0/6.5/7.0	4.0, 4.6, 5.0, 6.0, 7.0mm
Lengths	G/H :1.0/2.0/3.0/4.0/5.0/6.0Post : 4.0/5.5/7.0	G/H :1.0/1.5/2.0/2.5/3.0/3.5/4.0/4.5/5.0Post: 4.0/5.5/7.0	10, 10.4, 11, 11.4, 11.5,11.9, 12, 12.4, 12.5, 12.9,13, 13.4, 13.5, 13.9, 14,14.4, 14.5, 14.9, 15, 15.4,
SurfaceTreatment	None	Machine or TiN	N/A
Sterile	Non-sterile	Non-sterile	Non-sterile
SE	The subject device and reference devices (K153521, K161689) have the sameintended use, have similar technological characteristic, and are made of similarmaterials. The subject device and predicate devices have similar physicaldimensions, including diameter and lengths. Therefore, the subject device issubstantially equivalent to the currently cleared devices.
	Subject Device	Reference Devices
Part Name	D Basis Abutment-Cemented Type	Transfer Abutment	Cement Abutment
Design	Image: D Basis Abutment-Cemented Type	Image: Transfer Abutment	Image: Cement Abutment
Applicant	TruAbutment Korea Co., Ltd.	OSSTEM Implant Co., Ltd.	Sewon Medix Inc.
Trade Name	URIS OMNI System	Transfer & AngledAbutment	IH Prosthetic System
510(K) No.	K172100	K153015	K153521
ClassificationName	Endosseous Dental ImplantAbutments(872.3630)	Endosseous Dental ImplantAbutments(872.3630)	EndosseousImplantAbutments(872.3630)
Product Code	NHA	NHA	NHA
Material	Ti-6Al-4V ELI (ASTM F136)	Ti-6Al-4V ELI (ASTMF136)	Ti-6Al-4V ELI (ASTMF136)
IndicationsFor Use/Intended Use	URIS OMNI System isindicated for use in partially orfully edentulous mandiblesand maxillae, in support ofsingle or multiple-unitrestorations including:cemented retained, screwretained, or overdenturerestorations, and final ortemporary abutment supportfor fixed bridgework. It isintended for delayed loading.	Transfer & AngledAbutment is intended for usewith a dental implant toprovide support forprosthetic restorations suchas crowns, bridges, or over-dentures.	IH Implant System isdevice made of titaniumand titanium alloyindicated for in partiallyor fully edentulousmandibles and maxillae,in support of single ormultiple-unitrestorations including:cemented retained orscrew retainedrestorations andterminal or internalabutment support forfixed bridgework. IHImplant System is forsingle and two stagesurgical procedures. Itis intended for delayedloading.
Diameters	4.0/4.5/5.5/6.5mm	4.0mm	4.5/5.0/5.5/6.0/6.5
Lengths	G/H: 1.0/2.0/3.0/4.0/5.0/6.0Post: 4.0/5.5/7.0	G/H: 1.0/2.0/3.0/4.0/5.0Post: 5.5/7.0	G/H: 1.0/1.5/2.0/2.5/3.0/3.5/4.0/4.5/5.0Post: 4.0/5.5/7.0
SurfaceTreatment	None	Partially TiN coated	Machine or TiN
Sterile	Non-sterile	Non-sterile	Non-sterile
SE	The subject device and reference devices (K153015, K153521) have the sameintended use, have similar technological characteristic, and are made of similarmaterials. The subject device and predicate devices have similar physicaldimensions, including diameter and lengths. Therefore, the subject device issubstantially equivalent to the currently cleared devices.
	Subject Device	Reference Devices
Part Name	Angled Abutment	Angled Abutment	Angled Abutment
Design	Image: Angled Abutment	Image: Angled Abutment	Image: Angled Abutment
Applicant	TruAbutment Korea Co.,Ltd.	OSSTEM Implant Co., Ltd.	Sewon Medix Inc.
Trade Name	URIS OMNI System	Transfer & AngledAbutment	IH Prosthetic System
510(K) No.	K172100	K153015	K153521
ClassificationName	Endosseous Dental ImplantAbutments (872.3630)	Endosseous Dental ImplantAbutments (872.3630)	Endosseous Dental ImplantAbutments (872.3630)
Product Code	NHA	NHA	NHA
Material	Ti-6Al-4V ELI (ASTMF136)	Ti-6Al-4V ELI (ASTMF136)	Pure Titanium Gr.4(ASTMF67-06)
IndicationsFor Use/Intended Use	URIS OMNI System isindicated for use in partiallyor 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.	Transfer & AngledAbutment is intended foruse with a dental implant toprovide support forprosthetic restorations suchas crowns, bridges, or over-dentures.	IH Implant System is devicemade of titanium andtitanium alloy indicated forin partially or fullyedentulous mandibles andmaxillae, in support ofsingle or multiple-unitrestorations including;cemented retained or screwretained restorations andterminal or internalabutment support for fixedbridgework. IH ImplantSystem is for single and twostage surgical procedures. Itis intended for delayedloading.
Diameters	4.0/ 4.5/5.5mm	4.0mm	4.5/5.0/5.5/6.0mm
Post Angle	17°	17°	15°/25°
Lengths	G/H : 2.0mm~5.0mmPost : 5.5/7mm	G/H : 2.0mm~4.0mm	G/H : 2.0/3.0/4.0Post : 7.5/8.0
SurfaceTreatment	None	Partially TiN coated	Machine or TiN
Sterile	Non-sterile	Non-sterile	Non-sterile
SE	The subject device and reference devices (K153015, K153521) have the sameintended use, have similar technological characteristic, and are made of similarmaterials. The subject device and predicate devices have similar physicaldimensions, including diameter and lengths. Therefore, the subject device issubstantially equivalent to the currently cleared devices.
	Subject Device	Reference Devices
Part Name	Milling Abutment	FreeForm ST Abutment	FreeMilling Abutment
Design	Image: Milling Abutment	Image: FreeForm ST Abutment	Image: FreeMilling Abutment
Applicant	TruAbutment Korea Co.,Ltd.	OSSTEM Implant Co., Ltd.	Sewon Medix Inc.
Trade Name	URIS OMNI System	OSSTEM Implant System -Abutment	IH Prosthetic System
510(K) No.	K172100	K161689	K153521
ClassificationName	Endosseous Dental ImplantAbutments(872.3630)	Endosseous Dental ImplantAbutments(872.3630)	Endosseous Dental ImplantAbutments(872.3630)
Product Code	NHA	NHA	NHA
Material	Ti-6Al-4V ELI (ASTMF136)	Ti-6Al-4V ELI (ASTMF136)	Pure Titanium Gr.4(ASTMF67-06)
IndicationsFor Use/Intended Use	URIS OMNI System isindicated for use in partiallyor 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.	The OSSTEM ImplantSystem - Abutment isintended for use with adental implant toprovide support forprosthetic restorations suchas crowns, bridges, oroverdentures.	IH Implant System is devicemade of titanium andtitanium alloy indicated forin partially or fullyedentulous mandibles andmaxillae, in support ofsingle or multiple-unitrestorations including;cemented retained or screwretained restorations andterminal or internalabutment support for fixedbridgework. IH ImplantSystem is for single and twostage surgical procedures. Itis intended for delayedloading.
Diameters	4.0/5.0/6.0/7.0mm	4.0, 5.0, 5.5, 6.0, 7.0mm	4.5/5.0/5.5/6.0mm
Lengths	13.9/14.1/14.85mm	14, 14.5, 14.6mm	G/H : 1.0/2.0/3.0mmPost : 10/11/12mm
SurfaceTreatment	None	Partially TiN coated	Machine or TiN
Sterile	Non-sterile	Non-sterile	Non-sterile
Milled by hand	Yes	Yes	Yes
No Angularcorrection	Straight only	N/A	N/A
SE	The subject device and reference devices (K161689, K153521) have the sameintended use, have similar technological characteristic, and are made of similarmaterials. The subject device and predicate devices have similar physicaldimensions, including diameter and lengths. Therefore, the subject device issubstantially equivalent to the currently cleared devices.

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	Subject Device	Reference Devices
Part Name	Temporary Abutment	RC Temporary Abutment
Design	Image: Two temporary abutments	Image: RC Temporary Abutment
Applicant	TruAbutment Korea Co., Ltd.	Straumann USA
Trade Name	URIS OMNI System	Straumann RC Temporary Abutments
510(K) No.	K172100	K093027
ClassificationName	Endosseous Dental ImplantAbutments(872.3630)	Endosseous Dental ImplantAbutments(872.3630)
Product Code	NHA	NHA
Material	Ti-6Al-4V ELI (ASTM F136)	Titanium alloy (TAN)
IndicationsFor Use/Intended Use	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.	The Straumann RC Temporary Abutmentsare indicated for use in Straumann ROBone Level Implants for temporaryrestorations of single crowns and bridgesfor up to six months.
Diameters	3.7 / 4.3mm	4.5mm
Lengths	Height 10mm	Height 11mm
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 substantially equivalent inintended use, material, surface treatment, design, dimension and maximum duration of 6months. K093027 is selected as a reference device as it is indicated for temporaryrestorations of single crowns and bridges for up to six months. The diameters of thesubject device are slightly different from the Reference devices. However, the diameterof 4.3mm is in the range of diameters of predicates and this dimensional differencedoesn't affect substantial equivalence.

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	Subject Device	Reference Device
Part Name	Abutment Screw	Abutment Screw
Design	Image: Abutment Screw Subject Device	Image: Abutment Screw Reference Device
Applicant	TruAbutment Korea Co., Ltd.	OSSTEM Implant Co., Ltd.
Trade Name	URIS OMNI System	OSSTEM Implant System - Abutment
510(K) No.	K172100	K161689
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)
IndicationsFor Use/Intended Use	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.	The OSSTEM Implant System - Abutmentis intended for use with a dental implant toprovide support for prosthetic restorationssuch as crowns, bridges, or overdentures.
Diameters	1.9/2.3mm	2.0, 2.05, 2.2, 2.3, 2.5mm
Lengths	7.2/7.7mm	3.35, 5.6, 7.5, 8.35, 9.6, 10.2mm
SurfaceTreatment	None	N/A
Sterile	Non-sterile	Non-sterile
SE	The subject device and reference devices (K161689) have the same intended use,have similar technological characteristic, and are made of similar materials. Thesubject device and predicate devices have similar physical dimensions, includingdiameter and lengths. Therefore, the subject device is substantially equivalent to thecurrently cleared devices.

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URIS Fixture has same material, dimensions and indication for use and similar surface treatment, machining/manufacturing, design and technological characteristics as the predicate devices. URIS Prosthetic System has same indication for use and similar manufacturing process including raw material, machining, dimensions, angulation, and surface treatment and similar design and technological characteristics as the predicate devices.

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

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

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> ●
. Biocompatibility Testing such as cytotoxicity according to ISO 10993-5:2009. irritation according to ISO 10993-10:2010. sensitization according to ISO 10993-10:2010. systemic toxicity according to ISO 10993-11:2006, genotoxicity according to ISO 10993-3:2014, and implantation according to ISO 10993-6:2007.
Sterilization Testing according to ISO 11137-1,-2,-3 and ISO 11737-1,-2 ●
End user sterilization Testing according to ISO 17665-1,-2
. Shelf Life Testing according to ISO 11607-1,-2 / ASTM F1980-07, ASTM F88, ASTM F1140, ASTM F1929, ASTM F2096 and sterility testing.
. Fatigue Testing according to ISO 14801:2016
SEM (Scanning electron microscopy) images and EDS (Energy Dispersive X-ray Spectroscopy) analysis

Biocompatibility testing has been completed. 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.

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 criteria of 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 OMNI System is substantially equivalent to predicate 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.