(191 days)
No
The summary describes a dental implant system and prosthetic components, with no mention of AI or ML capabilities. The focus is on materials, dimensions, and mechanical testing.
No.
This device is a dental implant system used for the treatment of missing teeth, which is a restorative rather than a therapeutic function in the medical sense.
No
Explanation: The device is an implant system used for the treatment of missing teeth, providing support for prosthetic restorations. It is a therapeutic device, not a diagnostic one.
No
The device description explicitly details physical components made of titanium and titanium alloy, such as dental implants, abutments, and cylinders. It also mentions manufacturing processes like milling. This indicates the device is a physical medical device, not software-only.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes the device as a dental implant system used for the treatment of missing teeth and supporting prosthetic restorations. This is a surgical and restorative procedure performed directly on the patient's body.
- Device Description: The device description details the materials and components of dental implants and abutments, which are physical devices implanted into the bone or attached to the implant.
- Lack of Diagnostic Purpose: There is no mention of the device being used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes.
IVD devices are used to test samples like blood, urine, or tissue outside the body to diagnose or monitor medical conditions. This device is a medical device used within the body for structural support and restoration.
N/A
Intended Use / Indications for Use
URIS OMNI Narrow System is indicated for use in the treatment of missing maxillary lateral incisors or the mandbular central and lateral incisors, in support of single or multiple-unit restorations including: cemented retained, or overdenture restorations, and final or temporary abutment support for fixed bridgework. It is intended for delayed loading.
The URIS OMNI Prosthetic abutments are intended for use with URIS OMNI dental implants to provide support for prosthetic restorations such as crowns, bridges, or over-dentures.
All digitally designed abutments and/or coping for use with URIS OMNI Prosthetic abutments are intended to be sent to a TruAbutment-validated milling center for manufacture.
Product codes (comma separated list FDA assigned to the subject device)
DZE, NHA
Device Description
URIS OMNI Narrow System fixtures are dental implants made of Unalloyed Titanium, grade 4 (ASTM F67) intended for use in the treatment of missing maxillary lateral incisors or the mandibular central and lateral incisors. The surface is SLA (Sandblasted, Large grit and Acid etched) treated and is provided sterile. It consists of two implant lines, the OMNI Straight and the OMNI Tapered, with corresponding cover screws, healing abutments and prosthetic abutments. The OMNI Tapered implant has a tapered wall with a single thread design. The OMNI Straight implant has straight wall with smaller threading at the coronal end, and bigger threading at the apical end. Both implant lines have Narrow (Ø 3.15 mm) platform sizes. Both implant lines share the following diameters and lengths.
Ø 3.15 x 10, 11.5, 13, 14.5mm (L)
URIS Prosthetic System is made of titanium alloy (Ti-6Al-4V ELI) intended for use as an aid in prosthetic restoration. It consists of Ball Abutment, Retainer, T LOC Straight Abutment, T Loc Titanium Cap, Multi-Unit Straight Abutment, Multi-Unit Angled Abutment, Multi-Unit Healing Cap, Multi-Unit Ti Cylinder, Multi-unit temporary cylinder, Multi-Unit Cylinder screw, URIS DS, URIS Base. No additional angulation is to be included in the when using a coping or cylinder (i.e., Multi-unit Ti Cylinder, Multi-unit Temporary Cylinder, Multi-unit Base) with any of the Multi-unit Abutments.
URIS Base consists of a two-piece abutment, where the titanium base is a pre-manufactured abutment that will be used to support a CAD/CAM designed superstructure (the second part of the two-piece abutment) that composes the final abutment. URIS Base is made of titanium alloy conforming to ASTM F136 Standard Specification for Wrought Titanium-4Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant Applications. It is compatible with the following systems:
Dental Implants
URIS OMNI System Implants (K172100) 3.5, 4.0, 4.5, 5.0, 5.5, 6.0, 6.5mm
. URIS OMNI Narrow System Implants (Proposed) 3.15 mm
Raw material blanks
· InCoris Zi (ZrO2) by Sirona Dental Systems GmbH, L size blanks, cleared under K123664.
Cement
RelyX Unicem 2Automix by 3M ESPE, cleared under K100756.
All zirconia superstructure that composes the final abutment must be designed and milled through the 3 shape CAD/CAM System, by TruAbutment validated milling center, according to the prosthetic planning and patient clinical situation. The superstructure is cemented to the TruBase S in the lab. Use "RelyX Unicem 2Automix" as an adhesive extraorally to connect.
URIS Base is provided non-sterile therefore must be sterilized after the cementation of the zirconia superstructure on the URIS Base.
URIS DS abutment as a patient matched titanium abutment compatible with both URIS OMNI System (K172100) and URIS OMNI Narrow System (subject).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
maxillary lateral incisors or the mandibular central and lateral incisors
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)
The following tests were performed:
- Bacterial Endotoxin Testing (LAL) in accordance with USP and USP
- 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.
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.
URIS OMNI System (K172100)
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.
K102436, K161689, K140507, K182091, K123755, K120951, K123988, K160670, K183518, K081748, K123664, K100756, K183106
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 logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
October 7, 2020
TruAbutment Inc. Chris Choi Director 17742 Cowan Irvine, California 92614
Re: K200817
Trade/Device Name: URIS OMNI Narrow System & Prosthetic Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: Class II Product Code: DZE, NHA Dated: June 5. 2020 Received: September 8, 2020
Dear Chris Choi:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
1
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
for
Srinivas Nandkumar, Ph.D. Director DHT1B: Division of Dental Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K200817
Device Name URIS OMNI Narrow System & Prosthetic
Indications for Use (Describe)
URIS OMNI Narrow System is indicated for use in the treatment of missing maxillary lateral incisors or the mandbular central and lateral incisors, in support of single or multiple-unit restorations including: cemented retained, or overdenture restorations, and final or temporary abutment support for fixed bridgework. It is intended for delayed loading.
The URIS OMNI Prosthetic abutments are intended for use with URIS OMNI dental implants to provide support for prosthetic restorations such as crowns, bridges, or over-dentures.
All digitally designed abutments and/or coping for use with URIS OMNI Prosthetic abutments are intended to be sent to a TruAbutment-validated milling center for manufacture.
Type of Use (Select one or both, as applicable) | |
---|---|
☑ Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
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510(k) Summary
This 510(k) Summary is being submitted in accordance with requirement of 21 CFR part 807.92
Submitter:
TruAbutment Inc. Eunjin Jang 17742 Cowan, Irvine CA 92614 USA Email: eunjin.jang@truabutment.com
Phone: 1-714-956-1488
Device Information:
Device Name: URIS OMNI Narrow System & Prosthetic Classification Name: Endosseous Dental Implant Classification: Class II Primary Product Code: DZE Secondary Product Code: NHA Regulation number: 21 CFR 872.3640 Date Prepared: 10/06/2020
Predicate Device
- Primary Predicate Device:
- URIS OMNI System (K172100) by TruAbutment Korea Co., Ltd. -
- Reference Devices:
- -Nobel Active 3.0 (K102436) by Nobel Biocare.
- OSSTEM Implant System (K161689) by Osstem Implant Co., Ltd . -
- -Hiossen Prosthetic System (K140507) by Osstem Implant Co., Ltd .
- Osstem Abutment System (K182091) by Osstem Implant Co., Ltd . -
- Multi Angled Abutment (K123755) by Osstem Implant Co., Ltd . -
- -SMART builder System (K120951) by Osstem Implant Co., Ltd.
- AnyOne Internal Implant System (K123988) by Megagen Implant Co., Ltd. -
- ET US SS Prosthetic System (K160670) by Osstem Implant Co., Ltd. -
- Preat Abutments (K183518) by Preat Corporation. -
- Oneplant Dental Implant System (K081748) by WARANTEC Implant Co., Ltd. -
- InCoris Zi (K123664) by Sirona Dental Systems GmbH. -
- -RelyX Unicem 2Automix (K100756) by 3M ESPE
- TruAbutment DS (K183106) by TruAbutment Korea Co., Ltd. -
Official Correspondent
TruAbutment Inc. Chris Choi 17742 Cowan, Irvine CA 92614 USA Email: chris.choi@truabutment.com Phone: 1-714-956-1488
4
Device Description
URIS OMNI Narrow System fixtures are dental implants made of Unalloyed Titanium, grade 4 (ASTM F67) intended for use in the treatment of missing maxillary lateral incisors or the mandibular central and lateral incisors. The surface is SLA (Sandblasted, Large grit and Acid etched) treated and is provided sterile. It consists of two implant lines, the OMNI Straight and the OMNI Tapered, with corresponding cover screws, healing abutments and prosthetic abutments. The OMNI Tapered implant has a tapered wall with a single thread design. The OMNI Straight implant has straight wall with smaller threading at the coronal end, and bigger threading at the apical end. Both implant lines have Narrow (Ø 3.15 mm) platform sizes. Both implant lines share the following diameters and lengths.
Ø 3.15 x 10, 11.5, 13, 14.5mm (L)
URIS Prosthetic System is made of titanium alloy (Ti-6Al-4V ELI) intended for use as an aid in prosthetic restoration. It consists of Ball Abutment, Retainer, T LOC Straight Abutment, T Loc Titanium Cap, Multi-Unit Straight Abutment, Multi-Unit Angled Abutment, Multi-Unit Healing Cap, Multi-Unit Ti Cylinder, Multi-unit temporary cylinder, Multi-Unit Cylinder screw, URIS DS, URIS Base. No additional angulation is to be included in the when using a coping or cylinder (i.e., Multi-unit Ti Cylinder, Multi-unit Temporary Cylinder, Multi-unit Base) with any of the Multi-unit Abutments.
Device Component | Diameters (Ø) | Lengths | Angulation |
---|---|---|---|
OMNI Straight Fixture | 3.15mm | 10~14.5mm | |
OMNI Tapered Fixture | 3.15mm | 10~14.5mm | |
Ball Abutment | 3.5mm | Cuff Height: 1.0~6.0mm | |
Retainer Cap | 5.1mm | 3.9mm | |
Retainer | 5.1mm | 2.1mm | |
T LOC Straight Abutment | 3.8mm | Cuff Height: 1.0~6.0mm | |
T LOC Titanium Cap | 5.4mm | 2.3mm | |
Multi-Unit Straight Abutment | 5.0mm | Cuff Height: 1.0mm~6.0mm | |
Multi-Unit Angled Abutment | Cuff Height: 3.0mm~5.0mm | 17° | |
Cuff Height: 4.0mm~6.0mm | 29.5° | ||
Multi-Unit Healing Cap | 5.1mm | 4.5mm | |
Multi-Unit Ti Cylinder | 5.0mm | 5.0mm | |
Multi-unit temporary cylinder | 5.0mm | 12mm | |
Multi-Unit Base | 5.0mm | 4.35/7.35mm | |
Multi-unit cylinder screw | 1.6mm | 3.3mm | |
URIS DS | Ø3.8~ Ø 5.5mm | 6~11mm | 0~25° |
URIS Base – Titanium Base Component | 4.0mm/4.3mm | Cuff Height: 1.0/2.0mm | |
Post Height : 3.5/5.5mm |
Cover screw and healing abutment are anodized in yellow or green.
Fixtures and cover screw are provided sterile and other prosthetics are provided non-sterile. All non-sterile products must be sterilized by end users before use.
5
URIS Base consists of a two-piece abutment, where the titanium base is a pre-manufactured abutment that will be used to support a CAD/CAM designed superstructure (the second part of the two-piece abutment) that composes the final abutment. URIS Base is made of titanium alloy conforming to ASTM F136 Standard Specification for Wrought Titanium-4Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant Applications. It is compatible with the following systems:
Dental Implants
- URIS OMNI System Implants (K172100) 3.5, 4.0, 4.5, 5.0, 5.5, 6.0, 6.5mm
- . URIS OMNI Narrow System Implants (Proposed) 3.15 mm
Raw material blanks
- · InCoris Zi (ZrO2) by Sirona Dental Systems GmbH, L size blanks, cleared under K123664.
Cement
- RelyX Unicem 2Automix by 3M ESPE, cleared under K100756.
All zirconia superstructure that composes the final abutment must be designed and milled through the 3 shape CAD/CAM System, by TruAbutment validated milling center, according to the prosthetic planning and patient clinical situation. The superstructure is cemented to the TruBase S in the lab. Use "RelyX Unicem 2Automix" as an adhesive extraorally to connect.
URIS Base is provided non-sterile therefore must be sterilized after the cementation of the zirconia superstructure on the URIS Base.
Design Limitation for Zirconia superstructure
Design parameter | Design Limit |
---|---|
Minimum and Maximum abutment angle | 0~15° |
Minimum and Maximum Cuff Height | 0.5~5 mm |
Minimum and Maximum diameter at | |
abutment/implant interface | ∅5.0mm~∅8.0mm |
Minimum Thickness | 0.4 mm |
Minimum and Maximum length of | |
abutment post (length above the abutment | |
collar/gingival height) | 4 ~6 mm |
6
URIS DS abutment as a patient matched titanium abutment compatible with both URIS OMNI System (K172100) and URIS OMNI Narrow System (subject).
Design Limitation for URIS DS
| Design parameter | Subject System
(K200817)
Design Limit | URIS OMNI System
(K172100)
Design Limit |
|------------------------------------------------------------------------------------------------------|---------------------------------------------|-----------------------------------------------|
| Minimum and Maximum Gingival
Height | 0.54mm | 0.54mm |
| Minimum and Maximum diameter at
abutment/implant interface | $Ø$ 3.8~ $Ø$ 5.5 | $Ø$ 3.8~ $Ø$ 5.5 |
| Minimum and Maximum length of
abutment | 611mm | 611mm |
| Minimum and Maximum length of
abutment post (length above the
abutment collar/gingival height) | 48mm | 48mm |
| Minimum wall thickness at
abutment/implant interface | 0.4mm | 0.4mm |
| Minimum and Maximum abutment
angle | 025° | 025° |
Indication for Use
URIS OMNI Narrow System is indicated for use in the treatment of missing maxillary lateral incisors or the mandibular central and lateral incisors, in support of single or multiple-unit restorations including; cemented retained, screw retained, or overdenture restorations, and final or temporary abutment support for fixed bridgework. It is intended for delayed loading.
The URIS OMNI Prosthetic abutments are intended for use with URIS OMNI dental implants to provide support for prosthetic restorations such as crowns, bridges, or over-dentures.
All digitally designed abutments and/or coping for use with URIS OMNI Prosthetic abutments are intended to be sent to a TruAbutment-validated milling center for manufacture
Summary of Technological Characteristics
The subject device is substantially equivalent to the currently cleared devices. They are substantially equivalent in intended use, material, design, dimension, connection, functions and surface treatments. Comparison demonstrating Substantial Equivalence follows at the end of this section.
7
URIS Fixture
| | Subject Device | Primary
Predicate Device | Reference Devices |
|-----------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510K
Number | K200817 | K172100 | K102436 |
| Device
Name | URIS OMNI Narrow
System & Prosthetic | URIS OMNI System | Nobel Active 3.0 |
| Manufact
urer | TruAbutment Korea Co.,
Ltd | TruAbutment Korea Co.,
Ltd | Nobel Biocare |
| Indication
for Use | URIS OMNI Narrow
System is indicated for use
in the treatment of missing
maxillary lateral incisors
or the mandibular central
and lateral incisors, in
support of single or
multiple-unit restorations
including; cemented
retained, screw retained,
or overdenture
restorations, and final or
temporary abutment
support for fixed
bridgework. It is intended
for delayed loading.
The URIS OMNI
Prosthetic abutments are
intended for use with
URIS OMNI dental
implants to provide
support for prosthetic
restorations such as
crowns, bridges, or over-
dentures.
All digitally designed
abutments and/or coping
for use with URIS OMNI
Prosthetic abutments are
intended to be sent to a
TruAbutment-validated
milling center for
manufacture | 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 NobelActive
3.0mm implant is
indicated for use in the
treatment of missing
maxillary lateral incisors
or the mandibular
central and lateral
incisors to support
prosthetic devices, such as
artificial teeth,in order to
restore chewing
function in partially
edentulous patients. The
NobelActive 3.0
implants may be put into
immediate function
provided that stability
requirements detailed in
the manual are satisfied. |
| Design | Image: Subject Device Design | Image: Primary Predicate Device Design | Image: Reference Devices Design |
| | Subject Device | Primary
Predicate Device | Reference Devices |
| Structure | - Internal Hex- connected
- Submerged Fixture | - Internal Hex- connected
- Submerged Fixture | -Internal Hex
- Bone Level Implant |
| Body
Diameter
(D) | 3.15mm | 3.5, 4.0, 4.5, 5.0, 5.5, 6.0,
6.5 mm | 3.0mm |
| Length
(mm) | 10, 11.5, 13, 14.5mm | 7, 8.5, 10, 11.5, 13,
14.5mm | 10, 11.5, 13, 15mm |
| Material
of Fixture | CP Ti Grade 4 (ASTM
F67) | CP Ti Grade 4 (ASTM
F67) | Pure Titanium Grade 4
(ASTM F67) |
| Surface | Sand-blasted, Large grit,
Acid-etched
(S.L.A) | Sand-blasted, Large grit,
Acid-etched
(S.L.A) | TiUnite |
| Sterilizatio
n | Gamma Sterilization | Gamma Sterilization | Radiation Sterile |
| Shelf Life | 5years | 5years | N/A |
| Implant
Body
Features | Threaded | Threaded | Threaded |
| Product
Code | DZE | DZE | DZE |
| 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,
and the reference devices K102436. 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 subject device IFUS includes the term "URIS OMNI Narrow System &
Prosthetic is indicated for use in the treatment of missing maxillary lateral incisors or
the mandibular central and lateral incisors" and the primary predicate IFUS does not.
The other minor differences are related to the specific device names, validated
milling centers, and the compatible OEM implant lines. None of these minor
differences impact substantial equivalence because both IFUS express equivalent
intended use to facilitate dental prosthetic restorations, and the indications are
expressed equivalently using different specific wording. | | |
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9
URIS Abutments
Subject Device | Predicate Devices | ||
---|---|---|---|
Part Name | Ball Abutment | Stud Abutment | |
Design | |||
Applicant | TruAbutment Korea Co., Ltd | Osstem Implant Co., Ltd. | |
Trade Name | URIS OMNI Narrow System & | ||
Prosthetic | OSSTEM Implant System | ||
510(K) No. | K200817 | K161689 | |
Classification | |||
Name | Endosseous Dental Implant | ||
Abutments(872.3630) | Endosseous Dental Implant | ||
Abutments(872.3630) | |||
Product Code | NHA | NHA | |
Material | Ti-6Al-4V ELI (ASTM F136) | Ti-6Al-4V ELI (ASTM F136) | |
Indication | |||
For Use/ | |||
Intended Use | Ball 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 | The OSSTEM Implant System - | ||
Abutment is intended for use with a | |||
dental implant to provide support for | |||
prosthetic restorations such as crowns, | |||
bridges, or overdentures. | |||
Diameters | 3.5mm | 3.5mm | |
Lengths | G/H: 1.0/2.0/3.0/4.0/5.0/6.0mm | 6.0/6.4/7.0/7.4/8.0/8.4/9.0/9.4/10/10.4/11 | |
/11.4mm | |||
Surface | |||
Treatment | None | Partial TiN coated in upper | |
Sterile | Non-sterile | Non-sterile | |
SE | The following subject device (Ball Abutment) is substantially equivalent to the | ||
predicate device (Stud Abutment, K161689). The subject device and the | |||
predicate device K161689 have internal implant interface connections, and are | |||
made of Ti-6Al-4V ELI. The minor differences between the IFUS for the subject | |||
device and the predicate is surface treatment. The subject device doesn't include | |||
surface treatment. The predicate device includes partial TiN coasted in upper. | |||
Subject Device | Predicate Devices | ||
Part Name | Retainer Cap | O-ring Retainer Cap | |
Design | Image: Retainer Cap | Image: O-ring Retainer Cap | |
Applicant | TruAbutment Korea Co., Ltd | OSSTEM Implant Co., Ltd. | |
Trade Name | URIS OMNI Narrow System & | ||
Prosthetic | OSSTEM Implant System | ||
510(K) No. | K200817 | K161689 | |
Classification | |||
Name | Endosseous Dental Implant | ||
Abutments(872.3630) | Endosseous Dental Implant | ||
Abutments(872.3630) | |||
Product Code | NHA | NHA | |
Material | Ti-6Al-4V ELI (ASTM F136) | Titanium Gr. 3 (ASTM F67) | |
Indication | |||
For Use/ | |||
Intended Use | Retainer Cap is designed for use with | ||
overdentures or partial dentures, | |||
retained in whole or in part, by | |||
endosseous implants in the mandible | |||
or maxilla. | The OSSTEM Implant System - | ||
Abutment is intended for use with a | |||
dental implant to provide support for | |||
prosthetic restorations such as crowns, | |||
bridges, or overdentures. | |||
Diameters | 5.1mm | 5.0mm | |
Lengths | 3.9mm | 3.9mm | |
Surface | |||
Treatment | None | None | |
Sterile | Non-sterile | Non-sterile | |
SE | The subject device and predicate devices (K161689) have the same intended use, | ||
have similar technological characteristic, and are made of similar materials. The | |||
subject device and predicate devices have similar physical dimensions, including | |||
diameter and lengths. Therefore, the subject device is substantially equivalent to | |||
the currently cleared devices. | |||
Subject Device | Predicate Devices | ||
Part Name | Retainer | Retainer | |
Design | Image: Retainer | Image: Retainer | |
Applicant | TruAbutment Korea Co., Ltd | OSSTEM Implant Co., Ltd | |
Trade Name | URIS OMNI Narrow System & | ||
Prosthetic | Hiossen Prosthetic System | ||
510(K) No. | K200817 | K140507 | |
Classification | |||
Name | Endosseous Dental Implant | ||
Abutments(872.3630) | Endosseous Dental Implant | ||
Abutments(872.3630) | |||
Product Code | NHA | NHA | |
Material | Ti-6Al-4V ELI (ASTM F136) | Titanium | |
Indication | |||
For Use/ | |||
Intended Use | Retainer is designed for use with | ||
overdentures or partial dentures, | |||
retained in whole or in part, by | |||
endosseous implants in the mandible | |||
or maxilla. | Use for marking stud-type over denture | ||
Hiossen Prosthetic system is intended for | |||
use with a dental implant fixture to | |||
provide support for prosthetic restoration | |||
such as crowns, bridges, or over- | |||
dentures | |||
Diameters | 5.1mm | 5.0mm | |
Lengths | 3.9mm | 2.0mm | |
Surface | |||
Treatment | None | None | |
Sterile | Non-sterile | Non-sterile | |
SE | The subject device and predicate devices (K140507) have the same intended use, | ||
have similar technological characteristic, and are made of similar materials. The | |||
subject device and predicate devices have similar physical dimensions, including | |||
diameter and lengths. Therefore, the subject device is substantially equivalent to | |||
the currently cleared devices. | |||
Subject Device | Predicate Devices | ||
Part Name | T LOC Straight Abutment | Port Abutment | |
Design | Image: T LOC Straight Abutment | Image: Port Abutment | |
Applicant | TruAbutment Korea Co., Ltd. | OSSTEM Implant Co., Ltd | |
Trade Name | URIS OMNI Narrow System & | ||
Prosthetic | Osstem Abutment System | ||
510(K) No. | K200817 | K182091 | |
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(ASTM F136) | |
Indication | |||
For Use/ | |||
Intended Use | T LOC 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. | The Osstem Abutment System is | ||
intended for use with a dental implant to | |||
provide support for prosthetic | |||
restorations such as crowns, bridges, or | |||
overdentures. | |||
Diameters | 3.8mm | 3.5~5.1mm | |
Lengths | G/H : 1.0/2.0/3.0/4.0/5.0/6.0 mm | G/H: 1.0 ~ 7.0 mm | |
Surface | |||
Treatment | None | Partial TiN coated in upper | |
Sterile | Non-sterile | Non-sterile | |
SE | The subject device (T LOC Straight Abutment) is substantially equivalent to the | ||
predicate device (Port Abutment, K182091). The subject device and the predicate | |||
device K182091 have internal connections, are made of Ti-6A1-4V ELI, and are | |||
conducted End User Steam Sterilization. The minor differences between the | |||
IFUS for the subject device and the predicate is surface treatment. The subject | |||
device doesn't include surface treatment. The predicate device includes partial | |||
TiN coasted in upper. | |||
Subject Device | Predicate Devices | ||
Part Name | T LOC Titanium Cap | Port Male Cap | |
Design | Image: T LOC Titanium Cap | Image: Port Male Cap | |
Applicant | TruAbutment Korea Co., Ltd | Osstem Implant Co., Ltd. | |
Trade Name | URIS OMNI Narrow System & | ||
Prosthetic | Osstem Abutment System | ||
510(K) No. | K200817 | K182091 | |
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) | |
Indication | |||
For Use/ | |||
Intended Use | T LOC Titanium Cap is designed for | ||
use with overdentures or partial | |||
dentures, retained in whole or in part, | |||
by endosseous implants in the | |||
mandible or maxilla. | The Osstem Abutment System is | ||
intended for use with a dental implant to | |||
provide support for prosthetic | |||
restorations such as crowns, bridges, or | |||
overdentures. | |||
Diameters | 5.4mm | 5.5mm | |
Lengths | 2.3mm | 2.25mm | |
Surface | |||
Treatment | None | None | |
Sterile | Non-sterile | Non-sterile | |
SE | The subject device and predicate devices (K182091) have the same intended use, | ||
have similar technological characteristic, and are made of similar materials. The | |||
subject device and predicate devices have similar physical dimensions, including | |||
diameter and lengths. Therefore, the subject device is substantially equivalent to | |||
the currently cleared devices. | |||
Subject Device | Predicate Devices | ||
Part Name | Multi-unit Straight Abutment | Multi Abutment | |
Design | Image: Multi-unit Straight Abutment | Image: Multi Abutment | |
Applicant | TruAbutment Korea Co., Ltd. | OSSTEM Implant Co., Ltd. | |
Trade Name | URIS OMNI Narrow System & | ||
Prosthetic | OSSTEM Implant System | ||
510(K) No. | K200817 | K161689 | |
Classification | |||
Name | Endosseous Dental Implant | ||
Abutments(872.3630) | Endosseous Dental Implant | ||
Abutments(872.3630) | |||
Product Code | NHA | NHA | |
Material | Ti-6Al-4V ELI (ASTM F136) | Titanium Alloy (Ti-6Al-4V) | |
Indication | |||
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. | Using for edentulous mandible or | ||
maxilla. | |||
Usually use to make full denture Screw | |||
Retained Restoration | |||
Diameters | 5.0mm | 4.8mm | |
Lengths | G/H :1.0/2.0/3.0/4.0/5.0/6.0mm | 8.3,8.7, 9.3, 9.7, 10.3, 10.7, 11.3, 11.7, | |
12.3, 12.7mm | |||
Surface | |||
Treatment | None | TiN coating | |
Sterile | Non-sterile | Non-sterile | |
SE | The subject device (Multi-unit Straight Abutment) is substantially equivalent to | ||
the predicate device (Multi Abutment, K161689). The subject device and the | |||
predicate device K161689 have internal implant interface connections, are made | |||
of Ti-6Al-4V ELI, and are conducted End User Steam Sterilization. The minor | |||
differences between the subject device and the predicate is surface treatment. | |||
The subject device doesn't include surface treatment. The predicate device | |||
includes partial TiN coasted in upper. | |||
Subject Device | Predicate Devices | ||
Part Name | Multi-unit Angled Abutment | Multi Angled Abutment | |
Design | Image: Multi-unit Angled Abutment design | Image: Multi Angled Abutment design | |
Applicant | TruAbutment Korea Co., Ltd | OSSTEM Implant Co., Ltd. | |
Trade Name | URIS OMNI Narrow System & | ||
Prosthetic | Multi Angled Abutment | ||
510(K) No. | K200817 | K123755 | |
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) | |
Indication | |||
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. | Multi Angled Abutment is intended for | ||
use with a dental implant to provide | |||
support for prosthetic restorations such | |||
as crowns, bridges, or overdentures. | |||
Diameters | 5.0mm | 4.8mm | |
Lengths | G/H : 3.0/4.0/5.0(17°) | ||
G/H : 4.0/5.0/6.0(29.5°) | 3.17, 3.4, 4.17, 4.4, 4.76, 4.86, 5.17, 5.4, | ||
5.76, 5.86, 6.76, 6.86 (17°) | |||
3.17, 3.4, 4.17, 4.4, 4.76, 4.86, 5.17, 5.4, | |||
5.76, 5.86, 6.76, 6.86 (30°) | |||
Post Angle | 17° / 29.5° | 17° / 30° | |
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 Angled Abutment, K123755). The subject device and | |||
the predicate device K123755 have internal connections, are made of Ti-6Al-4V | |||
ELI, and are conducted End User Steam Sterilization. The minor differences | |||
between the subject device and the predicate is angulation. The subject device is | |||
for multiple-unit restorations, include angulations up to 29.5°. The predicate | |||
device is for multiple-unit restorations, include angulations up to 30° | |||
Subject Device | Predicate Devices | ||
Part Name | Multi-unit Healing Cap | Healing Abutment | |
Design | Image: Multi-unit Healing Cap | Image: Healing Abutment | |
Applicant | TruAbutment Korea Co., Ltd | Osstem Implant Co., Ltd. | |
Trade Name | URIS OMNI Narrow System & | ||
Prosthetic | SMART builder System | ||
510(K) No. | K200817 | K120951 | |
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) | Pure TitaniumGrade4 | |
(ASTMF67) | |||
Indication | |||
For Use/ | |||
Intended Use | The Multi-unit healing cap is a pre- | ||
manufactured prosthetic component | |||
directly connected to the | |||
endosseous dental implant and is | |||
intended for use as an aid in | |||
prosthetic rehabilitation. | SMART builder is a metaldevice intended | ||
for use with a dental implant to stabilize | |||
and support of bone graft in dento-alveolar | |||
bony defect sites. | |||
Diameters | 5.1mm | 4.0~7.0 | |
Lengths | 4.5mm | 3.35~4.22 | |
Surface | |||
Treatment | None | None | |
Sterile | Non-sterile | Gamma Sterilization | |
SE | The subject device and predicate devices (K120951) have the same intended use, | ||
have similar technological characteristic, and are made of similar materials. The | |||
subject device and predicate devices have similar physical dimensions, including | |||
diameter and lengths. Therefore, the subject device is substantially equivalent to | |||
the currently cleared devices. | |||
Subject Device | Predicate Devices | ||
Part Name | Multi-unit Ti Cylinder | Multi-unit EZ Post Cylinder | |
Design | Image: Multi-unit Ti Cylinder | Image: Multi-unit EZ Post Cylinder | |
Applicant | TruAbutment Korea Co., Ltd | Megagen Implant Co., Ltd. | |
Trade Name | URIS OMNI Narrow System & | ||
Prosthetic | AnyOne Internal Implant System | ||
510(K) No. | K200817 | K123988 | |
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) | CP4 Titanium and Ti-6A1-4V-ELI | |
Indication | |||
For Use/ | |||
Intended Use | Multi-unit Ti Cylinder is intended | ||
to be surgically placed in the | |||
maxillary or mandibular molar | |||
areas for the purpose providing | |||
prosthetic support for dental | |||
restorations in partially or fully | |||
edentulous individuals. It is used to | |||
restore a patient's chewing function. | The AnyOne TM Internal Implant System | ||
is intended to be surgically placed in the | |||
maxillary or mandibular molar areas for | |||
the purpose providing prosthetic support | |||
for dental restorations (Crown, bridges, | |||
and overdentures) in partially or fully | |||
edentulous individuals. It is used to restore | |||
a patient's chewing function. | |||
Smaller implants (less than 06.0 mm) are | |||
dedicated for immediate loading when | |||
good primary stability is achieved and | |||
with appropriate occlusal loading. Larger | |||
implants are dedicated for the molar | |||
region and are indicated for delayed | |||
loading. | |||
Diameters | 5.0mm | Hex/Non-Hex: 5.0mm | |
Lengths | 5.0mm | Not stated in 510(k) summary | |
Surface | |||
Treatment | None | None | |
Sterile | Non-sterile | Non-sterile | |
SE | The subject device and Predicate devices (K123988) have the same intended use, | ||
have similar technological characteristic, and are made of similar materials. The | |||
subject device and predicate devices have similar physical dimensions, including | |||
diameter and lengths. Therefore, the subject device is substantially equivalent to | |||
the currently cleared devices | |||
Subject Device | Predicate Devices | ||
Part Name | Multi-unit Temporary Cylinder | RC Temporary Abutment | |
Design | Image: Multi-unit Temporary Cylinder | Image: RC Temporary Abutment | |
Applicant | TruAbutment Korea Co., Ltd | OSSTEM Implant Co., Ltd. | |
Trade Name | URIS OMNI Narrow System & | ||
Prosthetic | ET US SS Prosthetic System | ||
510(K) No. | K200817 | K160670 | |
Classification | |||
Name | Endosseous Dental Implant | ||
Abutments(872.3630) | Endosseous Dental Implant | ||
Abutments(872.3630) | |||
Product | |||
Code | NHA | NHA | |
Material | Ti-6Al-4V ELI (ASTM F136) | Titanium (ASTM F 67) | |
Indication | |||
For Use/ | |||
Intended Use | Multi-unit Temporary Cylinder is | ||
intended to be surgically placed in the | |||
maxillary or mandibular molar areas | |||
for the purpose providing prosthetic | |||
support for dental restorations in | |||
partially or fully edentulous | |||
individuals. It is used to restore a | |||
patient's chewing function. | Esthetic-low Temporary Cylinder is | ||
used for prosthetic restoration. This is | |||
used to make temporary prosthesis and | |||
designed to minimized indication | |||
constraints. | |||
Diameters | 5.0mm | 4.8/5.5mm | |
Lengths | 12mm | 12mm | |
Surface | |||
Treatment | None | Not stated in 510(k) summary | |
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. K160670 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 4.8, 5.5mm is in the range of | |||
diameters of predicates and this dimensional difference doesn't affect substantial | |||
equivalence. | |||
Subject Device | Predicate Devices | ||
Part Name | Multi-unit Base | Multi-unit Cylinder | |
Design | Image: Multi-unit Base Design | Image: Multi-unit Cylinder Design | |
Applicant | TruAbutment Korea Co., Ltd | WARANTEC Implant | |
Co., Ltd. | |||
Trade Name | URIS OMNI Narrow System & | ||
Prosthetic | Oneplant Dental Implant System | ||
510(K) No. | K200817 | K081748 | |
Classification | |||
Name | Endosseous Dental Implant | ||
Abutments(872.3630) | Endosseous Dental Implant | ||
Abutments(872.3630) | |||
Product | |||
Code | NHA | NHA | |
Material | Ti-6Al-4V ELI (ASTM F136) | Titanium Alloy | |
Indication | |||
For Use/ | |||
Intended Use | Multi-unit Base is intended to be | ||
surgically placed in the maxillary or | |||
mandibular molar areas for the | |||
purpose providing prosthetic | |||
support for dental restorations in | |||
partially or fully edentulous | |||
individuals. It is used to restore a | |||
patient's chewing function. | ONEPLANT is designed for use in | ||
dental implant surgery. These are | |||
intended for use in partially or fully | |||
edentulous mandibles and maxillae to | |||
support for single or multiple-unit | |||
restorations such as cemented | |||
retained, or over denture restorations | |||
and terminal or intermediate abutment | |||
support for fixed bridgework. | |||
Diameters | 5.0mm | Hex/Non-Hex: 4.5/5.5mm | |
Lengths | 4.35/7.35mm | Not stated in 510(k) summary | |
Surface | |||
Treatment | None | None | |
Sterile | Non-sterile | Non-sterile | |
SE | The subject device and predicate devices (K081748) have the same intended use, | ||
have similar technological characteristic, and are made of similar materials. The | |||
subject device and predicate devices have similar physical dimensions, including | |||
diameter. Therefore, the subject device is substantially equivalent to the currently | |||
cleared devices. | |||
Subject Device | Predicate Device | ||
Part Name | Multi-unit Cylinder Screw | EbonyGold Cylinder Screw | |
Design | Image: Multi-unit Cylinder Screw | Image: EbonyGold Cylinder Screw | |
Applicant | TruAbutment Korea Co., Ltd | OSSTEM Implant Co., Ltd | |
Trade Name | URIS OMNI Narrow System & | ||
Prosthetic | Osstem Abutment System | ||
510(K) No. | K200817 | K182091 | |
Classification | |||
Name | Endosseous Dental Implant | ||
Abutments(872.3630) | Endosseous Dental Implant | ||
Abutments(872.3630) | |||
Product Code | NHA | NHA | |
Material | Ti-6Al-4V ELI (ASTM F136) | Titanium Alloy | |
Ti-6Al-4V (ASTM F136) | |||
Indication | |||
For Use/ | |||
Intended Use | 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. | The Osstem Abutment System is | ||
intended for use with a dental implant | |||
to provide support for prosthetic | |||
restorations such as crowns, bridges, or | |||
overdentures. | |||
Diameters | 1.6mm | 2.2/2.5 mm | |
Lengths | 3.3mm | 4.35/ 4.9 mm | |
Surface | |||
Treatment | None | N/A | |
Sterile | Non-sterile | Non-sterile | |
SE | The subject device and reference devices (K182091) have the same intended use, | ||
have similar technological characteristic, and are made of similar materials. The | |||
subject device and predicate devices have similar physical dimensions, including | |||
diameter and lengths. Therefore, the subject device is substantially equivalent to | |||
the currently cleared devices. | |||
Subject Device | Predicate Devices | ||
Part Name | URIS DS | TruAbutment DS | |
Design | Image: URIS DS | Image: TruAbutment DS | |
Applicant | TruAbutment Korea Co., Ltd | TruAbutment Korea Co., Ltd | |
Trade Name | URIS OMNI Narrow System & | ||
Prosthetic | TruAbutment DS | ||
510(K) No. | K200817 | K183106 | |
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-6AI-4V ELI | |
Indication | |||
For Use/ | |||
Intended Use | 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 mm | |||
All 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. | The TruAbutment 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: | |||
Tapered Internal Implants (K071638) | |||
(K143022) 3.4, 3.8, 4.6, 5.8 mmBioHorizons Laser-Lok Implant System | |||
(K093321) 3.0 mmThe available range of diameters is | |||
summarized below: | |||
Tapered Internal / Laser-Lok 3.0 | |||
Implant Ø (mm) : 3.0 / Implant Platform | |||
(mm) : 3.0 / Type of Implant-Abutment | |||
Connection : Internal Hex | |||
Tapered Internal | |||
Implant Ø (mm) : 3.4 / Implant Platform | |||
(mm) : 3.0 / Type of Implant-Abutment | |||
Connection : Internal Hex | |||
Implant Ø (mm) : 3.8 / Implant Platform | |||
(mm) : 3.5 / Type of Implant-Abutment | |||
Connection : Internal Hex | |||
Implant Ø (mm) : 4.6 / Implant Platform | |||
(mm) : 4.5 / Type of Implant-Abutment | |||
Connection : Internal Hex | |||
Implant Ø (mm) : 5.8 / Implant Platform | |||
(mm) : 5.7 / Type of Implant-Abutment | |||
Connection : Internal Hex | |||
All 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. | |||
Subject Device | Predicate Devices | ||
Part Name | URIS DS | TruAbutment DS | |
manufacture. | |||
CAD Design | |||
Limits | Minimum and Maximum Gingiva | ||
Height: 0.5~4mm | Minimum and Maximum Gingiva Height: | ||
0.5~4mm | |||
Minimum and Maximum diameter at | |||
abutment/implant interface: Ø3.8~Ø5.5 | 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: 6~11mm | |||
Minimum and Maximum length of | |||
abutment post (length above the | |||
abutment collar/gingival height): 4~8mm | 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 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 DS) are substantially equivalent to the predicate | ||
device (TruAbutment DS, K183106). The subject device and the predicate | |||
device K183106 have internal connections, are made of Ti-6Al-4V ELI, and are | |||
conducted End User Steam Sterilization and are same CAD Design Limits. The | |||
minor differences between the IFUS for the subject device and the primary | |||
predicate is compatible system. The subject device is compatible with URIS | |||
OMNI System Implants and URIS OMNI Narrow System. | |||
Subject Device | Predicate Devices | ||
Part Name | URIS Base | Titanium Base | |
Design | Image: URIS Base Design | Image: Titanium Base Design | |
Applicant | TruAbutment Korea Co., Ltd. | Preat Corporation | |
Trade Name | URIS OMNI Narrow System & | ||
Prosthetic | Preat Abutments | ||
510(K) No. | K200817 | K183518 | |
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) | ||
Zirconia Oxide | Ti-6Al-4V alloy | ||
Zirconia Oxide | |||
Indication | |||
For Use/ | |||
Intended Use | 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. | Preat Abutments are intended to be used | ||
in conjunction with endosseous dental | |||
implants in the maxillary or mandibular | |||
arch to provide support for single-unit or | |||
multi-unit prosthetic restorations. The | |||
Titanium Base abutments consists of the | |||
major parts. Specifically, the titanium | |||
base and mesostructured components | |||
make up a two-piece abutment, | |||
All digitally designed custom abutments, | |||
superstructures, and/or hybrid crowns | |||
for use with Titanium Base or Titanium | |||
Blank are to be sent to a Preat validated | |||
milling center for manufacture. | |||
Prosthesis | |||
Attachment | Cement-retained | ||
Screw-retained | Cement-retained | ||
Screw-retained | |||
Restoration | Single-unit | ||
Multi-unit | Single-unit | ||
Multi-unit | |||
Abutment | |||
/Implant | |||
Platform | |||
Diameter | |||
(mm) | Narrow 2.6 | ||
Regular 3.3 | 3.0 - 6.5 | ||
Design | |||
parameters of | |||
zirconia | |||
superstructures | Maximum Angulation 15° | ||
Maximum Cuff Height 5mm | |||
Minimum Diameter Ø 5.0mm | |||
Minimum Thickness 0.4mm | |||
Minimum Post Height 4~6mm | Minimum wall thickness-0.5mm; | ||
Minimum post height for single-unit | |||
restorations-4.0mm; | |||
Maximum gingival height-5.0mm; and | |||
All zirconia superstructures are for | |||
straight abutments only. | |||
Abutment | Internal connection | Internal connection | |
Subject Device | Predicate Devices | ||
Part Name | URIS Base | Titanium Base | |
/Implant | |||
Interface | |||
Sterile | Non-sterile | Non-sterile | |
SE | The subject device (URIS Base) are substantially equivalent to the predicate | ||
device (Titanium Base, K183518). The subject device and the predicate device | |||
K183518 have internal implant interface connections, same prosthesis | |||
attachment, restoration, are made of Ti-6Al-4V ELI, and are conducted End User | |||
Steam Sterilization. The minor differences between the subject device and the | |||
predicate is design parameters for abutment/implant platform diameter and | |||
zirconia superstructures. The predicate device are for straight abutments only, | |||
while the subject device can compensate for angles up to 15°. |
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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 K102436. 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 subject device IFUS includes the term "URIS OMNI Narrow System & Prosthetic is indicated for use in the treatment of missing maxillary lateral incisors or the mandibular central and lateral incisors." and the primary predicate IFUS does not.
The other minor differences are related to the specific device names, validated milling centers, and the compatible OEM implant lines. None of these minor differences impact substantial equivalence because both IFUS express equivalent intended use to facilitate dental prosthetic restorations, and the indications are expressed equivalently using different specific wording.
The following subject device (Ball Abutment) is substantially equivalent to the predicate device (Stud Abutment. K161689). The subject device and the predicate device K161689 have internal implant interface connections, and are made of Ti-6A1-4V ELI. The minor differences between the IFUS for the subject device and the predicate is surface treatment. The subject device doesn't include surface treatment. The predicate device includes partial TiN coasted in upper.
The subject device (T LOC Straight Abutment) is substantially equivalent to the predicate device (Port Abutment, K182091). The subject device and the predicate device K182091 have internal connections, are made of Ti-6A1-4V ELI, and are conducted End User Steam Sterilization. The minor differences between the IFUS for the subject device and the predicate is surface treatment. The subject device doesn't include surface treatment. The predicate device includes partial TiN coasted in upper.
The subject device (Multi-unit Straight Abutment) is substantially equivalent to the predicate device (Multi Abutment, K161689). The subject device and the predicate device K161689 have internal
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K200817
implant interface connections, are made of Ti-6A1-4V ELI, and are conducted End User Steam Sterilization. The minor differences between the IFUS for the subject device and the predicate is surface treatment. 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 predicate device includes partial TiN coasted in upper.
The subject device (Multi-unit Angled Abutment) are substantially equivalent to the predicate device (Multi Angled Abutment, K123755). The subject device and the predicate device K123755 have internal 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 angulation. The subject device is for multiple-unit restorations, include angulations up to 29.5°. and abutment with a post length of less than 4mm is only available for multi-unit cases. The predicate device is for multiple-unit restorations, include angulations up to 30°
The subject device (URIS DS) are substantially equivalent to the predicate device (TruAbutment DS, K183106). The subject device and the predicate device K183106 have internal connections, are made of Ti-6A1-4V ELI, and are conducted End User Steam Sterilization and are same CAD Design Limits. The minor differences between the IFUS for the subject device and the primary predicate is compatible system. The subject device is compatible with URIS OMNI System Implants and URIS OMNI Narrow System. and abutment with a post length of less than 4mm is only available for multiunit cases. The predicate device is compatible with BioHorizons Laser-Lok Implant System.
The subject device (URIS Base) are substantially equivalent to the predicate device (Titanium Base, K183518). The subject device and the predicate device K183518 have internal implant interface connections, same prosthesis attachment, restoration, are made of Ti-6AI-4V ELI, and are conducted End User Steam Sterilization. The minor differences between the subject device and the predicate is design parameters for abutment/implant platform diameter and zirconia superstructures. The predicate device are for straight abutments only, while the subject device can compensate for angles up to 15°. Other than the devices mentioned (Retainer Cap, T Loc titanium Cap, Multi-unit Healing Cap, Multi-unit Ti Cylinder, Multi-unit Temporary Cylinder, Multi-unit Base, Multi-unit Cylinder screw) have the same intended use, have similar technological characteristic, and are made of similar materials. The subject device and predicate devices have similar physical dimensions, including diameter. Therefore, the subject device is substantially equivalent to the currently cleared devices.
Non-Clinical Test Data
The following tests were performed:
- · Bacterial Endotoxin Testing (LAL) in accordance with USP and USP
- . 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
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Biocompatibility testing has been completed. Requirements for biological evaluation of the subject device were based on the ISO 10993-1 "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process.
Fatigue testing was conducted according to the "Guidance for industry and FDA staff Class II Special Controls Guidance Document Root-form Endosseous Dental Implants and Endosseous Dental Abutment" and ISO 14801:2016 Dentistry - Fatigue test for endosseous dental implants under the worst-case scenario.
The results of the non-clinical testing demonstrate that the results have met the criteria of the standards, and the subject device is substantially equivalent to the predicate device.
No clinical data were included in this submission.
Conclusions
In accordance with the Federal Food, Drug and Cosmetic Act, 21 CFR Part 807, and based on the information provided in this premarket notification, TruAbutment Korea Co., Ltd. concludes that the URIS OMNI Narrow System & URIS Prosthetic System is substantially equivalent to predicate devices as described herein.