K Number

Device Name

ZENEX Implant System

Manufacturer

Izenimplant Co., Ltd.

Date Cleared

2022-04-13

(366 days)

Product Code

DZE NHA

Regulation Number

872.3640

Intended Use

ZENEX Implant System is indicated for use in partially or fully edentulous mandibles and maxillae, in support of single or multiple unit restorations including; cemented retained, screw retained, or overdenture restorations, and final or temporary abutment support for fixed bridgework. It is intended for delayed loading. Wide Fixture System is intended to be used in the molar region

Device Description

ZENEX Implant System is consisted with ZENEX Fixtures (ZENEX MULTI Fixture and ZENEX PLUS Fixture) and Izenimplant Abutment System. The implant fixtures come in two unique systems, the I-System and the T-System, each with their own abutment compatibilities. 1) ZENEX Fixtures: This product is a dental implant which is put into the alveolar bone in order to support, or maintain the prosthetic tooth or denture when a patient's teeth are partially lost. To enhance the osseointegration with the alveolar bone, this titanium dental implant is treated with SLA surface. As a dental implant which is put into the alveolar bone to support the dental prostheses such as the artificial teeth which are used to rehabilitate a patient's masticatory function, it is used as a substructure which is implanted into the human body. This product is a dental implant fixture to be inserted into the bone and is intended to be used in partially or fully edentulous mandibles and maxillae, in support of single or multiple unit restorations. It is connected to the upper structure with Internal Hex fastening structure. In the surface treatment, machined surface was sanded with alumina (Al2O3) powder and acid (hydrochloric acid, sulfuric acid) etching process was applied to the surface to increase the contact surface with the bone. ZENEX PLUS is a design that adds a micro-groove at the collar compared to ZENEX MULTI. 2) Izenimplant Abutment System: Izenimplant Abutment System is compatible with the ZENEX Fixtures (ZENEX MULTI Fixture, ZENEX PLUS Fixture). Izenimplant Abutment System is intended for use with a dental implant to provide support for prosthetic restorations such as crowns, bridges, or overdentures. Separate sets of abutments are presented for compatibility with each I-System and T-System. Some subject abutments undergo Titanium Nitride (TiN) coating. Dental Abutment System is similar to other commercially available products based on the intended use, technology used, claims, material composition employed and performance characteristics.

More Information

Contact

Type

Center

Panel

Date Received

Product Code

Subsequent Product Codes

Applicant Name (Manufacturer)

Device Name

Decision

Street 1

Street 2

City

State

Country Code

ZIP

Postal Code

Class Advise Committee

SSP Indicator

Third Party Reviewed

Expedited Review

Predicate Devices

K161604

Reference Devices

K182091, K181138

AI/ML (Artificial Intelligence / Machine Learning)

No
The device description and performance studies focus on the mechanical and biological properties of dental implants and abutments, with no mention of AI or ML.

Therapeutic

No.
A therapeutic device is one that treats a disease or condition. This device is a dental implant system used to support prosthetic teeth, which rehabilitates a patient's masticatory function rather than treating a disease.

Diagnostic

This device is a dental implant system designed to support prosthetic teeth, not to diagnose a medical condition.

SaMD (Software as a Medical Device)

The device description clearly states it is a dental implant system consisting of physical components (fixtures and abutments) made of titanium, designed to be surgically implanted into bone. This is a hardware device, not software.

IVD (In Vitro Diagnostic)

Based on the provided text, the ZENEX Implant System is not an IVD (In Vitro Diagnostic) device.

Here's why:

Intended Use: The intended use is for supporting dental restorations in the mouth (mandibles and maxillae). This is a surgical and prosthetic application within the human body.
Device Description: The device is a dental implant fixture and abutment system designed to be surgically implanted into bone and support artificial teeth.
Lack of IVD Characteristics: The description does not mention any components or processes related to testing samples in vitro (outside the body) to diagnose diseases or conditions. IVD devices typically involve analyzing biological samples like blood, urine, or tissue.

The ZENEX Implant System is a medical device, specifically a dental implant system, intended for surgical and prosthetic use.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

ZENEX Implant System is indicated for use in partially or fully edentulous mandibles and maxillae, in support of single or multiple unit restorations including; cemented retained, or overdenture restorations, and final or temporary abutment support for fixed bridgework. It is intended for delayed loading. Wide Fixture System is intended to be used in the molar region

Product codes (comma separated list FDA assigned to the subject device)

DZE, NHA

Device Description

ZENEX Fixtures
This product is a dental implant which is put into the alveolar bone in order to support, or maintain the prosthetic tooth or denture when a patient's teeth are partially lost. To enhance the osseointegration with the alveolar bone, this titanium dental implant is treated with SLA surface.

As a dental implant which is put into the alveolar bone to support the dental prostheses such as the artificial teeth which are used to rehabilitate a patient's masticatory function, it is used as a substructure which is implanted into the human body.

This product is a dental implant fixture to be inserted into the bone and is intended to be used in partially or fully edentulous mandibles and maxillae, in support of single or multiple unit restorations. It is connected to the upper structure with Internal Hex fastening structure. In the surface treatment, machined surface was sanded with alumina (Al2O3) powder and acid (hydrochloric acid, sulfuric acid) etching process was applied to the surface to increase the contact surface with the bone.

ZENEX PLUS is a design that adds a micro-groove at the collar compared to ZENEX MULTI.

Izenimplant Abutment System
Izenimplant Abutment System is compatible with the ZENEX Fixtures (ZENEX MULTI Fixture, ZENEX PLUS Fixture). Izenimplant Abutment System is intended for use with a dental implant to provide support for prosthetic restorations such as crowns, bridges, or overdentures. Separate sets of abutments are presented for compatibility with each I-System and T-System. Some subject abutments undergo Titanium Nitride (TiN) coating.

Dental Abutment System is similar to other commercially available products based on the intended use, technology used, claims, material composition employed and performance characteristics.

Especially, the Izenimplant Abutment System is consisted following;

Category	Item	Description
Abutment	Cemented Abutment	It is an abutment for making cement and combination maintenance-type prosthetics by taking a fixture level impression. It is an abutment for making cement and combination-retaining prosthesis by taking a fixture level impression.
Abutment	Angled Abutment I-System – 15°/25°	It is an abutment for making cement and combination maintenance-type prosthetics by taking a fixture level impression.
	T-System – 17°
	Ball Abutment	It is an abutment for making cement and combination-retaining prosthesis by taking a fixture level impression.
	Ball Abutment	It is an abutment for making cement and combination maintenance-type prosthetics by taking a fixture level impression
	Multi Abutment (Multi Straight Abutment) (Multi Angled Abutment, 17°/30°)	It is an abutment used when manufacturing screw retaining prosthesis in multiple cases.
	Temporary Abutment	Temporary Abutment is used by removing the healing abutment as an abutment for making temporary prostheses
	Healing Abutment	Healing is used during the healing period prior to restorations and maintain the shape of the gum.
	Cover Screw	Cover Screw is used during the healing period prior to restorations and maintain the shape of the gum
	Multi Ti Link Cylinder	It is an abutment for manufacturing combination maintenance type prosthesis by taking an abutment level impression.
	Multi Temporary Cylinder	This product is an abutment for casting. Use temporarily
	Multi CCM Cast Cylinder	It is an abutment for manufacturing combination maintenance type prosthesis by taking an abutment level impression.
Component	Abutment Screw	It is used to fix the abutment to the fixture.
	Ball Abutment Component (Cap, Retainer and O-ring)	It is a product that is inserted into the overdenture, and it is installed on the ball abutment to support the overdenture.
	Multi Angled Abutment Screw	It is used to fix the Multi Angled Abutment to the fixture.
	Multi Cylinder Screw	It is fixed to cylinder
	Multi Healing Cap	This product protects the Multi Abutments during healing phase

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

mandibles and maxillae

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Not Found

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

Non-clinical performance testing was conducted.

Sterilization Validation: Gamma Sterilization Products (ZENEX Fixture, Healing Abutment, Cover Screw) validated per ISO 11137-1:2006+A2:2018, ISO 11137-2:2013, ISO 11137-3:2017. User Moist Heat Sterilization Product (All Abutment and accessories, except Healing Abutment and Cover Screw) validated per ISO 11138-1:2017, ISO 11138-3:2017, ISO 17665-1:2006, ISO/TS 17665-2:2009, ISO 11737-1:2018, ISO 11737-2:2019.
Packing Validation: Shelf-life and integrity test performed per ISO 11607-1:2019, ISO 11607-2:2019, ISO 11137, ASTM F1980, ASTM F88, ASTM F1140, ASTM F1929, ASTM F1140.
Biocompatibility Test: Performed according to ISO 10993-1, ISO 10993-5, and FDA Guidance - Use of International Standard ISO 10993-1.
Performance (Mechanical Properties): Tests performed according to standards and "Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Implant Abutments". Fatigue testing conducted on worst-case constructs per ISO 14801.
Surface Treatment Test:
- SLA Surface Treatment Product: SEM, EDS images including ICP and IC analysis result provided to demonstrate removal of manufacturing residuals.
- TiN Coating Surface Treatment Product: Surface characteristic including physical properties (thickness and abrasion) and surface roughness data provided.
MR Environment Condition: Non-clinical worst-case MRI review performed based on scientific rationale and published literature (e.g., Woods, Terry O., Jana G. Delfino, and Sunder Rajan. "Assessment of Magnetically Induced Displacement Force and Torque on Metal Alloys Used in Medical Devices." Journal of Testing and Evaluation 49.2 (2019): 783-795), addressing parameters per FDA guidance "Testing and Labeling Medical Devices for Safety in the Magnetic Resonance (MR) Environment."
Endotoxin Batch Test: Endotoxin level determined to be within 20 EU/device. Bacterial Endotoxin Testing (BET) performed by chromogenic kinetic method. LAL tests performed per USP, USP , referenced FDA Guidance (Pyrogen and Endotoxins Testing: Questions and Answers; 2012-06) and ANSI/AAMI ST72.

Key results: The results of the above tests have met the criteria of the standards and demonstrated the substantial equivalence with the predicate device.

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.

K161604

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.

K182091, K181138

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

Regulation Number and Section

§ 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.

Summary

Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA text logo on the right. The text logo has the FDA acronym in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.

Izenimplant Co., Ltd. % Milly Milly Official Correspondent of Izenimplant Co., Ltd. KMC. Inc. Room no. 1709, 123, Digital-ro 26-gil, Guro-gu Seoul. 08390 REPUBLIC OF KOREA

Re: K211090

Trade/Device Name: ZENEX Implant System Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: Class II Product Code: DZE, NHA Dated: March 10, 2022 Received: March 14, 2022

Dear Milly Milly:

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.

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 (QS) 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.

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 Ouality Center for Devices and Radiological Health

Enclosure

Indications for Use

510(k) Number (if known) K211090

Device Name ZENEX Implant System

Indications for Use (Describe)

ZENEX Implant System is indicated for use in partially or fully edentulous mandibles and maxillae, in support of single or multiple unit restorations including; cemented retained, or overdenture restorations, and final or temporary abutment support for fixed bridgework. It is intended for delayed loading. Wide Fixture System is intended to be used in the molar region

Type of Use (Select one or both, as applicable)
☑ Prescription Use (Part 21 CFR 801 Subpart D)	☐ Over-The-Counter Use (21 CFR 801 Subpart C)

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Image /page/3/Picture/0 description: The image contains the logo for IZEN Implant. The word "IZEN" is in large, bold, black letters, with a teal triangle in the upper right corner of the "N". Below "IZEN", the word "IMPLANT" is written in smaller, gray letters with spaces between each letter.

510(k) Summary

K211090

Date: April 13, 2022

1. Applicant / Submission Sponsor

Izenimplant Co., Ltd. Address: 1, 2Dong, 26-32, Suworam 4-gil, Seotan-myeon, Pyeongtaek-si, Gyeonggi-do, 17703, Republic of Korea Tel : +82-31-662-0657 Fax : +82-31-662-0658

2. Submission Correspondent

Milly (RA Consultant, KMC, Inc.) Address: Room no. 1709, 123, Digital-ro 26-gil, Guro-gu, Seoul, 08390, Republic of Korea Tel: +82-70-8965-5554 Fax: +82-2-856-5904 Email: milly@kmcerti.com

3. Device Identification

-Trade/Proprietary Name: ZENEX Implant System
-Classification Name: Root-form endosseous implant
-Common Name: Dental Implant System
-Classification Regulation: 21CFR 872.3640
-Product Code: DZE, NHA
-Device Class: Class II
-Review Panel: Dental

4. Predicate Devices

4.1 Primary Predicate

No.	K Number	Manufacturer	Trade Name
1	K161604	OSSTEM Implant Co., Ltd.	Osstem Implant System

4.2 Reference Device

No.	K Number	Manufacturer	Trade Name
1	K182091	OSSTEM Implant Co., Ltd	Osstem Abutment System
2	K181138	Neobiotech Co., Ltd.	IS-III Active System

Image /page/4/Picture/0 description: The image shows the logo for IZEN Implant. The word "IZEN" is in large, bold, black letters, with a teal triangle extending from the top right corner of the "N". Below "IZEN" is the word "IMPLANT" in smaller, gray letters. The logo is simple and modern, with a focus on the company name.

5. Device Description

1) ZENEX Fixtures

This product is a dental implant which is put into the alveolar bone in order to support, or maintain the prosthetic tooth or denture when a patient's teeth are partially lost. To enhance the osseointegration with the alveolar bone, this titanium dental implant is treated with SLA surface.

ZENEX PLUS is a design that adds a micro-groove at the collar compared to ZENEX MULTI.

2) Izenimplant Abutment System

Izenimplant Abutment System is compatible with the ZENEX Fixtures (ZENEX MULTI Fixture, ZENEX PLUS Fixture). Izenimplant Abutment System is intended for use with a dental implant to provide support for prosthetic restorations such as crowns, bridges, or overdentures. Separate sets of abutments are presented for compatibility with each I-System and T-System. Some subject abutments undergo Titanium Nitride (TiN) coating.

Dental Abutment System is similar to other commercially available products based on the intended use, technology used, claims, material composition employed and performance characteristics.

Especially, the Izenimplant Abutment System is consisted following;

Category	Item	Description
Abutment	Cemented Abutment	It is an abutment for making cement and combination maintenance-type prosthetics by taking a fixture level impression.
It is an abutment for making cement and combination-retaining prosthesis by taking a fixture level impression.
Abutment	Angled Abutment
I-System – 15°/25°	It is an abutment for making cement and combination maintenance-type prosthetics by
	T-System – 17°	taking a fixture level impression.
	Ball Abutment	It is an abutment for making cement and combination-retaining prosthesis by taking a fixture level impression.
	Ball Abutment	It is an abutment for making cement and combination maintenance-type prosthetics by taking a fixture level impression
	Multi Abutment
(Multi Straight Abutment)
(Multi Angled Abutment, 17°/30°)	It is an abutment used when manufacturing screw retaining prosthesis in multiple cases.
	Temporary Abutment	Temporary Abutment is used by removing the healing abutment as an abutment for making temporary prostheses
	Healing Abutment	Healing is used during the healing period prior to restorations and maintain the shape of the gum.
	Cover Screw	Cover Screw is used during the healing period prior to restorations and maintain the shape of the gum
	Multi Ti Link Cylinder	It is an abutment for manufacturing combination maintenance type prosthesis by taking an abutment level impression.
	Multi Temporary Cylinder	This product is an abutment for casting.
Use temporarily
	Multi CCM Cast Cylinder	It is an abutment for manufacturing combination maintenance type prosthesis by taking an abutment level impression.
Component	Abutment Screw	It is used to fix the abutment to the fixture.
	Ball Abutment Component
(Cap, Retainer and O-ring)	It is a product that is inserted into the overdenture, and it is installed on the ball abutment to support the overdenture.
	Multi Angled Abutment Screw	It is used to fix the Multi Angled Abutment to the fixture.
	Multi Cylinder Screw	It is fixed to cylinder
	Multi Healing Cap	This product protects the Multi Abutments during healing phase

Image /page/5/Picture/0 description: The image shows the logo for IZEN Implant. The logo is composed of the word "IZEN" in a bold, sans-serif font, with the letters in black. To the right of the "N" is a teal triangle. Below the word "IZEN" is the word "IMPLANT" in a smaller, sans-serif font, with the letters in black.

Image /page/6/Picture/0 description: The image shows the logo for IZEN Implant. The word "IZEN" is in large, bold, black letters, with a teal triangle extending from the top right corner of the "N". Below "IZEN" is the word "IMPLANT" in smaller, gray letters. The logo is simple and modern, with a focus on the company name.

5. Indications for Use

6. Substantial Equivalence 6.1 Comparison Table

Comparison of the technical characteristics of the subject device and predicate devices is shown in the Table of Substantial Equivalence Below.

Image /page/7/Picture/0 description: The image shows the logo for IZEN Implant. The word "IZEN" is in large, bold, black letters. To the right of the "N" is a green triangle. Below the word "IZEN" is the word "IMPLANT" in smaller, gray letters.

6.1.1 Indications for use

The Indications for Use Statements are compared in the Indications for Use Statements of the Subject and Primary Predicate devices, including reference devices, are similar as support for dental restorations.

Although the subject device does not have products with are less than 3.75mm or products that are indicated for use in lateral incisor, the test results of bench test of the products demonstrated that this difference does not raise new safety or effectiveness concerns for the provided intended use.

Subject Device	Primary Predicate Device	Secondary Predicate Device	Third Predicate Device
(ZENEX Implant System)	(K161604)	(K182091)	(K181138)
ZENEX Implant System is indicated for
use in partially or fully edentulous
mandibles and maxillae, in support of
single or multiple unit restorations
including; cemented retained, screw
retained, or overdenture restorations, and
final or temporary abutment support for
fixed bridgework. It is intended for
delayed loading. Wide Fixture System is
intended to be used in the molar region.	The Osstem Implant System is indicated
for use in partially or fully edentulous
mandibles and maxillae, in support of
single or multiple units restorations
including; cemented retained, screw
retained, or overdenture restorations, and
final or temporary abutment support for
fixed bridgework. It is intended for
delayed loading. Ultra wide Fixture
System is intended to be used in the molar
region. Products with diameter of less than
3.25mm should be used exclusively for the
lateral incisor in the maxilla and a central
or lateral incisor in the mandible.	The Osstem Abutment System is
intended for use with a dental implant
to provide support for prosthetic
restorations such as crowns, bridges,
or overdentures.	The IS-III active System is indicated
for use in Halfly or fully edentulous
mandibles and maxillae, in support of
single or multiple-unit restorations
including; cemented retained, screw
retained, or overdenture restorations,
and terminal or intermediate Abutment
support for fixed bridgework.

Image /page/8/Picture/0 description: The image is a logo for IZEN Implant. The word "IZEN" is written in large, bold, black letters. Below the word "IZEN" is the word "IMPLANT" written in smaller, gray letters. The upper right corner of the "N" in "IZEN" has a teal triangle.

6.1.2 Technical

1) ZENEX Fixture

| Descriptive

Information	Subject Device	Primary Predicate Device
Manufacturer	Izenimplant, Co., Ltd.	OSSTEM Implant Co., Ltd.
Product Name	ZENEX MULTI Fixture,
ZENEX PLUS Fixture	Osstem Implant System
510(K) Number	-	K161604
Product Code /
Regulation	DZE / 21CFR 872.3640	DZE / 21CFR 872.3640
Structure	- Internal Hex connected

Submerged Fixture
Straight/Taper body shape | - Internal Hex connected
Submerged Fixture
Straight/Taper body shape |
| Body Diameter and
Length (mm) | Mini
Ø 3.75 x L8.5, 10, 11.5, 13, 15

Regular
Ø 4.25 x L7, 8.5, 10, 11.5, 13, 15
Ø 4.6 x L7, 8.5, 10, 11.5, 13, 15

Wide
Ø 5.05 x 7, 8.5, 10, 11.5, 13, 15
Ø 5.4 x 7, 8.5, 10, 11.5, 13,
Ø 5.9 x 7, 8.5, 10, 11.5, 13
Ø 6.75 x 7, 8.5, 10, 11.5, 13 | Ø 3.2 x L8.5, 10, 11.5, 13. 15

Ø 4.4 x L7, 8.5, 10, 11.5, 13, 15
Ø 4.8 x 7, 8.5, 10, 11.5, 13, 15

Image /page/9/Picture/0 description: The image shows the logo for IZEN Implant. The word "IZEN" is written in large, bold, gray letters. Below "IZEN" is the word "IMPLANT" written in smaller, gray letters. The upper right corner of the "N" in "IZEN" is colored in a teal color.

2) Cemented Abutment

-		Subject Device	Predicate Device
Manufacturer		Izenimplant Co., Ltd.	Neobiotech Co., Ltd.
Device Name		ZENEX Implant System	IS-III active System
510(k) Number		-	K181138
Classification		Class II	Class II
Design		Image: Design of ZENEX Implant System	Image: Design of IS-III active System
Connection Type		Hex, Non-Hex	Hex, Non-Hex
Dimension	D(∅)	4.5 ~ 6.5	4.0 ~ 7.0
	G/H (mm)	1.0 ~ 7.0	1.0 ~ 5.0
	P/H (mm)	4.0 ~ 7.0	4.0 ~ 7.0
	Angle	0°	0°
Surface Treatment		Partial TiN coated in upper	Partial TiN coated in upper
Sterilization		Non-Sterile	Non-Sterile
Material		Ti 6Al 4V ELI
(ASTM F136)	Ti 6Al 4V ELI
(ASTM F136)

Image /page/10/Picture/0 description: The image shows the logo for IZEN Implant. The word "IZEN" is written in large, bold, black letters. Below the word "IZEN" is the word "IMPLANT" written in smaller, gray letters. The upper right corner of the "N" in IZEN is colored in a teal color.

3) Angled Abutment

-	Subject Device	Predicate Device
Manufacturer	Izenimplant Co., Ltd.	Neobiotech Co., Ltd.
Device Name	ZENEX Implant System	IS-III active System
510(k) Number	-	K181138
Classification	Class II	Class II
Design	Image: Design of Izenimplant	Image: Design of Neobiotech
Connection Type	Hex, Non-Hex	Hex, Non-Hex
Dimension	D($\emptyset$)	4.5 ~ 5.7	4.5 ~ 6.0
	G/H
(mm)	2.0 ~ 4.0	2.0 ~ 4.0
	P/H
(mm)	7.0	7.5 ~ 8.0
	Angle	15° ~ 25°	15° ~ 25°
Surface Treatment	Partial TiN coated in upper	Partial TiN coated in upper
Sterilization	Non-Sterile	Non-Sterile
Material	Ti 6Al 4V ELI
(ASTM F136)	Ti 6Al 4V ELI
(ASTM F136)

Image /page/11/Picture/0 description: The image shows the logo for IZEN Implant. The word "IZEN" is in large, bold, black letters. The word "IMPLANT" is in smaller, gray letters below the word "IZEN". The upper right corner of the "N" in "IZEN" has a teal triangle.

4) Ball Abutment

-		Subject Device	Predicate Device
Manufacturer		Izenimplant Co., Ltd.	Neobiotech Co., Ltd.
Device Name		ZENEX Implant System	IS-III active System
510(k) Number		-	K181138
Classification		Class II	Class II
Design
Connection Type		Non-Hex (Screw Type)	Non-Hex (Screw Type)
Dimension	D(θ)	3.5	3.5
	Length
(mm)	9.15 ~ 14.65	11.1 ~ 14.1
	Head
Diameter
(θ)	2.25	2.4
	Head
Length
(mm)	3.35	1.0 ~ 4.0
	Angle	0°	0°
Surface Treatment		Non-Coating	Non-Coating
Sterilization		Non-Sterile	Non-Sterile
Material		Ti 6Al 4V ELI
(ASTM F136)	Ti 6Al 4V ELI
(ASTM F136)

Image /page/12/Picture/0 description: The image shows the logo for IZEN Implant. The word "IZEN" is written in large, bold, black letters. Below the word "IZEN" is the word "IMPLANT" written in smaller, gray letters. The upper right corner of the "N" in "IZEN" has a teal triangle.

5) Multi Abutment

	Subject Device	Predicate Device
Manufacturer	Izenimplant Co., Ltd.	Osstem Implant Co., Ltd.
Device Name	ZENEX Implant System	Osstem Abutment System
510(k) Number		K182091
Classification	Class II	Class II
Design	Image: Subject Device Design	Image: Predicate Device Design
Connection Type	Hex, Non-Hex	Hex, Non-Hex
Dimension	D(Ø)	4.8	4.9
	Angle	0°, 17°, 30°	0°, 17°, 30°
Surface Treatment	Non-Coating (Angled Abutment)	Non-Coating (Angled Abutment)
Sterilization	Non-Sterile	Non-Sterile
Material	Ti 6Al 4V ELI
(ASTM F136)	Ti 6Al 4V ELI
(ASTM F136)

Image /page/13/Picture/0 description: The image shows the logo for IZEN Implant. The word "IZEN" is written in large, bold, black letters, with the "N" having a teal triangle in the upper right corner. Below the word "IZEN" is the word "IMPLANT" written in smaller, gray letters.

6) Temporary Abutment

		Subject Device	Predicate Device
Manufacturer		Izenimplant Co., Ltd.	Osstem Implant Co., Ltd.
Device Name		ZENEX Implant System	Osstem Abutment System
510(k) Number			K182091
Classification		Class II	Class II
Design		Image: ZENEX Implant System	Image: Osstem Abutment System
Connection Type		Hex, Non-Hex	Hex, Non-Hex
Dimension	D(Ø)	4.0 ~ 4.5	4.0 ~ 4.5
	P/H
(mm)	10	10
	Angle	0°	0°
Surface Treatment		Non-Coating	Non-Coating
Sterilization		Non-Sterile	Non-Sterile
Material		Ti 6Al 4V ELI
(ASTM F136)	Pure Titanium (Gr.3)

Image /page/14/Picture/0 description: The image shows the logo for IZEN Implant. The word "IZEN" is in large, bold, black letters. The word "IMPLANT" is in smaller, gray letters below the word "IZEN". The upper right corner of the "N" in "IZEN" has a teal triangle.

7) Healing Abutment

-		Subject Device	Predicate Device
Manufacturer		Izenimplant Co., Ltd.	Neobiotech Co., Ltd.
Device Name		ZENEX Implant System	IS-III active System
510(k) Number			K181138
Classification		Class II	Class II
Design
Connection Type		Non-Hex	Non-Hex
Dimension	D( $Φ$ )	4.3 ~ 9.0	4.0~9.0
	P/ $Φ$
(mm)	2.0 ~ 9.0	2.3 ~ 7.8
	Angle	0°	0°
Surface Treatment		Non-Coating	Non-Coating
Sterilization		Gamma	Gamma
Material		Ti 6Al 4V ELI
(ASTM F136)	Ti 6Al 4V ELI
(ASTM F136)

Image /page/15/Picture/0 description: The image shows the logo for IZEN Implant. The word "IZEN" is written in large, bold, black letters. To the right of the "N" is a green triangle. Below the word "IZEN" is the word "IMPLANT" written in smaller, gray letters.

8) Cover Screw

		Subject Device	Predicate Device
	Manufacturer	Izenimplant Co., Ltd.	Neobiotech Co., Ltd.
	Device Name	ZENEX Implant System	IS-III active System
	510(k) Number		K181138
	Classification	Class II	Class II
	Design	Image: Design of Izenimplant	Image: Design of Neobiotech
	Connection Type	Non-Hex	Non-Hex
	D( )	3.0 ~ 3.9	3.45 ~ 3.6
Dimension	Length (mm)	5 ~ 7.3	5.85 ~ 8.0
	Angle	0°	0°
	Surface Treatment	No Treatment	No Treatment / Anodizing
	Sterilization	Gamma	Gamma
	Material	Ti 6Al 4V ELI
(ASTM F136)	Ti 6Al 4V ELI
(ASTM F136)

Image /page/16/Picture/0 description: The image shows the logo for IZEN Implant. The word "IZEN" is written in large, bold, black letters. Below the word "IZEN" is the word "IMPLANT" written in smaller, gray letters. The upper right corner of the "N" in "IZEN" has a teal triangle.

9) Multi Ti Link Cylinder

-		Subject Device	Predicate Device
	Manufacturer	Izenimplant Co., Ltd.	Osstem Implant Co., Ltd.
	Device Name	ZENEX Implant System	Osstem Abutment System
	510(k) Number	-	K182091
	Classification	Class II	Class II
	Design	Image: Multi Ti Link Cylinder	Image: Multi Combination Cylinder
		(Multi Ti Link Cylinder)	(Multi Combination Cylinder)
	Connection Type	Non-Hex	Non-Hex
Dimension	D(θ)	4.8	5.0
	L
(mm)	4.5	7.3
	Angle	0°	0°
	Surface Treatment	Non-Coating	Non-Coating
	Sterilization	Non-Sterile	Non-Sterile
	Material	Ti 6Al 4V ELI
(ASTM F136)	Titanium Gr. 3
(ASTM F67)

Image /page/17/Picture/0 description: The image shows the logo for IZEN Implant. The word "IZEN" is in large, bold, black letters. To the right of the "N" is a teal triangle. Below the word "IZEN" is the word "IMPLANT" in smaller, gray letters.

10) Multi Temporary Cylinder

		Subject Device	Predicate Device
Manufacturer		Izenimplant Co., Ltd.	Osstem Implant Co., Ltd.
Device Name		ZENEX Implant System	Osstem Abutment System
510(k) Number		-	K182091
Classification		Class II	Class II
Design		Image: Multi Temporary Cylinder
(Multi Temporary Cylinder)	Image: Esthetic-low Temporary Cylinder
(Esthetic-low Temporary Cylinder)
Connection Type		Non-Hex	External Hex
Dimension	D(0)	4.8	4.8, 5.5
	L
(mm)	12	12
	Angle	0°	0°
Surface Treatment		Non-Coating	Non-Coating
Sterilization		Non-Sterile	Non-Sterile
Material		Ti 6Al 4V ELI
(ASTM F136)	Titanium Gr. 3
(ASTM F67)

Image /page/18/Picture/0 description: The image shows the logo for IZEN Implant. The word "IZEN" is written in large, bold, black letters. Below the word "IZEN" is the word "IMPLANT" written in smaller, gray letters. The upper right corner of the "N" in IZEN is colored in a teal color.

11) Multi CCM Cast Cylinder

-		Subject Device	Predicate Device
Manufacturer		Izenimplant Co., Ltd.	Osstem Implant Co., Ltd.
Device Name		ZENEX Implant System	Osstem Abutment System
510(k) Number		-	K182091
Classification		Class II	Class II
Design		Image: Multi CCM Cast Cylinder	Image: Multi NP Cast Cylinder
Connection Type		Non-Hex	Non-Hex
Dimension	D(θ)	4.8	5.0
	L
(mm)	11	7.3
	Angle	0°	0°
Surface Treatment		Non-Coating	Non-Coating
Sterilization		Non-Sterile	Non-Sterile
Material		CoCrMo Alloy	CoCrMo Alloy

6.2 Comparison Conclusion to predicate device

The subject devices are substantially equivalent to the predicate and reference devices with respect to indications for use, technology and construction. The differences between the predicate devices and the subject devices are minor and any risks have been mitigated through testing.

Image /page/19/Picture/0 description: The image shows the logo for IZEN Implant. The word "IZEN" is written in large, bold, black letters. The upper right portion of the "N" is colored in teal. Below the word "IZEN" is the word "IMPLANT" written in smaller, gray letters.

7. NON-CLINICAL DATA

As part of demonstrating substantial equivalence of the ZENEX Implant System to the predicate devices, Izenimplant Co., Ltd. conducted performance testing on the subject devices. Although there are slightly different points such as dimension or material, it does not impact the ability to determine substantial equivalence of the subject devices because the substantial equivalence of performance for ZENEX Implant System is demonstrated by the following verification and validation data to demonstrate the safety and performance effectiveness.

. Sterilization Validation
- 1. Gamma Sterilization Products

ZENEX Fixture (ZENEX MULTI Fixture and ZENEX PLUS Fixture), Healing Abutment and Cover Screw are sterilized by gamma on the sterilization process.

A. Gamma Sterilization Validation in accordance with ISO 11137-1: 2006+A2:2018, ISO 11137-2:2013 and ISO 11137-3:2017

2) User Moist Heat Sterilization Product

All Abutment and accessories, excepting Healing Abutment and Cover Screw, are provided nonsterilize

However, the device is intended to be sterilized by user moist heat sterilization.

A. Moist Heat Sterilization Validation Report in accordance with ISO 11138-1:2017, ISO 11138-3:2017, ISO 17665-1:2006, ISO/TS 17665-2:2009, ISO 11737-1:2018 and ISO 11737-2:2019
. Packing Validation with shelf-life and integrity test

Stability and the effectiveness of packaging as sterilized product (ZENEX Fixtures, Healing Abutment and Cover Screw) by evaluation in process of time and performance of packaging material according to the ISO 11607-1:2019, ISO 11607-2:2019, ISO 11137, ASTM F1980, ASTM F88, ASTM F1140, ASTM F1929, ASTM F1140

• Biocompatibility Test

The biocompatibility tests were performed to protect patients from undue risks arise from biological hazards associated with materials of manufacture and final device. The tests were performed in accordance with ISO 10993-1, ISO 10993-5, and FDA Guidance - Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process."

• Performance

The following tests were performed to assess effectiveness of the product performance including mechanical properties. The tests were performed in accordance with following standards and the "Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Implant Abutments"

The mechanical properties tests were performed by being based on each product different properties and dimensions. Fatigue testing was conducted on worst-case constructs per ISO 14801

. Surface Treatment Test

1) SLA Surface Treatment Product

The surface treatment information with SLA (Sandblasted with Large-grit and Acid-etching) was provided. To analyze surface modification, SEM, EDS images including ICP and IC analysis result were provided to demonstrated removal of manufacturing, residuals (blast media and acids).

2) TiN Coating Surface Treatment Product

The surface treatment information with TiN Coating was provided. To analyze surface modification, surface characteristic including physical properties (thickness and abrasion) and surface roughness data were provided and it demonstrated substantial equivalence.

MR Environment Condition ●

Non-clinical worst-case MRI review was performed to evaluate the metallic ZENEX Implant System devices in the MRI environment using scientific rationale and published literature (e.g., Woods, Terry O., Jana G. Delfino, and Sunder Rajan. "Assessment of Magnetically Induced Displacement Force and Torque on Metal Alloys Used in Medical Devices." Journal of Testing and Evaluation 49.2 (2019): 783-795), based on the entire system including all variations (all compatible implant bodies, dental abutments, and fixation screws) and material composition. Rationale addressed parameters per the FDA guidance "Testing and Labeling Medical Devices for Safety in the Magnetic Resonance (MR) Environment," including magnetically induced displacement force and torque

. Endotoxin Batch Test
Pyrogenicity information provided is based on FDA Guidance "Submission and Review of Sterility Information in Premarket Notification (510(k)) Submission for Devices Labeled as Sterile. Furthermore, the endotoxin level of the test item was determined and was within the limit of 20 EU/device. The Bacterial Endotoxin Testing (BET) was performed by the chromogenic kinetic method.

LAL tests was performed according to the United States Pharmacopoeia (USP and USP ) referenced FDA Guidance (Pyrogen and Endotoxins Testing: Questions and Answers; 2012-06) and the ANSI/AAMI ST72.

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

8. CLINICAL AND ANIMAL TEST

Clinical and animal testing were not performed for ZENEX Implant System as part of the premarket notification requirements for this 510(k) submission and the subject of this premarket submission, ZENEX Implant System, did not require clinical and animal studies to support substantial equivalence

9. CONCLUSION

Image /page/22/Picture/0 description: The image contains the logo for IZEN Implant. The logo features the word "IZEN" in bold, sans-serif font, with the "N" having a teal triangle extending from its upper right corner. Below "IZEN" is the word "IMPLANT" in a smaller, sans-serif font.

The comparison between the subject devices and the predicate devices shows that the general information, some technical and material information are the same. Although there are some differences, the performance test reports are supported to the substantial equivalence of the subject device, the performance test reports are provided to demonstrate substantial equivalence of the subject devices. Therefore, we conclude that the different characteristics do not raise different questions of safety and effectiveness, and thus the subject devices are substantially equivalent to the predicate devices.