URIS Smart Path Implant System & Prosthetic

K230438 · Truabutment, Inc. · DZE · Dec 29, 2023 · Dental

Device Facts

• Record ID: K230438
• Device Name: URIS Smart Path Implant System & Prosthetic
• Applicant: Truabutment, Inc.
• Product Code: DZE · Dental
• Decision Date: Dec 29, 2023
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3640
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

URIS Smart Path Implant System & Prosthetic is indicated for use in partially or fully edentulous mandibles and maxillae, in support of single or multiple-unit restorations including; cemented retained, screw retained, or overdenture restorations, and final or temporary abutment support for fixed bridgework. It is intended for delayed loading. All digitally designed abutments and/or coping for use with URIS Smart Path Prosthetic abutments are intended to be sent to a TruAbutment-validated milling center for manufacture.

Device Story

URIS Smart Path Implant System comprises endosseous dental implants and prosthetic components; fixtures made of unalloyed titanium (ASTM F67) with SLA surface treatment; prosthetic components made of titanium alloy (ASTM F136). System includes implant fixtures, cover screws, healing abutments, temporary abutments, multi-unit abutments, and base components for CAD/CAM superstructures. Used in dental clinics by clinicians for prosthetic rehabilitation of edentulous mandibles and maxillae. Clinicians perform surgical placement of fixtures; prosthetic components are used to support restorations. Digitally designed abutments/copings require manufacturing at a TruAbutment-validated milling center using 3Shape CAD/CAM systems. Device provides structural support for dental prosthetics, restoring chewing function and aesthetics for patients.

Clinical Evidence

No clinical data were included in this submission. Substantial equivalence is supported by non-clinical bench testing, including fatigue testing (ISO 14801), biocompatibility evaluation (ISO 10993), sterilization validation (ISO 11137), shelf-life testing, and human factors usability evaluation.

Technological Characteristics

Materials: CP Ti Grade 4 (ASTM F67) for fixtures; Ti-6Al-4V ELI (ASTM F136) for prosthetics. Surface: SLA (Sandblasted, Large grit, Acid-etched). Connection: Internal. Sterilization: Gamma (fixtures/screws), End-user steam (prosthetics). Connectivity: CAD/CAM integration via 3Shape system for custom superstructures. Dimensions: Various diameters/lengths per system specifications.

Indications for Use

Indicated for partially or fully edentulous adult patients requiring single or multiple-unit dental restorations, including cemented, screw-retained, or overdenture restorations, and fixed bridgework support. 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)

Reference Devices

• IBS System (K220517)
• URIS OMNI Narrow System & Prosthetic (K200817)
• 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 logos of the Department of Health and Human Services and the Food and Drug Administration (FDA). The Department of Health and Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. Food & Drug Administration" in blue text.

December 29, 2023

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

Re: K230438

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

Dear Chris Kim:

We have reviewed your section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (the Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

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Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

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For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

# Andrew I. Steen -S

Andrew I. Steen Assistant Director DHT1B: Division of Dental and ENT Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known) K230438

Device Name

URIS Smart Path Implant System & Prosthetic

#### Indications for Use (Describe)

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

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

| Type of Use (Select one or both, as applicable) |
|-------------------------------------------------|
|-------------------------------------------------|

| <span style="font-size:12px">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) |
|------------------------------------------------------------------------------------|
| <span style="font-size:12px">☐</span> Over-The-Counter Use (21 CFR 801 Subpart C) |

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

# 510(k) Summary K230438

Submitter TruAbutment Inc. Ki Yoon Nam 17666 Fitch, Irvine, CA 92614 USA Email: [e-mail] Phone: [phone]

#### Official Correspondent

TruAbutment Inc. Chris Kim 17666 Fitch, Irvine, CA 92614 USA Email: chris.kim(@truabutment.com Phone: [phone]

# Device Information

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

# Predicate Devices/ Reference Devices:

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

# Primary Predicate:

- . URIS OMNI System (K172100) by TruAbutment Korea Co., Ltd.
# Reference Devices:

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

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

# General Description

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

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

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

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

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

# Raw material blanks

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

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

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

#### Design Limitation for Zirconia superstructure

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

# Indication for Use

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

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

# Summary of Technological Characteristics

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

# URIS SP Fixture

| | Subject Device | Predicate Device | Reference Devices |
|--------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510K<br>Number | K230438 | K172100 | K220517 |
| Device<br>Name | URIS Smart Path Implant<br>System & Prosthetic | URIS OMNI System | IBS System |
| Manufactu<br>rer | TruAbutment Korea Co.,<br>Ltd | TruAbutment Korea Co.,<br>Ltd | InnoBioSurg Co., Ltd. |
| Indications<br>for Use | URIS Smart Path Implant<br>System & Prosthetic is<br>indicated for use in<br>partially or fully edentulous<br>mandibles and maxillae, in<br>support of single or<br>multiple-unit restorations<br>including; cemented<br>retained, screw retained, or<br>overdenture restorations,<br>and final or temporary<br>abutment support for fixed<br>bridgework. It is intended<br>for delayed loading.<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 | URIS OMNI System is<br>indicated for use in partially<br>or fully edentulous<br>mandibles and maxillae, in<br>support of single or multiple-<br>unit restorations including;<br>cemented retained, screw<br>retained, or overdenture<br>restorations, and final or<br>temporary abutment support<br>for fixed bridgework. It is<br>intended for delayed loading. | The IBS System is intended<br>to replace missing teeth to<br>restore chewing function.<br>The IBS System can be<br>placed in support of single<br>or multiple-unit restorations<br>including; cement retained,<br>screw retained, or<br>overdenture restorations,<br>and terminal or immediate<br>abutment support for fixed<br>bridgework. This system is<br>for one or two stage<br>surgical procedures.<br>This system is intended for<br>delayed loading. |
| | Subject Device | Predicate Device | Reference Devices |
| 510K<br>Number | K230438 | K172100 | K220517 |
| | manufacture. | | |
| Design | Image: Subject Device | Image: Predicate Device | Image: Reference Devices |
| Structure | - Internal - connected<br>- Submerged Fixture | - Internal Hex- connected<br>- Submerged Fixture | - Internal Hex- connected<br>- Non Submerged Fixture |
| Body<br>Diameter<br>(D)<br>and<br>Length<br>(mm) | SP OMNI Thread<br>Ø3.5 x 8.5, 10, 11.5, 13, 14.5mm,<br>Ø4.0 x 7, 8.5, 10, 11.5, 13, 14.5mm,<br>Ø4.5 x 7, 8.5, 10, 11.5, 13, 14.5mm,<br>Ø5.0 x 7, 8.5, 10, 11.5, 13, 14.5mm,<br>Ø5.5 x 7, 8.5, 10, 11.5, 13, 14.5mm,<br>Ø6.0 x 7, 8.5, 10mm,<br>Ø6.5 x 7, 8.5, 10mm<br>SP Extra Aggressive Thread<br>Ø3.5 x 7, 8.5, 10, 11.5, 13, 14.5mm,<br>Ø4.0 x 7, 8.5, 10, 11.5, 13, 14.5mm,<br>Ø4.5 x 7, 8.5, 10, 11.5, 13, 14.5mm,<br>Ø5.0 x 7, 8.5, 10, 11.5, 13, 14.5mm,<br>Ø5.5 x 7, 8.5, 10mm, | Ø3.5 x 8.5, 10, 11.5, 13, 14.5mm,<br>Ø4.0 x 7, 8.5, 10, 11.5, 13, 14.5mm,<br>Ø4.5 x 7, 8.5, 10, 11.5, 13, 14.5mm,<br>Ø5.0 x 7, 8.5, 10, 11.5, 13, 14.5mm,<br>Ø5.5 x 7, 8.5, 10, 11.5, 13, 14.5mm,<br>Ø6.0 x 7, 8.5, 10mm,<br>Ø6.5 x 7, 8.5, 10mm | Ø7.0 x 7, 8, 9, 10, 11, 12,<br>13mm<br>Ø7.5 x 7, 8, 9, 10, 11, 12,<br>13mm<br>Ø8.0 x 7, 8, 9, 10, 11, 12,<br>13mm |
| Material of<br>Fixture | CP Ti Grade 4 (ASTM<br>F67) | CP Ti Grade 4 (ASTM F67) | Ti-6Al-4V Eli |
| Surface | Sand-blasted, Large grit,<br>Acid-etched<br>(S.L.A) | Sand-blasted, Large grit,<br>Acid-etched<br>(S.L.A) | Sand-blasted, Large grit,<br>Acid-etched<br>(S.L.A) |
| Sterilizatio<br>n | Gamma Sterilization | Gamma Sterilization | Gamma Sterilization |
| Shelf Life | 5years | 5years | 5years |
| Implant<br>Body<br>Features | Threaded | Threaded | Threaded |
| Product<br>Code | DZE | DZE | DZE |
| | Subject Device | Predicate Device | Reference Devices |
| 510K<br>Number | K230438 | K172100 | K220517 |
| SE | The subject device is substantially equivalent in indications and design principles to the<br>primary predicate device and the reference devices listed above. Provided tables are<br>comparing the Indications for Use Statements and the technological characteristics of the<br>subject device, the primary predicate device, and the reference devices.<br><br>The Indications for Use Statement (IFUS) for subject device abutment is substantially<br>equivalent in intended use to the predicate device K172100. All are intended for use<br>with endosseous dental implants in the maxilla and mandible to provide functional and<br>esthetic rehabilitation of the edentulous maxilla and mandible.<br><br>Minor differences in the designs, implant connections, dimensions, or sizes between the<br>subject device, the predicate device, and the reference devices do not affect substantial<br>equivalence.<br><br>The implant body dimension of the subject device is the similar included in K172100.<br>URIS SP Extra Aggressive Implant bodies are only available in limited diameters/lengths.<br>Ø3.5 x 7, 8.5, 10, 11.5, 13, 14.5mm,<br>Ø4.5 x 7, 8.5, 10, 11.5, 13, 14.5mm,<br>Ø5.5 x 7, 8.5, 10mm<br><br>The subject device and reference device K220517 packaging methods are similar. | | |

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

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

# URIS SP Abutments

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

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

| Part Name | Healing Abutment | Healing Abutment |
|------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Design | Image: Healing Abutment Design 1 | Image: Healing Abutment Design 2 |
| Applicant | TruAbutment Korea Co., Ltd | TruAbutment Korea Co., Ltd |
| Trade Name | URIS Smart Path Implant System | URIS OMNI System |
| 510(K) No. | K230438 | K172100 |
| 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) |
| Description | URIS Smart Path Implant System &<br>Prosthetic is indicated for use in<br>partially or fully edentulous<br>mandibles and maxillae, in support of<br>single or multiple-unit restorations<br>including; cemented retained, screw<br>retained, or overdenture restorations,<br>and final or temporary abutment<br>support for fixed bridgework. It is<br>intended for delayed loading. | URIS OMNI System is indicated for use<br>in partially or fully edentulous mandibles<br>and maxillae, in support of single or<br>multiple-unit restorations including;<br>cemented retained, screw retained, or<br>overdenture restorations, and final or<br>temporary abutment support for fixed<br>bridgework. It is intended for delayed<br>loading. |
| Diameters | 4.0/4.5/5.0/6/7mm | 4.0/4.5/5.5/6.5/7.5mm |
| Surface<br>Treatment | Anodizing (Yellow, Green) | Anodizing (Yellow, Green) |
| Sterile | Non-sterile | Non-sterile |
| SE | The subject device and reference devices (K172100) have the similar intended<br>use, have similar technological characteristic, and are made of similar materials.<br>The subject device and reference device have similar physical dimensions,<br>including diameter. Therefore, the subject device is substantially equivalent to<br>the currently cleared devices. | The subject device and reference devices (K172100) have the similar intended<br>use, have similar technological characteristic, and are made of similar materials.<br>including diameter. Therefore, the subject device is substantially equivalent to<br>the currently cleared devices. |

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

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

| Part Name | T-L Straight Abutment | T LOC Straight Abutment |
|------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Design | Image: T-L Straight Abutment | Image: T LOC Straight Abutment |
| Applicant | TruAbutment Korea Co., Ltd. | TruAbutment Korea Co., Ltd. |
| Trade Name | URIS Smart Path Implant System | URIS OMNI Narrow System &<br>Prosthetic |
| 510(K) No. | K230438 | K200817 |
| 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) |
| Description | T-L Straight Abutment is intended<br>for use in conjunction with the<br>fixture in partially or fully edentulous<br>mandibles and maxillae, in support of<br>multiple-unit cement retained<br>restorations. | T LOC Straight Abutment is intended for<br>use in conjunction with the fixture in<br>partially or fully edentulous mandibles<br>and maxillae, in support of single or<br>multiple-unit cement retained<br>restorations. |
| Diameters | 3.8mm | 3.8mm |
| Lengths | G/H : 1.0/2.0/3.0/4.0/5.0/6.0 mm | G/H : 1.0/2.0/3.0/4.0/5.0/6.0 mm |
| Surface<br>Treatment | None | None |
| Sterile | Non-sterile | Non-sterile |
| SE | The subject device (T-L Straight Abutment) is substantially equivalent to the predicate device (TLOC Straight Abutment, K200817). The subject device and the predicate device K200817 have internal connections, are made of Ti-6Al-4V ELI, and are conducted End User Steam Sterilization. | |

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

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

| Design | Image: Dental implant | Image: Dental implant |
|-----------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------…