Predicate Devices

Reference Devices

K120503, K081748, K153521, K081575, K161689, K153015, K093027

AI/ML (Artificial Intelligence / Machine Learning)

No
The device description and performance studies focus on the material properties, mechanical testing, and biocompatibility of dental implants and prosthetic components. There is no mention of software, algorithms, image processing, or any terms related to AI/ML.

Therapeutic

Yes.

The device is a dental implant system used to support restorations in edentulous mandibles and maxillae, which directly treats a medical condition (edentulism) by replacing missing teeth.

Diagnostic

No

The device is described as a dental implant system intended for use in supporting single or multiple-unit restorations, not for diagnosing a medical condition.

SaMD (Software as a Medical Device)

No

The device description explicitly states that the URIS OMNI System fixtures are dental implants made of Unalloyed Titanium and includes details about their physical characteristics, materials, and testing (biocompatibility, sterilization, fatigue, etc.), indicating it is a physical medical device, not software-only.

IVD (In Vitro Diagnostic)

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

Here's why:

Intended Use: The intended use clearly describes a device used in the body to support dental restorations in the jawbone. This is a surgical implant, not a diagnostic test performed on samples outside the body.
Device Description: The description details the physical components of a dental implant system (fixtures, abutments, screws) made of titanium. This aligns with a medical device for implantation, not a diagnostic reagent or instrument.
Lack of IVD Characteristics: The text does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring specific substances or markers
- Providing information for diagnosis, monitoring, or screening of diseases or conditions

The performance studies mentioned (biocompatibility, sterilization, fatigue testing) are also typical for implantable medical devices, not IVDs.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

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.

Product codes

DZE, NHA

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.

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	-
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: 14.1/14.85mm Non-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.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

mandibles and maxillae

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Not Found

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

The following tests were performed for the subject device:

Bacterial Endotoxin Testing (LAL) in accordance with USP and USP
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.

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

Not Found

Predicate Device(s)

K121995

Reference Device(s)

K120503, K081748, K153521, K081575, K161689, K153015, K093027

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

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.

Summary

0

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.

1

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)

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.

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.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

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"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

3

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

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.

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	-

4

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: 14.1/14.85mm
Non-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

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.

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 | Primary
Predicate Device | Reference Devices | |
|------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510K
Number | K172100 | K121995 | K120503 | K081748 |
| Device
Name | URIS OMNI System | TS Fixture System | CMI Implant IS II
active | Oneplant Dental
Implant System |
| Manufactur
er | TruAbutment Co.,
Ltd. | OSSTEM Implant
Co., Ltd. | Neobiotech Co., Ltd. | WARANTEC Co.,
Ltd. |
| Indications
for Use | 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, screw
retained, or
overdenture
restorations, and
final or temporary
abutment support for
fixed bridgework. It
is intended for
delayed loading. | The TS Fixture
System is indicated
for use in partially or
fully edentulous
mandibles and
maxillae, in support
of single or multiple-
unit restorations
including; cemented
retained, screw
retained, or
overdenture
restorations, and
final or temporary
abutment support for
fixed bridgework. It
is intended for
delayed loading. TS
Fixture System is
compatible with
abutment in the
ET/SS Implant
System. | The CMI Implant IS
II active is intended
to be surgically
placed in the bone of
the upper or lower
jaw arches to provide
support for
prosthetics devices,
such as artificial
teeth, and to restore
the patient's chewing
function. It is
intended for
immediate loading
when good primary
stability is achieved
and with appropriate
occlusal loading. | ONEPLANT is
designed for use in
dental implant
Surgery. These are
intended for use in
partially or fully
edentulous
mandibles and
maxillae to support
for single or
multiple-unit
restorations such as
cemented retained,
screw retained, or
over denture
restorations and
terminal or
intermediate
abutment support for
fixed bridgework. |

5

Design	Image: Implant	Image: Implant	Image: Implant	Image: Implant
Structure	- Internal Hex-
connected

Submerged Fixture | - Internal Hex-
connected
Submerged Fixture
Tapered body
shape and straight
body shape
4-sided cutting
edge with self-
tapping | N/A | - Internal Connection
Morse Taper
Internal Octagon |
| Body
Diameter(D) | 3.5, 4.0, 4.5, 5.0, 5.5,
6.0, 6.5mm | TSII SA Fixture: 3.5,
4.2, 4.4, 4.9
TSIII 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 of
Fixture | 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, Large
grit, Acid-etched
(S.L.A) | SA (Sandblasting
and Acid etching) | Sand-blasted, Large
grit, Acid-etched
(S.L.A) | N/A |
| Sterilization | Gamma Sterilization | Radiation Sterile | Gamma Sterilization | Gamma Sterilization |
| Shelf Life | 5years | 8years | N/A | N/A |
| Implant
Body
Features | Threaded | Threaded | Threaded | Threaded |
| Product
Code | DZE | DZE | DZE | DZE |
| SE | 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. The URIS Implant system is similar in fundamental
scientific technology to the predicate device in that they all have been designed,
manufactured and tested in compliance with FDA's Class II special controls guidance
document root-food endosseous dental implants and endosseous dental implant
abutments.
Any differences in technology characteristics are accompanied by information that
demonstrated the device is substantially equivalent as the predicate and do not raise
different questions of safety and effectiveness than the predicate. | | | |

6

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 Prosthetic
System
510(K) No.	K172100	K153521	K081575
Classification
Name	Endosseous Dental Implant
Abutments(872.3630)	Endosseous Dental Implant
Abutments(872.3630)	Endosseous Dental Implant
Abutments(872.3630)
Product Code	NHA	NHA	NHA
Material	Ti-6A1-4V ELI (ASTM
F136)	Ti-6A1-4V ELI (ASTM
F136)	Ti-6A1-4V ELI (ASTM
F136)
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, screw retained, or
Indications
overdenture restorations,
For Use/
and final or temporary
Intended Use
abutment support for fixed
bridgework. It is intended
for delayed loading.		IH Implant System is device
made of titanium and
titanium alloy indicated for
in partially or fully
edentulous mandibles and
maxillae, in support of
single or multiple-unit
restorations including;
cemented retained or screw
retained restorations and
terminal or internal
abutment support for fixed
bridgework. IH Implant
System is for single and two
stage surgical procedures. It
is intended for delayed
loading.	HU/HS/HG Prosthetic
System is intended for use
with a dental implant to
provide support
for prosthetic restorations
such as crowns, bridges, or
overdentures.
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
Surface
Treatment	Anodizing (Yellow, Green)	None	N/A
Sterile	Non-sterile	Non-sterile	Non-sterile
SE	The subject device and reference devices (K153521, K081575) 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.
	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
Classification
Name	Endosseous Dental Implant
Abutments(872.3630)	Endosseous Dental Implant
Abutments(872.3630)	Endosseous Dental Implant
Abutments(872.3630)
Product Code	NHA	NHA	NHA
Material	Ti-6Al-4V ELI (ASTM
F136)	Ti-6Al-4V ELI (ASTM
F136)	Ti-6Al-4V ELI (ASTM
F136)
Indications
For Use/
Intended Use	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, screw retained, or
overdenture restorations,
and final or temporary
abutment support for fixed
bridgework. It is intended
for delayed loading.	IH Implant System is device
made of titanium and
titanium alloy indicated for
in partially or fully
edentulous mandibles and
maxillae, in support of
single or multiple-unit
restorations including;
cemented retained or screw
retained restorations and
terminal or internal
abutment support for fixed
bridgework. IH Implant
System is for single and two
stage surgical procedures. It
is intended for delayed
loading.	The OSSTEM Implant
System - Abutment is
intended for use with a
dental implant to
provide support for
prosthetic restorations such
as crowns, bridges, or
overdentures.
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 :1.0/2.0/3.0/4.0/5.0/6.0
Post : 4.0/5.5/7.0	G/H :1.0/1.5/2.0/2.5/3.0/3.5/
4.0/4.5/5.0
Post: 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,

7

8

9

10

11

	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
Classification
Name	Endosseous Dental Implant
Abutments(872.3630)	Endosseous Dental Implant
Abutments(872.3630)
Product Code	NHA	NHA
Material	Ti-6Al-4V ELI (ASTM F136)	Titanium alloy (TAN)
Indications
For Use/
Intended Use	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, screw retained, or overdenture
restorations, and final or temporary
abutment support for fixed bridgework. It
is intended for delayed loading.	The Straumann RC Temporary Abutments
are indicated for use in Straumann RO
Bone Level Implants for temporary
restorations of single crowns and bridges
for up to six months.
Diameters	3.7 / 4.3mm	4.5mm
Lengths	Height 10mm	Height 11mm
Surface
Treatment	None	None
Maximum
Duration	Less than 6 months	Less than 6 months
Sterile	Non-sterile	Non-sterile
SE	The subject temporary abutment and reference devices are substantially equivalent in
intended use, material, surface treatment, design, dimension and maximum duration of 6
months. K093027 is selected as a reference device as it is indicated for temporary
restorations of single crowns and bridges for up to six months. The diameters of the
subject device are slightly different from the Reference devices. However, the diameter
of 4.3mm is in the range of diameters of predicates and this dimensional difference
doesn't affect substantial equivalence.

12

	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
Classification
Name	Endosseous Dental Implant
Abutments(872.3630)	Endosseous Dental Implant
Abutments(872.3630)
Product Code	NHA	NHA
Material	Ti-6Al-4V ELI (ASTM F136)	Ti-6Al-4V ELI (ASTM F136)
Indications
For Use/
Intended Use	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, screw retained, or overdenture
restorations, and final or temporary
abutment support for fixed bridgework. It is
intended for delayed loading.	The OSSTEM Implant System - Abutment
is intended for use with a dental implant to
provide support for prosthetic restorations
such 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
Surface
Treatment	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. The
subject device and predicate devices have similar physical dimensions, including
diameter and lengths. Therefore, the subject device is substantially equivalent to the
currently cleared devices.

13

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 and USP ●
. 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.