The IU Implant System 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, and to restore the patient's chewing function.

Device Description

The IU Implant System is an integrated system of endosseous dental implants with corresponding various abutments (cover screw, two piece abutment, solid abutment, abutment screw, ball abutment, retained abutment, temporary abutment, and multi abutment). The IU Implant System is a dental implant made of titanium metal intended to be surgically placed in the bone of the upper or lower jaw arches. There are two types of Fixtures, triangular screw threads design and square screw threads design. The IU Implant System includes the each fixtures is available in various diameters (lengths) 3.6 mm (8.5 mm, 10.0 mm, 11.5 mm, 13.0 mm) & 4.1 mm, 4.6 mm, 5.1 mm, 5.6 mm, 6.1 mm (7.5 mm, 8.5 mm, 10.0 mm, 11.5 mm, 13.0 mm) of triangular screw threads design and 4.3 mm, 4.8 mm, 5.3 mm (7.0 mm, 8.5 mm, 10.0 mm, 11.5 mm, 13.0 mm) & 6.3 mm (7.0 mm, 8.5 mm, 10.0 mm, 11.5 mm) of square screw threads design according to the anatomical situation. Fixture is made of pure titanium metal and supplied sterile. The surface is SA, Sandblasting and Acid etching, treated. Abutment is device made of titanium alloy and it is intended for use to make permanent prostheses and/or temporary prosthesis. The abutments are provided non-sterile and should be sterilized before use.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study for the IU Implant System, extracted from the 510(k) summary:

The provided document (K172345) is a 510(k) Summary for a new medical device, the IU Implant System. In 510(k) submissions, the primary goal is to demonstrate "substantial equivalence" to a legally marketed predicate device, rather than to establish new safety and effectiveness through extensive clinical trials. Therefore, the "acceptance criteria" and "study that proves the device meets the acceptance criteria" are framed within the context of demonstrating equivalence to established standards and predicate devices, largely through non-clinical testing.

Acceptance Criteria and Reported Device Performance

The acceptance criteria for the IU Implant System are implicitly set by the standards and characteristics of the identified predicate and reference devices, as well as relevant ISO standards. The "performance" being demonstrated is that the subject device meets these established benchmarks, thereby showing substantial equivalence.

Table of Acceptance Criteria and Reported Device Performance

Criterion Category	Specific Acceptance Criteria (Inferred from Predicate/Standard)	Reported Device Performance (IU Implant System)
Intended Use	Same intended use as predicate devices.	"The IU Implant System 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, and to restore the patient's chewing function." (Identical to primary predicate and similar to reference devices)
Technological Characteristics	Similar design, dimensions, material, surface treatment, sterilization method as predicate devices.	Similar designs, dimensions, and has the same material (Pure titanium - ASTM F67 for fixture, Titanium alloy - ASTM F136 for abutments), intended use, surface treatment (S.L.A), and technological characteristics. (Demonstrated through comparative tables)
Biocompatibility	Biocompatible according to ISO 10993-1 and ISO 7405:2008.	Biocompatibility evaluation conducted in accordance with ISO 7405:2008 and ISO 10993-1:2009/AC:2010. Specific tests performed: Cytotoxicity (Elution), Sensitization, Oral irritation, Systemic Toxicity (acute), Genotoxicity, Implantation, Endotoxin Test (LAL test) with limit below 5 EU/mL. Results demonstrated safety.
Sterilization	Achieves a Sterility Assurance Level (SAL) of 10^-6 according to ISO 11137 (gamma) and ISO 17665 (steam).	Sterilization validating testing performed following ISO 11137-1/2/3 (gamma) and ISO 17665-1/2 (steam). Test results demonstrated that the SAL of 10^-6 was achieved and all testing requirements were met.
Shelf Life	Demonstrated shelf life comparable to predicate/acceptable standards (accelerated aging).	Accelerated aging shelf life testing conducted according to ASTM F1980; real time testing is being conducted to support accelerated aging results. (No specific years stated for the subject device shelf-life, but one reference device has 8 years and the primary predicate device's shelf life is not mentioned in the table.)
Risk Analysis	Risk analysis conducted according to ISO 14971, with all risks determined to be acceptable and as low as reasonably possible.	Risk analysis for IU Implant System was conducted in accordance with ISO 14971. It was determined that all risks associated with IU Implant System were acceptable and as low as reasonably possible.
Physical Testing	Mechanical testing performed according to ISO 14801 (for predicate devices).	"Not tested/no angulation submitted for clearance" for the subject device. This indicates that direct mechanical testing of the subject's angulation characteristics wasn't performed for its own clearance but relies on similarity to predicates that performed such tests.

Study Details

Given this is a 510(k) submission, the "study" that proves the device meets the acceptance criteria is primarily a non-clinical comparative testing and documentation of material/design equivalence to predicate devices and recognized standards.

1. Sample size used for the test set and the data provenance:

Test Set Sample Size: Not explicitly stated in terms of a "test set" as one might refer to it in a clinical study. The non-clinical tests (biocompatibility, sterilization, shelf-life) would typically involve a sample of the manufactured device components. The exact number of samples for each specific test (e.g., cytotoxicity, sensitization, mechanical flexural strength) is not detailed in this summary.
Data Provenance: The biocompatibility testing was conducted according to International Standard ISO 7405:2008 and ISO 10993-1:2009/AC:2010. Sterilization testing followed ISO 11137-1/2/3 and ISO 17665-1/2. Shelf-life testing followed ASTM F1980. Risk analysis followed ISO 14971. This indicates testing against internationally recognized standards. The country of origin of the data generation isn't specified beyond the device manufacturer being WARANTEC Co., Ltd. from Korea. This is a retrospective analysis of non-clinical design and safety data against known standards and predicate devices.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

This is not applicable in the context of this 510(k) submission. "Ground truth" in this scenario is established by adherence to recognized international standards (ISO, ASTM) and demonstrative equivalence to predicate devices, rather than expert consensus on a test set (e.g., interpretation of medical images). The experts involved would be those who conducted the laboratory tests and certified compliance with the standards (e.g., microbiologists, material scientists, toxicologists), but their number and specific qualifications are not detailed in this summary.

3. Adjudication method for the test set:

Not applicable. There is no "adjudication method" in the sense of reconciling divergent expert opinions on test data. Compliance with each standard (e.g., passing a cytotoxicity test, achieving a certain SAL) is a binary outcome based on pre-defined criteria within the standard itself.

4. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

No, an MRMC comparative effectiveness study was not done. This device is an endosseous dental implant system, not an AI-powered diagnostic or assistive tool for human readers. This type of study is irrelevant for this device.

5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

No, this is not an AI algorithm. This question is not applicable.

6. The type of ground truth used (expert consensus, pathology, outcomes data, etc):

The "ground truth" for this P(re-market) N(otification) is
- Compliance with recognized international standards for biocompatibility (ISO 10993, ISO 7405), sterilization (ISO 11137, ISO 17665), shelf-life (ASTM F1980), and risk management (ISO 14971).
- Substantial equivalence to predicate devices in terms of intended use, materials, design, and manufacturing processes, which implicitly means the predicate devices' established safety and effectiveness serve as the benchmark.

7. The sample size for the training set:

Not applicable. There is no "training set" in the context of a 510(k) submission for this type of device. The information refers to the manufacturing and testing of physical medical devices and their components, not machine learning models.

8. How the ground truth for the training set was established:

Not applicable. As stated, there is no training set for this type of device.

Summary of the "Study" (Non-Clinical Evidence):

The "study" presented is a collection of non-clinical tests and comparisons to establish substantial equivalence. It confirms:

The IU Implant System has the same intended use as the primary predicate device (Luna Dental Implant System / SHINHUNG MST Co., Ltd. / K123155).
Its technological characteristics (design, dimensions, material, surface treatment, connection, sterilization method) are similar to or identical to the predicate and reference devices.
It meets all relevant biocompatibility standards (ISO 7405, ISO 10993-1) through specific lab tests (Cytotoxicity, Sensitization, Oral irritation, Systemic Toxicity, Genotoxicity, Implantation, Endotoxin).
Its sterilization process achieves the required sterility assurance level (SAL 10^-6) validated by ISO standards.
It has demonstrated shelf-life stability through accelerated aging testing (ASTM F1980).
A risk analysis was conducted according to ISO 14971, finding all risks acceptable.

Key Point from the Submission: "No clinical data were included in this submission." This explicitly states that the substantial equivalence determination relies entirely on non-clinical data and comparison to legally marketed predicate devices, as is common for many Class II medical devices in the 510(k) process.

Summary

{0}------------------------------------------------

Image /page/0/Picture/0 description: The image contains the logos of the U.S. Department of Health and Human Services and the U.S. Food and Drug Administration (FDA). The Department of Health and Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, and the word "ADMINISTRATION" in a smaller font below. The logos are placed side-by-side.

WARANTEC Company, Limited % Peter Chung Representative Plus Global 300 Atwood Street Pittsburgh, Pennsylvania 15213

Re: K172345

Trade/Device Name: IU Implant System Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: Class II Product Code: DZE, NHA Dated: May 21, 2018 Received: May 24, 2018

Dear Peter Chung:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

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

June 18, 2018

{1}------------------------------------------------

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Mary S. Runner -S

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

Enclosure

{2}------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known) K172345

Device Name IU Implant System

Indications for Use (Describe)

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)

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

{3}------------------------------------------------

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."

{4}------------------------------------------------

510(k) Summary [as required by 807.92(c)]

I. SUBMITTER

a) Company: WARANTEC Co., Ltd.
b) Address: #411, #412, 474, Dunchon-daero, Jungwon-gu, Seongnam-si, Gyeonggi-do, 13229, Korea
Tel : +82-31-778-6328 c)
Fax : +82-70-4324-6328 d)
President of Company: Mr. Dong-Hwa Jang e)
f) Contact Person : Peter Chung, 412-687-3976
Contact Person Address: 300, Atwood Street, Pittsburgh, PA, 15213, USA g)
Date Prepared: June 16, 2018 h)

II. DEVICE

IU Implant System a) Trade Name :
Common Name : Endosseous Dental Implant System b)
c) Classification Name : implant, endosseous, root-form
Product Code : DZE (primary), NHA (secondary) d)
Regulation Number : 872.3640 e)
f) Class of device : Class II
Panel : Dental g)

III.PREDICATE DEVICE

Primary Predicate Device: a) Luna Dental Implant System / SHINHUNG MST Co., Ltd. / K123155
Reference Device: b) SuperLine / DENTIUM CO., LTD. / K160965 AnyOne 100 Internal Implant System / MegaGenImplant Co., Ltd. / K123988 Dentium Implantium® & SuperLine® Prosthetics / DENTIUM CO., LTD. / K141457 Dentium Implantium & SuperLine Prosthetics / DENTIUM CO., LTD. / K160828

IV. DEVICE DESCRIPTION

The IU Implant System is a dental implant made of titanium metal intended to be

{5}------------------------------------------------

surgically placed in the bone of the upper or lower jaw arches.

There are two types of Fixtures, triangular screw threads design and square screw threads design. The IU Implant System includes the each fixtures is available in various diameters (lengths) 3.6 mm (8.5 mm, 10.0 mm, 11.5 mm, 13.0 mm) & 4.1 mm, 4.6 mm, 5.1 mm, 5.6 mm, 6.1 mm (7.5 mm, 8.5 mm, 10.0 mm, 11.5 mm, 13.0 mm) of triangular screw threads design and 4.3 mm, 4.8 mm, 5.3 mm (7.0 mm, 8.5 mm, 10.0 mm, 11.5 mm, 13.0 mm) & 6.3 mm (7.0 mm, 8.5 mm, 10.0 mm, 11.5 mm) of square screw threads design according to the anatomical situation. Fixture is made of pure titanium metal and supplied sterile. The surface is SA, Sandblasting and Acid etching, treated.

Abutment is device made of titanium alloy and it is intended for use to make permanent prostheses and/or temporary prosthesis. The abutments are provided non-sterile and should be sterilized before use.

V. INDICATIONS FOR USE

VI. SUBSTANIAL EQUIVALNECE COMPARISON

The IU Implant System is similar designs and dimensions, and has the same material, intended use, surface treatment and technological characteristics as the identified primary predicate device (K123155) and reference devices (K160965/K123988/ K141457). When compared with predicate device, no new questions of substantial equivalence have been raised for the IU Implant System.

	Subject Device	Primary PredicateDevice	Reference Device	Reference Device
510(k) Number	K172345	K123155	K160965	K123988
Manufacturer	WARANTEC Co., Ltd.	SHINHUNG MST Co., Ltd.	DENTIUM CO., LTD.	MegaGenImplant Co., Ltd.
Common Name	Endosseous Dental Implant System	Endosseous Dental Implant System	Endosseous Dental Implant System	Endosseous Dental Implant System
Trade Name	IU Implant System	Luna Dental Implant System	SuperLine	AnyOneTM Internal Implant System
Device class	Class II	Class II	Class II	Class II
Product Code(s)	DZE	DZE	DZE	DZE
Indications for Use/Intended Use	The IU Implant System is intended to be surgically placed in the bone of the upper or lower jaw arches to	The Luna Dental Implant System is intended to be surgically placed in the bone of the upper or	SuperLine is indicated for use in surgical and restorative applications for placement in the bone of the upper or	The AnyOneTM Internal Implant System is intended to be surgically placed in the maxillary or
	provide support for	lower jaw arches to	lower jaw to provide	mandibular molar
	prosthetic devices,	provide support for	support for prosthetic	areas for the purpose
	such as artificial teeth,	prosthetic devices,	devices, such as	providing prosthetic
	and to restore the	such as artificial teeth,	artificial teeth, in order	support for dental
	patient's chewing	and to restore the	to restore the patient's	restorations (Crown,
	function.	patient's chewing	chewing function.	bridges, and
		function.	SuperLine is indicated	overdentures) in
			also for immediate	partially or fully
			loading when good	edentulous individuals.
			primary stability is	It is used to restore a
			achieved and with	patient's chewing
			appropriate occlusal	function. Smaller
			loading.	implants (less than
				06.0 mm) are
				dedicated for
				immediate loading
				when good primary
				stability is achieved
				and with appropriate
				occlusal loading.
				Larger implants are
				dedicated for the molar
				region and are
				indicated for delayed
				loading.
Implant design	Root-form endosseous	Implant, Endosseous,	Root-form endosseous	Root-form endosseous
	dental implants	Root-Form	dental implants	dental implants
Shape	a)b)
Connection	2.1, 2.5 Internal Hex	2.1, 2.5 Internal Hex	Internal Hex	Internal Hex
Diameter of fixture	a) 3.6, 4.1, 4.6, 5.1,	3.7, 4.2 – 5.7 mm	3.6, 4.0, 4.4, 4.9, 6.0,	Internal type
	5.6, 6.1 mm		7.0 mm	3.9, 4.3, 5.3, 6.3, 7.3
	b) 4.3, 4.8, 5.3, 6.3			mm (for normal
	mm			thread)
				4.8, 5.8, 6.8, 7.8, 8.3
				mm (for deep thread)
				4.8, 5.3, 6.3, 7.3 mm
				(for special length)
Length of fixture	a) 7.5, 8.5, 10.0, 11.5,	8.5 — 15.0 mm	7.0, 8.0, 10.0, 12.0,	Internal type
	13.0 mm		14.0 mm	7.0, 8.0, 9.5, 11.0,
	(cf. 3.6 mm diameter			12.5, 14.5 mm (for
	does not include a 7.5			normal and deep
	mm length.)			thread)
	b) 7.0, 8.5, 10.0, 11.5,			7.0 mm (for special
	13.0 mm			length)
	(cf. 6.3 mm diameter
	does not include a 13.0
	mm length.)
Material	Pure titanium (ASTMF67)	Pure titanium (ASTMF67)	Pure titanium (ASTMF67)	Pure titanium (ASTMF67)
Physical testingperformed	Not tested/noangulation submittedfor clearance.	Test according to ISO14801	Test according to ISO14801	Test according to ISO14801
Biocompatibility	Biocompatibleaccording to ISO10993-1	Biocompatibleaccording to ISO10993-1	Biocompatibleaccording to ISO10993-1	Biocompatibleaccording to ISO10993-1
Surface treatment	S.L.A	S.L.A	S.L.A	S.L.A
Sterilization method	Gamma radiation	Gamma radiation	Gamma radiation	Gamma sterilization
Shelf-life	7years	-	8years	-

Table 1 - Comparison of Endosseous Implant Characteristics

{6}------------------------------------------------

{7}------------------------------------------------

Table 2 - Comparison of Endosseous Abutments Characteristics

	Subject Device	Primary PredicateDevice	Reference Device	Reference Device
510(k) Number	K172345	K123155	K141457	K123988
Manufacturer	WARANTEC Co., Ltd.	SHINHUNG MSTCo., Ltd.	DENTIUM CO., LTD.	MegaGenImplant Co.,Ltd.
Common Name	Endosseous DentalImplant System	Endosseous DentalImplant System	Endosseous DentalImplant System	Endosseous DentalImplant System
Trade Name	IU Implant System	Luna Dental ImplantSystem	Dentium Implantium®& SuperLine®Prosthetics	AnyOne™ InternalImplant System
Device class	Class II	Class II	Class II	Class II
Product Code(s)	NHA	NHA	NHA	NHA
Indications for Use	The IU ImplantSystem is intended tobe surgically placed inthe bone of the upperor lower jaw arches toprovide support forprosthetic devices,such as artificial teeth,and to restore thepatient's chewingfunction.	The Luna DentalImplant System isintended to besurgically placed in thebone of the upper orlower jaw arches toprovide support forprosthetic devices,such as artificial teeth,and to restore thepatient's chewingfunction.	Dentium Implantium®& SuperLine®Prosthetics areintended for use as anaid in prostheticrehabilitation.	The AnyOne ™Internal ImplantSystem is intended tobe surgically placed inthe maxillary ormandibular molarareas for the purposeproviding prostheticsupport for dentalrestorations (Crown,bridges, andoverdentures) inpartially or fullyedentulous individuals.It is used to restore apatient's chewingfunction. Smaller

{8}------------------------------------------------

	Subject Device	Primary PredicateDevice	Reference Device	Reference Device
510(k) Number	K172345	K123155	K141457	K123988implants (less than06.0 mm) arededicated forimmediate loadingwhen good primarystability is achievedand with appropriateocclusal loading.Larger implants arededicated for the molarregion and areindicated for delayedloading.
Cover Screw
Shape	Image: Cover Screw Shape 1	Image: Cover Screw Shape 2	Image: Cover Screw Shape 3	Image: Cover Screw Shape 4
Material	Pure titanium (ASTMF67)	Pure titanium (ASTMF67)	Ti-6Al-4V-ELI(ASTM F136)	CP4 Titanium (ASTMF67)
Diameter	2.82, 3.32 mm	-	3.6 mm	-
Abutment Screw
Shape	Image: Abutment Screw Shape 1	Image: Abutment Screw Shape 2	Image: Abutment Screw Shape 3	Image: Abutment Screw Shape 4
Material	Titanium alloy (ASTMF136)	Titanium alloy (ASTMF136)	Titanium alloy (ASTMF136)	Ti-6Al-4V-ELI
Diameter	2.2 mm	-	1.8 ~ 2.3 mm	3.8 ~ 10.0 mm
	Subject Device	Primary PredicateDevice	Reference Device	Reference Device
510(k) Number	K172345	K123155	K160828	K123988
Manufacturer	WARANTEC Co., Ltd.	SHINHUNG MSTCo., Ltd.	DENTIUM CO., LTD.	MegaGenImplant Co.,Ltd.
Common Name	Endosseous DentalImplant System	Endosseous DentalImplant System	Endosseous DentalImplant System	Endosseous DentalImplant System
Trade Name	IU Implant System	Luna Dental ImplantSystem	Dentium Implantium®& SuperLine®Prosthetics	AnyOneTM InternalImplant System
Device class	Class II	Class II	Class II	Class II
Product Code(s)	NHA	NHA	NHA	NHA
Indications for Use	The IU ImplantSystem is intended tobe surgically placed in	The Luna DentalImplant System isintended to be	Dentium Implantium®& SuperLine®Prosthetics are	The AnyOne TMInternal ImplantSystem is intended to
	Subject Device	Primary PredicateDevice	Reference Device	Reference Device
510(k) Number	K172345	K123155	K160828	K123988
	the bone of the upperor lower jaw arches toprovide support forprosthetic devices,such as artificial teeth,and to restore thepatient's chewingfunction.	surgically placed in thebone of the upper orlower jaw arches toprovide support forprosthetic devices,such as artificial teeth,and to restore thepatient's chewingfunction.	intended for use as anaid in prostheticrehabilitation.	be surgically placed inthe maxillary ormandibular molarareas for the purposeproviding prostheticsupport for dentalrestorations (Crown,bridges, andoverdentures) inpartially or fullyedentulous individuals.It is used to restore apatient's chewingfunction. Smallerimplants (less than06.0 mm) arededicated forimmediate loadingwhen good primarystability is achievedand with appropriateocclusal loading.Larger implants arededicated for the molarregion and areindicated for delayedloading.
Temporary Abutment
Shape	Image: (Hex) (Non-Hex)	Image: (Hex) (Non-Hex)	Image: (Hex) (Non-Hex)	Image: Ti-6A1-4V-ELI
Material	Titanium alloy (ASTMF136)	Titanium alloy (ASTMF136)	Pure Titanium Grade 5(ASTM F67)	Ti-6A1-4V-ELI
Diameter	3.9 mm	4.0 ~ 6.0 mm	4.5 mm	3.8 ~ 10.0 mm
Two Piece Abutment
Shape	Image: (Hex)	Image: (Hex) (Non-Hex)	Image: (Hex) (Non-Hex)	Image: (Hex) (Non-Hex)
	Subject Device	Primary PredicateDevice	Reference Device	Reference Device
510(k) Number	K172345	K123155	K160828	K123988
	(Hex) (Non-Hex)
Material	Titanium alloy (ASTMF136)	Titanium alloy (ASTMF136)	Pure Titanium Grade 5(ASTM F67)	Ti-6Al-4V-ELI
Diameter	3.8, 4.5, 5.5 mm3.95, 4.95, 5.95 mm	4.0 ~ 6.0 mm	4.5, 5.5, 6.5 mm	3.8 ~ 10.0 mm
Solid Abutment
Shape	Image: Solid Abutment Shape Subject Device	Image: Solid Abutment Shape Primary Predicate Device	Image: Solid Abutment Shape Reference Device	Image: Solid Abutment Shape Reference Device
Material	Titanium alloy (ASTMF136)	Titanium alloy (ASTMF136)	Pure Titanium Grade 5(ASTM F67)	Ti-6Al-4V-ELI
Diameter	3.8, 4.95, 5.5 mm3.95, 4.95, 5.95 mm	4.0 ~ 6.0 mm	4.5, 5.5, 6.5 mm	3.8 ~ 10.0 mm
Healing Abutment
Shape	Image: Healing Abutment Shape Subject Device	Image: Healing Abutment Shape Primary Predicate Device	Image: Healing Abutment Shape Reference Device	Image: Healing Abutment Shape Reference Device
Material	Titanium alloy (ASTMF136)	Titanium alloy (ASTMF136)	Pure Titanium Grade 5(ASTM F67)	Ti-6Al-4V-ELI
Diameter	3.95, 4.95, 5.95 mm	4.0 ~ 6.0 mm	4.0, 4.5, 5.5, 6.5 mm	3.8 ~ 10.0 mm
Height	9.0, 10.0, 11.0, 12.0,13.0 14.0 mm	8.5 ~ 15.0 mm	8.2~14.6mm	7.7 ~ 18.7 mm
Ball Abutment
Shape	Image: Ball Abutment Shape Subject Device	Image: Ball Abutment Shape Primary Predicate Device	Image: Ball Abutment Shape Reference Device	-
Material	Titanium alloy (ASTMF136)	Titanium alloy (ASTMF136)	Pure Titanium Grade 5(ASTM F67)	Ti-6Al-4V-ELI
Diameter	4.3 mm	4.0~6.0 mm	3.3, 3.5 mm	3.8 ~ 10.0 mm
Multi Abutment
Shape	Image: Multi Abutment Shape Subject Device	Image: Multi Abutment Shape Primary Predicate Device	Image: Multi Abutment Shape Reference Device	Image: Multi Abutment Shape Reference Device
	Subject Device	Primary Predicate Device	Reference Device	Reference Device
510(k) Number	K172345	K123155	K160828	K123988
Material	Titanium alloy (ASTMF136)	Titanium alloy (ASTMF136)	Pure Titanium Grade 5(ASTM F67)	Ti-6Al-4V-ELI
Diameter	4.95 mm	4.0 ~ 6.0 mm	4.5, 5.5 mm	3.8 ~ 10.0 mm
Retained Abutment
Shape	Image: Retained Abutment	-	Image: Retained Abutment	-
Material	Titanium alloy (ASTMF136)	Titanium alloy (ASTMF136)	Ti-6A1-4V-ELI(ASTM F136)	Ti-6A1-4V-ELI(ASTM F136)
Diameter	4.3 mm	4.0 ~ 6.0 mm	3.7mm	3.8 ~ 10.0 mm
Height	8.4, 8.4, 9.4, 9.5, 10.4,10.5, 11.4, 11.5, 12.4,12.5, 13.4, 13.5 mm	8.5 ~ 15.0 mm	7.7~12.1mm	7.7 ~ 18.7 mm
Physical testingperformed	Not tested/noangulation submittedfor clearance.	Test according to ISO14801	Test according to ISO14801	Test according to ISO14801
Biocompatibility	Biocompatibleaccording to ISO10993-1	Biocompatibleaccording to ISO10993-1	Biocompatibleaccording to ISO10993-1	Biocompatibleaccording to ISO10993-1
Sterilization method	Non-sterile (Steamsterilization prior touse)	Non-sterile (Steamsterilization prior touse)	Non-sterile (Steamsterilization prior touse)	Non-sterile (Steamsterilization prior touse)

{9}------------------------------------------------

{10}------------------------------------------------

{11}------------------------------------------------

VII. NON-CLINICAL TEST DATA

The results of the non-clinical testing demonstrate that the results have met the criteria of the standards, and the subject device is substantially equivalent to the predicate device. This testing included:

Biocompatibility testing

The biocompatibility evaluation for the IU Implant System was conducted in accordance with the International Standard ISO 7405:2008, "Dentistry - Evaluation of biocompatibility of medical devices used in dentistry", ISO 10993-1:2009/AC:2010, "Biological Evaluation of Medical Devices - Part 1: Evaluation and Testing" as recognized by FDA.

Cytotoxicity (Elusion) -
Sensitization -
-Oral irritation
-Systemic Toxicity (acute)
Genotoxicity -
Implantation -

{12}------------------------------------------------

-Endotoxin Test (LAL test)
The USP <85> test method will be used to evaluate pyrogen limit specifications for the subject device. The endotoxin testing will be conducted on every batch for the subject device and the testing limit will be below 5 EU/mL. We referenced the USP 39 <85> to device on the endotoxin limit which is 5 EU/mL.

Sterilization Testing

Sterilization validating testing has been performed in accordance with ISO 11137-1:2006/Amd.1:2013, ISO 11137-2:2013 and ISO 11137-3:2006 for gamma sterilization and ISO 17665-1 and ISO 17665-2 for steam sterilization. Test results have demonstrated that the SAL of 10-6 was achieved and all testing requirements were met.

Shelf Life Testing

For the subject devices provided sterile, accelerated aging shelf life testing was conducted according to ASTM F1980; real time testing is being conducted to support accelerated aging results.

Risk Analysis

Risk analysis for IU Implant System was conducted in accordance with ISO 14971, Medical Devices: Application of Risk Analysis, for medical devices. It was determined by IU Implant System that all risks associated with IU Implant System were acceptable and as low as reasonably possible.

No clinical data were included in this submission.

VIII. Conclusion

In accordance with the Federal Food, Drug and Cosmetic Act, 21 CFR Part 807, and based on the information provided in this premarket notification WARANTEC Co., Ltd. concludes that the SHINHUNG MST Co., Ltd., DENTIUM CO., LTD., and MegaGenImplant Co., Ltd. is substantially equivalent to the predicate devices as described herein.

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.