(261 days)
URIS Long Implant & Abutments are 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.
URIS Long Implants 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.
URIS OMNI Long Implants consist of two implant lines, the OMNI Straight and the OMNI Tapered. The OMNI Straight implant features straight walls, with smaller threads at the coronal end and larger threads at the apical end. The OMNI Tapered implant has a tapered wall with a single-thread design.
Both implant lines have two platform sizes, Narrow (Ø 3.5 mm) and Regular (Ø 4.0 – Ø 4.5 mm).
Both implant lines share the following diameters and lengths:
| Type | Platform | Diameter (Ø) | Length (mm) |
|---|---|---|---|
| Straight | Narrow | Ø 3.5 | 16, 18 |
| Straight | Regular | Ø 4.0 – 4.5 | 16, 18 |
| Tapered | Narrow | Ø 3.5 | 16, 18 |
| Tapered | Regular | Ø 4.0 – 4.5 | 16, 18 |
URIS OMNI Long Implants are compatible with the following abutments:
- Cover Screw (K172100)
- Healing Abutments (K172100)
- Multi-Unit Straight Abutment (K200817)
- Multi-Unit Angled Abutment (K200817)
- Multi-Unit Healing Cap (K200817)
- Multi-Unit Ti Cylinder (K200817)
- Multi-Unit Temporary Cylinder (K200817)
- Multi-Unit Base (K200817)
- Multi-Unit Cylinder Screw (K200817)
- AOT Base (K231874)
- AOT Temporary (K231874)
- AOT Straight Abutment (K243255)
- AOT Angled Abutment (K243255)
- Multi-Unit Base (K243255)
- Multi-Unit Base Screw (K243255)
- Multi-Unit Temporary Abutment (K243255)
- AOT Direct Screw (K243255)
- AOT Plus Direct Screw (K243255)
- Multi-Unit Direct Screw (K243255)
The abutments are provided non-sterile. All non-sterile products must be sterilized by the end user prior to use.
The AOT Angled Abutment, Multi-Unit Base, and Multi-Unit Temporary Abutment are packaged with their corresponding screw(s).
For convenience, the Multi-Unit Base and Multi-Unit Temporary Abutment are each supplied with two screws included in the package.
The abutments are designed for use with the two implant types submitted in this application. They are also compatible with the implants included in the K172100 URIS OMNI Implant system (Narrow: Ø3.5 mm, lengths 8.5–14.5 mm / Regular: Ø4.0–Ø6.5 mm, lengths 7.0–14.5 mm).
The AOT Straight and AOT Angled Abutments are compatible with the Base and Temporary Abutments included in this submission, as well as those previously cleared under K231874.
The provided FDA 510(k) clearance letter for URIS Long Implant & Abutments does not contain information about acceptance criteria and study proving device performance as typically expected for AI/ML-driven medical devices. This submission is for a traditional dental implant system, and the clearance is based on substantial equivalence to predicate devices through non-clinical testing, primarily focusing on mechanical, material, and biocompatibility properties.
Therefore, many of the requested elements regarding acceptance criteria for device performance (e.g., sensitivity, specificity, AUC), study design (sample size, data provenance, ground truth establishment, expert adjudication), and AI/ML-specific study types (MRMC, standalone performance) are not applicable to this submission.
However, I can extract the information relevant to the type of device and submission, specifically the non-clinical acceptance criteria and the tests performed to meet them.
Acceptance Criteria and Supporting Study for URIS Long Implant & Abutments
As this FDA 510(k) pertains to a traditional dental implant and abutment system (URIS Long Implant & Abutments, K243255), and not an AI/ML device, the acceptance criteria and study details are focused on non-clinical performance, primarily demonstrating mechanical integrity, material compatibility, and safety through established engineering and biological standards, rather than diagnostic accuracy metrics.
The clearance is largely based on demonstrating substantial equivalence to previously cleared predicate devices through a series of non-clinical tests.
1. Table of Acceptance Criteria and Reported Device Performance
Given the nature of this device (dental implants), the "performance" is demonstrated through engineering and biocompatibility testing rather than diagnostic accuracy. The acceptance criteria are implicitly meeting the requirements of the cited ISO and USP standards. The document doesn't provide specific quantitative "pass/fail" values for each test, but rather states that the device "met the criteria of the standards."
| Acceptance Criteria Category | Specific Test/Evaluation | Reported Device Performance |
|---|---|---|
| Biocompatibility | Bacterial Endotoxin Testing (LAL) in accordance with USP <85> and USP <161> | Met criteria of the standards |
| Biocompatibility | Biocompatibility testing according to ISO 10993-1 | Met criteria of the standards (Completed) |
| Sterilization | Sterilization Testing according to ISO 11137-1,-2,-3 and ISO 11737-1,-2 | Met criteria of the standards |
| Sterilization (End-user) | End user sterilization Testing according to ISO 17665-1,-2 | Met criteria of the standards |
| Shelf-Life & Packaging Integrity | Shelf-Life Testing according to ISO 11607-1,-2 / ASTM F1980-07, ASTM F88, ASTM F1140, ASTM F1929, ASTM F2096 and sterility testing | Met criteria of the standards |
| Mechanical Integrity | Fatigue Testing according to ISO 14801:2016 and FDA Guidance (worst-case scenario) | Met criteria of the standards (Addressed dimensional differences from predicates via this testing) |
| Material Characterization | SEM (Scanning electron microscopy) images and EDS (Energy Dispersive X-ray Spectroscopy) analysis | Met criteria of the standards (Implicitly, as part of material verification) |
| Substantial Equivalence | Comparison of Indications for Use, Material, Design, Dimension, Connection, Functions, and Surface Treatments to Predicate Devices | Demonstrated substantial equivalence |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not explicitly stated in terms of a "test set" as one would expect for an AI/ML device. The "sample size" would refer to the number of physical dental implants/abutments subjected to each non-clinical test (e.g., number of units for fatigue testing, number of samples for biocompatibility). These numbers are not detailed in the summary but would be standard for regulatory testing required by the ISO/ASTM standards cited (e.g., minimum of 5-10 samples for fatigue per condition).
- Data Provenance: Not applicable in the context of patient data for diagnostic accuracy. The "data" originated from laboratory testing of the manufactured dental implants and abutments.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
- Not Applicable: This clearance is based on non-clinical engineering and biological safety tests (e.g., fatigue strength, sterility, biocompatibility), not on the interpretation of medical images or patient data requiring expert consensus or ground truth establishment by clinical experts like radiologists.
4. Adjudication Method for the Test Set
- Not Applicable: As there is no human interpretation of data for diagnostic purposes, there's no need for an adjudication process. Test results are objective measurements (e.g., force at failure, sterility present/absent).
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- Not Performed / Not Applicable: MRMC studies are specific to evaluating diagnostic devices, particularly those involving human readers and AI assistance. This device is a physical dental implant, not a diagnostic AI tool.
6. Standalone (Algorithm Only) Performance Study
- Not Performed / Not Applicable: This is a physical medical device, not a software algorithm.
7. Type of Ground Truth Used
- Engineering/Material Standards and Biological Safety Standards: The "ground truth" for this device's performance is established by the specified ISO and ASTM standards (e.g., ISO 14801 for fatigue testing, ISO 10993-1 for biocompatibility). These standards define acceptable performance limits for mechanical properties and biological responses.
8. Sample Size for the Training Set
- Not Applicable: This device is not an AI/ML algorithm that requires a training set. Its design and manufacturing are based on established engineering principles and materials science.
9. How the Ground Truth for the Training Set Was Established
- Not Applicable: As there is no training set for an AI/ML algorithm, this question is not relevant.
FDA 510(k) Clearance Letter - URIS Long Implant & Abutments
Page 1
U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov
Doc ID # 04017.07.05
TruAbutment Inc.
Suna Kim
RA Senior Manager
17666 Fitch
Irvine, California 92614
Re: K243255
Trade/Device Name: URIS Long Implant & Abutments
Regulation Number: 21 CFR 872.3640
Regulation Name: Endosseous Dental Implant
Regulatory Class: Class II
Product Code: DZE, NHA
Dated: May 29, 2025
Received: May 29, 2025
July 3, 2025
Dear Suna 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.
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K243255 - Ki Yoon Nam Page 2
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).
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 QS 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 (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-reporting-combination-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.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
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-devices/medical-device-safety/medical-device-reporting-mdr-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/medical-devices/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-devices/device-advice-comprehensive-regulatory-
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K243255 - Ki Yoon Nam Page 3
assistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Sherrill Lathrop Blitzer
for Andrew 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
Page 4
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120
Expiration Date: 07/31/2026
See PRA Statement below.
Submission Number (if known): K243255
Device Name: URIS Long Implant & Abutments
Indications for Use (Describe)
URIS Long Implant & Abutments are 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.
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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Page 5
510(k) Submission
URIS Long Implant & Abutments
K243255
Page 1 of 12 07/01/2025
510(K) Summary
This 510(K) Summary is being submitted in accordance with requirement of 21 CFR part 807.92.
Submitter:
TruAbutment Inc.
John Kim
17666 Fitch,
Irvine, CA 92614 USA
Email: trura@truabutment.com
Phone: 1-714-7675123
Official Correspondent:
TruAbutment Inc.
Dong uk Shin
17666 Fitch,
Irvine, CA 92614 USA
Email: trura@truabutment.com
Phone: 1-714-7675123
Device Information:
Device Name: URIS Long Implant & Abutments
Classification Name: Endosseous Dental Implant
Classification: Class II
Primary Product Code: DZE
Secondary Product Code: NHA
Regulation number: 21 CFR 872.3640
Date Prepared: 07/02/2025.
Predicate Device
Primary Predicate Device:
- URIS OMNI System (K172100) by TruAbutment Korea Co., Ltd.
Reference Predicate Device:
- Single Platform SP1 Implant System (K232418) by Southern Implants (Pty) Ltd
- URIS OMNI Narrow System & Prosthetic (K200817) by TruAbutment Korea Co., Ltd.
- AOT & T-L Abutment (K231874) by TruAbutment Korea Co., Ltd.
Page 6
Device Description
General Description
URIS Long Implants 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.
URIS OMNI Long Implants consist of two implant lines, the OMNI Straight and the OMNI Tapered. The OMNI Straight implant features straight walls, with smaller threads at the coronal end and larger threads at the apical end. The OMNI Tapered implant has a tapered wall with a single-thread design.
Both implant lines have two platform sizes, Narrow (Ø 3.5 mm) and Regular (Ø 4.0 – Ø 4.5 mm).
Both implant lines share the following diameters and lengths:
| Type | Platform | Diameter (Ø) | Length (mm) |
|---|---|---|---|
| Straight | Narrow | Ø 3.5 | 16, 18 |
| Straight | Regular | Ø 4.0 – 4.5 | 16, 18 |
| Tapered | Narrow | Ø 3.5 | 16, 18 |
| Tapered | Regular | Ø 4.0 – 4.5 | 16, 18 |
URIS OMNI Long Implants are compatible with the following abutments:
| 510(K) | Device Component | Diameters (Ø) | Lengths | Angulation |
|---|---|---|---|---|
| K172100 | Cover Screw | 2.78 (N) /3.48 (R) | 4.875/ 5.375 | - |
| Healing Abutments | 4.0 (N)/ 4.5 (N, R) / 5.5, 6.5, 7.5 (R) | Cuff Height: 1.0 ~ 5.0 | - | |
| K200817 | Multi-Unit Straight Abutment | 5.0 (N, R) | Cuff Height: 1.0 ~ 6.0 | - |
| Multi-Unit Angled Abutment | 5.0 (N, R) | Cuff Height: 3.0 ~ 5.0 | 17 | |
| Cuff Height: 4.0 ~ 6.0 | 29.5 | |||
| Multi-Unit Healing Cap | 5.1 (N, R) | 4.5 | - | |
| Multi-Unit Ti Cylinder | 5.0 (N, R) | 5.0 | - | |
| Multi-Unit Temporary Cylinder | 5.0 (N, R) | 12 | - | |
| Multi-Unit Base | 5.0 (N, R) | 4.35/ 7.35 | - | |
| Multi-Unit Cylinder Screw | 1.6 (N, R) | 3.3 | - | |
| K231874 | AOT Base | 5.3 (N,R) | 4.35/ 7.35 | - |
| AOT Temporary | 4.8 (N,R) | 12 | - | |
| K243255 | AOT Straight Abutment | 4.8 (N, R) | Cuff Height: 1.0 ~ 6.0 | - |
| AOT Angled Abutment | 4.8 (N, R) | Cuff Height: 3.0 ~ 5.0 | 17° | |
| Cuff Height: 4.0 ~ 6.0 | 30° | |||
| Multi-Unit Base | 5.3 (N,R) | 4.35 / 7.35 | - | |
| Multi-Unit Base Screw | 2.2 | 4.2 | - | |
| Multi-Unit Temporary Abutment | 4.8 (N, R) | 12 | - | |
| AOT Direct Screw | 2.2 | 1.35 | - | |
| AOT Plus Direct Screw | 2.3 | 1.56 | - | |
| Multi-Unit Direct Screw | 2.2 | 4.85 | - |
The abutments are provided non-sterile. All non-sterile products must be sterilized by the end user prior to use.
The AOT Angled Abutment, Multi-Unit Base, and Multi-Unit Temporary Abutment are packaged with their corresponding screw(s).
For convenience, the Multi-Unit Base and Multi-Unit Temporary Abutment are each supplied with two screws included in the package.
Page 7
The abutments are designed for use with the two implant types submitted in this application. They are also compatible with the implants included in the K172100 URIS OMNI Implant system (Narrow: Ø3.5 mm, lengths 8.5–14.5 mm / Regular: Ø4.0–Ø6.5 mm, lengths 7.0–14.5 mm).
The AOT Straight and AOT Angled Abutments are compatible with the Base and Temporary Abutments included in this submission, as well as those previously cleared under K231874.
Indication for Use
URIS Long Implant & Abutments are 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.
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.
Page 8
URIS Fixture
| Subject Device | Primary Predicate Device | Reference Devices | |
|---|---|---|---|
| 510K Number | K243255 | K172100 | K232418 |
| Device Name | URIS Long Implant & Abutments | URIS OMNI System | Single Platform SP1 Implant System |
| Manufacturer | TruAbutment Korea Co., Ltd | TruAbutment Korea Co., Ltd | Southern Implants (Pty) Ltd |
| Indications for Use | URIS Long Implant & Abutments are 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. | 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 Single Platform SP1 Implant System is intended for surgical placement in the upper or lower jaw to provide a means for prosthetic attachment of crowns, bridges or overdentures utilizing delayed or immediate loading. The Single Platform SP1 Implant System is intended for immediate function when good primary stability with Appropriate occlusal loading is achieved. The Single Platform SP1 implants in lengths 20, 22 and 24 mm when placed in the maxilla are only indicated for multiple unit restorations in splinted applications that utilize at least two implants. |
Design
Page 9
| Subject Device | Primary Predicate Device | Reference Devices | |
|---|---|---|---|
| Structure | - Internal Hex- connected- Submerged Fixture | - Internal Hex- connected- Submerged Fixture | - Internal Cone and Hex |
| Body Diameter (D) | 3.5, 4.0, 4.5 mm | 3.5, 4.0, 4.5, 5.0, 5.5, 6.0, 6.5 mm | 3.50, 4.0 and 5.0mm |
| Length (mm) | 16, 18 mm | 7, 8.5, 10, 11.5, 13, 14.5 mm | For Ø3.5implants: 8, 10,11.5, 13, 16, 18, 20 mmFor Ø4.0 implants: 8, 10,11.5, 13, 16, 18, 20, 22, 24 mmFor Ø5.0 implants: 8, 10, 11.5, 13, 16, 18mm |
| Material of Fixture | CP Ti Grade 4(ASTM F67) | CP Ti Grade 4(ASTM F67) | Unalloyed titanium (ASTM F67) Grade 4,and UTS ≥ 900MPa (coldworked) |
| Surface | Sand-blasted, large grit, Acid-etched.(S.L.A) | Sand-blasted, large grit, Acid-etched.(S.L.A) | Grit-blasted with a 3.0mm machined section only at coronal end |
| Sterilization | Gamma Sterilization | Gamma Sterilization | Gamma Sterilization |
| Shelf Life | 5 years | 5 years | 10 years |
| Implant Body Features | Threaded | Threaded | Threaded |
| Product Code | DZE | DZE | DZE |
Page 10
| Subject Device | Primary Predicate Device | Reference Devices | |
|---|---|---|---|
| Structure | - Internal Hex- connected- Submerged Fixture | - Internal Hex- connected- Submerged Fixture | - Internal Cone and Hex |
| Body Diameter (D) | 3.5, 4.0, 4.5 mm | 3.5, 4.0, 4.5, 5.0, 5.5, 6.0, 6.5 mm | 3.50, 4.0 and 5.0mm |
| Length (mm) | 16, 18 mm | 7, 8.5, 10, 11.5, 13, 14.5 mm | For Ø3.5implants: 8, 10,11.5, 13, 16, 18, 20 mmFor Ø4.0 implants: 8, 10,11.5, 13, 16, 18, 20, 22, 24 mmFor Ø5.0 implants: 8, 10, 11.5, 13, 16, 18mmUnalloyed titanium (ASTM F67) Grade 4,and UTS ≥ 900MPa (coldworked) |
| Material of Fixture | CP Ti Grade 4(ASTM F67) | CP Ti Grade 4(ASTM F67) | Unalloyed titanium (ASTM F67) Grade 4,and UTS ≥ 900MPa (coldworked) |
| Surface | Sand-blasted, large grit, Acid-etched.(S.L.A) | Sand-blasted, large grit, Acid-etched.(S.L.A) | Grit-blasted with a 3.0mm machined section only at coronal end |
| Sterilization | Gamma Sterilization | Gamma Sterilization | Gamma Sterilization |
| Shelf Life | 5 years | 5 years | 10 years |
| Implant Body Features | Threaded | Threaded | Threaded |
| Product Code | DZE | DZE | DZE |
Page 11
| Subject Device | Primary Predicate Device | Reference Devices | |
|---|---|---|---|
| SE | The subject device is substantially equivalent in indications and design principles to the primary predicate device and the reference devices listed above. Provided tables are comparing the Indications for Use Statements and the technological characteristics of the subject device, the primary predicate device, and the reference devices.The Indications for Use Statement (IFUS) for subject device abutment is substantially equivalent in intended use to the primary predicate device K172100. All are intended for use with endosseous dental implants in the maxilla and mandible to provide functional and esthetic rehabilitation of the edentulous maxilla and mandible. The minor differences between the IFUS for the subject device and the primary predicate include:The minor difference compared to the predicate device lies in the length. However, this variation does not affect substantial equivalence, as both IFUs clearly state an equivalent intended use to facilitate dental prosthetic restorations and the indications for use are expressed in a substantially similar manner.To support the differences in diameter and length, we have included additional reference devices that are already cleared under 510(k) and cover the range of our subject device. These reference devices demonstrate that the subject device's dimensions fall within the scope of previously cleared implants: K232418: Ø3.5–5.0 mm, Length 16, 18 mm |
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URIS Abutments
| Subject Device | Reference Devices | |
|---|---|---|
| Part Name | AOT Straight Abutment | Multi-Unit Straight Abutment |
| Applicant | TruAbutment Korea Co., Ltd. | TruAbutment Korea Co., Ltd. |
| Trade Name | URIS Long Implant & Abutments | URIS OMNI Narrow System & Prosthetic |
| 510(K) No. | K243255 | K200817 |
| 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 | Multi-Unit Straight Abutment is intended for use in conjunction with the fixture in partially or fully edentulous mandibles and maxillae, in support of multiple-unit cement retained restorations only. | Multi-Unit Straight Abutment is intended for use in conjunction with the fixture in partially or fully edentulous mandibles and maxillae, in support of single or multiple-unit cement retained restorations. |
| Diameters | 4.8 mm | 5.0 mm |
| 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 Treatment | None | None |
| Sterile | Non-sterile | Non-sterile |
| SE | The subject device (AOT Straight Abutment) is substantially equivalent to the predicate device (Multi-Unit Straight Abutment, K200817). The subject device and the predicate device K200817 have internal implant interface connections, are made of Ti-6Al-4V ELI, and are conducted End User Steam Sterilization. The subject device doesn't include surface treatment. and abutment with a post length of less than 4mm is only available for multi-unit cases.The diameters of the subject device are slightly different from the predicate devices. However, this dimensional difference doesn't affect substantial equivalence. |
Page 13
| Subject Device | Reference Devices | |
|---|---|---|
| Part Name | AOT Straight Abutment | Multi-Unit Straight Abutment |
| Applicant | TruAbutment Korea Co., Ltd. | TruAbutment Korea Co., Ltd. |
| Trade Name | URIS Long Implant & Abutments | URIS OMNI Narrow System & Prosthetic |
| 510(K) No. | K243255 | K200817 |
| 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 | Multi-Unit Straight Abutment is intended for use in conjunction with the fixture in partially or fully edentulous mandibles and maxillae, in support of multiple-unit cement retained restorations only. | Multi-Unit Straight Abutment is intended for use in conjunction with the fixture in partially or fully edentulous mandibles and maxillae, in support of single or multiple-unit cement retained restorations. |
| Diameters | 4.8 mm | 5.0 mm |
| 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 Treatment | None | None |
| Sterile | Non-sterile | Non-sterile |
| SE | The subject device (AOT Straight Abutment) is substantially equivalent to the predicate device (Multi-Unit Straight Abutment, K200817). The subject device and the predicate device K200817 have internal implant interface connections, are made of Ti-6Al-4V ELI, and are conducted End User Steam Sterilization. The subject device doesn't include surface treatment. and abutment with a post length of less than 4mm is only available for multi-unit cases.The diameters of the subject device are slightly different from the predicate devices. However, this dimensional difference doesn't affect substantial equivalence. |
Page 14
| Subject Device | Reference Devices | |
|---|---|---|
| Part Name | AOT Angled Abutment | Multi-Unit Angled Abutment |
| Applicant | TruAbutment Korea Co., Ltd | TruAbutment Korea Co., Ltd |
| Trade Name | URIS Long Implant & Abutments | URIS OMNI Narrow System & Prosthetic |
| 510(K) No. | K243255 | K200817 |
| 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 | Multi-Unit Angled Abutment is intended for use in conjunction with the fixture in partially or fully edentulous mandibles and maxillae, in support of multiple-unit cement retained restorations only. | Multi-Unit Angled Abutment is intended for use in conjunction with the fixture in partially or fully edentulous mandibles and maxillae, in support of single or multiple-unit cement retained restorations. |
| Diameters | 4.8 mm | 5.0 mm |
| Lengths | G/H: 3.0/4.0/5.0 (17°)G/H: 4.0/5.0/6.0 (30°) | G/H: 3.0/4.0/5.0 (17°)G/H: 4.0/5.0/6.0 (29.5°) |
| Post Angle | 17° / 29.5° | 17° / 29.5° |
| Surface Treatment | None | None |
| Sterile | Non-sterile | Non-sterile |
| SE | The subject device (AOT Angled Abutment) is substantially equivalent to the predicate device (Multi unit Angled Abutment, K200817). The subject device and the predicate device have internal connections, are made of Ti-6Al-4V ELI, and are conducted End User Steam Sterilization. The subject device is for single-unit or multiunit restorations, including angulations up to 30°, and abutment with a post length of less than 4 mm is only available for multi-unit cases. The diameters of the subject device are slightly different from the predicate devices. However, this dimension difference was addressed via fatigue testing. |
Page 15
| Subject Device | Reference Devices | |
|---|---|---|
| Part Name | AOT Angled Abutment | Multi-Unit Angled Abutment |
| Applicant | TruAbutment Korea Co., Ltd | TruAbutment Korea Co., Ltd |
| Trade Name | URIS Long Implant & Abutments | URIS OMNI Narrow System & Prosthetic |
| 510(K) No. | K243255 | K200817 |
| 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 | Multi-Unit Angled Abutment is intended for use in conjunction with the fixture in partially or fully edentulous mandibles and maxillae, in support of multiple-unit cement retained restorations only. | Multi-Unit Angled Abutment is intended for use in conjunction with the fixture in partially or fully edentulous mandibles and maxillae, in support of single or multiple-unit cement retained restorations. |
| Diameters | 4.8 mm | 5.0 mm |
| Lengths | G/H: 3.0/4.0/5.0 (17°)G/H: 4.0/5.0/6.0 (30°) | G/H: 3.0/4.0/5.0 (17°)G/H: 4.0/5.0/6.0 (29.5°) |
| Post Angle | 17° / 29.5° | 17° / 29.5° |
| Surface Treatment | None | None |
| Sterile | Non-sterile | Non-sterile |
| SE | The subject device (AOT Angled Abutment) is substantially equivalent to the predicate device (Multi unit Angled Abutment, K200817). The subject device and the predicate device have internal connections, are made of Ti-6Al-4V ELI, and are conducted End User Steam Sterilization.-The subject device is for single-unit or multiunit restorations, including angulations up to 30°, and abutment with a post length of less than 4 mm is only available for multi-unit cases. The diameters of the subject device are slightly different from the predicate devices. However, this dimension difference was addressed via fatigue testing. |
Page 16
| Subject Device | Reference Devices | |
|---|---|---|
| Part Name | Multi-unit Temporary Abutment | Multi-Unit Temporary Cylinder |
| Applicant | TruAbutment Korea Co., Ltd | TruAbutment Korea Co., Ltd |
| Trade Name | URIS Long Implant & Abutments | URIS OMNI Narrow System & Prosthetic |
| 510(K) No. | K243255 | K200817 |
| 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 | Multi-unit Temporary Cylinder is intended to be surgically placed in the maxillary or mandibular molar areas for the purpose of providing prosthetic support for dental restorations in partially or fully edentulous individuals. It is used to restore a patient's chewing function. | Multi-unit Temporary Cylinder is intended to be surgically placed in the maxillary or mandibular molar areas for the purpose of providing prosthetic support for dental restorations in partially or fully edentulous individuals. It is used to restore a patient's chewing function. |
| Diameters | 4.8 mm | 5.0 mm |
| Lengths | 12 mm | 12 mm |
| 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 Predicate devices are substantially equivalent in intended use, material, surface treatment, design, dimension and maximum duration of 6 months. K200817 is selected as a predicate 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 predicate devices. However, this dimensional difference doesn't affect substantial equivalence. |
Page 17
| Subject Device | Reference Devices | |
|---|---|---|
| Part Name | Multi-unit Temporary Abutment | Multi-Unit Temporary Cylinder |
| Applicant | TruAbutment Korea Co., Ltd | TruAbutment Korea Co., Ltd |
| Trade Name | URIS Long Implant & Abutments | URIS OMNI Narrow System & Prosthetic |
| 510(K) No. | K243255 | K200817 |
| 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 | Multi-unit Temporary Cylinder is intended to be surgically placed in the maxillary or mandibular molar areas for the purpose of providing prosthetic support for dental restorations in partially or fully edentulous individuals. It is used to restore a patient's chewing function. | Multi-unit Temporary Cylinder is intended to be surgically placed in the maxillary or mandibular molar areas for the purpose of providing prosthetic support for dental restorations in partially or fully edentulous individuals. It is used to restore a patient's chewing function. |
| Diameters | 4.8 mm | 5.0 mm |
| Lengths | 12 mm | 12 mm |
| 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 Predicate devices are substantially equivalent in intended use, material, surface treatment, design, dimension and maximum duration of 6 months. K200817 is selected as a predicate 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 predicate devices. However, this dimensional difference doesn't affect substantial equivalence. |
Page 18
| Subject Device | Reference Devices | |
|---|---|---|
| Part Name | Multi-unit Base | Multi-unit Cylinder |
| Applicant | TruAbutment Korea Co., Ltd | TruAbutment Korea Co., Ltd |
| Trade Name | URIS Long Implant & Abutments | URIS OMNI Narrow System & Prosthetic |
| 510(K) No. | K243255 | K200817 |
| 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 | Multi-unit Base is intended to be surgically placed in the maxillary or mandibular molar areas for the purpose of providing prosthetic support for dental restorations in partially or fully edentulous individuals. It is used to restore a patient's chewing function. | Multi-unit Base is intended to be surgically placed in the maxillary or mandibular molar areas for the purpose of providing prosthetic support for dental restorations in partially or fully edentulous individuals. It is used to restore a patient's chewing function. |
| Diameters | 5.3 mm | 5.0 mm |
| Lengths | 4.35/7.35 mm | 4.35/7.35 mm |
| Surface Treatment | None | None |
| Sterile | Non-sterile | Non-sterile |
| SE | The subject device and predicate devices (K200817) have the same intended use, have similar technological characteristics, 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. |
Page 19
| Subject Device | Reference Devices | |
|---|---|---|
| Part Name | Multi-unit Base | Multi-unit Cylinder |
| Applicant | TruAbutment Korea Co., Ltd | TruAbutment Korea Co., Ltd |
| Trade Name | URIS Long Implant & Abutments | URIS OMNI Narrow System & Prosthetic |
| 510(K) No. | K243255 | K200817 |
| 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 | Multi-unit Base is intended to be surgically placed in the maxillary or mandibular molar areas for the purpose of providing prosthetic support for dental restorations in partially or fully edentulous individuals. It is used to restore a patient's chewing function. | Multi-unit Base is intended to be surgically placed in the maxillary or mandibular molar areas for the purpose of providing prosthetic support for dental restorations in partially or fully edentulous individuals. It is used to restore a patient's chewing function. |
| Diameters | 5.3 mm | 5.0 mm |
| Lengths | 4.35/7.35 mm | 4.35/7.35 mm |
| Surface Treatment | None | None |
| Sterile | Non-sterile | Non-sterile |
| SE | The subject device and predicate devices (K200817) have the same intended use, have similar technological characteristics, 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. |
Page 20
| Subject Device | Reference Devices | |
|---|---|---|
| Part Name | Multi-Unit Base Screw / AOT Direct Screw/ AOT Plus Screw/ Multi-Unit Direct Screw | Multi-unit Cylinder Screw |
| Applicant | TruAbutment Korea Co., Ltd | TruAbutment Korea Co., Ltd |
| Trade Name | URIS Long Implant & Abutments | URIS OMNI Narrow System & Prosthetic |
| 510(K) No. | K243255 | K200817 |
| 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 | AOT Base Screw/AOT Plus Screw/Multi Unit Direct Screw is a pre-manufactured prosthetic component directly connected to the endosseous dental implant and is intended for use as an aid in prosthetic rehabilitation. | Multi-unit Cylinder Screw is a pre-manufactured prosthetic component directly connected to the endosseous dental implant and is intended for use as an aid in prosthetic rehabilitation. |
| Diameters | 2.2/2.3 mm | 1.6 mm |
| Lengths | 4.2/4.5/4.75/4.8/4.85 mm | 3.3 mm |
| Surface Treatment | None | None |
| Sterile | Non-sterile | Non-sterile |
| SE | The subject device and reference devices (K200817) have the same intended use, have similar technological characteristics, and are made of similar materials. The subject device and predicate devices have similar physical dimensions, including diameter and lengths. The diameters of the subject device are slightly different from the predicate devices. However, this dimensional difference doesn't affect substantial equivalence. The length of the primary predicate device is 3.3mm, while the subject device is 4.2mm, 4.5mm , 4.75mm, and 4.8, 4.85mm. |
Page 21
| Subject Device | Reference Devices | |
|---|---|---|
| Part Name | Multi-Unit Base Screw / AOT Direct Screw/ AOT Plus Screw/ Multi-Unit Direct Screw | Multi-unit Cylinder Screw |
| Applicant | TruAbutment Korea Co., Ltd | TruAbutment Korea Co., Ltd |
| Trade Name | URIS Long Implant & Abutments | URIS OMNI Narrow System & Prosthetic |
| 510(K) No. | K243255 | K200817 |
| 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 | AOT Base Screw/AOT Plus Screw/Multi Unit Direct Screw is a pre-manufactured prosthetic component directly connected to the endosseous dental implant and is intended for use as an aid in prosthetic rehabilitation. | Multi-unit Cylinder Screw is a pre-manufactured prosthetic component directly connected to the endosseous dental implant and is intended for use as an aid in prosthetic rehabilitation. |
| Diameters | 2.2/2.3 mm | 1.6 mm |
| Lengths | 4.2/4.5/4.75/4.8/4.85 mm | 3.3 mm |
| Surface Treatment | None | None |
| Sterile | Non-sterile | Non-sterile |
| SE | The subject device and reference devices (K200817) have the same intended use, have similar technological characteristics, and are made of similar materials. The subject device and predicate devices have similar physical dimensions, including diameter and lengths. The diameters of the subject device are slightly different from the predicate devices. However, this dimensional difference doesn't affect substantial equivalence. The length of the primary predicate device is 3.3mm, while the subject device is 4.2mm, 4.5mm , 4.75mm, and 4.8, 4.85mm. |
Page 22
Substantial equivalence summary
The subject device is substantially equivalent in indications and design principles to the primary predicate device and the reference devices listed above. Provided tables are comparing the Indications for Use Statements and the technological characteristics of the subject device, the primary predicate device, and the reference devices.
The Indications for Use Statement (IFUS) for subject device abutment is substantially equivalent in intended use to the primary predicate device K172100, and the reference devices K200817. All are intended for use with endosseous dental implants in the maxilla and mandible to provide functional and esthetic rehabilitation of the edentulous maxilla and mandible. The minor differences between the IFUS for the subject device and the primary predicate include:
The minor difference compared to the predicate device lies in the length. However, this variation does not affect substantial equivalence, as the lengths are supported by the K232418 reference device.
Non-Clinical Test Data
The following tests were performed:
- Bacterial Endotoxin Testing (LAL) in accordance with USP <85> and USP <161>
- Biocompatibility testing according to ISO 10993-1
- Sterilization Testing according to ISO 11137-1,-2,-3 and ISO 11737-1,-2
- End user sterilization Testing according to ISO 17665-1,-2
- Shelf-Life Testing according to ISO 11607-1,-2 / ASTM F1980-07, ASTM F88, ASTM F1140, ASTM F1929, ASTM F2096 and sterility testing.
- Fatigue Testing according to ISO 14801:2016
- SEM (Scanning electron microscopy) images and EDS (Energy Dispersive X-ray Spectroscopy) analysis
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 Long Implant is substantially equivalent to predicate devices as described herein.
§ 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.