URIS OMNI Narrow System is indicated for use in the treatment of missing maxillary lateral incisors or the mandbular central and lateral incisors, 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.

The URIS OMNI Prosthetic abutments are intended for use with URIS OMNI dental implants to provide support for prosthetic restorations such as crowns, bridges, or over-dentures.

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.

Device Description

URIS OMNI Narrow System fixtures are dental implants made of Unalloyed Titanium, grade 4 (ASTM F67) intended for use in the treatment of missing maxillary lateral incisors or the mandibular central and lateral incisors. The surface is SLA (Sandblasted, Large grit and Acid etched) treated and is provided sterile. It consists of two implant lines, the OMNI Straight and the OMNI Tapered, with corresponding cover screws, healing abutments and prosthetic abutments. The OMNI Tapered implant has a tapered wall with a single thread design. The OMNI Straight implant has straight wall with smaller threading at the coronal end, and bigger threading at the apical end. Both implant lines have Narrow (Ø 3.15 mm) platform sizes. Both implant lines share the following diameters and lengths.

Ø 3.15 x 10, 11.5, 13, 14.5mm (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 Ball Abutment, Retainer, T LOC Straight Abutment, T Loc Titanium Cap, Multi-Unit Straight Abutment, Multi-Unit Angled Abutment, Multi-Unit Healing Cap, Multi-Unit Ti Cylinder, Multi-unit temporary cylinder, Multi-Unit Cylinder screw, URIS DS, URIS Base. No additional angulation is to be included in the when using a coping or cylinder (i.e., Multi-unit Ti Cylinder, Multi-unit Temporary Cylinder, Multi-unit Base) with any of the Multi-unit Abutments.

URIS 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-4Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant Applications.

URIS DS abutment as a patient matched titanium abutment compatible with both URIS OMNI System (K172100) and URIS OMNI Narrow System (subject).

AI/ML Overview

The provided document is a 510(k) Summary for a dental implant system. It discusses the substantial equivalence of the "URIS OMNI Narrow System & Prosthetic" to predicate devices based on non-clinical testing. The document does not contain information about acceptance criteria or a study proving the device meets acceptance criteria in the context of human reader performance or a standalone algorithm performance for AI/ML-driven devices.

The document states: "No clinical data were included in this submission." and focuses on demonstrating substantial equivalence through comparisons of technological characteristics and non-clinical test data.

Therefore, I cannot provide the requested information for an AI/ML device related to acceptance criteria, detailed study design, sample sizes, expert ground truth, adjudication methods, or MRMC comparative effectiveness studies, as these types of studies are not discussed in this 510(k) summary for this device.

The "acceptance criteria" presented in this document are primarily related to the successful completion and results of non-clinical tests to demonstrate equivalence to predicate devices. These are not performance metrics for an AI/ML algorithm.

Here's an analysis of what is provided regarding acceptance criteria in the context of this traditional medical device:

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

The document implicitly defines acceptance criteria by listing the standards to which tests were performed and stating that "the results have met the criteria of the standards." The "reported device performance" is that it successfully met these standards, thereby demonstrating substantial equivalence.

Acceptance Criteria (Standards Met)	Reported Device Performance
USP <85> and USP <161> for Bacterial Endotoxin	Met the criteria of the standards
ISO 10993-1 for Biocompatibility	Met the criteria of the standards
ISO 11137-1,-2,-3 and ISO 11737-1,-2 for Sterilization	Met the criteria of the standards
ISO 17665-1,-2 for End user sterilization	Met the criteria of the standards
ISO 11607-1,-2 / ASTM F1980-07, ASTM F88, ASTM F1140, ASTM F1929, ASTM F2096 and sterility testing for Shelf Life	Met the criteria of the standards
ISO 14801:2016 and FDA Guidance for Fatigue Testing	Met the criteria of the standards ("worst-case scenario")
SEM and EDS analysis	Performed (implied acceptable by equivalence conclusion)

2. Sample size used for the test set and the data provenance:
Not applicable for this type of non-clinical, non-AI device study. The document refers to testing on the device itself (e.g., fatigue testing, sterilization testing, biocompatibility).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
Not applicable. Ground truth as typically understood for AI/ML performance is not relevant here. The "ground truth" for these tests would be the accepted parameters and methods defined by the referenced ISO/ASTM standards and FDA guidance.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
Not applicable. This is not a human reader or AI performance study.

5. 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:
No. This is not an AI/ML device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
No. This is not an AI/ML device.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc):
Not applicable in the context of AI/ML device performance. For the described non-clinical tests, the "ground truth" is defined by the specific parameters and requirements of the referenced ISO/ASTM standards. For example, for biocompatibility, the ground truth is whether the materials meet the criteria specified in ISO 10993-1.

8. The sample size for the training set:
Not applicable. This is not an AI/ML device.

9. How the ground truth for the training set was established:
Not applicable. This is not an AI/ML device.

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.

October 7, 2020

TruAbutment Inc. Chris Choi Director 17742 Cowan Irvine, California 92614

Re: K200817

Trade/Device Name: URIS OMNI Narrow System & Prosthetic Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: Class II Product Code: DZE, NHA Dated: June 5. 2020 Received: September 8, 2020

Dear Chris Choi:

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.

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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) 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 (OS) 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.

for

Srinivas Nandkumar, Ph.D. Director DHT1B: Division of Dental Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K200817

Device Name URIS OMNI Narrow System & Prosthetic

Indications for Use (Describe)

The URIS OMNI Prosthetic abutments are intended for use with URIS OMNI dental implants to provide support for prosthetic restorations such as crowns, bridges, or over-dentures.

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.

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

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

Submitter:

TruAbutment Inc. Eunjin Jang 17742 Cowan, Irvine CA 92614 USA Email: eunjin.jang@truabutment.com

Phone: 1-714-956-1488

Device Information:

Device Name: URIS OMNI Narrow System & Prosthetic Classification Name: Endosseous Dental Implant Classification: Class II Primary Product Code: DZE Secondary Product Code: NHA Regulation number: 21 CFR 872.3640 Date Prepared: 10/06/2020

Predicate Device

Primary Predicate Device:
- URIS OMNI System (K172100) by TruAbutment Korea Co., Ltd. -
Reference Devices:
- -Nobel Active 3.0 (K102436) by Nobel Biocare.
- OSSTEM Implant System (K161689) by Osstem Implant Co., Ltd . -
- -Hiossen Prosthetic System (K140507) by Osstem Implant Co., Ltd .
- Osstem Abutment System (K182091) by Osstem Implant Co., Ltd . -
- Multi Angled Abutment (K123755) by Osstem Implant Co., Ltd . -
- -SMART builder System (K120951) by Osstem Implant Co., Ltd.
- AnyOne Internal Implant System (K123988) by Megagen Implant Co., Ltd. -
- ET US SS Prosthetic System (K160670) by Osstem Implant Co., Ltd. -
- Preat Abutments (K183518) by Preat Corporation. -
- Oneplant Dental Implant System (K081748) by WARANTEC Implant Co., Ltd. -
- InCoris Zi (K123664) by Sirona Dental Systems GmbH. -
- -RelyX Unicem 2Automix (K100756) by 3M ESPE
- TruAbutment DS (K183106) by TruAbutment Korea Co., Ltd. -

Official Correspondent

TruAbutment Inc. Chris Choi 17742 Cowan, Irvine CA 92614 USA Email: chris.choi@truabutment.com Phone: 1-714-956-1488

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Device Description

Ø 3.15 x 10, 11.5, 13, 14.5mm (L)

Device Component	Diameters (Ø)	Lengths	Angulation
OMNI Straight Fixture	3.15mm	10~14.5mm
OMNI Tapered Fixture	3.15mm	10~14.5mm
Ball Abutment	3.5mm	Cuff Height: 1.0~6.0mm
Retainer Cap	5.1mm	3.9mm
Retainer	5.1mm	2.1mm
T LOC Straight Abutment	3.8mm	Cuff Height: 1.0~6.0mm
T LOC Titanium Cap	5.4mm	2.3mm
Multi-Unit Straight Abutment	5.0mm	Cuff Height: 1.0mm~6.0mm
Multi-Unit Angled Abutment		Cuff Height: 3.0mm~5.0mm	17°
		Cuff Height: 4.0mm~6.0mm	29.5°
Multi-Unit Healing Cap	5.1mm	4.5mm
Multi-Unit Ti Cylinder	5.0mm	5.0mm
Multi-unit temporary cylinder	5.0mm	12mm
Multi-Unit Base	5.0mm	4.35/7.35mm
Multi-unit cylinder screw	1.6mm	3.3mm
URIS DS	Ø3.8~ Ø 5.5mm	6~11mm	0~25°
URIS Base – Titanium Base Component	4.0mm/4.3mm	Cuff Height: 1.0/2.0mmPost Height : 3.5/5.5mm

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

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.

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Dental Implants

URIS OMNI System Implants (K172100) 3.5, 4.0, 4.5, 5.0, 5.5, 6.0, 6.5mm
. URIS OMNI Narrow System Implants (Proposed) 3.15 mm

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. The superstructure is cemented to the TruBase S in the lab. Use "RelyX Unicem 2Automix" as an adhesive extraorally to connect.

URIS Base is provided non-sterile therefore must be sterilized after the cementation of the zirconia superstructure on the URIS Base.

Design Limitation for Zirconia superstructure

Design parameter	Design Limit
Minimum and Maximum abutment angle	0~15°
Minimum and Maximum Cuff Height	0.5~5 mm
Minimum and Maximum diameter atabutment/implant interface	∅5.0mm~∅8.0mm
Minimum Thickness	0.4 mm
Minimum and Maximum length ofabutment post (length above the abutmentcollar/gingival height)	4 ~6 mm

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URIS DS abutment as a patient matched titanium abutment compatible with both URIS OMNI System (K172100) and URIS OMNI Narrow System (subject).

Design Limitation for URIS DS

Design parameter	Subject System(K200817)Design Limit	URIS OMNI System(K172100)Design Limit
Minimum and Maximum GingivalHeight	0.5~4mm	0.5~4mm
Minimum and Maximum diameter atabutment/implant interface	$Ø$ 3.8~ $Ø$ 5.5	$Ø$ 3.8~ $Ø$ 5.5
Minimum and Maximum length ofabutment	6~11mm	6~11mm
Minimum and Maximum length ofabutment post (length above theabutment collar/gingival height)	4~8mm	4~8mm
Minimum wall thickness atabutment/implant interface	0.4mm	0.4mm
Minimum and Maximum abutmentangle	0~25°	0~25°

Indication for Use

URIS OMNI Narrow System is indicated for use in the treatment of missing maxillary lateral incisors or the mandibular central and lateral incisors, 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.

The URIS OMNI Prosthetic abutments are intended for use with URIS OMNI dental implants to provide support for prosthetic restorations such as crowns, bridges, or over-dentures.

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.

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URIS Fixture

	Subject Device	PrimaryPredicate Device	Reference Devices
510KNumber	K200817	K172100	K102436
DeviceName	URIS OMNI NarrowSystem & Prosthetic	URIS OMNI System	Nobel Active 3.0
Manufacturer	TruAbutment Korea Co.,Ltd	TruAbutment Korea Co.,Ltd	Nobel Biocare
Indicationfor Use	URIS OMNI NarrowSystem is indicated for usein the treatment of missingmaxillary lateral incisorsor the mandibular centraland lateral incisors, insupport of single ormultiple-unit restorationsincluding; cementedretained, screw retained,or overdenturerestorations, and final ortemporary abutmentsupport for fixedbridgework. It is intendedfor delayed loading.The URIS OMNIProsthetic abutments areintended for use withURIS OMNI dentalimplants to providesupport for prostheticrestorations such ascrowns, bridges, or over-dentures.All digitally designedabutments and/or copingfor use with URIS OMNIProsthetic abutments areintended to be sent to aTruAbutment-validatedmilling center formanufacture	URIS OMNI System isindicated for use inpartially or fullyedentulous mandibles andmaxillae, in support ofsingle or multiple-unitrestorations including;cemented retained, screwretained, or overdenturerestorations, and final ortemporary abutmentsupport for fixedbridgework. It is intendedfor delayed loading.	The NobelActive3.0mm implant isindicated for use in thetreatment of missingmaxillary lateral incisorsor the mandibularcentral and lateralincisors to supportprosthetic devices, such asartificial teeth,in order torestore chewingfunction in partiallyedentulous patients. TheNobelActive 3.0implants may be put intoimmediate functionprovided that stabilityrequirements detailed inthe manual are satisfied.
Design	Image: Subject Device Design	Image: Primary Predicate Device Design	Image: Reference Devices Design
	Subject Device	PrimaryPredicate Device	Reference Devices
Structure	- Internal Hex- connected- Submerged Fixture	- Internal Hex- connected- Submerged Fixture	-Internal Hex- Bone Level Implant
BodyDiameter(D)	3.15mm	3.5, 4.0, 4.5, 5.0, 5.5, 6.0,6.5 mm	3.0mm
Length(mm)	10, 11.5, 13, 14.5mm	7, 8.5, 10, 11.5, 13,14.5mm	10, 11.5, 13, 15mm
Materialof Fixture	CP Ti Grade 4 (ASTMF67)	CP Ti Grade 4 (ASTMF67)	Pure Titanium Grade 4(ASTM F67)
Surface	Sand-blasted, Large grit,Acid-etched(S.L.A)	Sand-blasted, Large grit,Acid-etched(S.L.A)	TiUnite
Sterilization	Gamma Sterilization	Gamma Sterilization	Radiation Sterile
Shelf Life	5years	5years	N/A
ImplantBodyFeatures	Threaded	Threaded	Threaded
ProductCode	DZE	DZE	DZE
SE	The subject device is substantially equivalent in indications and design principles tothe primary predicate device and the reference devices listed above. Provided tablesare comparing the Indications for Use Statements and the technologicalcharacteristics of the subject device, the primary predicate device, and the referencedevices.The Indications for Use Statement (IFUS) for subject device abutment issubstantially equivalent in intended use to the primary predicate device K172100,and the reference devices K102436. All are intended for use with endosseous dentalimplants in the maxilla and mandible to provide functional and esthetic rehabilitationof the edentulous maxilla and mandible. The minor differences between the IFUS forthe subject device and the primary predicate include:the subject device IFUS includes the term "URIS OMNI Narrow System &Prosthetic is indicated for use in the treatment of missing maxillary lateral incisors orthe mandibular central and lateral incisors" and the primary predicate IFUS does not.The other minor differences are related to the specific device names, validatedmilling centers, and the compatible OEM implant lines. None of these minordifferences impact substantial equivalence because both IFUS express equivalentintended use to facilitate dental prosthetic restorations, and the indications areexpressed equivalently using different specific wording.

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URIS Abutments

	Subject Device	Predicate Devices
Part Name	Ball Abutment	Stud Abutment
Design
Applicant	TruAbutment Korea Co., Ltd	Osstem Implant Co., Ltd.
Trade Name	URIS OMNI Narrow System &Prosthetic	OSSTEM Implant System
510(K) No.	K200817	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)
IndicationFor Use/Intended Use	Ball Abutment is intended for use inconjunction with the fixture inpartially or fully edentulousmandibles and maxillae, in support ofmultiple-unit cement retainedrestorations	The OSSTEM Implant System -Abutment is intended for use with adental implant to provide support forprosthetic restorations such as crowns,bridges, or overdentures.
Diameters	3.5mm	3.5mm
Lengths	G/H: 1.0/2.0/3.0/4.0/5.0/6.0mm	6.0/6.4/7.0/7.4/8.0/8.4/9.0/9.4/10/10.4/11/11.4mm
SurfaceTreatment	None	Partial TiN coated in upper
Sterile	Non-sterile	Non-sterile
SE	The following subject device (Ball Abutment) is substantially equivalent to thepredicate device (Stud Abutment, K161689). The subject device and thepredicate device K161689 have internal implant interface connections, and aremade of Ti-6Al-4V ELI. The minor differences between the IFUS for the subjectdevice and the predicate is surface treatment. The subject device doesn't includesurface treatment. The predicate device includes partial TiN coasted in upper.
	Subject Device	Predicate Devices
Part Name	Retainer Cap	O-ring Retainer Cap
Design	Image: Retainer Cap	Image: O-ring Retainer Cap
Applicant	TruAbutment Korea Co., Ltd	OSSTEM Implant Co., Ltd.
Trade Name	URIS OMNI Narrow System &Prosthetic	OSSTEM Implant System
510(K) No.	K200817	K161689
ClassificationName	Endosseous Dental ImplantAbutments(872.3630)	Endosseous Dental ImplantAbutments(872.3630)
Product Code	NHA	NHA
Material	Ti-6Al-4V ELI (ASTM F136)	Titanium Gr. 3 (ASTM F67)
IndicationFor Use/Intended Use	Retainer Cap is designed for use withoverdentures or partial dentures,retained in whole or in part, byendosseous implants in the mandibleor maxilla.	The OSSTEM Implant System -Abutment is intended for use with adental implant to provide support forprosthetic restorations such as crowns,bridges, or overdentures.
Diameters	5.1mm	5.0mm
Lengths	3.9mm	3.9mm
SurfaceTreatment	None	None
Sterile	Non-sterile	Non-sterile
SE	The subject device and predicate 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 tothe currently cleared devices.
	Subject Device	Predicate Devices
Part Name	Retainer	Retainer
Design	Image: Retainer	Image: Retainer
Applicant	TruAbutment Korea Co., Ltd	OSSTEM Implant Co., Ltd
Trade Name	URIS OMNI Narrow System &Prosthetic	Hiossen Prosthetic System
510(K) No.	K200817	K140507
ClassificationName	Endosseous Dental ImplantAbutments(872.3630)	Endosseous Dental ImplantAbutments(872.3630)
Product Code	NHA	NHA
Material	Ti-6Al-4V ELI (ASTM F136)	Titanium
IndicationFor Use/Intended Use	Retainer is designed for use withoverdentures or partial dentures,retained in whole or in part, byendosseous implants in the mandibleor maxilla.	Use for marking stud-type over dentureHiossen Prosthetic system is intended foruse with a dental implant fixture toprovide support for prosthetic restorationsuch as crowns, bridges, or over-dentures
Diameters	5.1mm	5.0mm
Lengths	3.9mm	2.0mm
SurfaceTreatment	None	None
Sterile	Non-sterile	Non-sterile
SE	The subject device and predicate devices (K140507) 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 tothe currently cleared devices.
	Subject Device	Predicate Devices
Part Name	T LOC Straight Abutment	Port Abutment
Design	Image: T LOC Straight Abutment	Image: Port Abutment
Applicant	TruAbutment Korea Co., Ltd.	OSSTEM Implant Co., Ltd
Trade Name	URIS OMNI Narrow System &Prosthetic	Osstem Abutment System
510(K) No.	K200817	K182091
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(ASTM F136)
IndicationFor Use/Intended Use	T LOC Straight Abutment isintended for use in conjunction withthe fixture in partially or fullyedentulous mandibles and maxillae,in support of multiple-unit cementretained restorations.	The Osstem Abutment System isintended for use with a dental implant toprovide support for prostheticrestorations such as crowns, bridges, oroverdentures.
Diameters	3.8mm	3.5~5.1mm
Lengths	G/H : 1.0/2.0/3.0/4.0/5.0/6.0 mm	G/H: 1.0 ~ 7.0 mm
SurfaceTreatment	None	Partial TiN coated in upper
Sterile	Non-sterile	Non-sterile
SE	The subject device (T LOC Straight Abutment) is substantially equivalent to thepredicate device (Port Abutment, K182091). The subject device and the predicatedevice K182091 have internal connections, are made of Ti-6A1-4V ELI, and areconducted End User Steam Sterilization. The minor differences between theIFUS for the subject device and the predicate is surface treatment. The subjectdevice doesn't include surface treatment. The predicate device includes partialTiN coasted in upper.
	Subject Device	Predicate Devices
Part Name	T LOC Titanium Cap	Port Male Cap
Design	Image: T LOC Titanium Cap	Image: Port Male Cap
Applicant	TruAbutment Korea Co., Ltd	Osstem Implant Co., Ltd.
Trade Name	URIS OMNI Narrow System &Prosthetic	Osstem Abutment System
510(K) No.	K200817	K182091
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)
IndicationFor Use/Intended Use	T LOC Titanium Cap is designed foruse with overdentures or partialdentures, retained in whole or in part,by endosseous implants in themandible or maxilla.	The Osstem Abutment System isintended for use with a dental implant toprovide support for prostheticrestorations such as crowns, bridges, oroverdentures.
Diameters	5.4mm	5.5mm
Lengths	2.3mm	2.25mm
SurfaceTreatment	None	None
Sterile	Non-sterile	Non-sterile
SE	The subject device and predicate devices (K182091) 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 tothe currently cleared devices.
	Subject Device	Predicate Devices
Part Name	Multi-unit Straight Abutment	Multi Abutment
Design	Image: Multi-unit Straight Abutment	Image: Multi Abutment
Applicant	TruAbutment Korea Co., Ltd.	OSSTEM Implant Co., Ltd.
Trade Name	URIS OMNI Narrow System &Prosthetic	OSSTEM Implant System
510(K) No.	K200817	K161689
ClassificationName	Endosseous Dental ImplantAbutments(872.3630)	Endosseous Dental ImplantAbutments(872.3630)
Product Code	NHA	NHA
Material	Ti-6Al-4V ELI (ASTM F136)	Titanium Alloy (Ti-6Al-4V)
IndicationFor Use/Intended Use	Multi-Unit Straight Abutment isintended for use in conjunction withthe fixture in partially or fullyedentulous mandibles and maxillae,in support of multiple-unit cementretained restorations.	Using for edentulous mandible ormaxilla.Usually use to make full denture ScrewRetained Restoration
Diameters	5.0mm	4.8mm
Lengths	G/H :1.0/2.0/3.0/4.0/5.0/6.0mm	8.3,8.7, 9.3, 9.7, 10.3, 10.7, 11.3, 11.7,12.3, 12.7mm
SurfaceTreatment	None	TiN coating
Sterile	Non-sterile	Non-sterile
SE	The subject device (Multi-unit Straight Abutment) is substantially equivalent tothe predicate device (Multi Abutment, K161689). The subject device and thepredicate device K161689 have internal implant interface connections, are madeof Ti-6Al-4V ELI, and are conducted End User Steam Sterilization. The minordifferences between the subject device and the predicate is surface treatment.The subject device doesn't include surface treatment. The predicate deviceincludes partial TiN coasted in upper.
	Subject Device	Predicate Devices
Part Name	Multi-unit Angled Abutment	Multi Angled Abutment
Design	Image: Multi-unit Angled Abutment design	Image: Multi Angled Abutment design
Applicant	TruAbutment Korea Co., Ltd	OSSTEM Implant Co., Ltd.
Trade Name	URIS OMNI Narrow System &Prosthetic	Multi Angled Abutment
510(K) No.	K200817	K123755
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)
IndicationFor Use/Intended Use	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 Angled Abutment is intended foruse with a dental implant to providesupport for prosthetic restorations suchas crowns, bridges, or overdentures.
Diameters	5.0mm	4.8mm
Lengths	G/H : 3.0/4.0/5.0(17°)G/H : 4.0/5.0/6.0(29.5°)	3.17, 3.4, 4.17, 4.4, 4.76, 4.86, 5.17, 5.4,5.76, 5.86, 6.76, 6.86 (17°)3.17, 3.4, 4.17, 4.4, 4.76, 4.86, 5.17, 5.4,5.76, 5.86, 6.76, 6.86 (30°)
Post Angle	17° / 29.5°	17° / 30°
SurfaceTreatment	None	None
Sterile	Non-sterile	Non-sterile
SE	The subject device (Multi-unit Angled Abutment) are substantially equivalent tothe predicate device (Multi Angled Abutment, K123755). The subject device andthe predicate device K123755 have internal connections, are made of Ti-6Al-4VELI, and are conducted End User Steam Sterilization. The minor differencesbetween the subject device and the predicate is angulation. The subject device isfor multiple-unit restorations, include angulations up to 29.5°. The predicatedevice is for multiple-unit restorations, include angulations up to 30°
	Subject Device	Predicate Devices
Part Name	Multi-unit Healing Cap	Healing Abutment
Design	Image: Multi-unit Healing Cap	Image: Healing Abutment
Applicant	TruAbutment Korea Co., Ltd	Osstem Implant Co., Ltd.
Trade Name	URIS OMNI Narrow System &Prosthetic	SMART builder System
510(K) No.	K200817	K120951
ClassificationName	Endosseous Dental ImplantAbutments(872.3630)	Endosseous Dental ImplantAbutments(872.3630)
Product Code	NHA	NHA
Material	Ti-6Al-4V ELI (ASTM F136)	Pure TitaniumGrade4(ASTMF67)
IndicationFor Use/Intended Use	The Multi-unit healing cap is a pre-manufactured prosthetic componentdirectly connected to theendosseous dental implant and isintended for use as an aid inprosthetic rehabilitation.	SMART builder is a metaldevice intendedfor use with a dental implant to stabilizeand support of bone graft in dento-alveolarbony defect sites.
Diameters	5.1mm	4.0~7.0
Lengths	4.5mm	3.35~4.22
SurfaceTreatment	None	None
Sterile	Non-sterile	Gamma Sterilization
SE	The subject device and predicate devices (K120951) 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 tothe currently cleared devices.
	Subject Device	Predicate Devices
Part Name	Multi-unit Ti Cylinder	Multi-unit EZ Post Cylinder
Design	Image: Multi-unit Ti Cylinder	Image: Multi-unit EZ Post Cylinder
Applicant	TruAbutment Korea Co., Ltd	Megagen Implant Co., Ltd.
Trade Name	URIS OMNI Narrow System &Prosthetic	AnyOne Internal Implant System
510(K) No.	K200817	K123988
ClassificationName	Endosseous Dental ImplantAbutments(872.3630)	Endosseous Dental ImplantAbutments(872.3630)
Product Code	NHA	NHA
Material	Ti-6Al-4V ELI (ASTM F136)	CP4 Titanium and Ti-6A1-4V-ELI
IndicationFor Use/Intended Use	Multi-unit Ti Cylinder is intendedto be surgically placed in themaxillary or mandibular molarareas for the purpose providingprosthetic support for dentalrestorations in partially or fullyedentulous individuals. It is used torestore a patient's chewing function.	The AnyOne TM Internal Implant Systemis intended to be surgically placed in themaxillary or mandibular molar areas forthe purpose providing prosthetic supportfor dental restorations (Crown, bridges,and overdentures) in partially or fullyedentulous individuals. It is used to restorea patient's chewing function.Smaller implants (less than 06.0 mm) arededicated for immediate loading whengood primary stability is achieved andwith appropriate occlusal loading. Largerimplants are dedicated for the molarregion and are indicated for delayedloading.
Diameters	5.0mm	Hex/Non-Hex: 5.0mm
Lengths	5.0mm	Not stated in 510(k) summary
SurfaceTreatment	None	None
Sterile	Non-sterile	Non-sterile
SE	The subject device and Predicate devices (K123988) 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 tothe currently cleared devices
	Subject Device	Predicate Devices
Part Name	Multi-unit Temporary Cylinder	RC Temporary Abutment
Design	Image: Multi-unit Temporary Cylinder	Image: RC Temporary Abutment
Applicant	TruAbutment Korea Co., Ltd	OSSTEM Implant Co., Ltd.
Trade Name	URIS OMNI Narrow System &Prosthetic	ET US SS Prosthetic System
510(K) No.	K200817	K160670
ClassificationName	Endosseous Dental ImplantAbutments(872.3630)	Endosseous Dental ImplantAbutments(872.3630)
ProductCode	NHA	NHA
Material	Ti-6Al-4V ELI (ASTM F136)	Titanium (ASTM F 67)
IndicationFor Use/Intended Use	Multi-unit Temporary Cylinder isintended to be surgically placed in themaxillary or mandibular molar areasfor the purpose providing prostheticsupport for dental restorations inpartially or fully edentulousindividuals. It is used to restore apatient's chewing function.	Esthetic-low Temporary Cylinder isused for prosthetic restoration. This isused to make temporary prosthesis anddesigned to minimized indicationconstraints.
Diameters	5.0mm	4.8/5.5mm
Lengths	12mm	12mm
SurfaceTreatment	None	Not stated in 510(k) summary
MaximumDuration	Less than 6 months	Less than 6 months
Sterile	Non-sterile	Non-sterile
SE	The subject temporary abutment and Predicate devices are substantiallyequivalent in intended use, material, surface treatment, design, dimension andmaximum duration of 6 months. K160670 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 4.8, 5.5mm is in the range ofdiameters of predicates and this dimensional difference doesn't affect substantialequivalence.
	Subject Device	Predicate Devices
Part Name	Multi-unit Base	Multi-unit Cylinder
Design	Image: Multi-unit Base Design	Image: Multi-unit Cylinder Design
Applicant	TruAbutment Korea Co., Ltd	WARANTEC ImplantCo., Ltd.
Trade Name	URIS OMNI Narrow System &Prosthetic	Oneplant Dental Implant System
510(K) No.	K200817	K081748
ClassificationName	Endosseous Dental ImplantAbutments(872.3630)	Endosseous Dental ImplantAbutments(872.3630)
ProductCode	NHA	NHA
Material	Ti-6Al-4V ELI (ASTM F136)	Titanium Alloy
IndicationFor Use/Intended Use	Multi-unit Base is intended to besurgically placed in the maxillary ormandibular molar areas for thepurpose providing prostheticsupport for dental restorations inpartially or fully edentulousindividuals. It is used to restore apatient's chewing function.	ONEPLANT is designed for use indental implant surgery. These areintended for use in partially or fullyedentulous mandibles and maxillae tosupport for single or multiple-unitrestorations such as cementedretained, or over denture restorationsand terminal or intermediate abutmentsupport for fixed bridgework.
Diameters	5.0mm	Hex/Non-Hex: 4.5/5.5mm
Lengths	4.35/7.35mm	Not stated in 510(k) summary
SurfaceTreatment	None	None
Sterile	Non-sterile	Non-sterile
SE	The subject device and predicate devices (K081748) 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. Therefore, the subject device is substantially equivalent to the currentlycleared devices.
	Subject Device	Predicate Device
Part Name	Multi-unit Cylinder Screw	EbonyGold Cylinder Screw
Design	Image: Multi-unit Cylinder Screw	Image: EbonyGold Cylinder Screw
Applicant	TruAbutment Korea Co., Ltd	OSSTEM Implant Co., Ltd
Trade Name	URIS OMNI Narrow System &Prosthetic	Osstem Abutment System
510(K) No.	K200817	K182091
ClassificationName	Endosseous Dental ImplantAbutments(872.3630)	Endosseous Dental ImplantAbutments(872.3630)
Product Code	NHA	NHA
Material	Ti-6Al-4V ELI (ASTM F136)	Titanium AlloyTi-6Al-4V (ASTM F136)
IndicationFor Use/Intended Use	Multi-unit Cylinder Screw is a pre-manufactured prosthetic componentdirectly connected to the endosseousdental implant and is intended for useas an aid in prosthetic rehabilitation.	The Osstem Abutment System isintended for use with a dental implantto provide support for prostheticrestorations such as crowns, bridges, oroverdentures.
Diameters	1.6mm	2.2/2.5 mm
Lengths	3.3mm	4.35/ 4.9 mm
SurfaceTreatment	None	N/A
Sterile	Non-sterile	Non-sterile
SE	The subject device and reference devices (K182091) 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 tothe currently cleared devices.
	Subject Device	Predicate Devices
Part Name	URIS DS	TruAbutment DS
Design	Image: URIS DS	Image: TruAbutment DS
Applicant	TruAbutment Korea Co., Ltd	TruAbutment Korea Co., Ltd
Trade Name	URIS OMNI Narrow System &Prosthetic	TruAbutment DS
510(K) No.	K200817	K183106
ClassificationName	Endosseous Dental ImplantAbutments(872.3630)	Endosseous Dental ImplantAbutments(872.3630)
Product Code	NHA	NHA
Material	Ti-6Al-4V ELI (ASTM F136)	Ti-6AI-4V ELI
IndicationFor Use/Intended Use	URIS DS is a patient-specificCAD/CAM abutment, directlyconnected to endosseous dental implantsand is intended for use as an aid inprosthetic 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 SystemImplants (Proposed) 3.15 mmAll digitally designed abutments and/orcoping for use with the TruAbutmentDS abutments are intended to be sent toa TruAbutment-validated milling centerfor manufacture.	The TruAbutment DS is a patient-specificCAD/CAM abutment, directly connected toendosseous dental implants and is intendedfor use as an aid in prosthetic rehabilitation.It is compatible with the following systems:Tapered Internal Implants (K071638)(K143022) 3.4, 3.8, 4.6, 5.8 mmBioHorizons Laser-Lok Implant System(K093321) 3.0 mmThe available range of diameters issummarized below:Tapered Internal / Laser-Lok 3.0Implant Ø (mm) : 3.0 / Implant Platform(mm) : 3.0 / Type of Implant-AbutmentConnection : Internal HexTapered InternalImplant Ø (mm) : 3.4 / Implant Platform(mm) : 3.0 / Type of Implant-AbutmentConnection : Internal HexImplant Ø (mm) : 3.8 / Implant Platform(mm) : 3.5 / Type of Implant-AbutmentConnection : Internal HexImplant Ø (mm) : 4.6 / Implant Platform(mm) : 4.5 / Type of Implant-AbutmentConnection : Internal HexImplant Ø (mm) : 5.8 / Implant Platform(mm) : 5.7 / Type of Implant-AbutmentConnection : Internal HexAll digitally designed abutments and/orcoping for use with the TruAbutment DSabutments are intended to be sent to aTruAbutment-validated milling center for manufacture.
	Subject Device	Predicate Devices
Part Name	URIS DS	TruAbutment DS
		manufacture.
CAD DesignLimits	Minimum and Maximum GingivaHeight: 0.5~4mm	Minimum and Maximum Gingiva Height:0.5~4mm
	Minimum and Maximum diameter atabutment/implant interface: Ø3.8~Ø5.5	Minimum and Maximum diameter atabutment/implant interface: Ø3.8~Ø5.5
	Minimum and Maximum length ofabutment: 6~11mm	Minimum and Maximum length ofabutment: 6~11mm
	Minimum and Maximum length ofabutment post (length above theabutment collar/gingival height): 4~8mm	Minimum and Maximum length of abutmentpost (length above the abutmentcollar/gingival height): 4~8mm
	Minimum wall thickness atabutment/implant interface: 0.4mm	Minimum wall thickness atabutment/implant interface: 0.4mm
	Minimum and Maximum abutmentangle: 0~25°	Minimum and Maximum abutment angle:0~25°
SurfaceTreatment	None	None
Sterile	Non-sterile	Non-sterile
SE	The subject device (URIS DS) are substantially equivalent to the predicatedevice (TruAbutment DS, K183106). The subject device and the predicatedevice K183106 have internal connections, are made of Ti-6Al-4V ELI, and areconducted End User Steam Sterilization and are same CAD Design Limits. Theminor differences between the IFUS for the subject device and the primarypredicate is compatible system. The subject device is compatible with URISOMNI System Implants and URIS OMNI Narrow System.
	Subject Device	Predicate Devices
Part Name	URIS Base	Titanium Base
Design	Image: URIS Base Design	Image: Titanium Base Design
Applicant	TruAbutment Korea Co., Ltd.	Preat Corporation
Trade Name	URIS OMNI Narrow System &Prosthetic	Preat Abutments
510(K) No.	K200817	K183518
ClassificationName	Endosseous Dental ImplantAbutments(872.3630)	Endosseous Dental ImplantAbutments(872.3630)
Product Code	NHA	NHA
Material	Ti-6Al-4V ELI (ASTM F136)Zirconia Oxide	Ti-6Al-4V alloyZirconia Oxide
IndicationFor Use/Intended Use	URIS Base is intended for use inconjunction with the fixture inpartially or fully edentulousmandibles and maxillae, in supportof single or multiple-unit cementretained restorations.All digitally designed zirconiasuperstructures for use with the URISBase are intended to be sent to aTruAbutment-validated milling centerfor manufacture.	Preat Abutments are intended to be usedin conjunction with endosseous dentalimplants in the maxillary or mandibulararch to provide support for single-unit ormulti-unit prosthetic restorations. TheTitanium Base abutments consists of themajor parts. Specifically, the titaniumbase and mesostructured componentsmake up a two-piece abutment,All digitally designed custom abutments,superstructures, and/or hybrid crownsfor use with Titanium Base or TitaniumBlank are to be sent to a Preat validatedmilling center for manufacture.
ProsthesisAttachment	Cement-retainedScrew-retained	Cement-retainedScrew-retained
Restoration	Single-unitMulti-unit	Single-unitMulti-unit
Abutment/ImplantPlatformDiameter(mm)	Narrow 2.6Regular 3.3	3.0 - 6.5
Designparameters ofzirconiasuperstructures	Maximum Angulation 15°Maximum Cuff Height 5mmMinimum Diameter Ø 5.0mmMinimum Thickness 0.4mmMinimum Post Height 4~6mm	Minimum wall thickness-0.5mm;Minimum post height for single-unitrestorations-4.0mm;Maximum gingival height-5.0mm; andAll zirconia superstructures are forstraight abutments only.
Abutment	Internal connection	Internal connection
	Subject Device	Predicate Devices
Part Name	URIS Base	Titanium Base
/ImplantInterface
Sterile	Non-sterile	Non-sterile
SE	The subject device (URIS Base) are substantially equivalent to the predicatedevice (Titanium Base, K183518). The subject device and the predicate deviceK183518 have internal implant interface connections, same prosthesisattachment, restoration, are made of Ti-6Al-4V ELI, and are conducted End UserSteam Sterilization. The minor differences between the subject device and thepredicate is design parameters for abutment/implant platform diameter andzirconia superstructures. The predicate device are for straight abutments only,while the subject device can compensate for angles up to 15°.

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Substantial equivalence summary

The subject device is substantially equivalent in indications and design principles to the primary predicate device and the reference devices listed above. Provided tables are comparing the Indications for Use Statements and the technological characteristics of the subject device, the primary predicate device, and the reference devices.

The Indications for Use Statement (IFUS) for subject device abutment is substantially equivalent in intended use to the primary predicate device K172100, and the reference devices K102436. All are intended for use with endosseous dental implants in the maxilla and mandible to provide functional and esthetic rehabilitation of the edentulous maxilla and mandible. The minor differences between the IFUS for the subject device and the primary predicate include:

the subject device IFUS includes the term "URIS OMNI Narrow System & Prosthetic is indicated for use in the treatment of missing maxillary lateral incisors or the mandibular central and lateral incisors." and the primary predicate IFUS does not.

The other minor differences are related to the specific device names, validated milling centers, and the compatible OEM implant lines. None of these minor differences impact substantial equivalence because both IFUS express equivalent intended use to facilitate dental prosthetic restorations, and the indications are expressed equivalently using different specific wording.

The following subject device (Ball Abutment) is substantially equivalent to the predicate device (Stud Abutment. K161689). The subject device and the predicate device K161689 have internal implant interface connections, and are made of Ti-6A1-4V ELI. The minor differences between the IFUS for the subject device and the predicate is surface treatment. The subject device doesn't include surface treatment. The predicate device includes partial TiN coasted in upper.

The subject device (T LOC Straight Abutment) is substantially equivalent to the predicate device (Port Abutment, K182091). The subject device and the predicate device K182091 have internal connections, are made of Ti-6A1-4V ELI, and are conducted End User Steam Sterilization. The minor differences between the IFUS for the subject device and the predicate is surface treatment. The subject device doesn't include surface treatment. The predicate device includes partial TiN coasted in upper.

The subject device (Multi-unit Straight Abutment) is substantially equivalent to the predicate device (Multi Abutment, K161689). The subject device and the predicate device K161689 have internal

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K200817

implant interface connections, are made of Ti-6A1-4V ELI, and are conducted End User Steam Sterilization. The minor differences between the IFUS for the subject device and the predicate is surface treatment. The subject device doesn't include surface treatment. and abutment with a post length of less than 4mm is only available for multi-unit cases. The predicate device includes partial TiN coasted in upper.

The subject device (Multi-unit Angled Abutment) are substantially equivalent to the predicate device (Multi Angled Abutment, K123755). The subject device and the predicate device K123755 have internal connections, are made of Ti-6Al-4V ELI. and are conducted End User Steam Sterilization. The minor differences between the IFUS for the subject device and the predicate is angulation. The subject device is for multiple-unit restorations, include angulations up to 29.5°. and abutment with a post length of less than 4mm is only available for multi-unit cases. The predicate device is for multiple-unit restorations, include angulations up to 30°

The subject device (URIS DS) are substantially equivalent to the predicate device (TruAbutment DS, K183106). The subject device and the predicate device K183106 have internal connections, are made of Ti-6A1-4V ELI, and are conducted End User Steam Sterilization and are same CAD Design Limits. The minor differences between the IFUS for the subject device and the primary predicate is compatible system. The subject device is compatible with URIS OMNI System Implants and URIS OMNI Narrow System. and abutment with a post length of less than 4mm is only available for multiunit cases. The predicate device is compatible with BioHorizons Laser-Lok Implant System.

The subject device (URIS Base) are substantially equivalent to the predicate device (Titanium Base, K183518). The subject device and the predicate device K183518 have internal implant interface connections, same prosthesis attachment, restoration, are made of Ti-6AI-4V ELI, and are conducted End User Steam Sterilization. The minor differences between the subject device and the predicate is design parameters for abutment/implant platform diameter and zirconia superstructures. The predicate device are for straight abutments only, while the subject device can compensate for angles up to 15°. Other than the devices mentioned (Retainer Cap, T Loc titanium Cap, Multi-unit Healing Cap, Multi-unit Ti Cylinder, Multi-unit Temporary Cylinder, Multi-unit Base, Multi-unit Cylinder screw) have the same intended use, have similar technological characteristic, and are made of similar materials. The subject device and predicate devices have similar physical dimensions, including diameter. Therefore, the subject device is substantially equivalent to the currently cleared devices.

Non-Clinical Test Data

The following tests were performed:

· Bacterial Endotoxin Testing (LAL) in accordance with USP <85> and USP <161>
. Biocompatibility Testing according to ISO 10993-1.
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

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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 Narrow System & URIS Prosthetic 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.