IH Implant System is device made of titanium and titanium alloy indicated for in partially or fully edentulous mandibles and maxillae, in support of single or multiple-unit restorations including ; cemented retained or screw retained restorations and terminal abutment support for fixed bridgework. IH Implant System is for single and two stage surgical procedures. It is intended for delayed loading.

Device Description

IH2 SLA Fixture is dental implant made of titanium metal intended to be surgically placed in the bone of the upper or lower jaw arches. Fixture is made of pure titanium metal and supplied sterile. The surface is SLA (Sandblasted, Large grit and Acid etched) treated. IH2 SLA Fixture has a various diameters 3.7 to 5.1 mm (3.7, 4.2, 4.6 and 5.1mm) and lengths 8.5 to 15mm (8.5, 10, 11.5, 13 and 15mm).

AI/ML Overview

The provided text describes information for a 510(k) premarket notification for the "IH Implant System" by Sewon Medix Inc. This document focuses on demonstrating substantial equivalence to existing predicate devices rather than proving the device meets acceptance criteria through a traditional clinical study with reported performance metrics.

Therefore, many of the requested elements for a study proving device acceptance against specific criteria are not explicitly present in the provided text. The document details bench testing, specifically fatigue testing and biocompatibility, to show equivalence.

Here's a breakdown of the available information based on your request:

Acceptance Criteria and Device Performance

The concept of "acceptance criteria" in this 510(k) pertains to demonstrating that the new device is as safe and effective as a legally marketed predicate device. For the non-clinical testing performed, the acceptance criteria are generally "in compliance with" or "similar to" established standards and predicate device characteristics, rather than specific performance thresholds.

Table 1: Acceptance Criteria and Reported Device Performance (Non-Clinical Equivalence)

Test	Acceptance Criteria	Reported Device Performance ("IH Implant System")
Biocompatibility (Fixture)	In compliance with applicable international and US regulations (similar to predicate)	Cytotoxicity (OK), Sensitization (OK), Intracutaneous Reactivity (OK), Acute Systemic (OK), Implantation (OK), Genotoxicity (OK)
Biocompatibility (Prosthetic)	In compliance with applicable international and US regulations (similar to predicate)	Cytotoxicity (OK), Sensitization (OK), Irritation (OK), Acute Systemic (OK), Genotoxicity (OK)
Roughness of SLA Surface (Ra)	2.5~3.0 μm (similar to Osstem product catalog)	2.861 ± 0.262 μm
Sterilization Validation	VDmax 25 SAL 10-6 (similar to predicate)	VDmax 25 SAL 10-6
Packaging Validation (Shelf life)	8 years (predicate device shelf life)	5 years
Fatigue Testing	In compliance with "Guidance for industry and FDA staff Class II Special Controls Guidance Document Root-form Endosseous Dental Implants and Endosseous Dental Abutment" and ISO 14801:2007 (similar to predicate)	Results are in compliance and were similar to previously cleared predicate devices.

Study Details (as far as available in the text)

Sample size used for the test set and the data provenance:
- The document does not specify a "test set" in the context of a clinical study or human performance evaluation.
- For biocompatibility and fatigue testing, the sample sizes are not explicitly stated. These are typically bench tests performed on a representative number of devices.
- Data provenance: For Fatigue Testing, it was "conducted according to... ISO 14801:2007 Dentistry - Fatigue test for endosseous dental implants with the worst case scenario." For Biocompatibility, it states "Testing including biocompatibility has been performed to demonstrate that the devices comply with the applicable international and US regulations." The text does not provide country of origin or whether it was retrospective/prospective data, as these are non-clinical lab tests.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. This document describes non-clinical bench testing for substantial equivalence, not a study requiring human expert ground truth.
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable. This is not a study requiring adjudication of expert interpretations.
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:
- Not applicable. This is not an AI-assisted device or an MRMC study.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is a physical dental implant system, not an algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not applicable in the sense of clinical ground truth. For non-clinical tests (biocompatibility, fatigue, surface roughness), the "ground truth" or reference is established by international standards (e.g., ISO 14801, ASTM F67-06), regulatory guidance, and the characteristics of the legally marketed predicate devices.
The sample size for the training set:
- Not applicable. This device does not involve a "training set" as it is a physical medical device, not an AI/machine learning product.
How the ground truth for the training set was established:
- Not applicable for the same reason mentioned above.

In summary: The provided 510(k) focuses on demonstrating substantial equivalence of a physical dental implant system through non-clinical laboratory testing. It does not present a clinical study with human subjects, associated acceptance criteria as performance metrics, or the human-involved "ground truth" and reader performance details common in studies for diagnostic devices or AI algorithms. The "acceptance criteria" here refer to meeting established safety and performance standards via bench testing to show similarity to predicate devices.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, with flowing lines representing hair or clothing.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

October 14, 2016

Sewon Medix Inc. % April Lee Consultant Withus Group Inc. 2531 Pepperdale Drive Rowland Heights, California 91748

Re: K153521

Trade/Device Name: IH Implant System Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: Class II Product Code: DZE, NHA Dated: September 12, 2016 Received: September 16, 2016

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. 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 (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in

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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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Michael J. Ryan -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

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Image /page/2/Picture/0 description: The image contains the logo for Sewonmedix Inc., a dental implant system company. The logo features a stylized, colorful graphic to the left of the company name, which is written in a bold, blue font. Below the main logo, the text "Sewonmedix Inc." is written in a smaller, serif font. The overall design is clean and professional, reflecting the company's focus on dental implants.

9, Sa-sang-ro, 375beon-gil, Sa-sang-gu, Busan, Korea Tel : +82.51.303.1713/Fax : +82.51.303.1714 / www.sewonmedix.com

Indication for Use Statement

510(k) Number: K 153521

Device Name: IH Implant System

Prescription Use______________________________________________________________________________________________________________________________________________________________

Over-The-Counter Use _ _ _ _ _ _

(Per 21CFR801 Subpart D)

(Per 21CFR807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

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510(k) Summary

This summary information is being submitted in accordance with requirements of 21 CFR Part 807.92.

Submitter

Sewon Medix Inc. Mr. Bum-keun Park #29, Sa-sang-ro, 375beon-gil, Sa-sang-gu, Busan, South Korea Email: iceing99@sewonmedix.com Tel. +82-51-303-1713 Fax. +82-51-303-1714

Official Correspondent

Withus Group Inc April Lee 2531 Pepperdale Drive, Rowland Heights, CA 91748 USA Email: withus6664@gmail.com Phone: 1-909-274-9971 Fax: 1-909-460-8122

Trade Name: IH Implant System
Common Name: Dental Implant System ●
Classification Name: Endosseous dental implant
Primary Product Code: DZE
Secondary Product Code: NHA
Panel: Dental
Regulation Number: 872.3640 ●
Device Class: Class II
Date prepared: 10/05/2016 .

General Description :

IH Prosthetic System is device made of titanium alloy, CCM alloy and POM intended for use as an aid in prosthetic restoration. It consists of Abutments (Healing Abutment, Solid Abutment, Cement Abutment, Angled Abutment, Temporary Abutment, Multi-unit Abutment and FreeMilling Abutment), Solid Protect Cap, Abutment Screws, Healing Cap, Cylinders (CCM Cylinder, Temporary Cylinder, Plastic Cylinder) and Cylinder Screws. Its surfaces are partially TiN coated or uncoated. IH Prosthetic System is supplied non-sterile and should be sterilized before use. It has a various diameters, gingival heights, heights and angles. Healing Abutment has a various diameters 4 to 6.5mm (4, 4.5, and 5, 5.5, 6 and 6.5 mm) and lengths 7.5 to 12.4mm (7.5, 8.4, 9.5, 10.4, 11.5 and 12.4mm). Solid Abutment has various diameters 4 to 7mm (4, 4.5, and 6.5 mm), gingival heights 1 to 5mm (1, 1.5, 2, 2.5, 3, and 3.5, 4, 4.5 and 5 mm) and heights 4 to 7mm (4, 5.5 and 7mm). Cement Abutment has various diameters 4.5 to 6.5mm (4.5, 5, 5.5, 6 and 6.5mm), gingival heights 1 to 5mm (1, 1.5, 2, 2.5, 3, and 3.5, 4, 4.5 and 5 mm) and heights 4 to 7mm (4, 5.5 and 7mm). Angled Abutment has various diameters 4.5 to 6mm (4.5, 5.5 and 6mm), gingival heights 2 to 4mm ( 2, 3, and 4mm), heights 7.5 to 8mm (7.5 and 8mm) and angle 15° to 25° (15° and 25°), Temporary Abutment has various diameters 4 to 4.5mm (4 and

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4.5mm), gingival heights 1 to 3mm (1 and 3mm) and height 9.6mm. Multi-unit Abutment has various diameters 4.7 to 5.13mm (4.7, 4.8 and 5.13mm), gingival heights 1.5 to 4.5mm (1.5, 2.5, 3.5 and 4.5mm) and angle 17° to 30° (17° and 30°) and FreeMilling Abutment has various diameters 4.5 to 6.5mm (4.5, 5, 5.5, 6 and 6.5mm), gingival heights 1 to 3mm (1, 2 and 3mm) and heights 10 to 12mm (10, 11 and 12mm). IH Prosthetic System is device made of titanium, titanium alloy, CCM alloy and POM. Angled Abutment, Temporary Abutment, Healing Cap, Temporary Cylinder and FreeMilling Abutment are made of titanium. Healing Abutment, Solid Abutment, Cement Abutment, Multi-unit Abutment Screw and Cylinder Screw are made of titanium alloy. CCM Cylinder is made of Cobalt-Chrome-Molybdenum alloy. Solid Protect Cap and Plastic Cylinder are made of POM.

Indications for Use:

IH Implant System is device made of titanium and titanium alloy indicated for in partially or fully edentulous mandibles and maxillae, in support of single or multiple-unit restorations including; cemented retained or screw retained restorations and terminal or interminal abutment support for fixed bridgework. IH Implant System is for single and two stage surgical procedures. It is intended for delayed loading.

Predicate Device:

Substantial Equivalence Matrix (IH2 SLA Fixture)

. TS Fixture System, OSSTEM Implant Co., Ltd. K121995 - primary predicate
Straumann® Bone Level Tapered Implant, Institut Straumann Ag, K140878 ●

	IH2 SLA Fixture	Predicate devices
		primary predicate	reference predicate
		TS Fixture System	Straumann® BoneLevel Tapered Implant
Manufacturer	Sewon Medix Inc.	OSSTEM Implant Co.,Ltd.	Institut Straumann Ag
Design	Image: IH2 SLA Fixture	Image: TSIII SA Fixture	Image: Straumann Bone Level Tapered Implant
510(k) No.	K153521	K121995	K140878
Indication forUse	IH Implant System isdevice made of titaniumand titanium alloyindicated for in partiallyor fully edentulousmandibles and maxillae,in support of single or	The TS Fixture Systemis indicated for use inpartially or fulllyedentulous mandiblesand maxillae, in supportof single or multiple unitrestorations including;cemented retained, screw	Straumann® dentalimplants are indicate fororal endostealimplantation in the upperand low jaw and for thefunctional and estheticoral rehabiliation ofedentulous and partially
	multiple-unit restorationsincluding; cementedretained or screwretained restorations andterminal or interminalabutment support forfixed bridgework. IHImplant System is forsingle and two stagesurgical procedures. It isintended for delayedloading.	retained, or overdenturerestorations, and final ortemporary abutmentsupport for fixed bridgework. It is intended fordelayed loading.	dentate patients.Straumann dentalimplants can also beused for immedicate orearly implantationfollowing extraction orloss of natural teeth.Implants can be placedwith immediate functionon single-tooth and/ormultiple toothapplications when goodprimary stability isachieved and withappropriate occlusalloading, to restorechewing function. Theprosthetic restorationsused are single crowns,bridge and partial or fulldentures, which areconnected to theimplants by thecorrepondingelements(abutments). Incase of fully edentulouspatients, 4 or moreimplants must be used inimmediately loadedcase.
Surgery Type	One or two stageSurgery	One or two stageSurgery	One or two stageSurgery
Structure	- Internal Hex connected- Submerged fixture- Tapered body shape- Cutting edge with self-tapping- 0.8mm thread pitch	- Internal Hex connected- Submerged fixture- Tapered body shape(TSIII SA Fixture)- Cutting edge with self-tapping- 0.8mm thread pitch	- Internal connected- Submerged fixture- Tapered body shape- Cutting flutes- 0.8mm thread pitch
ConnectionType	Internal hex connection	Internal hex connection	Internal connection
Diameter (D)	3.7, 4.2, 4.6, 5.1	TSIII SA Fixture3.75, 3.77, 4.2, 4.25, 4.64.63, 4.65, 5.05, 5.08,5.1	3.3, 4.1, 4.8
Length (mm)	8.5, 10, 11.5, 13, 15	7, 8.5, 10, 11.5, 13, 15	8, 10, 12, 14, 16
Material ofFixture	Pure Titanium Grade 4(ASTMF67-06)	Pure Titanium Grade 4(ASTMF67-06)	Pure Titanium Grade 4(ASTMF67-06)
Surface	SLA	SA	SLA

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Sterilization	Radiation Sterile	Radiation Sterile	Radiation Sterile
Shelf life	5 years	8 years	-

Substantial Equivalence Matrix (IH Prosthetic System)

Hiossen Prosthetic System, OSSTEM Implant Co., Ltd., K140507 - primary predicate
Multi Angled Abutment, OSSTEM Implant Co., Ltd., K123755
. Healing Abutment, OSSTEM Implant Co., Ltd., K081575

	IH Prosthetic System	Predicate devices
		primary predicate	reference predicate
		Hiossen Prosthetic System	Multi Angled Abutment	Healing Abutment
Manufacturer	Sewon Medix Inc.	OSSTEM Implant Co., Ltd.	OSSTEM Implant Co., Ltd.	OSSTEM Implant Co., Ltd.
Design	Image: Healing	-	-	Image: Healing
	Image: Solid	Image: Rigid	-	-
	Image: Cement	Image: Transfer	-	-
	Image: Angled	Image: Angled	-	-


Image: Temporary	Image: Temporary
Image: Straight Angled Multi-Unit	Image: Convertible	Image: Multi Angle


Image: FreeMilling	Image: Freeform
510(k) No.	K140507	K123755	K081575
Description	Healing Abutment isused to make a softtissue shape beforesetting up prostheticsand removing coverscrew afterosseointergration.Angled Abutment isan abutment which hascertain angle to easyfor adjustment ofinstallation angle ofprosthesis.Temporary Abutmentis used temporary untilfinal prosthesis ismade to maintainesthetic appreciationand chew ability.Multi-Unit Abutmentis used for screwretained multiple case.Solid, Cement and	The HiossenProsthetic System isintended for use anaid in prostheticrestoration. Itconsists ofAbutment,overdenturecomponents andAbutment Screws.The HiossenProsthetic system issimilar to othercommerciallyavailable productsbase on the intendeduse, the technologyused, the claims, thematerial compositionemployed andpermanencecharacteristics.	Multi AngledAbutment isused to elevaterestorationplatform whenrestoration toimplant levelis not practicaldue to depth orangle ofimplant for theedentulouspatients inAnterior andPosterior , notcustomizableand can't beuse a singleproduct.	Used to makea soft tissueshape beforesetting upprosthetics andremovingcover screwafterosseointergration.
	to fabricate aprosthesis of internalsingle & bridgecement retained type.
Indication forUse	IH Implant System isdevice made oftitanium and titaniumalloy indicated for inpartially or fullyedentulous mandiblesand maxillae, insupport of single ormultiple-unitrestorations including;cemented retained orscrew retainedrestorations andterminal or interminalabutment support forfixed bridgework. IHImplant System is forsingle and two stagesurgical procedures. Itis intended for delayedloading.	Hiossen ProstheticSystem is intendedfor use with a dentalimplant to providesupport for prostheticrestorations such ascrowns, bridges, oroverdentures.	Multi AngledAbutment isintended foruse a dentalimplant toprovidesupport forprostheticrestorationsuch ascrowns,bridges, oroverdentures.	HU/HS/HGProstheticSystem isintended foruse as an aidprestheticrestioration.
Structure	External Hex	External Hex	External Hex	-
ConnectionType	Screw & ExternalHex-Connected	Screw & ExternalHex-Connected	Screw &External Hex-Connected	ScrewConnected
Diameter (D)	Healing :4.0/4.5/5.0/5.5/6.0/6.5Solid : 4.0/4.5/5.0/5.5/6.0/6.5/7.0Cement : 4.5/5.0/5.5/6.0 /6.5Angled : 4.5/5.0/5.5/6.0Temporary Abutment :4.0/4.5Multi-unit Abutment_Straight : 4.8_Angled : 4.7/5.13FreeMilling : 4.5/5.0/5.5/6.0/6.5	Rigid :4.0/4.6/5.0/6.0/7.0/8.0Transfer :4.0/4.6/5.0/6.0/7.0/8.0Angled : 4.0/4.3/4.5/4.8/5.5/6.0Temporary : 4.0/4.3/4.5Convertible : 3.5/4.0/4.8/5.5/6.0Freeform : 4.0/5.5/7.0	Multi Angle : -	Healing :4.0/4.5/5.0/6.0/7.0/8.0

G/H Length (mm)	Healing : -Solid : 1.0/1.5/2.0/2.5/3.0/3.5/4.0/4.5/5.0Cement: 1.0/1.5/2.0/2.5/3.0/3.5/4.0/4.5/5.0Angled : 2.0/3.0/4.0Temporary: 1.0/3.0Multi-unit AbutmentStraight: 1.5/2.5/3.5/4.5Angled : 2.5/3.5/.5FreeMilling: 1.0/2.0/3.0	Rigid :0.5/1.0/2.0/2.5/3.0/4.0/5.0Transfer :0.5/1.0/2.0/2.5/3.0/4.0/5.0Angled : 0.5/1.0/2.0/2.5 / 3.0 / 4.0Temporary: 1.0/2.0/3.0/4.0Convertible: 0.5/1.0/2.0/2.5/3.0/4.0/5.0/6.0Freeform: 0.5/1.0/1.5/2.0/2.5/3.0/4.0/5.0	Multi Angle : -	Healing :3.0/4.0/5.0/7.0
Post Length (mm)	Healing : -Solid: 4.0/5.5/7.0Cement: 4.0/5.5/7.0Angled: 7.5/8.0Temporary : -Multi-unit AbutmentStraight : 2.2Angled : -FreeMilling: 10.0/11.0/12.0	Rigid : 4.0/5.5/7.0Transfer : 4.0/5.5/7.0/8.0Angled : -Temporary : -Convertible : -Freeform :-	Multi Angle:-	Healing: -
Angle(°)	Angled : 15°/25°Multi-unit_Angled :17°/30°	Angled : 17°	Multi Angel :17°/30°	-
Material of Abutment	Titanium Alloy(ASTM F 136) :Healing, Solid,Cement, Multi-unitPure Titanium Gr. 4(ASTMF67-06) :Angled, Temporary,FreeMilling	Titanium Alloy(ASTM F 136) :Rigid, Transfer,Angled, Convertible,FreeformPure Titanium Gr. 4(ASTMF67-06) :Temporary	TitaniumAlloy (ASTMF 136) :	Pure TitaniumGr.4(ASTMF67-06)
Surface	Machine or TiN	Machine or TiN	Machine	Machine
Sterilization	Non-Sterile	Non-Sterile	Non-Sterile	RadiationSterile
Technological Characteristics	IH Prosthetic System is similar to predicate devices such as shape, structure, dimension and material. but it has different characteristics for each abutment.1.Material
	IH Prosthetic System		Predicate device
	HealingTitanium Alloy		Pure Titanium Gr.4
	AngledPure Titanium Gr.4		Titanium Alloy
	FreeMillingPure Titanium Gr.4		Titanium Alloy
	2.Shape (TiN Coating area)
	IH Prosthetic System		Predicate device

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FreeMilling	Non Coating	Only Gingiva (Middle)
3.Shape (Post Angle)
	IH Prosthetic System	Predicate device
Angled	15° / 25°	17°
4.Sterilization
	IH Prosthetic System	Predicate device
Healing	Non-Sterile	Radiation Sterile
others	Non-Sterile	Non-Sterile

Substantial Equivalence Review:

IH2 SLA Fixture has same material, machining, surface treatment, and indication for use and similar design and technological characteristics as the predicate device. IH Prosthetic System has same indication for use and manufacturing process including raw material, machining, cleaning and surface treatment and similar design and technological characteristics as the predicate device.

IH Implant System has been subjected to performance and product validations prior to release. Testing including biocompatibility has been performed to ensure the devices comply with the applicable International and US regulations.

The differences between the subject device and predicate devices are detailed shape and detailed dimension of diameter and length.

Any differences between the subject device and predicate devices do not raise new types of substantially equivalent issues.

		IH ImplantSystem	PredicateDevice	Ref.
Biocompatibility(Fixture)	Cytotoxicity	OK	OK	-
	Sensitization	OK	OK	-
	IntracutaneousReactivity	OK	OK	-
	Acute Systemic	OK	OK	-
	Implantation	OK	OK	-
	Genotoxicity	OK	OK	-
Biocompatibility(Prosthetic)	Cytotoxicity :	OK	OK	-
	Sensitization :	OK	OK	-
	Irritation	OK	OK	-
	Acute Systemic	OK	OK	-
	Genotoxicity	OK	OK	-
Roughness of SLA Surface (Ra)		2.861±0.262 μm	2.5~3.0 μm	Osstem productCatalog
Sterilization Validation		VDmax 25SAL 10-6	VDmax 25SAL 10-6	-
Packaging Validation (Shelf life)		5years	8years	-

Summary of non-clinical testing:

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K153521

Testing including biocompatibility has been performed to demonstrate that the devices comply with the applicable international and US regulations.

Fatigue testing for IH2 SLA Fixture and IH Angled Abutment was conducted according to the "Guidance for industry and FDA staff Class II Special Controls Guidance Document Root-form Endosseous Dental Implants and Endosseous Dental Abutment" and ISO 14801:2007 Dentistry - Fatigue test for endosseous dental implants with the worst case scenario. The results are in compliance with it and were similar to previously cleared predicate devices.

Conclusion:

In accordance with the Federal Food, Drug and Cosmetic Act.21 CFR Part 807and based on the information provided in this premarket notification Sewon Medix Inc. Therefore, the IH Implant System is substantially equivalent to the predicate device 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.