(311 days)
No
The summary describes a dental implant system and prosthetic components made of titanium. There is no mention of software, algorithms, image processing, or any terms related to AI/ML. The performance studies focus on material properties, sterilization, packaging, and fatigue testing.
No
This device is a dental implant system used for prosthetic restoration, not for treating a disease or condition. While it improves quality of life by replacing missing teeth, its primary function is structural support.
No
Explanation: The device is an implant system and prosthetic intended for the physical replacement of teeth in edentulous areas, not for diagnosing conditions or diseases.
No
The device description explicitly details physical components made of titanium and titanium alloy, such as dental implants, abutments, and screws. The performance studies also focus on physical properties and testing of these hardware components (e.g., fatigue testing, sterilization, biocompatibility).
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a dental implant system and prosthetic components used for supporting dental restorations in the mouth. This is a surgical and prosthetic device, not a device used to examine specimens derived from the human body for the purpose of providing information for diagnosis, monitoring, or compatibility testing.
- Device Description: The description details the materials and components of dental implants, abutments, and screws. These are physical devices implanted or used within the oral cavity.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), reagents, calibrators, or controls, which are typical components or uses of IVD devices.
- Performance Studies: The performance studies described focus on mechanical properties (fatigue), sterilization, biocompatibility, packaging, and MRI compatibility, all of which are relevant to implantable and prosthetic devices, not IVDs.
Therefore, the URIS Smart Path Implant System & Prosthetic falls under the category of a dental device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications 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.
Product codes (comma separated list FDA assigned to the subject device)
DZE, NHA
Device 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 Limitation for Zirconia superstructure
Maximum Angulation: 015°5.0 mm
Maximum Cuff Height: 0.5
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
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
partially or fully edentulous mandibles and maxillae
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-clinical worst-case MRI review was performed to evaluate the metallic URIS SP Implant system in the MRI environment using scientific rationale and published literature (e.g., Woods, Terry O., Jana G. Delfino, and Sunder Rajan. "Assessment of Magnetically Induced Displacement Force and Torque on Metal Alloys Used in Medical Devices." Journal of Testing and Evaluation 49.2 (2019): 783-795), based on the entire system including all variations (all compatible implant bodies, dental abutments, and fixation screws) and material composition. Rationale addressed parameters per the FDA guidance "Testing and Labeling Medical Devices for Safety in the Magnetic Resonance (MR) Environment," including magnetically induced displacement force and torque.
The following tests were performed for the subject device:
- Bacterial Endotoxin Testing (LAL) in accordance with USP and USP
- Sterilization Testing according to ISO 11137-1,-2,-3 and ISO 11737-1,-2
- Shelf Life Testing according to ISO 11607-1,-2 / ASTM F1980-07, ASTM F88, ASTM F1140, ASTM F1929, ASTM F2096 and sterility testing.
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. Biocompatibility testing information is also leveraged from predicate and reference device (K172100 and K200817). The Biocompatibility Test was conducted on the predicate and reference devices is leveraged for the subject device because both products are manufactured with similar materials, manufacturer, manufacturing process.
SEM (Scanning electron microscopy) images and EDS (Energy Dispersive X-ray Spectroscopy) analysis were conducted on the predicate and reference devices is leveraged from our own prior clearance for the identical SLA surface treatment and manufacturing.
Below performance testing and information have been provided for subject implant fixture packaging:
- Human Factors testing (A usability evaluation for aseptic presentation of the subject device, in line with ISO 11607-1:2019 and the recommendations of the FDA guidance document, "Applying Human Factors and Usability Engineering to Medical Devices.")
- Low and high magnification images at various degrees of rotation following the removal from the packaging (Evaluation of the broken tip at various degrees rotation at a high magnification and low magnification for damage after removal from the packaging and disconnection of the fixture iig)
- Quality System (OS) plan including the method and frequency of acceptance activities to ensure that the devices conform with product specifications with packaging design.
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 standards, and the subject device is substantially equivalent to the predicate device.
No clinical data were included in this submission.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
K220517, K200817, K123664, K100756
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
0
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).
1
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.
2
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
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
3
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) |
|---|
| ------------------------------------------------- |
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) |
|---|
| ☐ 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: kiyoon.nam@truabutment.com Phone: 1-714-956-1488
Official Correspondent
TruAbutment Inc. Chris Kim 17666 Fitch, Irvine, CA 92614 USA Email: chris.kim(@truabutment.com Phone: 1-714-956-1488
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 | |||
| Number | K230438 | K172100 | K220517 |
| Device | |||
| Name | URIS Smart Path Implant | ||
| System & Prosthetic | URIS OMNI System | IBS System | |
| Manufactu | |||
| rer | TruAbutment Korea Co., | ||
| Ltd | TruAbutment Korea Co., | ||
| Ltd | InnoBioSurg Co., Ltd. | ||
| Indications | |||
| 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 | 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 IBS System is intended | ||
| to replace missing teeth to | |||
| restore chewing function. | |||
| The IBS System can be | |||
| placed in support of single | |||
| or multiple-unit restorations | |||
| including; cement retained, | |||
| screw retained, or | |||
| overdenture restorations, | |||
| and terminal or immediate | |||
| abutment support for fixed | |||
| bridgework. This system is | |||
| for one or two stage | |||
| surgical procedures. | |||
| This system is intended for | |||
| delayed loading. | |||
| Subject Device | Predicate Device | Reference Devices | |
| 510K | |||
| Number | K230438 | K172100 | K220517 |
| manufacture. | |||
| Design | Image: Subject Device | Image: Predicate Device | Image: Reference Devices |
| Structure | - Internal - connected |
- Submerged Fixture | - Internal Hex- connected
- Submerged Fixture | - Internal Hex- connected
- Non Submerged Fixture |
| Body
Diameter
(D)
and
Length
(mm) | SP OMNI Thread
Ø3.5 x 8.5, 10, 11.5, 13, 14.5mm,
Ø4.0 x 7, 8.5, 10, 11.5, 13, 14.5mm,
Ø4.5 x 7, 8.5, 10, 11.5, 13, 14.5mm,
Ø5.0 x 7, 8.5, 10, 11.5, 13, 14.5mm,
Ø5.5 x 7, 8.5, 10, 11.5, 13, 14.5mm,
Ø6.0 x 7, 8.5, 10mm,
Ø6.5 x 7, 8.5, 10mm
SP Extra Aggressive Thread
Ø3.5 x 7, 8.5, 10, 11.5, 13, 14.5mm,
Ø4.0 x 7, 8.5, 10, 11.5, 13, 14.5mm,
Ø4.5 x 7, 8.5, 10, 11.5, 13, 14.5mm,
Ø5.0 x 7, 8.5, 10, 11.5, 13, 14.5mm,
Ø5.5 x 7, 8.5, 10mm, | Ø3.5 x 8.5, 10, 11.5, 13, 14.5mm,
Ø4.0 x 7, 8.5, 10, 11.5, 13, 14.5mm,
Ø4.5 x 7, 8.5, 10, 11.5, 13, 14.5mm,
Ø5.0 x 7, 8.5, 10, 11.5, 13, 14.5mm,
Ø5.5 x 7, 8.5, 10, 11.5, 13, 14.5mm,
Ø6.0 x 7, 8.5, 10mm,
Ø6.5 x 7, 8.5, 10mm | Ø7.0 x 7, 8, 9, 10, 11, 12,
13mm
Ø7.5 x 7, 8, 9, 10, 11, 12,
13mm
Ø8.0 x 7, 8, 9, 10, 11, 12,
13mm |
| Material of
Fixture | CP Ti Grade 4 (ASTM
F67) | CP Ti Grade 4 (ASTM F67) | Ti-6Al-4V Eli |
| Surface | Sand-blasted, Large grit,
Acid-etched
(S.L.A) | Sand-blasted, Large grit,
Acid-etched
(S.L.A) | Sand-blasted, Large grit,
Acid-etched
(S.L.A) |
| Sterilizatio
n | Gamma Sterilization | Gamma Sterilization | Gamma Sterilization |
| Shelf Life | 5years | 5years | 5years |
| Implant
Body
Features | Threaded | Threaded | Threaded |
| Product
Code | DZE | DZE | DZE |
| | Subject Device | Predicate Device | Reference Devices |
| 510K
Number | K230438 | K172100 | K220517 |
| 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 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.
Minor differences in the designs, implant connections, dimensions, or sizes between the
subject device, the predicate device, and the reference devices do not affect substantial
equivalence.
The implant body dimension of the subject device is the similar included in K172100.
URIS SP Extra Aggressive Implant bodies are only available in limited diameters/lengths.
Ø3.5 x 7, 8.5, 10, 11.5, 13, 14.5mm,
Ø4.5 x 7, 8.5, 10, 11.5, 13, 14.5mm,
Ø5.5 x 7, 8.5, 10mm
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.
8
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 | ||
| 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) |
| Description | 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. | 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. | ||
| Diameters | 4.0/4.5/5.0/6/7mm | 4.0/4.5/5.5/6.5/7.5mm |
| Surface | ||
| Treatment | Anodizing (Yellow, Green) | Anodizing (Yellow, Green) |
| Sterile | Non-sterile | Non-sterile |
| SE | The subject device and reference devices (K172100) have the similar intended | |
| use, have similar technological characteristic, and are made of similar materials. | ||
| The subject device and reference device have similar physical dimensions, | ||
| including diameter. Therefore, the subject device is substantially equivalent to | ||
| the currently cleared devices. | The subject device and reference devices (K172100) have the similar intended | |
| use, have similar technological characteristic, and are made of similar materials. | ||
| including diameter. Therefore, the subject device is substantially equivalent to | ||
| 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 & |
| Prosthetic | ||
| 510(K) No. | K230438 | 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) |
| Description | T-L 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. | T LOC 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 | 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 | ||
| 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 |
|---|---|---|
| Applicant | TruAbutment Korea Co., Ltd. | TruAbutment Korea Co., Ltd. |
| Trade Name | URIS Smart Path Implant System | URIS OMNI Narrow System & Prosthetic |
| 510(K) No. | K230438 | 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) |
| Description | 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. | 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 | 5.0mm | 5.0mm |
| Lengths | G/H :1.0/2.0/3.0/4.0/5.0/6.0mm | G/H :1.0/2.0/3.0/4.0/5.0/6.0mm |
| Angular | ||
| correction | No angular correction allowed | No angular correction allowed |
| Surface | ||
| Treatment | None | None |
| Sterile | Non-sterile | Non-sterile |
| SE | The subject device (Multi-unit Straight Abutment) is substantially equivalent to the | |
| predicate device (Multi Straight Abutment, K172100). The subject device and the | ||
| predicate device K172100 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. |
| Subject Device | Reference Device |
|---|---|
| ---------------- | ------------------ |
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Image /page/12/Picture/0 description: The image shows a logo with the word "ABUTMENT" in white letters on a blue background. The letters are stylized, with the "A" being larger than the other letters. Below the word "ABUTMENT" is a blue image that resembles a screw or bolt. The logo is simple and eye-catching, and the use of blue and white gives it a clean and professional look.
| Part Name | Multi-Unit Angled Abutment | Multi-Unit Angled Abutment |
|---|---|---|
| Design | Image: Multi-Unit Angled Abutment | Image: Multi-Unit Angled Abutment |
| Applicant | TruAbutment Korea Co., Ltd | TruAbutment Korea Co., Ltd |
| Trade Name | URIS Smart Path Implant System | URIS OMNI Narrow System & |
| Prosthetic | ||
| 510(K) No. | K230438 | 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) |
| Description | 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. | 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 | 5.0mm | 5.0mm |
| Lengths | G/H : 3.0/4.0/5.0(17°) | |
| G/H : 4.0/5.0/6.0(29.5°) | 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 (Multi-unit Angled Abutment) are 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. |
| Subject Device | Predicate Device |
|---|---|
| ---------------- | ------------------ |
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Image /page/13/Picture/0 description: The image shows the word "ABUTMENT" in a stylized font. The letters are white and set against a blue background. The bottom of the image has a design that resembles the threads of a screw, also in blue.
| Part Name | Temporary Abutment | Temporary Abutment |
|---|---|---|
| Design | Image: Temporary Abutment Design 1 | Image: Temporary 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 | ||
| 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) |
| Description | URIS Smart Path Implant 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. | 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. | ||
| Diameters | 3.7 / 4.2 / 4.7mm | 3.7 / 4.3mm |
| Lengths | Height 10mm | Height 10mm |
| Angular | ||
| correction | Patient-specific customized by hand- | |
| milling with no angular correction. | Patient-specific customized by hand- | |
| milling with no angular correction. | ||
| Surface | ||
| Treatment | None | None |
| Maximum | ||
| Duration | Less than 6 months | Less than 6 months |
| Sterile | Non-sterile | Non-sterile |
| SE | The subject temporary abutment and reference devices are substantially | |
| equivalent in intended use, material, surface treatment, design, dimension and | ||
| maximum duration of 6 months. K172100 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 | ||
| Reference devices. However, the diameter of 4.7mm is in the range of diameters | ||
| of predicates and this dimensional difference doesn't affect substantial | ||
| equivalence. |
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Image /page/14/Picture/0 description: The image shows the word "ABUTMENT" in a stylized font. The word is written in all capital letters, with the "A" slightly larger than the other letters. The letters are blue, and the image has a white background. The bottom of the image has a design that looks like the bottom of a screw.
| Subject Device | Reference Device | |
|---|---|---|
| Part Name | URIS SP DS | URIS DS |
| Design | Image: URIS SP DS | Image: URIS DS |
| Applicant | TruAbutment Korea Co., Ltd | TruAbutment Korea Co., Ltd |
| Trade Name | URIS Smart Path Implant System | URIS OMNI Narrow System & Prosthetic |
| 510(K) No. | K230438 | 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) |
| Description | URIS SP DS is a patient-specific CAD/CAM | |
| abutment, directly connected to endosseous | ||
| dental implants and is intended for use as an | ||
| aid in prosthetic rehabilitation. | ||
| All digitally designed abutments and/or coping | ||
| for use with the URIS SP DS abutments are | ||
| intended to be sent to a TruAbutment-validated | ||
| milling center for manufacture. | URIS DS is a patient-specific CAD/CAM | |
| abutment, directly connected to endosseous | ||
| dental implants and is intended for use as an | ||
| aid in prosthetic rehabilitation. It is compatible | ||
| with the following systems: | ||
| URIS OMNI System Implants | ||
| (K172100) 3.5, 4.0, 4.5, 5.0, 5.5, 6.0, | ||
| 6.5mmURIS OMNI Narrow System Implants | ||
| (Proposed) 3.15 mmAll digitally designed abutments and/or coping | ||
| for use with the TruAbutment DS abutments are | ||
| intended to be sent to a TruAbutment-validated | ||
| milling center for manufacture. | ||
| CAD Design | ||
| Limits | Minimum and Maximum Gingiva Height: | |
| 0.5~4mm | ||
| Minimum and Maximum diameter at | ||
| abutment/implant interface: Ø3.8~Ø5.5 | ||
| Minimum and Maximum length of | ||
| abutment: 6~11mm | ||
| Minimum and Maximum length of | ||
| abutment post (length above the abutment | ||
| collar/gingival height): 4~8mm | ||
| Minimum wall thickness at | ||
| abutment/implant interface: 0.4mm | Minimum and Maximum Gingiva Height: | |
| 0.5~4mm | ||
| Minimum and Maximum diameter at | ||
| abutment/implant interface: Ø3.8~Ø5.5 | ||
| Minimum and Maximum length of | ||
| abutment: 6~11mm | ||
| Minimum and Maximum length of | ||
| abutment post (length above the abutment | ||
| collar/gingival height): 4~8mm | ||
| Minimum wall thickness at | ||
| abutment/implant interface: 0.4mm | ||
| Minimum and Maximum abutment angle: | ||
| 0~25° | Minimum and Maximum abutment angle: | |
| 0~25° | ||
| Surface | ||
| Treatment | None | None |
| Sterile | Non-sterile | Non-sterile |
| SE | The subject device (URIS SP DS) are substantially equivalent to the reference device | |
| (URIS DS, 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 | ||
| and are similar CAD Design Limits. |
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Image /page/15/Picture/0 description: The image shows a logo with the word "ABUTMENT" in a stylized font. The "A" in "ABUTMENT" is larger than the other letters. Below the word "ABUTMENT" is the letter "ru" in a large, stylized font. The logo is blue and white.
.
| Subject Device | Reference Device | |
|---|---|---|
| Part Name | URIS Base | URIS Base |
| Design | Image: URIS Base Subject Device | Image: URIS Base Reference Device |
| Applicant | TruAbutment Korea Co., Ltd. | TruAbutment Korea Co., Ltd. |
| Trade Name | URIS Smart Path Implant System | URIS OMNI Narrow System & Prosthetic |
| 510(K) No. | K230438 | K200817 |
| Classificatio | ||
| n 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) |
| Description | URIS SP Base 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. | ||
| All digitally designed zirconia | ||
| superstructures for use with the URIS SP | ||
| Base are intended to be sent to a | ||
| TruAbutment-validated milling center for | ||
| manufacture. | URIS Base 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. | ||
| All digitally designed zirconia superstructures | ||
| for use with the URIS Base are intended to be | ||
| sent to a TruAbutment-validated milling center | ||
| for manufacture. | ||
| Diameters | 3.8mm/4.08mm/4.78mm/4.3mm | 4.0mm/4.3mm |
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Image /page/16/Picture/0 description: The image contains the word "ABUTMENT" in a stylized font. Below the word, there is a graphic that resembles a screw or bolt head, with a series of jagged edges. The letter "ru" is written in a large, stylized font and is placed to the right of the screw graphic. The color of the text and graphic is a bright blue.
| Subject Device | Reference Device | |
|---|---|---|
| /4.8mm/5.08mm | ||
| Lengths | Cuff Height: 1.0/2.0/3.0/4.0mm | |
| Post Height : 3.5/5.5mm | Cuff Height: 1.0/2.0mm | |
| Post Height : 3.5/5.5mm | ||
| Design | ||
| parameters | ||
| of zirconia | ||
| superstruct- | ||
| ures | Min / Max Angulation 15° | |
| Min / Max Cuff Height 0.5~5mm | ||
| Min / Max Diameter Ø5.0~ Ø 8.0mm | Min / Max Angulation 15° | |
| Min / Max Cuff Height 0.5~5mm | ||
| Min / Max Diameter Ø5.0~ Ø 8.0mm | ||
| superstruct- | ||
| ures | Minimum Thickness 0.4mm | |
| Minimum Post Height 4~6mm | Minimum Thickness 0.4mm | |
| Minimum Post Height 4~6mm | ||
| Surface | ||
| Treatment | None | None |
| Sterile | Non-sterile | Non-sterile |
| SE | The subject device (URIS SP Base) are substantially equivalent to the reference device | |
| (URIS Base, K200817). The subject device and the reference device K200817 have | ||
| internal implant interface connections, are made of Ti-6Al-4V ELI, and are conducted | ||
| End User Steam Sterilization. The minor differences between the IFUS for the subject | ||
| device and the predicate is diameter and Length. The subject device includes diameter | ||
| size 3.8mm, 4.08mm, 4.3mm, 4.78mm, 4.8mm, 5.08mm and Length range of 3.5mm to | ||
| 5.5mm. The predicate device includes diameter size of 4.0mm, 4.3mm and length range | ||
| of 3.5mm to 5.5mm. |
| Subject Device | Predicate Device | |
|---|---|---|
| Part Name | Abutment Screw | Abutment Screw |
| Design | Image: Subject Device Design | Image: Predicate Device Design |
| Applicant | TruAbutment Korea Co., Ltd. | TruAbutment Korea Co., Ltd. |
| Trade Name | URIS Smart Path Implant System | URIS OMNI System |
| 510(K) No. | K230438 | K172100 |
| Subject Device | Predicate Device | |
| Part Name | Abutment Screw | Abutment Screw |
| Design | Image: Subject Device Design | Image: Predicate Device Design |
| 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) |
| Description | 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. | 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. | ||
| Diameters | 2.0 / 2.1mm | 1.9 / 2.3mm |
| Lengths | 7.7 / 7.9 / 8.2mm | 7.2 / 7.7mm |
| Surface | ||
| Treatment | Anodizing (Yellow, Green, Purple) | None |
| Sterile | Non-sterile | Non-sterile |
| SE | The subject device and predicate device (K172100) have the similar intended | |
| use, have similar technological characteristic, and are made of similar materials. | ||
| The minor differences between the subject device and the predicate is diameter and | ||
| Length. The subject device includes diameter size 2.0mm, 2.1mm and Length range | ||
| of 7.7mm to 8.2mm. The predicate device includes diameter size of 1.9mm, 2.3mm | ||
| and length range of 7.2mm to 7.7mm. | ||
| The subject device has three color (yellow, green, and purple) anodized treatment on | ||
| the surface, while the reference device has no surface treatment. It is the similar as | ||
| the anodizing method of the healing abutment included in K172100. | ||
| However, those differences don't affect substantial equivalence. |
17
Image /page/17/Picture/0 description: The image shows the word "ABUTMENT" in a stylized font. The letters are blue and the word is written in all caps. The letter "A" is larger than the other letters and is positioned slightly above the rest of the word.
Subject Device implant bodies has similar material, dimensions and indication for use and similar surface treatment, machining/manufacturing, design and technological characteristics as the predicate and reference devices. URIS SP Prosthetic System has similar indication for use and similar manufacturing
18
Image /page/18/Picture/0 description: The image is a logo for Abutment. The logo is blue and features the word "Abutment" in a stylized font. The "A" in Abutment is larger than the other letters. Below the word "Abutment" is a stylized image of a screw.
process including raw material, machining, dimensions, angulation, and surface treatment and similar design and technological characteristics as the predicate and reference devices.
The differences between the subject device and predicate and reference devices are detailed shape and detailed dimension of diameter and length.
Any differences between the subject device and predicate and reference devices do not raise new types of substantially equivalent issues.
MR Environment Condition
Non-clinical worst-case MRI review was performed to evaluate the metallic URIS SP Implant system in the MRI environment using scientific rationale and published literature (e.g., Woods, Terry O., Jana G. Delfino, and Sunder Rajan. "Assessment of Magnetically Induced Displacement Force and Torque on Metal Alloys Used in Medical Devices." Journal of Testing and Evaluation 49.2 (2019): 783-795), based on the entire system including all variations (all compatible implant bodies, dental abutments, and fixation screws) and material composition. Rationale addressed parameters per the FDA guidance "Testing and Labeling Medical Devices for Safety in the Magnetic Resonance (MR) Environment," including magnetically induced displacement force and torque.
Non-Clinical Test Data
The following tests were performed for the subject device:
- Bacterial Endotoxin Testing (LAL) in accordance with USP and USP
- Sterilization Testing according to ISO 11137-1,-2,-3 and ISO 11737-1,-2
- Shelf Life Testing according to ISO 11607-1,-2 / ASTM F1980-07, ASTM F88, ASTM F1140, ASTM F1929, ASTM F2096 and sterility testing.
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. Biocompatibility testing information is also leveraged from predicate and reference device (K172100 and K200817). The Biocompatibility Test was conducted on the predicate and reference devices is leveraged for the subject device because both products are manufactured with similar materials, manufacturer, manufacturing process.
SEM (Scanning electron microscopy) images and EDS (Energy Dispersive X-ray Spectroscopy) analysis were conducted on the predicate and reference devices is leveraged from our own prior clearance for the identical SLA surface treatment and manufacturing.
19
Image /page/19/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 letter "A" is larger than the other letters and is placed above the rest of the word. Below the word "Abutment" is a graphic that resembles a tooth implant. The logo is simple and modern, and the blue color gives it a professional look.
Below performance testing and information have been provided for subject implant fixture packaging:
- · Human Factors testing (A usability evaluation for aseptic presentation of the subject device, in line with ISO 11607-1:2019 and the recommendations of the FDA guidance document, "Applying Human Factors and Usability Engineering to Medical Devices.")
- · Low and high magnification images at various degrees of rotation following the removal from the packaging (Evaluation of the broken tip at various degrees rotation at a high magnification and low magnification for damage after removal from the packaging and disconnection of the fixture iig)
- Quality System (OS) plan including the method and frequency of acceptance activities to ensure that the devices conform with product specifications with packaging design.
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 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 Smart Path Implant System & Prosthetic is substantially equivalent to predicate and reference devices as described herein.