URIS OMNI System

K172100 · Truabutment, Inc. · DZE · May 4, 2018 · Dental

Device Facts

• Record ID: K172100
• Device Name: URIS OMNI System
• Applicant: Truabutment, Inc.
• Product Code: DZE · Dental
• Decision Date: May 4, 2018
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3640
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

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, or overdenture restorations, and final or temporary abutment support for fixed bridgework. It is intended for delayed loading.

Device Story

URIS OMNI System comprises endosseous dental implants (fixtures) and prosthetic components (cover screws, healing abutments, D-basis abutments, angled abutments, milling abutments, temporary abutments). Fixtures are unalloyed titanium (Grade 4); prosthetic components are titanium alloy (Ti-6Al-4V ELI). Fixtures feature SLA surface treatment. System used by dental professionals in clinical settings for tooth replacement. Fixtures are surgically placed into jaw bone; prosthetic components are attached to fixtures to support restorations. Output is a stable foundation for dental prosthetics, restoring chewing function and aesthetics. Benefits include improved oral function for edentulous patients.

Clinical Evidence

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

Technological Characteristics

Fixtures: Unalloyed Titanium Grade 4 (ASTM F67), SLA surface. Abutments: Ti-6Al-4V ELI (ASTM F136). Internal hex connection. Sterilization: Gamma (fixtures/cover screws), end-user sterilization required for others. Dimensions: 3.5-6.5mm diameter, 7-14.5mm length.

Indications for Use

Indicated for partially or fully edentulous mandibles and maxillae in patients requiring single or multiple-unit restorations (cemented, screw-retained, or overdenture) or fixed bridgework support. Intended for delayed loading.

Regulatory Classification

Identification

An endosseous dental implant is a prescription device made of a material such as titanium or titanium alloy that is intended to be surgically placed in the bone of the upper or lower jaw arches to provide support for prosthetic devices, such as artificial teeth, in order to restore a patient's chewing function.

Special Controls

*Classification.* (1) Class II (special controls). The device is classified as class II if it is a root-form endosseous dental implant. The root-form endosseous dental implant is characterized by four geometrically distinct types: Basket, screw, solid cylinder, and hollow cylinder. The guidance document entitled “Class II Special Controls Guidance Document: Root-Form Endosseous Dental Implants and Endosseous Dental Implant Abutments” will serve as the special control. (See § 872.1(e) for the availability of this guidance document.)(2) *Classification.* Class II (special controls). The device is classified as class II if it is a blade-form endosseous dental implant. The special controls for this device are:(i) The design characteristics of the device must ensure that the geometry and material composition are consistent with the intended use; (ii) Mechanical performance (fatigue) testing under simulated physiological conditions to demonstrate maximum load (endurance limit) when the device is subjected to compressive and shear loads; (iii) Corrosion testing under simulated physiological conditions to demonstrate corrosion potential of each metal or alloy, couple potential for an assembled dissimilar metal implant system, and corrosion rate for an assembled dissimilar metal implant system; (iv) The device must be demonstrated to be biocompatible; (v) Sterility testing must demonstrate the sterility of the device; (vi) Performance testing to evaluate the compatibility of the device in a magnetic resonance (MR) environment; (vii) Labeling must include a clear description of the technological features, how the device should be used in patients, detailed surgical protocol and restoration procedures, relevant precautions and warnings based on the clinical use of the device, and qualifications and training requirements for device users including technicians and clinicians; (viii) Patient labeling must contain a description of how the device works, how the device is placed, how the patient needs to care for the implant, possible adverse events and how to report any complications; and (ix) Documented clinical experience must demonstrate safe and effective use and capture any adverse events observed during clinical use.

Predicate Devices

• TS Fixture System (K121995)

Reference Devices

• CMI Implant IS II active (K120503)
• Oneplant Dental Implant System (K081748)
• IH Implant System (K153521)
• HU/HS/HG Prosthetic System (K081575)
• OSSTEM Implant System - Abutment (K161689)
• Transfer & Angled Abutment (K153015)
• Straumann RC Temporary Abutments (K093027)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

May 4, 2018

TruAbutment Inc. c/o April Lee Consultant Withus Group Inc. 106 Superior Irvine, California 92620

Re: K172100

Trade/Device Name: URIS OMNI System Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: Class II Product Code: DZE, NHA Dated: April 3, 2018 Received: April 5, 2018

## Dear April Lee:

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. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

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

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Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely.

# Andrew I. Steen -S

for Tina Kiang, Ph.D. Acting Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below.

510(k) Number (if known) K172100

Device Name URIS OMNI System

#### Indications for Use (Describe)

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, or overdenture restorations, and final or temporary abutment support for fixed bridgework. It is intended for delayed loading.

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

> Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

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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. Brandon Kim 17742 Cowan, Irvine CA 92614 USA Email: [e-mail] Phone: [phone]

#### Device Information:

Device Name: URIS OMNI System Classification Name: Endosseous Dental Implant Classification: Class II Primary Product Code: DZE Secondary Product Code: NHA Regulation number: 21 CFR 872.3640 Date Prepared: 05/04/2018

## Official Correspondent

Withus Group Inc. April Lee 106 Superior, Irvine, CA 92620 USA Email: [e-mail] Phone: [phone] Fax: [phone]

#### Predicate Device

- · Primary Predicate Device:
- TS Fixture System (K121995) by Osstem Implant Co., Ltd. –
- · Reference Devices:
- -CMI Implant IS II active (K120503) by Neobiotech Co., Ltd.
- -Oneplant Dental Implant System (K081748) by Warantec Co., Ltd.
- -IH Implant System (K153521) by Sewon Medix Inc.
- -HU/HS/HG Prosthetic System(K081575) by Osstem Implant Co., Ltd.
- -OSSTEM Implant System - Abutment (K161689) by Osstem Implant Co., Ltd.
- -Transfer & Angled Abutment (K153015) by Osstem Implant Co., Ltd.
- -Straumann RC Temporary Abutments (K093027) by Straumann USA

#### Device Description

URIS OMNI 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 multiple-unit restorations. The surface is SLA (Sandblasted, Large grit and Acid etched) treated and is provided sterile. It consists of two implant lines, the OMNI and the OMNI Tapered, with corresponding cover screws, healing abutments and prosthetic abutments. The OMN Tapered implant has a tapered wall with a single thread design. The OMN is straight walled with smaller threading at the coronal end, and bigger threading at the apical end. Both implant lines have two platform sizes, Narrow (Ø 3.5 mm) and Regular (Ø 4.0 - Ø 6.5 mm). Both implant lines share the following diameters and lengths:

Ø 3.5 x 8.5, 10, 11.5, 13, 14.5mm (L) Ø 4.0 x 7. 8.5. 10. 11.5. 13. 14.5mm (L) Ø 4.5 x 7, 8.5, 10, 11.5, 13, 14.5mm (L) Ø 5.0 x 7, 8.5, 10, 11.5, 13, 14.5mm (L) Ø 5.5 x 7. 8.5. 10. 11.5. 13. 14.5mm (L) Ø 6.0 x 7, 8.5, 10mm (L) Ø 6.5 x 7, 8.5, 10mm (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 Cover screw, Healing abutment-direct type, D-basis abutmentcemented type, Angled abutment, Milling abutment, Temporary abutment screw. The surface of cover screw and healing abutment are anodized in yellow and green.

| Device Component | Diameters (Ø) | Lengths | Angulation |
|-------------------|-----------------------|--------------------------|------------|
| Cover Screw | 2.78/3.48mm | 4.875/5.375mm | - |
| Healing Abutments | 4.0/4.5/5.5/6.5/7.5mm | Cuff Height: 1.0mm~5.0mm | - |

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| D-Basis Abutment-direct type | 4.0/4.5/5.5/6.5mm | Cuff Height: 1.0mm~6.0mm | - |
|--------------------------------|-------------------|------------------------------------------------------|-----|
| D-basis abutment-cemented type | 4.0/4.5/5.5/6.5mm | Cuff Height: 1.0mm~6.0mm | - |
| Angled abutment | 4.0/ 4.5/5.5mm | Cuff Height: 2.0mm~5.0mm | 17° |
| Milling abutment | 4.0/5.0/6.0/7.0mm | Hex Type: 14.1/14.85mm<br>Non-Hex Type: 13.9/14.85mm | - |
| Temporary abutment | 3.7 / 4.3mm | Cuff Height: 1.0mm~3.0mm | - |
| Abutment screw | 1.9/2.3mm | 7.2/7.7mm | - |

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

## Indication for Use

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, or overdenture restorations, and final or temporary abutment support for fixed bridgework. It is intended for delayed loading.

## Summary of Technological Characteristics

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

#### URIS Fixture

| | Subject Device | Primary<br>Predicate Device | Reference Devices | |
|------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510K<br>Number | K172100 | K121995 | K120503 | K081748 |
| Device<br>Name | URIS OMNI System | TS Fixture System | CMI Implant IS II<br>active | Oneplant Dental<br>Implant System |
| Manufactur<br>er | TruAbutment Co.,<br>Ltd. | OSSTEM Implant<br>Co., Ltd. | Neobiotech Co., Ltd. | WARANTEC Co.,<br>Ltd. |
| Indications<br>for Use | URIS OMNI System<br>is indicated for use in<br>partially or fully<br>edentulous<br>mandibles and<br>maxillae, in support<br>of single or multiple-<br>unit restorations<br>including; cemented<br>retained, screw<br>retained, or<br>overdenture<br>restorations, and<br>final or temporary<br>abutment support for<br>fixed bridgework. It<br>is intended for<br>delayed loading. | The TS Fixture<br>System is indicated<br>for use in partially or<br>fully edentulous<br>mandibles and<br>maxillae, in support<br>of single or multiple-<br>unit restorations<br>including; cemented<br>retained, screw<br>retained, or<br>overdenture<br>restorations, and<br>final or temporary<br>abutment support for<br>fixed bridgework. It<br>is intended for<br>delayed loading. TS<br>Fixture System is<br>compatible with<br>abutment in the<br>ET/SS Implant<br>System. | The CMI Implant IS<br>II active is intended<br>to be surgically<br>placed in the bone of<br>the upper or lower<br>jaw arches to provide<br>support for<br>prosthetics devices,<br>such as artificial<br>teeth, and to restore<br>the patient's chewing<br>function. It is<br>intended for<br>immediate loading<br>when good primary<br>stability is achieved<br>and with appropriate<br>occlusal loading. | ONEPLANT is<br>designed for use in<br>dental implant<br>Surgery. These are<br>intended for use in<br>partially or fully<br>edentulous<br>mandibles and<br>maxillae to support<br>for single or<br>multiple-unit<br>restorations such as<br>cemented retained,<br>screw retained, or<br>over denture<br>restorations and<br>terminal or<br>intermediate<br>abutment support for<br>fixed bridgework. |

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| Design | Image: Implant | Image: Implant | Image: Implant | Image: Implant |
|-----------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------|--------------------------------------------------------------|
| Structure | - Internal Hex-<br>connected<br>- Submerged Fixture | - Internal Hex-<br>connected<br>- Submerged Fixture<br>- Tapered body<br>shape and straight<br>body shape<br>- 4-sided cutting<br>edge with self-<br>tapping | N/A | - Internal Connection<br>- Morse Taper<br>- Internal Octagon |
| Body<br>Diameter(D) | 3.5, 4.0, 4.5, 5.0, 5.5,<br>6.0, 6.5mm | TSII SA Fixture: 3.5,<br>4.2, 4.4, 4.9<br>TSIII SA Fixture:<br>3.75, 3.77, 4.2, 4.25,<br>4.6, 4.63, 4.65, 5.05,<br>5.08, 5.1 | 3.5/4.0/4.5/5.0/5.5/6.<br>0/7.0/8.0mm | 3.3, 3.6,4.3, 5.3mm |
| Length<br>(mm) | 7, 8.5, 10, 11.5, 13,<br>14.5mm | 7.0~15mm | 7.0/7.3/8.5/10.0/11.5<br>/13.0/15.0mm | 8.5, 10, 11.5, 13,<br>15mm |
| Material of<br>Fixture | CP Ti Grade 4<br>(ASTM F67) | CP Ti Grade 4<br>(ASTM F67) | CP Ti Grade 4<br>(ASTM F67) | CP Ti Grade 4<br>(ASTM F67) |
| Surface | Sand-blasted, Large<br>grit, Acid-etched<br>(S.L.A) | SA (Sandblasting<br>and Acid etching) | Sand-blasted, Large<br>grit, Acid-etched<br>(S.L.A) | N/A |
| Sterilization | Gamma Sterilization | Radiation Sterile | Gamma Sterilization | Gamma Sterilization |
| Shelf Life | 5years | 8years | N/A | N/A |
| Implant<br>Body<br>Features | Threaded | Threaded | Threaded | Threaded |
| Product<br>Code | DZE | DZE | DZE | DZE |
| SE | The subject device is substantially equivalent to the currently cleared devices. They are<br>substantially equivalent in intended use, material, design, dimension, connection,<br>functions and surface treatments. The URIS Implant system is similar in fundamental<br>scientific technology to the predicate device in that they all have been designed,<br>manufactured and tested in compliance with FDA's Class II special controls guidance<br>document root-food endosseous dental implants and endosseous dental implant<br>abutments.<br>Any differences in technology characteristics are accompanied by information that<br>demonstrated the device is substantially equivalent as the predicate and do not raise<br>different questions of safety and effectiveness than the predicate. | | | |

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## URIS Abutments

| | Subject Device | Reference Devices | |
|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Part Name | Healing Abutment | Healing Abutment | Healing Abutment |
| Design | | | |
| Applicant | TruAbutment Korea Co.,<br>Ltd. | Sewon Medix Inc. | OSSTEM Implant Co., Ltd. |
| Trade Name | URIS OMNI System | IH Prosthetic System | HU/HS/HG Prosthetic<br>System |
| 510(K) No. | K172100 | K153521 | K081575 |
| Classification<br>Name | Endosseous Dental Implant<br>Abutments(872.3630) | Endosseous Dental Implant<br>Abutments(872.3630) | Endosseous Dental Implant<br>Abutments(872.3630) |
| Product Code | NHA | NHA | NHA |
| Material | Ti-6A1-4V ELI (ASTM<br>F136) | Ti-6A1-4V ELI (ASTM<br>F136) | Ti-6A1-4V ELI (ASTM<br>F136) |
| URIS OMNI System is<br>indicated for use in partially<br>or fully edentulous<br>mandibles and maxillae, in<br>support of single or<br>multiple-unit restorations<br>including; cemented<br>retained, screw retained, or<br>Indications<br>overdenture restorations,<br>For Use/<br>and final or temporary<br>Intended Use<br>abutment support for fixed<br>bridgework. It is intended<br>for delayed loading. | | IH Implant System is device<br>made of titanium and<br>titanium alloy indicated for<br>in partially or fully<br>edentulous mandibles and<br>maxillae, in support of<br>single or multiple-unit<br>restorations including;<br>cemented retained or screw<br>retained restorations and<br>terminal or internal<br>abutment support for fixed<br>bridgework. IH Implant<br>System is for single and two<br>stage surgical procedures. It<br>is intended for delayed<br>loading. | HU/HS/HG Prosthetic<br>System is intended for use<br>with a dental implant to<br>provide support<br>for prosthetic restorations<br>such as crowns, bridges, or<br>overdentures. |
| Diameters | 4.0/4.5/5.5/6.5/7.5mm | 4.0/4.5/5.0/5.5/6.0/6.5mm | N/A |
| Surface<br>Treatment | Anodizing (Yellow, Green) | None | N/A |
| Sterile | Non-sterile | Non-sterile | Non-sterile |
| SE | The subject device and reference devices (K153521, K081575) have the same<br>intended use, have similar technological characteristic, and are made of similar<br>materials. The subject device and predicate devices have similar physical<br>dimensions, including diameter. Therefore, the subject device is substantially<br>equivalent to the currently cleared devices. | | |
| | Subject Device | Reference Devices | |
| Part Name | D Basis Abutment -<br>Direct Type | Solid Abutment | Rigid Abutment |
| Design | Image: D Basis Abutment | Image: Solid Abutment | Image: Rigid Abutment |
| Applicant | TruAbutment Korea Co.,<br>Ltd. | Sewon Medix Inc. | OSSTEM Implant Co., Ltd. |
| Trade Name | URIS OMNI System | IH Prosthetic System | OSSTEM Implant System -<br>Abutment |
| 510(K) No. | K172100 | K153521 | K161689 |
| Classification<br>Name | Endosseous Dental Implant<br>Abutments(872.3630) | Endosseous Dental Implant<br>Abutments(872.3630) | Endosseous Dental Implant<br>Abutments(872.3630) |
| Product Code | NHA | NHA | NHA |
| Material | Ti-6Al-4V ELI (ASTM<br>F136) | Ti-6Al-4V ELI (ASTM<br>F136) | Ti-6Al-4V ELI (ASTM<br>F136) |
| Indications<br>For Use/<br>Intended Use | URIS OMNI System is<br>indicated for use in partially<br>or fully edentulous<br>mandibles and maxillae, in<br>support of single or<br>multiple-unit restorations<br>including; cemented<br>retained, screw retained, or<br>overdenture restorations,<br>and final or temporary<br>abutment support for fixed<br>bridgework. It is intended<br>for delayed loading. | IH Implant System is device<br>made of titanium and<br>titanium alloy indicated for<br>in partially or fully<br>edentulous mandibles and<br>maxillae, in support of<br>single or multiple-unit<br>restorations including;<br>cemented retained or screw<br>retained restorations and<br>terminal or internal<br>abutment support for fixed<br>bridgework. IH Implant<br>System is for single and two<br>stage surgical procedures. It<br>is intended for delayed<br>loading. | The OSSTEM Implant<br>System - Abutment is<br>intended for use with a<br>dental implant to<br>provide support for<br>prosthetic restorations such<br>as crowns, bridges, or<br>overdentures. |
| Diameters | 4.0/4.5/5.5/6.5mm | 4.0/4.5/5.0/5.5/6.0/6.5/7.0 | 4.0, 4.6, 5.0, 6.0, 7.0mm |
| Lengths | G/H :1.0/2.0/3.0/4.0/5.0/6.0<br>Post : 4.0/5.5/7.0 | G/H :1.0/1.5/2.0/2.5/3.0/3.5/<br>4.0/4.5/5.0<br>Post: 4.0/5.5/7.0 | 10, 10.4, 11, 11.4, 11.5,<br>11.9, 12, 12.4, 12.5, 12.9,<br>13, 13.4, 13.5, 13.9, 14,<br>14.4, 14.5, 14.9, 15, 15.4,<br> |
| Su…