URIS OMNI Narrow System & Prosthetic

K200817 · Truabutment, Inc. · DZE · Oct 7, 2020 · Dental

Device Facts

• Record ID: K200817
• Device Name: URIS OMNI Narrow System & Prosthetic
• Applicant: Truabutment, Inc.
• Product Code: DZE · Dental
• Decision Date: Oct 7, 2020
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3640
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

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 Story

Dental implant system comprising fixtures and prosthetic abutments; fixtures made of unalloyed titanium (ASTM F67) with SLA surface treatment; prosthetic components made of titanium alloy (ASTM F136). Inputs include patient clinical data for CAD/CAM design of custom abutments (URIS DS, URIS Base). Device transforms inputs via 3Shape CAD/CAM software into patient-specific designs manufactured at validated milling centers. Used in dental clinics by clinicians to support crowns, bridges, or overdentures. Output provides structural support for prosthetic restorations, restoring chewing function. Benefits include functional and esthetic rehabilitation of edentulous sites.

Clinical Evidence

No clinical data included. Evidence consists of bench testing: biocompatibility (ISO 10993-1), fatigue testing (ISO 14801:2016), sterilization validation (ISO 11137, ISO 17665), shelf-life testing (ASTM F1980), and material analysis (SEM/EDS).

Technological Characteristics

Fixtures: CP Ti Grade 4 (ASTM F67), SLA surface. Abutments: Ti-6Al-4V ELI (ASTM F136). Connection: Internal hex. Dimensions: Fixture diameter 3.15mm, lengths 10-14.5mm. Sterilization: Gamma (fixtures), steam (prosthetics). CAD/CAM workflow for custom components.

Indications for Use

Indicated for treatment of missing maxillary lateral incisors or mandibular central and lateral incisors in partially or fully edentulous patients. Supports single or multiple-unit restorations (cemented, screw-retained, overdenture) and fixed bridgework. Intended for delayed loading.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

• URIS OMNI System (K172100)
• OSSTEM Implant System (K161689)
• Hiossen Prosthetic System (K140507)
• Osstem Abutment System (K182091)
• Multi Angled Abutment (K123755)
• SMART builder System (K120951)
• AnyOne Internal Implant System (K123988)
• ET US SS Prosthetic System (K160670)
• Preat Abutments (K183518)
• Oneplant Dental Implant System (K081748)
• TruAbutment DS (K183106)

Reference Devices

• Nobel Active 3.0 (K102436)
• InCoris Zi (K123664)
• RelyX Unicem 2Automix (K100756)

Submission Summary (Full Text)

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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 ([e-mail]) or phone [phone] 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)

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.

| Type of Use (Select one or both, as applicable) | |
|-----------------------------------------------------------------------------------------------|---------------------------------------------|
| <div><span style="font-size:16px">☑</span> Prescription Use (Part 21 CFR 801 Subpart D)</div> | 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: [e-mail]

Phone: [phone]

#### 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: [e-mail] Phone: [phone]

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# 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.

| 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: 1.0/2.0mm<br>Post 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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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. It is compatible with the following systems:

## 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 at<br>abutment/implant interface | ∅5.0mm~∅8.0mm |
| Minimum Thickness | 0.4 mm |
| Minimum and Maximum length of<br>abutment post (length above the abutment<br>collar/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<br>(K200817)<br>Design Limit | URIS OMNI System<br>(K172100)<br>Design Limit |
|------------------------------------------------------------------------------------------------------|---------------------------------------------|-----------------------------------------------|
| Minimum and Maximum Gingival<br>Height | 0.5~4mm | 0.5~4mm |
| Minimum and Maximum diameter at<br>abutment/implant interface | $Ø$ 3.8~ $Ø$ 5.5 | $Ø$ 3.8~ $Ø$ 5.5 |
| Minimum and Maximum length of<br>abutment | 6~11mm | 6~11mm |
| Minimum and Maximum length of<br>abutment post (length above the<br>abutment collar/gingival height) | 4~8mm | 4~8mm |
| Minimum wall thickness at<br>abutment/implant interface | 0.4mm | 0.4mm |
| Minimum and Maximum abutment<br>angle | 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 | Primary<br>Predicate Device | Reference Devices |
|-----------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510K<br>Number | K200817 | K172100 | K102436 |
| Device<br>Name | URIS OMNI Narrow<br>System & Prosthetic | URIS OMNI System | Nobel Active 3.0 |
| Manufact<br>urer | TruAbutment Korea Co.,<br>Ltd | TruAbutment Korea Co.,<br>Ltd | Nobel Biocare |
| Indication<br>for Use | URIS OMNI Narrow<br>System is indicated for use<br>in the treatment of missing<br>maxillary lateral incisors<br>or the mandibular central<br>and lateral incisors, in<br>support of single or<br>multiple-unit restorations<br>including; cemented<br>retained, screw retained,<br>or overdenture<br>restorations, and final or<br>temporary abutment<br>support for fixed<br>bridgework. It is intended<br>for delayed loading.<br>The URIS OMNI<br>Prosthetic abutments are<br>intended for use with<br>URIS OMNI dental<br>implants to provide<br>support for prosthetic<br>restorations such as<br>crowns, bridges, or over-<br>dentures.<br>All digitally designed<br>abutments and/or coping<br>for use with URIS OMNI<br>Prosthetic abutments are<br>intended to be sent to a<br>TruAbutment-validated<br>milling center for<br>manufacture | URIS OMNI System is<br>indicated for use in<br>partially or fully<br>edentulous mandibles and<br>maxillae, in support of<br>single or multiple-unit<br>restorations including;<br>cemented retained, screw<br>retained, or overdenture<br>restorations, and final or<br>temporary abutment<br>support for fixed<br>bridgework. It is intended<br>for delayed loading. | The NobelActive<br>3.0mm implant is<br>indicated for use in the<br>treatment of missing<br>maxillary lateral incisors<br>or the mandibular<br>central and lateral<br>incisors to support<br>prosthetic devices, such as<br>artificial teeth,in order to<br>restore chewing<br>function in partially<br>edentulous patients. The<br>NobelActive 3.0<br>implants may be put into<br>immediate function<br>provided that stability<br>requirements detailed in<br>the manual are satisfied. |
| Design | Image: Subject Device Design | Image: Primary Predicate Device Design | Image: Reference Devices Design |
| | Subject Device | Primary<br>Predicate Device | Reference Devices |
| Structure | - Internal Hex- connected<br>- Submerged Fixture | - Internal Hex- connected<br>- Submerged Fixture | -Internal Hex<br>- Bone Level Implant |
| Body<br>Diameter<br>(D) | 3.15mm | 3.5, 4.0, 4.5, 5.0, 5.5, 6.0,<br>6.5 mm | 3.0mm |
| Length<br>(mm) | 10, 11.5, 13, 14.5mm | 7, 8.5, 10, 11.5, 13,<br>14.5mm | 10, 11.5, 13, 15mm |
| Material<br>of Fixture | CP Ti Grade 4 (ASTM<br>F67) | CP Ti Grade 4 (ASTM<br>F67) | Pure Titanium Grade 4<br>(ASTM F67) |
| Surface | Sand-blasted, Large grit,<br>Acid-etched<br>(S.L.A) | Sand-blasted, Large grit,<br>Acid-etched<br>(S.L.A) | TiUnite |
| Sterilizatio<br>n | Gamma Sterilization | Gamma Sterilization | Radiation Sterile |
| Shelf Life | 5years | 5years | N/A |
| Implant<br>Body<br>Features | Threaded | Threaded | Threaded |
| Product<br>Code | DZE | DZE | DZE |
| SE | The subject device is substantially equivalent in indications and design principles to<br>the primary predicate device and the reference devices listed above. Provided tables<br>are comparing the Indications for Use Statements and the technological<br>characteristics of the subject device, the primary predicate device, and the reference<br>devices.<br>The Indications for Use Statement (IFUS) for subject device abutment is<br>substantially equivalent in intended use to the primary predicate device K172100,<br>and the reference devices K102436. All are intended for use with endosseous dental<br>implants in the maxilla and mandible to provide functional and esthetic rehabilitation<br>of the edentulous maxilla and mandible. The minor differences between the IFUS for<br>the subject device and the primary predicate include:<br>the subject device IFUS includes the term "URIS OMNI Narrow System &<br>Prosthetic is indicated for use in the treatment of missing maxillary lateral incisors or<br>the mandibular central and lateral incisors" and the primary predicate IFUS does not.<br>The other minor differences are related to the specific device names, validated<br>milling centers, and the compatible OEM implant lines. None of these minor<br>differences impact substantial equivalence because both IFUS express equivalent<br>intended use to facilitate dental prosthetic restorations, and the indications are<br>expressed 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 &<br>Prosthetic | OSSTEM Implant System | |
| 510(K) No. | K200817 | K161689 | |
| Classification<br>Name | Endosseous Dental Implant<br>Abutments(872.3630) | Endosseous Dental Implant<br>Abutments(872.3630) | |
| Product Code | NHA | NHA | |
| Material | Ti-6Al-4V ELI (ASTM F136) | Ti-6Al-4V ELI (ASTM F136) | |
| Indication<br>For Use/<br>Intended Use | Ball Abutment is intended for use in<br>conjunction with the fixture in<br>partially or fully edentulous<br>mandibles and maxillae, in support of<br>multiple-unit cement retained<br>restorations…