K Number

Device Name

ZENEX Implant System_Narrow

Manufacturer

Izenimplant Co., Ltd.

Date Cleared

2023-07-31

(146 days)

Product Code

DZE NHA

Regulation Number

872.3640

Intended Use

The ZENEX Implant System Narrow (3.0, 3.2mm) may be used as an artificial root structure for single tooth replacement of mandibular central and lateral incisors and maxillary lateral incisors. The implants may be restored immediately 1) with a temporary prosthesis that is not in functional occlusion, 2) when splinted together as an artificial root structure for multiple tooth replacement of mandibular incisors, or 3) for denture stabilization using multiple implants in the anterior mandible and maxilla. The implants may be placed in immediate function when good primary stability has been achieved and with appropriate occlusal loading.

Device Description

The ZENEX Implant System Narrow consists of dental implants, and screws for use in one or two-stage dental implant placement and restorations. The fixtures and abutments in this system are: ZENEX MULTI Fixture, ZENEX PLUS Fixture, Cover Screw, Healing Abutment, Cemented Abutment (Hex, Non-Hex), Angled Abutment (Hex, Non-Hex), Temporary Abutment (Hex, Non-Hex), FreeMilling Abutment (Hex, Non-Hex), CCM Cast Abutment (Hex, Non-Hex), and Abutment Screw. An endosseous dental implant is a device made of a material such as Ti 6AL 4V Eli (Conforming to ASTM Standard F-136). The implant-Abutment connection is tight and precise fitting with internal hex and Morse taper bevel. The surface of the ZENEX MULTI and PLUS Fixtures are treated with SLA(sand-blasted, large-grit, acid-etched). The subject fixture, cover screw and healing abutment are provided sterile. Other abutments are provided non-sterile and packaged separately.

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

K161244

Reference Devices

K161604, K161987, K172100, K182081, K182194, K190849, K211090, K220079

AI/ML (Artificial Intelligence / Machine Learning)

No
The description focuses on the physical components, materials, and mechanical testing of a dental implant system. There is no mention of software, algorithms, or data processing related to AI/ML.

Therapeutic

Yes

The "Intended Use / Indications for Use" section states that the device "may be used as an artificial root structure for single tooth replacement," "multiple tooth replacement," or "for denture stabilization," all of which are directly related to the treatment or amelioration of a disease, injury, or handicap (tooth loss/missing teeth).

Diagnostic

Explanation: The "Intended Use / Indications for Use" section clearly states that the device is an artificial root structure for tooth replacement and stabilization, which describes a therapeutic or reconstructive function, not a diagnostic one.

SaMD (Software as a Medical Device)

The device description explicitly states it consists of dental implants and screws, which are physical hardware components.

IVD (In Vitro Diagnostic)

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

Here's why:

Intended Use: The intended use describes the device as an "artificial root structure for single tooth replacement" and for "denture stabilization." These are all related to surgical implantation and mechanical support within the body.
Device Description: The description details the physical components of a dental implant system (fixtures, abutments, screws) and the materials used.
Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or treatment.

The device is clearly a medical device intended for surgical implantation and structural support, not for in vitro diagnostic testing.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The ZENEX Implant System Narrow (3.0, 3.2mm) may be used as an artificial root structure for single tooth replacement of mandibular central and lateral incisors and maxillary lateral incisors.

The implants may be restored immediately

with a temporary prosthesis that is not in functional occlusion,
when splinted together as an artificial root structure for multiple tooth replacement of mandibular incisors, or
for denture stabilization using multiple implants in the anterior mandible and maxilla.

The implants may be placed in immediate function when good primary stability has been achieved and with appropriate occlusal loading.

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

DZE, NHA

Device Description

The ZENEX Implant System Narrow consists of dental implants (fixtures) and screws for use in one or two-stage dental implant placement and restorations. The fixtures are ZENEX MULTI Fixture and ZENEX PLUS Fixture, made of Ti 6AL 4V Eli. The implant-Abutment connection is tight and precise fitting with internal hex and Morse taper bevel. The surface of the ZENEX MULTI and PLUS Fixtures are treated with SLA (sand-blasted, large-grit, acid-etched).

The system includes various abutments: Cover Screw, Healing Abutment, Cemented Abutment (Hex, Non-Hex), Angled Abutment (Hex, Non-Hex), Temporary Abutment (Hex, Non-Hex), FreeMilling Abutment (Hex, Non-Hex), CCM Cast Abutment (Hex, Non-Hex), and Abutment Screw. The CCM Cast Abutment is made of Co-Cr-Mo Alloy, while other components are made of Ti-6Al-4V Eli.

The subject fixture, cover screw and healing abutment are provided sterile. Other abutments are provided non-sterile and packaged separately and require end-user sterilization.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

mandibular central and lateral incisors and maxillary lateral incisors; anterior mandible and maxilla

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 Data:

Bacterial Endotoxin Testing: Performed on Fixture according to USP .
Fatigue Testing: Performed under the worst-case scenario according to ISO 14801:2016.

Leveraged tests from predicate devices (K211090):

Sterilization Validation Testing: For Healing Abutment provided sterile according to ISO 11137-1 and ISO 11137-2.
Shelf-Life Testing: For Fixture and Healing Abutment according to ASTM F1980.
End User Sterilization Validation Testing: For Ti-6A1-4V ELI and CCM material according to ANSI/AAMI ST79, ISO 17665-1, ISO 17665-2, ISO 11737-1, ISO 11737-2, and ISO 11138-1.
Biocompatibility testing: On abutments according to ISO 10993-1:2018.

Surface modification information:

Surface modification with SLA (sand-blasted, large-grit, acid-etched) was provided.
Surface roughness, surface composition analysis, and SEM imaging were provided to compare surface modification between the subject and predicate device (K211090), demonstrating substantial equivalence.

MR Environment Condition:

Non-clinical worst-case MRI review was performed to evaluate the ZENEX Implant System_Narrow 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).
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.

Conclusion: Clinical testing was not necessary to establish substantial equivalency of the device. The device meets all declared requirements of its intended use and has the same intended use and fundamental scientific technology as its predicate devices, demonstrating substantial equivalence.

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.

K161244

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.

K161604, K161987, K172100, K182081, K182194, K190849, K211090, K220079

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 contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health and Human Services logo. To the right of that 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.

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

Re: K230630

Trade/Device Name: ZENEX Implant System Narrow Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: Class II Product Code: DZE, NHA Dated: July 5, 2023 Received: July 5, 2023

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. 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 -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 Ouality Center for Devices and Radiological Health

Enclosure

Indications for Use

510(k) Number (if known) K230630

Device Name ZENEX Implant System Narrow

Indications for Use (Describe)

The ZENEX Implant System Narrow (3.0, 3.2mm) may be used as an artificial root structure for single tooth replacement of mandibular central and lateral incisors and maxillary lateral incisors.

The implants may be restored immediately

with a temporary prosthesis that is not in functional occlusion,
when splinted together as an artificial root structure for multiple tooth replacement of mandibular incisors, or

1. for denture stabilization using multiple implants in the anterior mandible and maxilla.
  The implants may be placed in immediate function when good primary stability has been achieved and with appropriate occlusal loading.

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

X Prescription Use (Part 21 CFR 801 Subpart D)

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

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

510(K) Summary

Submitter

Izenimplant Co., Ltd. Kwon, Mi-Kyung 1, 2Dong, 26-32, Suworam 4-Gil, Seotan-Myeon, Pyeongtaek-Si, Gyeonggi, 17703 Republic of Korea Email: mkkwon@izenimplant.com Tel. +82-31-662-0657 Fax. +82-31-662-0655

Official Correspondent

Withus Group Inc April Lee 106 Superior Irvine, CA 92620 USA Email: withus6664@gmail.com Phone: 1-909-274-9971 Fax: 1-909-460-8122

Device Information

. Trade Name: ZENEX Implant System Narrow
Common Name: Endosseous Dental Implant
. Classification Name: Implant, Endosseous, Root-Form
Product Code: DZE
. Secondary Product Code: NHA
. Panel: Dental
. Regulation Number: 872.3640
. Date prepared: 07/28/2023

Predicate Devices:

The subject device is substantially equivalent to the following Devices:

Primary Predicate K161244, s-Clean OneQ-SL Narrow Implant System manufactured by Dentis Co., Ltd.

Reference Device

K161604, OSSTEM Implant System by Osstem Implant Co., Ltd.

K161987, UF(II) Narrow Implant System - Fixture, UF(II) Narrow Implant System - Suprastructure by DIO Corporation

K172100, URIS OMNI System by TruAbutment Korea Co.,Ltd.

K182081, JDentalCare Implant System JDIcon by J Dental Care S.R.L.

K182194, UV Active Implant System by DIO Corporation

K190849. IS-III active System S-narrow Type by Neobiotech Co., Ltd.

K211090, ZENEX Implant System by Izenimplant Co., Ltd.

K220079, Magicore Narrow System by InnobioSurg Co., Ltd.

Indications for Use

The ZENEX Implant System Narrow (3.0. 3.2mm) may be used as an artificial root structure for single tooth replacement of mandibular central and lateral incisors and maxillary lateral incisors.

The implants may be restored immediately

with a temporary prosthesis that is not in functional occlusion,
when splinted together as an artificial root structure for multiple tooth replacement of mandibular incisors, or
for denture stabilization using multiple implants in the anterior mandible and maxilla.

The implants may be placed in immediate function when good primary stability has been achieved and with appropriate occlusal loading.

Device Description:

The fixtures and abutments in this system are below:

Fixture

. ZENEX MULTI Fixture
. ZENEX PLUS Fixture
1. Abutment
- Cover Screw ●
- Healing Abutment
- Cemented Abutment (Hex, Non-Hex) ●
- Angled Abutment (Hex, Non-Hex)
- Temporary Abutment (Hex, Non-Hex) ●
- FreeMilling Abutment (Hex, Non-Hex)
- CCM Cast Abutment (Hex, Non-Hex) ●
- . Abutment Screw

An endosseous dental implant is a device made of a material such as Ti 6AL 4V Eli (Conforming to ASTM Standard F-136). The ZENEX Implant System Narrow consists of dental implants, and screws for use in one or two-stage dental implant placement and restorations.

The implant-Abutment connection is tight and precise fitting with internal hex and Morse taper bevel. The surface of the ZENEX MULTI and PLUS Fixtures are treated with SLA(sand-blasted, large-grit, acid-etched).

| Fixture | Compatible
Abutment | Abutment
Diameter | Abutment Length (mm) | Abutment
Angle |
|-----------------------------------------------------------------|-------------------------|----------------------|-------------------------------------------------------------------------------------|-------------------|
| ZENEX
PLUS
Fixture
Ø 3.0
X
10, 11.5,
13, 15mm | Cover Screw | Ø2.6 | 4.0 | 0° |
| | Healing
Abutment | Ø4.0 | 7/8/9/10/11/13 | 0° |
| | Cemented
Abutment | Ø4.0 | Hex: 9.5/10.5/11.5/11/11.5/12/12.5/13/14
Non-Hex: 9/10/10.5/11/11.5/12/12.5/13.5 | 0° |
| | Angled
Abutment | Ø4.0 | Hex: 11/13
Non-Hex: 10.5/12.5 | 15° |
| | Temporary
Abutment | Ø4.0 | Hex: 13/15
Non-Hex: 12.5/14.5 | 0° |
| | FreeMilling
Abutment | Ø4.0 | Hex: 13/15
Non-Hex: 12.5/14.5 | 0° |
| | CCM Cast
Abutment | Ø4.0 | Hex: 13/15
Non-Hex: 12.5/14.5 | 0° |

ZENEX Plus Fixture is compatible with the subject abutments as below:

ZENEX MULTI Fixture is compatible with the abutments cleared in K211090 except cover screw as below:

| Fixture | Compatible
Abutment | Abutment
Diameter | Abutment Length (mm) | Abutment
Angle |
|---------------------------------------------|---------------------------------|----------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------|
| ZENEX
MULTI
Fixture | Cover Screw
(Subject device) | Ø2.9/ Ø3.2 | 4.5/5.5/6.1 | 0° |
| | Healing Abutment | Ø4.3/ Ø4.8 | 7.5/8.5/9.5/11.5/13.5 | 0° |
| Ø 3.2
X
8.5, 10,
11.5, 13,
15mm | Cemented
Abutment | Ø4.0/ Ø4.5 | Hex:9.08/10.08/10.58/11.08/11.58/12.08/12.58/
13.08/13.58/14.08/14.58/15.08/15.58/16.08/16.58
Non-Hex:8.48/9.48/9.98/10.48/10.98/11.48/
11.98/12.48/12.98/13.48/13.98/14.48/14.98/15.98 | 0° |
| | Temporary
Abutment | Ø4.0 | Hex:13.58/15.58
Non-Hex: 12.98/14.98 | 0° |

Abutments	Uses	Surface Treatment
Cover Screw	The cover Screw is used during the healing period prior to
restorations and maintain the shape of the gum	Non
Healing Abutment	The Abutment is used during the healing period prior to
restorations and maintain the shape of the gum.	Non
Cemented Abutment
(Hex, Non-Hex)	The Abutment is connected with fixture, and it supports
prosthesis which restores tooth function.	Partial TiN coated
in upper
Angled Abutment
(Hex, Non-Hex)	The Abutment is connected with fixture, and it supports
prosthesis which restores tooth function.	Partial TiN coated
in upper
Temporary Abutment
(Hex, Non-Hex)	The Abutment is used by removing the healing abutment as an
abutment for making temporary prostheses	Non
FreeMilling Abutment
(Hex, Non-Hex)	The Abutment is connected with fixture, and it supports
prosthesis which restores tooth function.
The FreeMilling Abutment is only intended to be modified by
hand-milling.	Partial TiN coated
in upper
CCM Cast Abutment
(Hex, Non-Hex)	It is used when there are restrictions on the prosthesis
production because of path, aesthetics, and space of fixture.
Production the prosthesis by casting with dental alloy after wax
up with desired shape	Non
Abutment Screw	Connection body to connect abutment to fixture.	Non

Below are the abutment's features:

The subject fixture, cover screw and healing abutment are provided sterile.

Other abutments are provided non-sterile and packaged separately. The abutments should be sterilized before use by End User sterilization.

Materials:

ZENEX Implant Narrow Fixtures and abutments are made of Ti-6Al-4V Eli
-CCM Cast Abutment is made of Co-Cr-Mo Alloy

K230630

Summaries of Technological Characteristics & Substantial Equivalence Discussion

Fixture – ZENEX MULTI Fixture and ZENEX PLUS Fixture

	Subject Device	Primary Predicate	Reference Device	Reference Device
Manufacturer	Izenimplant Co.,Ltd	Dentis Co., Ltd.	InnoBioSurg Co.,Ltd	Neobiotech Co., Ltd
Product Name	ZENEX Implant	s-Clean OneQ-SL Narrow	Magicore Narrow System	IS-III active System_
	System_Narrow	Implant System		S-Narrow Type
510(K) #	K230630	K161244	K220079	K190849
Classification	Class II	Class II	Class II	Class II
Design	Image: ZENEX Implant System_Narrow Design	Image: s-Clean OneQ-SL Narrow Implant System Design	Image: Magicore Narrow System Design	Image: IS-III active System_S-Narrow Type Design
Connection	Internal Hex	Internal Hex	Internal Hex	Internal Hex
Endosseous
Implant	Tapered, macro threads	Tapered, macro threads	Tapered, macro threads	Tapered, macro threads
Surgical
Technique	1 and 2 stage, self-tapping	1 and 2 stage, self-tapping	1 and 2 stage, self-tapping	1 and 2 stage, self-tapping
Diameter and
Length(mm)	• Ф3.0mm
X10,11.5,13,15 mm	Ф3.0, 3.3mm X10,12,14mm	Ф3.0mm
11,13,15mm	Ф3.2mm
8.5/10.0/11.5/13.0/15.0
	• Ф3.2mm X
8.5,10,11.5,13,15 mm
Material	Ti-6Al-4V ELI	Ti-6Al-4V ELI	Ti-6Al-4V ELI	Ti-6Al-4V ELI
Surface	Sandblasted and acid-etched	Sandblasted and acid-etched	Sandblasted and acid-etched	Sandblasted and acid-etched
Sterilization	Radiation	Radiation	Radiation	Radiation
Shelf life	5 years	8 years	8 years	5 years
Indications for
use	The ZENEX Implant
System_Narrow (3.0,
3.2mm) may be used as an
artificial root structure for	The s-Clean OneQ-SL Narrow
Implant System (3.0, 3.3mm)
may be used as an artificial
root structure for single tooth	The Magicore Narrow System
(3.0, 3.5mm) may be used as an
artificial root structure for single
tooth replacement of mandibular	The IS-III active System_S-
narrow Type is indicated for use
in surgical and restorative
applications for placement in the
	single tooth replacement of
mandibular central and
lateral incisors and
maxillary lateral incisors.
The implants may be
restored immediately	replacement of mandibular
central and lateral incisors and
maxillary lateral incisors.
The implants may be restored
immediately

with a temporary prosthesis
that is not in functional
occlusion, | central and lateral incisors and
maxillary lateral incisors.
The implants may be restored
immediately
with a temporary prosthesis
that is not in functional occlusion,
when splinted together as an
artificial root structure for | mandibular central, lateral
incisor and maxillary lateral
incisor regions of partially
edentulous jaws where the
horizontal space is limited by the
adjacent teeth and roots, to
provide support for prosthetic
devices, such as artificial teeth, |
| | 1) with a temporary
prosthesis that is not in
functional occlusion,
when splinted together as
an artificial root structure for
multiple tooth replacement
of mandibular incisors, or
for denture stabilization
using multiple implants in
the anterior mandible and
maxilla.
The implants may be placed
in immediate function when
good primary stability has
been achieved and with
appropriate occlusal loading. | 2) when splinted together as an
artificial root structure for
multiple tooth replacement of
mandibular incisors, or
for denture stabilization
using multiple implants in the
anterior mandible and maxilla.
The implants may be placed in
immediate function when good
primary stability has been
achieved and with appropriate
occlusal loading. | multiple tooth replacement of
mandibular incisors, or
for denture stabilization using
multiple implants in the anterior
mandible and maxilla.
The implants may be placed in
immediate function when good
primary stability has been
achieved and with appropriate
occlusal loading. | in order to restore the patient's
chewing function.
The IS-III active System_S-
narrow Type is indicated also for
immediate loading when good
primary stability is achieved and
with appropriate occlusal
loading. |
| SE Discussion | The ZENEX Implant System_Narrow has similar device characteristics with the Primary predicate, K161244 such as intended use,
functions, material, surface treatment, fixture diameter, structure and applied production method.
The difference between the subject device and primary predicate are device design, 15mm length fixtures, Ø3.2X8.5mm and shelf life.
The difference of the device design of both device's fundamental functions and safety. To support the 15mm
length for each diameter, K220079 and K190849 were added as reference device. To support the difference of the Ø3.2X8.5mm and
shelf life, the K190849 was added.
Any differences do not raise different questions of safety and effectiveness than the primary predicate; therefore, it is substantial
equivalent. | | | |

Abutment

1) Cover Screw

		Subject Device	Reference Device
Manufacturer		Izenimplant Co.,Ltd	Izenimplant Co.,Ltd
Product Name		ZENEX Implant System_Narrow	ZENEX Implant System
510(K) Number		K230630	K211090
Classification		Class II	Class II
Design		Image: Subject Device Design	Image: Reference Device Design
	D	$Φ2.6~3.2$	$Φ3.0~3.9$
Dimension	L	4~6.1mm	5~7.3mm
	Angle	0°	0°
Material		Ti-6Al-4V ELI	Ti-6Al-4V ELI
Surface		Non-Coating	Non-Coating
Sterilization		Radiation	Radiation
Shelf life		5 years	5 years
SE Discussion		The subject device is similar in intended use, fundamental scientific technology, principle
of operation, general design, technology, functions, and materials with the identified
reference device, K211090.
The difference between the subject and reference device is dimension of the device.
However, it does not affect device's fundamental functions and safety; therefore, it is
substantial equivalent.

2) Healing Abutment

	Subject Device	Reference Device	Reference Device
Manufacturer	Izenimplant Co.,Ltd	Izenimplant Co.,Ltd	Osstem Implant Co., Ltd
Product Name	ZENEX Implant
System_Narrow	ZENEX Implant System	Osstem Implant System
510(K) Number	K230630	K211090	K161604
Classification	Class II	Class II	Class II
Design
Dimension	D	Φ4.0	Φ4.3~9.0	Φ4.0
	P/H	3.0~9.0mm	2.0~9.0mm	3.0~9.0mm
	Angle	0°	0°	0°
Material	Ti-6Al-4V ELI	Ti-6Al-4V ELI	Ti-6Al-4V ELI
Surface	Non-Coating	Non-Coating	TiN Coating
Sterilization	Radiation	Radiation	Radiation
Shelf life	5 years	5 years	5 years
SE Discussion	The subject device is similar in intended use, fundamental scientific technology, principle of operation, general design, technology, functions, and materials with the identified reference device, K161604.
	The difference between the subject and reference device, K161604 is surface treatment. To support the discrepancy, K211090 was added. Therefore, it is substantial equivalent

3) Cemented Abutment

	Subject Device	Reference Device
Manufacturer	Izenimplant Co.,Ltd	Neobiotech Co., Ltd
Product Name	ZENEX Implant System_Narrow	IS-III active System_S-Narrow Type
Abutment Name	Cemented Abutment	IS Shapable Abutment
510(K) Number	K230630	K190849
Classification	Class II	Class II
Design	Image: Hex design of subject device
Image: Non-Hex design of subject device	Image: Hex design of reference device
Image: Non-Hex design of reference device
Dimension	D	$Φ4.0$	$Φ3.5/4.0$
	G/H	2.0-5.0mm	2.0-5.0mm
	P/H	5.5/7.0mm	5.5/7.0mm
	Angle	0°	0°
Material	Ti-6Al-4V ELI	Ti-6Al-4V ELI
Surface	Partial TiN coated in upper	Partial TiN coated in upper
Sterilization	End User Sterilization	End User Sterilization
SE Discussion	The subject device is similar in intended use, fundamental scientific technology, principle of operation, general design, technology, functions, dimension and materials with the identified reference device, K190849.
The design of the subject and reference device is slightly different. However, it does not affect device's fundamental functions and safety; therefore, it is substantial equivalent.

4) Angled Abutment

		Subject Device		Reference Device
Manufacturer		Izenimplant Co.,Ltd		DIO Corporation
Product Name		ZENEX Implant System_Narrow		UV Active Implant System
510(K) Number		K230630		K182194
Classification		Class II		Class II
Design
		Hex	Non-Hex	Hex	Non-Hex
Dimension	D	Ф4.0		Ф4.0/4.5/5.5
	G/H	2.0/4.0mm		1.5/2.0/3.0/4.0/5.0
	Angle	15°		Ф4.0 - 15 °
Ф4.5 - 15, 25 °
Ф5.5 - 15, 25 °
Material		Ti-6Al-4V ELI		Ti-6Al-4V ELI
Surface		Partial TiN coated in upper		Partial TiN coated in upper
Sterilization		End User Sterilization		End User Sterilization
SE Discussion		The subject device is similar in intended use, fundamental scientific technology,
principle of operation, general design, technology, functions, and materials with the
identified reference device, K182194. The difference between the subject device and
K182194 is design and dimensions.
The design of the subject and reference device is slightly different, and it does not
affect device's fundamental functions and safety. The dimension of the subject device
is in range of the dimension of the predicate. Therefore, it is substantial equivalent.

		Subject Device	Reference Device	Reference Device
Manufacturer		Izenimplant Co.,Ltd	DIO Corporation	J DENTALCARE®S.R.L.
Product Name		ZENEX Implant
System_Narrow	UV Active Implant System	JDIcon® Implant System
Abutment Name		FreeMilling Abutment	Mill abutment	GP Abutment
510(K) Number		K230630	K182194	K182081
Classification		Class II	Class II	Class II
Design		Image: abutment	Image: abutment	Image: abutment
		Hex	Non-Hex	Hex	Non-Hex	Hex	Non-Hex
Hand Milling Only		Yes		Yes		Yes
D		$ Φ 4.0 $		$ Φ 3.2 / 4.0 $		$ Φ 3.2 / 4.0 $
Dimension	G/H	2.0/4.0mm		1.5mm		1.5mm
	Angle	0°		0°		0°
Material		Ti-6Al-4V ELI		Titanium Grade4		Ti-6Al-4V ELI
Surface		Partial TiN coated in upper		Partial TiN coated in upper		No Coating
Sterilization		End User Sterilization
SE Discussion		The subject device is similar in intended use, fundamental scientific technology, principle
of operation, general design, technology, functions with the identified reference device,
K182194.
The difference between the subject device and K182194 is design, dimensions and
materials. To support this material difference, K182081 was added.
The design of the subject and reference device is slightly different, and it does not affect
device's fundamental functions and safety. The dimension of the subject device is in range
of the dimension of the predicate. Therefore, it is substantial equivalent.

5) FreeMilling Abutment

6) CCM Cast Abutment

		Subject Device	Primary Predicate
Manufacturer		Izenimplant Co.,Ltd	Dentis Co.,Ltd
Product Name		ZENEX Implant System_Narrow	s-Clean One-Q-SL Narrow Implant System
510(K) Number		K230630	K161244
Classification		Class II	Class II
Design		Image: red implant with hex	Image: silver implant with hex
		Hex	Hex
		Image: silver implant without hex	Image: gray implant without hex
		Non-Hex	Non-Hex
	D	$Φ4.0$	$Φ4.0$
Dimension	Length	12.5/13/14.5/15mm	14.5/15mm
	Angle	0°	0°

Material		Co-Cr-Mo Alloy	Co-Cr-Mo Alloy
Surface		No Coating	No Coating
Sterilization		End User Sterilization	End User Sterilization
SE Discussion		The subject device is similar in intended use, fundamental scientific technology, principle of operation, general design, technology, functions, diameter and materials with the primary predicate, K161244. The difference between the subject device and predicate is lengths. Since it is the case abutment, the different length does not affect device's fundamental functions and safety. Therefore, it is substantial equivalent.

7) Temporary Abutment

	Subject Device	Reference Device
Manufacturer	Izenimplant Co.,Ltd	TruAbutment Korea Co.,Ltd
Product Name	ZENEX Implant System_Narrow	URIS OMNI System
510(K) Number	K230630	K172100
Classification	Class II	Class II
Design	Image: Subject Device Design Hex	Image: Reference Device Design
	Hex
	Non-Hex
Dimension	D	$Φ4.0$	$Φ3.7/ Φ4.3mm$
	P/H	10.0mm	10.0mm
	Angle	0°	0°
Maximum duration	Placed less than six months and out of
occlusion	Placed less than six months and out of
occlusion
Material	Ti-6Al-4V ELI	Ti-6Al-4V ELI
Surface	No Coating	No Coating
Sterilization	End User Sterilization	End User Sterilization
SE Discussion	The subject device is similar in intended use, fundamental scientific technology,
principle of operation, general design, technology, functions, and materials with the
identified reference device, K172100.
The design of the subject and reference device is slightly different, and it does not
affect device's fundamental functions and safety. The dimension of the subject device
is in range of the dimension of the predicate. Therefore, it is substantial equivalent.

8) Abutment Screw

		Subject Device	Reference Device
Manufacturer		Izenimplant Co.,Ltd	Neobiotech Co., Ltd
Product Name		ZENEX Implant System_Narrow	IS-III active System_S-Narrow
Type
510(K) Number		K230630	K190849
Classification		Class II	Class II
Design		Image: Subject Device Design	Image: Reference Device Design
	D	$Φ2.0$	$Φ2.0$
Dimension	Length	8.9mm	10.2mm
Material		Ti-6Al-4V ELI	Ti-6Al-4V ELI
Surface		No Coating	No Coating
Sterilization		End User Sterilization	End User Sterilization
SE Discussion		The subject device is similar in intended use, fundamental scientific
technology, principle of operation, general design, technology, functions,
diameter, and materials with the identified reference device.
The difference between the subject and reference device is length of the
device. However, it does not affect device's fundamental functions and
safety; therefore, it is substantial equivalent.

Non-Clinical Data:

Below tests were performed on subject device:

Bacterial Endotoxin Testing on Fixture according to USP .
. Fatigue Testing under the worst-case scenario according to ISO 14801:2016

Below tests were performed for predicate devices and leveraged for the subject device:

Sterilization Validation Testing for Healing Abutment provided sterile according to ISO 11137-1 and ISO 11137-2 referenced in K211090
Shelf-Life Testing on Fixture and Healing Abutment according to ASTM F1980 referenced in K211090
End User Sterilization Validation Testing for Ti-6A1-4V ELI and CCM material according to ● ANSI/AAMI ST79, ISO 17665-1, ISO 17665-2, ISO 11737-1, ISO 11737-2, and ISO 11138-1 referenced in K211090
. Biocompatibility testing on abutments according to ISO 10993-1:2018 referenced in K211090

The surface modification information with SLA (sand-blasted, large-grit, acid-etched) was provided. To compare surface modification between the subject and predicate device. K211090, surface roughness, surface composition analysis, and SEM imaging were provided, and it demonstrate the substantial equivalence.

In accordance with the Association for the AAMI ST72:2002/R2010, Bacterial Endotoxins-Test Methodologies, Routine Monitoring, and Alternatives to Batch Testing (AAMI ST72), validation cycle of endotoxin will be processed and managed.

The Fatigue Testing was performed under the worst-case scenario according to ISO 14801:2016.

MR Environment Condition

Non-clinical worst-case MRI review was performed to evaluate the ZENEX Implant System_Narrow 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.

Clinical testing was not necessary to establish substantial equivalency of the device.

Conclusion

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

Intended Use / Indications for Use

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

Device Description

Mentions image processing

Mentions AI, DNN, or ML

Input Imaging Modality

Anatomical Site

Indicated Patient Age Range

Intended User / Care Setting

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

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

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

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

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).

§ 872.3640 Endosseous dental implant.

Andrew I. Steen -S

Indications for Use

Indications for Use (Describe)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

*DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW *

510(K) Summary

Submitter

Official Correspondent

Device Information

Predicate Devices:

Indications for Use

Device Description:

Materials:

K230630

Summaries of Technological Characteristics & Substantial Equivalence Discussion

Fixture – ZENEX MULTI Fixture and ZENEX PLUS Fixture

Abutment

1) Cover Screw

2) Healing Abutment

3) Cemented Abutment

4) Angled Abutment

5) FreeMilling Abutment

6) CCM Cast Abutment

7) Temporary Abutment

8) Abutment Screw

Non-Clinical Data:

MR Environment Condition

Conclusion

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW