ZENEX Implant System_Long

K240560 · Izenimplant Co., Ltd. · DZE · Oct 30, 2024 · Dental

Device Facts

• Record ID: K240560
• Device Name: ZENEX Implant System_Long
• Applicant: Izenimplant Co., Ltd.
• Product Code: DZE · Dental
• Decision Date: Oct 30, 2024
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3640
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

ZENEX Implant System Long 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. ZENEX Implants in the 20 mm length when placed in the maxilla are only indicated for multiple unit restorations in splinted applications that utilize at least two implants.

Device Story

The ZENEX Implant System Long consists of root-form endosseous dental implants and associated abutments. The implants are manufactured from pure titanium (ASTM F67) and feature an SLA (Sandblasted with Large-grit and Acid-etching) surface treatment. The system is designed for surgical placement into the alveolar bone by a dental professional to support prosthetic teeth or dentures. The device acts as an artificial root, providing a stable foundation for crowns, bridges, or overdentures. The system is supplied sterile and is intended for delayed loading protocols. By replacing missing teeth, the device restores oral function and aesthetics for the patient. The clinician selects the appropriate fixture diameter and length based on the patient's anatomical needs and uses compatible abutments to connect the final prosthetic restoration. The system is used in a clinical dental setting.

Clinical Evidence

Bench testing only. No clinical data provided. Evidence includes fatigue testing per ISO 14801:2016, biocompatibility testing per ISO 10993 series, sterilization validation per ISO 11137, shelf-life testing per ASTM F1980, and bacterial endotoxin testing. MR safety was established via scientific rationale and literature review.

Technological Characteristics

Material: Pure titanium (ASTM F67). Surface: SLA (Sandblasted with Large-grit and Acid-etching). Design: Root-form, internal hex connection, straight/tapered body. Dimensions: Diameters 3.75mm, 4.25mm, 4.6mm; Lengths 18mm, 20mm. Sterilization: Gamma radiation (SAL 10^-6). Shelf life: 5 years.

Indications for Use

Indicated for partially or fully edentulous adult patients requiring dental implants for single or multiple unit restorations (cemented, screw-retained, or overdenture) and fixed bridgework. 20mm implants in the maxilla require splinting with at least two implants. 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

• Zenex Implant System (K211090)

Reference Devices

• Osstem Implant System (K161604)
• S.I.N. Dental Implant System (K221453)
• Osstem Implant System (K222778)
• Single Platform SP1 Implant System (K232418)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image shows the logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.

Izenimplant Co., Ltd. % April Lee Consultant Withus Group Inc 106 Superior Irvine, California 92620

October 30, 3024

Re: K240560

Trade/Device Name: ZENEX Implant System Long Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: Class II Product Code: DZE Dated: February 28, 2024 Received: October 08, 2024

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 (the Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

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

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

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

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

All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.

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

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

Sincerely,

# Andrew I. Steen -S

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

Enclosure

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# Indications for Use

510(k) Number (if known) K240560

Device Name ZENEX Implant System Long

#### Indications for Use (Describe)

ZENEX Implant System Long 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.

ZENEX Implants in the 20 mm length when placed in the maxilla are only indicated for multiple unit restorations in splinted applications that utilize at least two implants.

| Type of Use (Select one or both, as applicable) | |
|--------------------------------------------------------------------------------------------------------|---------------------------------------------|
| <span style="text-decoration: underline;"><b>X</b></span> Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |

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## 510(k) Summary

### Submitter

Izenimplant Co., Ltd. Ji-Hwan Jeong 1, 2Dong, 26-32, Suworam 4-Gil, Seotan-Myeon, Pyeongtaek-Si, Gyeonggi, 17703 Republic of Korea Email: [e-mail] Tel. [phone] Fax. [phone]

## Official Correspondent

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

## Device Information

- Trade Name: ZENEX Implant System Long ●
- Common Name: Endosseous Dental Implant ●
- Classification Name: Implant, Endosseous, Root-Form
- Primary Product Code: DZE
- Panel: Dental
- Regulation Number: 21 CFR 872.3640
- Device Class: Class II
- . Date Prepared: 10/30/2024

### Predicate Devices:

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

Primary Predicate

- . K211090, Zenex Implant System manufactured by Izenimplant Co., Ltd.
### Reference Devices

- K161604, Osstem Implant System manufactured by OSSTEM Implant Co., Ltd.
- K221453, S.I.N. Dental Implant System manufactured by S.I.N. Sistema de Implante Nacional ● S.A.
- K222778. Osstem Implant System manufactured by OSSTEM Implant Co., Ltd.
- . K232418, Single Platform SP1 Implant System manufactured by Southern Implants (Pty) Ltd.

### Indications for Use:

ZENEX Implant System Long 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.

ZENEX Implants in the 20 mm length when placed in the maxilla are only indicated for multiple unit restorations in splinted applications that utilize at least two implants.

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## Device Description

ZENEX Implant System_Long is a thread type implant made of pure titanium according to ASTM F 67 and supplied sterile, which will be placed in the alveolar bone in order to support or maintain the prosthetic tooth or denture when a patient's teeth are partially or totally lost.

The fixture's surface is treated with SLA (Sandblasted with Large-grit and Acid-etching).

| Name | Fixture Type | Diameter (mm) | Length (mm) | Material |
|----------------------------------------------------------|-----------------------|---------------|-------------|----------|
| ZENEX Implant<br>System_Long<br>(ZENEX MULTI<br>Fixture) | Image: Fixture Type 1 | $Ø$ 3.75/4.25 | 18mm/20mm | |
| | $Ø$ 4.6 | 18mm | | |
| ZENEX Implant<br>System_Long<br>(ZENEX PLUS<br>Fixture) | Image: Fixture Type 2 | $Ø$ 3.75/4.25 | 18mm/20mm | |
| | | $Ø$ 4.6 | 18mm | |

There are 2 types of fixtures, and the dimensions are as following:

Tolerance of dimension shall be within ± 1% range.

| 510(K) | Abutment<br>Name | Diameter (Ø) | Angulation | Length or<br>Cuff(mm) | Multi-unit<br>Loading |
|---------|-----------------------|---------------------------------------------------------------------------------------------------|------------------------------------|-----------------------------------------|-----------------------|
| K211090 | Cover<br>Screw | I-System: Ø3.45 / Ø3.6<br>T-System: Ø3.0/Ø3.4/Ø3.6/Ø3.9 | 0° | P/H: 0.4/1.4/2.0 | |
| | Healing<br>Abutment | I-System:<br>Ø4.3/Ø4.8/Ø5.5/Ø6.0/Ø6.8/Ø8.0<br>/09.0<br>T-System:<br>Ø4.3/Ø4.8/Ø5.3/Ø6.3/Ø7.3/Ø8.3 | 0° | P/H: 2/3/4/5/6/7/9 | |
| | Cemented<br>Abutment | I-System: Ø4.5/Ø5.2/Ø5.7/Ø6.5<br>T-System:<br>Ø4.0/Ø4.5/Ø5.0/Ø6.0/Ø7.0 | 0° | G/H: 1/2/3/4/5/6/7<br>PH: 4/5/5.5/7 | Bridges |
| | Angled<br>Abutment | I-System: Ø4.5/Ø5.2/Ø5.7<br>T-System: Ø4.0/Ø4.5/Ø5.0/Ø6.0 | I-System: 15°/25°<br>T-System: 17° | G/H: 2/3/4<br>P/H: 7 | Bridges |
| | Temporary<br>Abutment | I-System: Ø4.5<br>T-System: Ø4.0/Ø4.5 | 0° | G/H: 1/3<br>P/H: 10 | |
| | Ball<br>Abutment | I-System: Ø3.5<br>T-System: Ø3.5 | N/A | G/H: 1/2/3/4/5/6 | Overdentures |
| | Abutment<br>Screw | I-System: Ø2.3<br>T-System: Ø2.2/Ø2.3 | N/A | I-System: 8.2<br>T-System:<br>8.35/10.2 | |

The subject devices are compatible with the following abutments made by Izenimplant Co., Ltd.

ZENEX Implant System_Long is provided sterile, and valid for 5 years.

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# Summaries of Technological Characteristics:

ZENEX Implant System_Long are similar to other commercially available products based on the intended used, the claims, the material composition employed and performance characteristics.

| | Subject Device | Primary Predicate | Reference Device | Reference Device | Reference Device | Reference Device |
|----------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Company | Izenimplant Co., Ltd. | Izenimplant Co., Ltd. | OSSTEM Implant<br>Co., Ltd. | OSSTEM Implant<br>Co., Ltd. | S.I.N. - Sistema de<br>Implante Nacional S.A. | Southern Implants (Pty) Ltd |
| Device Name | ZENEX Implant<br>System Long | ZENEX Implant<br>System | Osstem Implant<br>System | Osstem Implant<br>System | S.I.N. Dental Implant<br>System | Single Platform SP1 Implant<br>System |
| 510(k) Number | N/A | K211090 | K222778 | K161604 | K221453 | K232418 |
| Device<br>Classification<br>Name | Implant, Endosseous,<br>Root-Form | Implant, Endosseous,<br>Root-Form | Implant.<br>Endosseous.<br>Root-Form | Implant, Endosseous,<br>Root-Form | Implant, Endosseous,<br>Root-Form | Implant, Endosseous,<br>Root-Form |
| Product Code | DZE | DZE | DZE, NHA | DZE, NHA | DZE, NHA | DZE |
| Regulation<br>Number | 872.3640 | 872.3640 | 872.3640 | 872.3640 | 872.3640 | 872.3640 |
| Reason for<br>Predicate/<br>Reference Device | | Indications for Use<br>Design of implants and<br>abutments, Materials | Ø3.75 x L18,20<br>Implant | Ø4.6 X L18 Implant | Implant that can contain<br>Ø4.25 X L18. 20 | 20, 22 and 24 mm length of<br>Implants |
| Intended Use | ZENEX Implant<br>System_Long is indicated<br>for use in partially or<br>fully edentulous<br>mandibles and maxillae,<br>in support of single or<br>multiple unit restorations<br>including; cemented<br>retained, screw retained,<br>or overdenture<br>restorations, and final or<br>temporary abutment<br>support for fixed<br>bridgework. It is intended<br>for delayed loading.<br>ZENEX Implants in the<br>20 mm length when<br>placed in the maxilla are<br>only indicated for<br>multiple unit restorations<br>in splinted applications<br>that utilize at least two<br>implants. | ZENEX Implant<br>System is indicated for<br>use in partially or fully<br>edentulous mandibles<br>and maxillae, in support<br>of single or multiple<br>unit restorations<br>including; cemented<br>retained, screw retained,<br>or overdenture<br>restorations, and final or<br>temporary abutment<br>support for fixed<br>bridgework. It is<br>intended for delayed<br>loading. Wide Fixture<br>System is intended to be<br>used in the molar region | The Osstem Implant<br>System is indicated<br>for use in partially<br>or fully edentulous<br>mandibles and<br>maxillae, in support<br>of single or<br>multiple-units<br>restorations<br>including; cemented<br>retained, screw<br>retained, or<br>overdenture<br>restorations, and<br>final or temporary<br>abutment support<br>for fixed<br>bridgework. It is<br>intended for delayed<br>loading. Ultra wide<br>Implant system is<br>intended to be used<br>in the molar region. | The Osstem Implant<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>units restorations<br>including; cemented<br>retained, screw<br>retained, or<br>overdenture<br>restorations, and final<br>or temporary<br>abutment support for<br>fixed bridgework. It is<br>intended for delayed<br>loading. Ultra wide<br>Implant system is<br>intended to be used in<br>the molar region.<br>Products with<br>diameter or less than | S.I.N. Dental Implant<br>System is intended for<br>placement in the<br>maxillary or mandibular<br>arch to provide support<br>for single-unit or multi-<br>unit restorations. When a<br>one-stage surgical<br>approach is applied, the<br>S.I.N. Dental Implant<br>System is intended for<br>immediate loading when<br>good primary stability is<br>achieved and with<br>appropriate occlusal<br>loading.<br>S.I.N. Dental Implant<br>System implants with<br>lengths of 18, 20, 22, or<br>24 mm may be tilted up to<br>30°. When used in the<br>mandible or maxilla with<br>implants with lengths of | The Single Platform SPI<br>Implant System is intended<br>for surgical placement in the<br>upper or lower jaw to provide<br>a means for prosthetic<br>attachment of crowns, bridges<br>or overdentures utilizing<br>delayed or immediate loading.<br>The Single Platform SPI<br>Implant System is intended<br>for immediate function when<br>good primary stability with<br>appropriate occlusal loading<br>is achieved. The Single<br>Platform SPI implants in<br>lengths 20, 22 and 24 mm<br>when placed in the maxilla<br>are only indicated for multiple<br>unit restorations in splinted<br>applications that utilize at<br>least two implants. For the<br>conventional abutment and<br>screws: The Conventional |

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| | Products with | 3.25mm should be | 18, 20, 22, or 24 mm at an | Abutments and Prosthetic |
|--|---------------------|------------------------|------------------------------------|-------------------------------------------------------------|
| | diameter or less | used exclusively for | angulation of 30°, a | Screws are premanufactured |
| | than 3.25mm should | the lateral incisor in | minimum of four implants | prosthetic components |
| | be used exclusively | the maxilla and a | must be used and must be | directly connected to |
| | for the lateral | central or lateral | splinted. When placed in | endosseous dental implants |
| | incisor in the | incisor in the | the maxilla with lengths | and intended for use in fully |
| | maxilla and a | mandible. | of 18, 20, 22, or 24 mm at | edentulous or partially |
| | central or lateral | | angulations between 0° | edentulous maxilla and/or |
| | incisor in the | | and less than 30°, the | mandible to provide support |
| | mandible. | | S.I.N. Dental Implant | for crowns, bridges or |
| | | | System implants are only | overdentures. For the |
| | | | indicated for multiple unit | Titanium Abutment Bases |
| | | | restorations in splinted | and Passive Abutments: The |
| | | | applications that utilize at | TIB and Passive Abutments |
| | | | least two implants. | are premanufactured |
| | | | All digitally-designed | prosthetic components |
| | | | custom abutments for use | directly connected to |
| | | | with Interface CAD-CAM | endosseous dental implants |
| | | | abutments are to be sent | and are intended for use as an |
| | | | to a S.I.N.-validated | aid in prosthetic |
| | | | milling center for<br>manufacture. | rehabilitation. The TIB and<br>Passive abutments consist of |
| | | | | two major parts. Specifically, |
| | | | | the titanium base and |
| | | | | mesostructure components |
| | | | | make up a two-piece |
| | | | | abutment. The system |
| | | | | integrates multiple |
| | | | | components of the digital |
| | | | | dentistry workflow: Scan files |
| | | | | from desktop scanners, CAD |
| | | | | software, CAM software, |
| | | | | ceramic material, milling |
| | | | | machine and associated |
| | | | | tooling and accessories. For |
| | | | | the Temporary Titanium |
| | | | | Cylinders: The Southern |
| | | | | Implants Temporary Titanium |
| | | | | Abutments are |
| | | | | premanufactured prosthetic |
| | | | | components directly |
| | | | | connected to endosseous |
| | | | | dental implants and are |
| | | | | intended for provisional use |
| | | | | up to 180 days as an aid in |
| | | | | prosthetic rehabilitation |

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K240560

| Material | Titanium Grade 4 of<br>ASTM F67 | Titanium Grade 4 of<br>ASTM F67 | Titanium Grade 4 of<br>ASTM F67 | Titanium Grade 4 of<br>ASTM F67 | Titanium Grade 4 of<br>ASTM F67 | Titanium Grade 4 of ASTM<br>F67 | | | | | | | good primary stability is<br>achieved and with<br>appropriate occlusal<br>loading. | |
|---------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------|----------------------------------|----------------------------------|----------------------------------|------------------------------------------------------------------------------------|--|
| Design | Image: Titanium Grade 4 of ASTM F67 | Image: Titanium Grade 4 of ASTM F67 | Image: Titanium Grade 4 of ASTM F67 | Image: Titanium Grade 4 of ASTM F67 | Image: Titanium Grade 4 of ASTM F67 | Image: Titanium Grade 4 of ASTM F67 | Shelf Life | 5 Years | 5 Years | 8 Years | 8 Years | 4 Years | 10 Years | |
| Structure | - Internal Hex connected<br>- Submerged Fixture<br>- Straight/Taper body<br>shape | - Internal Hex<br>connected<br>- Submerged Fixture<br>- Straight/Taper body<br>shape | - Internal Hex<br>connected | - Internal Hex<br>connected | - Internal Hex connected | Internal Cone and Hex | Compatible<br>Abutments | Straight and angled<br>abutments | Straight and angled<br>abutments | Straight and angled<br>abutments | Straight and angled<br>abutments | Straight and angled<br>abutments | Straight and angled abutments | |
| Diameters (Ø)<br>X Lengths (mm) | Ø3.75X L18, 20<br>Ø4.25 X L18, 20<br>Ø4.6 X L18 | Ø3.75XL8.5, 10, 11.5,<br>13, 15<br>Ø4.25X L7, 8.5, 10,<br>11.5, 13, 15<br>Ø4.6X L7, 8.5, 10, 11.5,<br>13, 15<br>Ø5.05X L7, 8.5, 10,<br>11.5, 13, 15<br>Ø5.4X L7, 8.5, 10, 11.5,<br>13<br>Ø5.9X L7, 8.5, 10, 11.5,<br>13<br>Ø6.75X L7, 8.5, 10,<br>11.5, 13 | Ø3.75 x L18,20<br>Ø3.77 x L7<br>Ø4.25 x L7<br>Ø4.65 x L7<br>Ø5.45 x<br>L10,11.5,13,15<br>Ø5.48 x L8.5<br>Ø5.5 x L7 | Ø3.2 X<br>L8.5,10,11.5,13,15<br>Ø4.4 X<br>L7,8.5,10,11.5,13,15<br>Ø4.6 X L18<br>Ø4.8 X<br>L7,8.5,10,11.5,13,15<br>Ø5.05 X L18<br>Ø5.25 X<br>L7,8.5,10,11.5,13,15<br>Ø6.2 X<br>L6.2,7,8.5,10,11.5,13<br>Ø7.1 X<br>L6.2,7,8.5,10,11.5,13 | Ø3.8 X L18,20,22,24<br>Ø4.0 X L18,20,22,24<br>Ø4.5 X L18,20,22,24 | Ø3.5 X<br>L8,10,11.5,13,16,18,20<br>Ø4.0 X<br>L8,10,11.5,13,16,18,20,22,24<br>Ø5.0 X L8,10,11.5,13,16,18 | Similarities | The ZENEX Implant System_Long have same device characteristics with the Primary devices, ZENEX Implant System (K211090) such as the intended use, material,<br>functions, general shape (Design), connection type, structure and applied production method are similar. | | | | | | |
| Surface Treatment | Sand blasting & Acid<br>Etching | Sand blasting & Acid<br>Etching | Sand blasting &<br>Acid Etching | Sand blasting & Acid<br>Etching | Acid Etched | Grit-blasted with a 3.0mm<br>machined section only at<br>coronal end | Differences | The differences between the subject device and the primary device, ZENEX Implant System (K211090) are the indications for Use and fixture length. The reason for<br>the difference of the indications for use between two devices is the subject device system does not include wide fixtures which is intended to be used in the molar<br>region. The whole length of the subject device is longer than the primary Device. To support this discrepancy, K222778, K161604 and K221453 was added, and it<br>covers all range of the fixture diameter and length combination. The Single Platform SPI implants (K232418) in lengths 20, 22 and 24 mm when placed in the<br>maxilla are only indicated for multiple unit restorations in splinted applications that utilize at least two implants. Therefore, these differences don't affect the device's<br>fundamental functions, safety and effectiveness. | | | | | | |
| Sterilization | Gamma Sterilization | Gamma Sterilization | Gamma<br>Sterilization | Gamma Sterilization | Gamma Sterilization | Gamma Sterilization | | | | | | | | |
| Principle of<br>Operation | This product is a root-<br>type fixture which is<br>inserted in the alveolar<br>bone. It replaces the<br>functions of the missing<br>teeth as a dental implant<br>fixture. | This product is a root-<br>type fixture which is<br>inserted in the alveolar<br>bone. It replaces the<br>functions of the missing<br>teeth as a dental implant<br>fixture. | This product is a<br>root-type fixture<br>which is inserted in<br>the alveolar bone. It<br>replaces the<br>functions of the<br>missing teeth as a<br>dental implant<br>fixture | This product is a root-<br>type fixture which is<br>inserted in the<br>alveolar bone. It<br>replaces the functions<br>of the missing teeth as<br>a dental implant<br>fixture | S.I.N. Dental Implant<br>System is intended for<br>placement in the<br>maxillary or mandibular<br>arch to provide support<br>for single-unit or multi-<br>unit restorations. When a<br>one-stage surgical<br>approach is applied, the<br>S.I.N. Dental Implant<br>System is intended for<br>immediate loading when | The Conventional Abutments<br>and Prosthetic Screws are<br>premanufactured prosthetic<br>components directly<br>connected to endosseous<br>dental implants and intended<br>for use in fully edentulous or<br>partially edentulous maxilla<br>and/or mandible to provide<br>support for crowns, bridges or<br>overdentures. | | | | | | | | |

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## Non-clinical testing data:

Below tests were performed on subject device:

- Fatigue Testing according to ISO 14801:2016 under the worst-case scenario ●
Below tests were performed for predicate device, K211090 and leveraged for the subject device:

- Biocompatibility testing according to ISO 10993-1:2018, ISO 10993-3:2014, ISO 10993-● 5:2009, ISO 10993-6:2007, ISO 10993-10:2010 and ISO 10993-11:2006
- Gamma sterilization validation Test Report according to ISO 11137-1. ISO 11137-2 and ISO . 11137-3
- Shelf Life Test on Fixtures according to ASTM F 1980 ●
- . Bacterial Endotoxin Test Report on Fixtures according to ANSI/AAMI ST72:2011, USP <161>, and USP <85>

The surface modification information such as surface roughness, surface composition analysis, and SEM imaging with SLA (Sandblasted with Large-grit and Acid-etching) for fixtures was leveraged from K211090.

## Sterilization and Shelf Life Testing

For devices provided sterile, a sterility assurance level (SAL) of 10 6 have been validated in accordance with ISO 11137-1:2006, Sterilization of health care products - Radiation - Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices.

Shelf Life Testing was performed in accordance with ASTM F1980, Standard Guide for Accelerated Aging of Sterile Medical Device Packages. The worst-case construct was tested, and results demonstrated equivalence to the predicate devices. The shelf life for devices provided sterile is 5 years.

## Biocompatibility Testing

The Biocompatibility Test was conducted on the predicate device, K211090 and leveraged for the subject device because both products are manufactured with the same material and manufacturing process. It demonstrates that the subject device is biocompatible and substantial equivalence with the predicate.

## Fatigue Testing

Due to the length of the subject devices. Dynamic fatigue tests were newly performed to demonstrate the mechanical value according to the FDA guidance document "Guidance for Industry and FDA Staff -Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Abutments" and ISO 14801. The Results of fatigue testing showed that subject devices are substantially equivalent under the worst-case scenario.

# MR Environment Condition

Non-clinical worst-case MRI review was performed to evaluate the metallic ZENEX Implant System_Long in the MRI environment using scientific rationale and published literature (e.g., Woods, Terry O., Jana G. Delfino, and Sunder Rajan, "Assessment of Magnetically Induced Displacement Force

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and Torque on Metal Alloys Used in Medical Devices". Journal of Testing and Evaluation 49.2 (2019): 783-795), based on the entire system including all variations (all compatible implant bodies, dental abutments, and fixation screws) and material composition. Rationale addressed parameters per the FDA guidance "Testing and Labeling Medical Devices for Safety in the Magnetic Resonance (MR) Environment," including magnetically induced displacement force and torque. MR Conditional Labeling was leveraged from K211090.

The results of the above non-clinical tests have met the standards and demonstrated the substantial equivalence with the predicate device.

### Conclusion

ZENEX Implant System_Long constitutes a substantially equivalent medical device, meeting all the declared requirements of its intended use. This system has similar intended use and fundamental scientific technology as its predicate devices. Therefore, ZENEX Implant System_Long and their predicates are substantially equivalent.