Predicate Devices

Reference Devices

AI/ML (Artificial Intelligence / Machine Learning)

No
The 510(k) summary describes a physical dental implant system made of titanium. There is no mention of software, algorithms, image processing, or any terms related to AI/ML. The performance studies focus on mechanical and biological properties, not computational performance.

Therapeutic

Yes
The device is an implant system designed to support prosthetic teeth, which directly addresses a medical condition (edentulism) by restoring function and mitigating the effects of tooth loss.

Diagnostic

No

The device is an implant system designed to support dental restorations, not to diagnose a medical condition.

SaMD (Software as a Medical Device)

No

The device description explicitly states it is a "thread type implant made of pure titanium" and describes its physical dimensions and surface treatment, indicating it is a physical hardware device.

IVD (In Vitro Diagnostic)

No, this device is not an IVD (In Vitro Diagnostic).

Here's why:

IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
Device Description: The ZENEX Implant System Long is a physical implant made of titanium that is surgically placed into the bone (mandibles and maxillae). It is a medical device used to support dental prosthetics.
Intended Use: The intended use is to support dental restorations in partially or fully edentulous patients. This is a structural and functional purpose within the body, not an analysis of biological samples.

The provided information clearly describes a surgically implanted medical device, not a device used for in vitro testing of biological specimens.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / 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.

Product codes

DZE

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).

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

Name: ZENEX Implant System_Long (ZENEX MULTI Fixture)
Fixture Type: Image: Fixture Type 1
Diameter (mm): Ø 3.75/4.25, Ø 4.6
Length (mm): 18mm/20mm, 18mm
Material: Not Found

Name: ZENEX Implant System_Long (ZENEX PLUS Fixture)
Fixture Type: Image: Fixture Type 2
Diameter (mm): Ø 3.75/4.25, Ø 4.6
Length (mm): 18mm/20mm, 18mm
Material: Not Found

Tolerance of dimension shall be within ± 1% range. 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.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

partially or fully edentulous mandibles and maxillae

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Not Found

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

Not Found

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

Not Found

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

Non-clinical testing data:

Fatigue Testing according to ISO 14801:2016 under the worst-case scenario. The Results of fatigue testing showed that subject devices are substantially equivalent under the worst-case scenario.
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. 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.
Gamma sterilization validation Test Report according to ISO 11137-1. ISO 11137-2 and ISO . 11137-3. For devices provided sterile, a sterility assurance level (SAL) of 10-6 have been validated in accordance with ISO 11137-1:2006.
Shelf Life Test on Fixtures according to ASTM F 1980. Shelf Life Testing was performed in accordance with ASTM F1980. The worst-case construct was tested, and results demonstrated equivalence to the predicate devices. The shelf life for devices provided sterile is 5 years.
Bacterial Endotoxin Test Report on Fixtures according to ANSI/AAMI ST72:2011, USP , and USP .
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.

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 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.

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

Not Found

Predicate Device(s)

K211090

Reference Device(s)

K161604, K221453, K222778, K232418

Predetermined Change Control Plan (PCCP) - All Relevant Information

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

0

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.

1

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.

2

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 Quality Center for Devices and Radiological Health

Enclosure

3

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)
X Prescription Use (Part 21 CFR 801 Subpart D)	Over-The-Counter Use (21 CFR 801 Subpart C)

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4

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: jjhwan@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 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.

5

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)
ZENEX Implant
System_Long
(ZENEX MULTI
Fixture)	Image: Fixture Type 1	$Ø$ 3.75/4.25	18mm/20mm
	$Ø$ 4.6	18mm
ZENEX Implant
System_Long
(ZENEX PLUS
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
Name | Diameter (Ø) | Angulation | Length or
Cuff(mm) | Multi-unit
Loading |
|---------|-----------------------|---------------------------------------------------------------------------------------------------|------------------------------------|-----------------------------------------|-----------------------|
| K211090 | Cover
Screw | I-System: Ø3.45 / Ø3.6
T-System: Ø3.0/Ø3.4/Ø3.6/Ø3.9 | 0° | P/H: 0.4/1.4/2.0 | |
| | Healing
Abutment | I-System:
Ø4.3/Ø4.8/Ø5.5/Ø6.0/Ø6.8/Ø8.0
/09.0
T-System:
Ø4.3/Ø4.8/Ø5.3/Ø6.3/Ø7.3/Ø8.3 | 0° | P/H: 2/3/4/5/6/7/9 | |
| | Cemented
Abutment | I-System: Ø4.5/Ø5.2/Ø5.7/Ø6.5
T-System:
Ø4.0/Ø4.5/Ø5.0/Ø6.0/Ø7.0 | 0° | G/H: 1/2/3/4/5/6/7
PH: 4/5/5.5/7 | Bridges |
| | Angled
Abutment | I-System: Ø4.5/Ø5.2/Ø5.7
T-System: Ø4.0/Ø4.5/Ø5.0/Ø6.0 | I-System: 15°/25°
T-System: 17° | G/H: 2/3/4
P/H: 7 | Bridges |
| | Temporary
Abutment | I-System: Ø4.5
T-System: Ø4.0/Ø4.5 | 0° | G/H: 1/3
P/H: 10 | |
| | Ball
Abutment | I-System: Ø3.5
T-System: Ø3.5 | N/A | G/H: 1/2/3/4/5/6 | Overdentures |
| | Abutment
Screw | I-System: Ø2.3
T-System: Ø2.2/Ø2.3 | N/A | I-System: 8.2
T-System:
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.

6

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

7

	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
manufacture.	rehabilitation. The TIB and
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

8

K240560

| Material | Titanium Grade 4 of
ASTM F67 | Titanium Grade 4 of
ASTM F67 | Titanium Grade 4 of
ASTM F67 | Titanium Grade 4 of
ASTM F67 | Titanium Grade 4 of
ASTM F67 | Titanium Grade 4 of ASTM
F67 | | | | | | | good primary stability is
achieved and with
appropriate occlusal
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

Submerged Fixture
Straight/Taper body
shape | - Internal Hex
connected
Submerged Fixture
Straight/Taper body
shape | - Internal Hex
connected | - Internal Hex
connected | - Internal Hex connected | Internal Cone and Hex | Compatible
Abutments | Straight and angled
abutments | Straight and angled
abutments | Straight and angled
abutments | Straight and angled
abutments | Straight and angled
abutments | Straight and angled abutments | |
| Diameters (Ø)
X Lengths (mm) | Ø3.75X L18, 20
Ø4.25 X L18, 20
Ø4.6 X L18 | Ø3.75XL8.5, 10, 11.5,
13, 15
Ø4.25X L7, 8.5, 10,
11.5, 13, 15
Ø4.6X L7, 8.5, 10, 11.5,
13, 15
Ø5.05X L7, 8.5, 10,
11.5, 13, 15
Ø5.4X L7, 8.5, 10, 11.5,
13
Ø5.9X L7, 8.5, 10, 11.5,
13
Ø6.75X L7, 8.5, 10,
11.5, 13 | Ø3.75 x L18,20
Ø3.77 x L7
Ø4.25 x L7
Ø4.65 x L7
Ø5.45 x
L10,11.5,13,15
Ø5.48 x L8.5
Ø5.5 x L7 | Ø3.2 X
L8.5,10,11.5,13,15
Ø4.4 X
L7,8.5,10,11.5,13,15
Ø4.6 X L18
Ø4.8 X
L7,8.5,10,11.5,13,15
Ø5.05 X L18
Ø5.25 X
L7,8.5,10,11.5,13,15
Ø6.2 X
L6.2,7,8.5,10,11.5,13
Ø7.1 X
L6.2,7,8.5,10,11.5,13 | Ø3.8 X L18,20,22,24
Ø4.0 X L18,20,22,24
Ø4.5 X L18,20,22,24 | Ø3.5 X
L8,10,11.5,13,16,18,20
Ø4.0 X
L8,10,11.5,13,16,18,20,22,24
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,
functions, general shape (Design), connection type, structure and applied production method are similar. | | | | | | |
| Surface Treatment | Sand blasting & Acid
Etching | Sand blasting & Acid
Etching | Sand blasting &
Acid Etching | Sand blasting & Acid
Etching | Acid Etched | Grit-blasted with a 3.0mm
machined section only at
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
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
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
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
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
fundamental functions, safety and effectiveness. | | | | | | |
| Sterilization | Gamma Sterilization | Gamma Sterilization | Gamma
Sterilization | Gamma Sterilization | Gamma Sterilization | Gamma Sterilization | | | | | | | | |
| Principle of
Operation | This product is a root-
type fixture which is
inserted in the alveolar
bone. It replaces the
functions of the missing
teeth as a dental implant
fixture. | This product is a root-
type fixture which is
inserted in the alveolar
bone. It replaces the
functions of the missing
teeth as a dental implant
fixture. | This product is a
root-type fixture
which is inserted in
the alveolar bone. It
replaces the
functions of the
missing teeth as a
dental implant
fixture | This product is a root-
type fixture which is
inserted in the
alveolar bone. It
replaces the functions
of the missing teeth as
a dental implant
fixture | S.I.N. Dental Implant
System is intended for
placement in the
maxillary or mandibular
arch to provide support
for single-unit or multi-
unit restorations. When a
one-stage surgical
approach is applied, the
S.I.N. Dental Implant
System is intended for
immediate loading when | The Conventional Abutments
and Prosthetic Screws are
premanufactured prosthetic
components directly
connected to endosseous
dental implants and intended
for use in fully edentulous or
partially edentulous maxilla
and/or mandible to provide
support for crowns, bridges or
overdentures. | | | | | | | | |

9

10

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 , and USP

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

11

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.

Intended Use / Indications for Use

Product codes

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)

Reference Device(s)

Predetermined Change Control Plan (PCCP) - All Relevant Information

§ 872.3640 Endosseous dental implant.

Andrew I. Steen -S

Indications for Use

Indications for Use (Describe)

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510(k) Summary

Submitter

Official Correspondent

Device Information

Predicate Devices:

Reference Devices

Indications for Use:

Device Description

Summaries of Technological Characteristics:

Non-clinical testing data:

Sterilization and Shelf Life Testing

Biocompatibility Testing

Fatigue Testing

MR Environment Condition

Conclusion

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