IH Implant System is device made of titanium alloy indicated for in partially or fully edentulous mandibles and maxillae, in support of single or multiple-unit restorations including; cemented retained restorations and terminal or interminal abutment support for fixed bridgework. IH Implant System is for stage surgical procedures. It is intended for delayed loading. The system includes IH2 SLA Fixtures, IH Healing Abutments, IH Cement Abutments, and IH Multi-unit Abutments. The fixtures are endosseous threaded implants with a surface treatment of sand blasting and acid etching. The abutments are premanufactured and connect directly to the implant. The materials used are Pure Titanium Grade 4 (ASTMF67-06) and Titanium Alloy (ASTM F 136).

AI/ML Overview

The provided text is a 510(k) Summary for the "IH Implant System." It describes the device and its claimed substantial equivalence to predicate devices, but it does not contain information about acceptance criteria for device performance or a study proving it meets those criteria, nor does it include details like sample sizes for test sets, data provenance, ground truth establishment, or multi-reader multi-case study results.

This document focuses on demonstrating that the new IH Implant System is safe and effective as existing legally marketed dental implant systems. The "Substantial Equivalence Review" section details how various components of the IH Implant System are similar to previously cleared devices.

The "Summary of non-clinical testing" section lists various types of tests performed to support substantial equivalence, such as:

Endotoxin testing (USP <85> and <161>)
Biological Evaluation (ISO 10993-1, Cytotoxicity Testing ISO 10993-5)
Fatigue Testing (ISO 14801:2016)
Gamma sterilization validation (ISO 11137-1 and ISO 11137-2)
End User Sterilization Validation (ANSI/AAMI ST79, ISO 17665-2, ISO 11737-1, ISO 11737-2, ISO 11138-1 and ISO 11138-3)
Shelf Life Test (ASTM F1140, ASTM F1929, ASTM F2096, ASTM F1980 and ISO 11607)
Worst-case MRI review

However, it does not provide the specific acceptance criteria for these tests, nor does it report the quantitative results or performance metrics that would typically be described in the context of an "acceptance criteria and study" table. The document concludes that "The non-clinical testing results demonstrate that the subject device is substantially equivalent to the predicate devices," implying that the device passed these tests relative to the predicate, but the specific performance data is not disclosed here.

Therefore, I cannot provide the requested table and detailed information based on the provided text. The document is a regulatory submission for substantial equivalence, not a clinical or performance study report with specific acceptance criteria and detailed device performance outcomes.

Summary

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

Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

Sewon Medix Inc. Jinsoo Lee CEO #29, Sa-sang-ro, 375beon-gil, Sa-sang-gu Sa-sang-gu, Busan 46700 Korea. South

7/7/2023

Re: K222707

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: June 01, 2023 Received: June 08, 2023

Dear Jinsoo Lee:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

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

{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) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely.

Sherrill Lathrop Blitzer

for Andrew 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

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Indications for Use

510(k) Number (if known) K222707

Device Name IH Implant System

Indications for Use (Describe)

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

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Image /page/3/Picture/0 description: The image shows the alphanumeric string "K222707" in a simple, sans-serif font. The characters are uniformly sized and spaced, creating a clear and legible sequence. The text is presented in black against a plain white background, ensuring high contrast and readability.

Image /page/3/Picture/1 description: The image shows the logo for Sewon Medix Dental Implant System. The logo features a stylized geometric shape in shades of orange and blue on the left. To the right of the shape, the words "SEWON MEDIX" are written in a bold, blue sans-serif font. Above the company name, the words "DENTAL IMPLANT SYSTEM" are written in a smaller, gray sans-serif font.

510(k) Summary

Date: July 7, 2023 K22707

1. Submitter

SEWONMEDIX Inc. JinSoo, Lee #29, Sa-sang-ro, 375beon-gil, Sa-sang-gu, Busan, Republic of Korea TEL: +82-51-303-1713 FAX: +82-51-303-1714 info@sewonmedix.com

2. Device Information

. 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

3. Predicate Device

Primary Predicate Device

IH Implant System, SEWONMEDIX Inc., K153521

Reference Devices

HIOSSEN Implant System, HIOSSEN Inc., K140934 OSSTEM Implant System-Abutment, OSSTEM Implant Co., Ltd., K161689 Multi Angled Abutment, OSSTEM Implant Co., Ltd. K123755

4. General Description

4-1) IH2 SLA Fixture

IH2 SLA Fixtures are endosseous threaded implants available in diameters of 3.7, 4.2, 4.6, 5.1 and 5.95mm. IH2 SLA Fixture is dental implant fixture that is used to replace root part of the tooth on full or partial edentulous patients. The surface treatment was carried out by sand blasting with alumina (A12O3) powder followed by acid etching on the surface of machined titanium in order to provide roughness on the surface that would increase the surface area for the bone contact. The implants are compatible with SEWONMEDIX restorative components featuring the internal conical connection.

Platform	Fixture Diameter	Height(mm)
		7	8.5	10	11.5	13	15
Mini	Ø3.7	-	○	○	○	○	○
Regular	Ø3.8	●	○	○	○	○	○
	Ø4.2	●	○	○	○	○	○
	Ø4.5	●	○	○	○	○	○
	Ø5.0	●	○	○	○	○	○
	Ø5.95	●	●	●	●	●	-

< Table a: Identification of subiect device and primary predicate device >

(●: Subject Device / ○: primary predicate device)

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

Image /page/4/Picture/1 description: The image shows the logo for Sewon Medix Dental Implant System. The logo features a stylized, geometric design in shades of orange and blue on the left. To the right of the design is the company name, "SEWONMEDIX," in bold, blue capital letters, with the words "DENTAL IMPLANT SYSTEM" in smaller, gray letters above the company name.

4-2) IH Healing Abutment

IH Healing Abutments is premanufactured dental implant abutments which can be directly connected to the endosseous dental implant to support healing of the surrounding soft tissue. The following table summarizes the matching of various healing abutments and Abutment Gingival height, including key information of each type of IH Healing Abutment according to the connection type.

Diameter	Height(mm)
	6.5	7.5	8.4	8.5	9.5	10.4	10.5	11.5	12.4
Ø4	●	○	○	●	○	○	●	○	○
Ø4.5	●	○	○	●	○	○	●	○	○
Ø5	●	○	○	●	○	○	●	○	○
Ø5.5	●	○	○	●	○	○	●	○	○
Ø6	●	○	○	●	○	○	●	○	○
Ø6.5	●	○	○	●	○	○	●	○	○
Ø9	●	●	●	●	●	●	●	●	●

< Table b: Identification of subject device and primary predicate device >

: Subject Device / ○: primary predicate device)

4-3) IH Cement Abutment

A Premanufactured dental implant abutment directly connected to the endosseous dental implant intended for use as an aid in prosthetic rehabilitation.

Cement retained restoration: IH Cement Abutment

IH Prosthetic System is device made of titanium alloy intended for use as an aid in prosthetic restoration. Its surfaces are partially TiN-Coated or uncoated.

		Height(mm)
Platform	Diameter	4	5.5	7
Mini	Ø4.5	-	O	●
Regular	Ø4.5	●	O	●
	Ø5	O	O	O
	Ø5.5	O	O	O
	Ø6	O	O	O
	Ø6.5	O	O	O

< Table c: Identification of subject device and primary predicate device >

(●: Subject Device / ○: primary predicate device)

4-4) IH Multi-unit Abutment

A pre-manufactured dental implant abutment to be directly connected to an endosseous dental implant intended for use as an aid in prosthetic rehabilitation.

The IH Multi-unit Abutment is made of titanium alloy.

< Table d: Identification of subject device and primary predicate device >

Straight type ।

Connect Diameter	Gingival Height(mm)
	1.5	2.5	3.5	4.5
Ø 2.88	●	●	●	●
Ø 3.43	○	○	○	○

Angled type =

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

Image /page/5/Picture/1 description: The image shows the logo for Sewonmedix Dental Implant System. The logo features a stylized flower-like graphic in shades of orange and blue on the left. To the right of the graphic is the company name "SEWONMEDIX" in bold, blue letters, with the words "DENTAL IMPLANT SYSTEM" in smaller, gray letters above the company name.

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

Connect Diameter	Angle(°)	Gingival Height(mm)
		2.5	3	3.5	4	4.5	5
Ø 2.88	17	●	●	-	●	-	-
Ø 2.88	30	-	-	●	●	-	●
Ø 3.43	17	○	●	○	●	-	-
Ø 3.43	30	-	-	○	●	○	●

(●: Subject Device / ○: primary predicate device)

5. Indications for Use

6. Substantial Equivalence

● Substantial Equivalence (Fixture System)

Item	Subject device	Primary predicate device	Reference device
			ET III SA Fixture / ET III SAUltra Wide Fixture / ET II SA
Device name	IH2 SLA Fixture	IH2 SLA Fixture	Fixture

510(k) No.	N/A	K153521	K140934
Design	Image: design of IH2 SLA Fixture	Image: design of IH2 SLA Fixture	Image: design of ET III SA Fixture / ET III SA Ultra Wide Fixture / ET II SA Fixture
	IH Implant System is device	IH Implant System is device	The HIOSSEN Implant System is
Indication for Use	made of titanium and titaniumalloy indicated for in partially orfully edentulous mandibles andmaxillae, in support of single ormultiple-unit restorationsincluding; cemented retained orscrew retained restorations andterminal or interminal abutmentsupport for fixed bridgework. IHImplant System is for single andtwo stage surgical procedures. Itis intended for delayed loading.	made of titanium and titaniumalloy indicated for in partially orfully edentulous mandibles andmaxillae, in support of single ormultiple-unit restorationsincluding; cemented retained orscrew retained restorations andterminal or interminal abutmentsupport for fixed bridgework. IHImplant System is for single andtwo stage surgical procedures. Itis intended for delayed loading.	indicated for use in partially orfully edentulous mandibles andmaxillae, in support of single ormultiple-unit restorationsincluding; cemented retained,screw retained, or overdenturerestorations, and final ortemporary abutment support forfixed bridgework. It is intendedfor delayed loading. ETIII SAUltra-Wide Fixture is intended tobe used in the molar region.
Surgery Type	One or two stage Surgery	One or two stage Surgery	One or two stage Surgery
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- Cutting edge with self-tapping- 0.8mm thread pitch	- Internal Hex connected- Submerged fixture- Tapered body shape & straightbody shape
Diameter (D)	3.7, 4.2, 4.6, 5.1, 5.95	3.7, 4.2, 4.6, 5.1	3.5, 3.75, 3.77, 4.2, 4.25, 4.45,4.6, 4.25, 4.63, 4.65, 4.9, 5.0,5.05, 5.08, 5.1, 5.92, 5.95, 6, 6.8
Length (mm)	7.0, 8.5, 10, 11.5, 13, 15	8.5, 10, 11.5, 13, 15	6.2, 7.2, 8.7, 10.2, 11.7, 13.2,15.2, 18.2
Material ofFixture	Pure Titanium Grade 4(ASTMF67-06)	Pure Titanium Grade 4(ASTMF67-06)	Pure Titanium Grade 4(ASTMF67-06)

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

K222707

Image /page/6/Picture/1 description: The image shows the logo for Sewon Medix Dental Implant System. The logo features a stylized geometric shape in orange and blue on the left, followed by the company name "SEWONMEDIX" in bold, blue letters. Above the company name, the words "DENTAL IMPLANT SYSTEM" are written in smaller, gray font.

SEWONMEDIX Inc.

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

Surface	SLA	SLA	SLA
Sterilization	Radiation Sterile	Radiation Sterile	Radiation Sterile
Shelf life	5 years	5 years	8 years

As previously cleared in K153521 except with added new models of diameter 5.95 or length 7.0, new packaging types (IH2 Fixture with Pre-Mount type). The subject device has the same indications for use as the primary predicate device (K153521) and there is no difference that would impact substantial equivalence.

Item	Subject device	Primary predicate device	Reference device
Device name	IH Cover Screw	IH Cover Screw	Cover Screw
510(k) No.	N/A	K153521	K140934
Design	Image: Subject device	Image: Primary predicate device	Image: Reference device
DeviceDescription	Used to protect the exposedplatform of the implant duringhealing period.	Used to protect the exposedplatform of the implant duringhealing period.	Used to protect the exposedplatform of the implant duringhealing period.
Diameter (D)	3.13, 3.6	3.13/3.6	3.03, 3.58, 3.25, 3.4, 3.75, 3.9
Length (mm)	5/5.2/5.8	5/5.8	5.25, 5.9, 6.25, 6.85, 6.9, 7.5
Material	Pure Titanium Gr. 4(ASTMF67)	Pure Titanium Gr. 4(ASTMF67)	Pure Titanium (ASTM F 67)
Surface	Anodizing	Anodizing	Anodizing

As previously cleared in K153521 except with added new models of length 5.2mm.

● Substantial Equivalence (IH Prosthetic System)

Item	Subject device	Primary predicate device
Device name	IH Healing Abutment	IH Healing Abutment
510(k) No.	N/A	K153521
Design	Image: Subject device design	Image: Primary predicate device design
Description	IH Healing Abutment is used to make a softtissue shape before setting up prosthetics andremoving cover screw after osseointergration.	IH Healing Abutment is used to make a softtissue shape before setting up prosthetics andremoving cover screw after osseointergration.
Connection Type	Screw Connected	Screw Connected
Diameter (D)	4/4.5/5/5.5/6/6.5/9	4/4.5/5/5.5/6/6.5
Height(mm)	6.5/7.5/8.4/8.5/9.5/10.4/10.5/11.5/12.4	7.5/8.4/9.5/10.4/11.5/12.4
Material	Titanium Alloy (ASTM F 136)	Titanium Alloy (ASTM F 136)
Surface	None	None

As previously cleared in K153521 except with added new models of diameter 9 and height 6.5, 8.5, 10.5, 11.5mm.

Item	Subject device	Primary predicate device
------	----------------	--------------------------

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

Image /page/7/Picture/1 description: The image shows the logo for Sewon Medix Dental Implant System. The logo features a stylized, segmented circular design in shades of orange and blue on the left. To the right of the design is the company name "SEWON MEDIX" in bold, blue sans-serif font. Above the company name, in smaller gray font, are the words "DENTAL IMPLANT SYSTEM."

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

Device name	IH Cement Abutment	IH Cement Abutment
510(k) No.	NA	K153521
Design	Image: IH Cement Abutment	Image: IH Cement Abutment
Description	A Premanufactured dental implant abutmentdirectly connected to the endosseous dentalimplant intended for use as an aid in prostheticrehabilitation.Cement retained restoration: IH CementAbutmentIH Prosthetic System is device made oftitanium, titanium alloy intended for use as anaid in prosthetic restoration. Its surfaces arepartially TiN-Coated or uncoated.	IH Cement Abutment to fabricate a prosthesis ofinternal single & bridge cement retained type.
Connection Type	External Hex-Connected	External Hex-Connected
Diameter (D)	4.5/5/5.5/6/6.5	4.5/5/5.5/6/6.5
G/H Length (mm)	1/1.5/2/2.5/3/3.5/4/4.5/5	1/1.5/2/2.5/3/3.5/4/4.5/5
Post Length (mm)	4/5.5/7	4/5.5/7
Material	Titanium Alloy (ASTM F 136)	Titanium Alloy (ASTM F 136)
Surface	Partial TiN coated	Partial TiN coated

As previously cleared in K153521 except with added new models of diameter 4.5 x G/H x 4 and 7 mm.

Item	Subject device	Primary predicate device	Reference device
Device name	IH Multi-unit Abutment(Straight type)	IH Multi-unit Abutment(Straight type)	Multi Abutment
510(k) No.	N/A	K153521	K161689
Design	Image: Subject device	Image: Primary predicate device	Image: Reference device
Description	A pre-manufactured dentalimplant abutment to be directlyconnected to an endosseousdental implant intended for use asan aid in prosthetic rehabilitation.The IH Multi-unit Abutment ismade of titanium alloy.	IH Multi-Unit Abutment is usedfor screw retained multiple case.	Multi Abutment is used foredentulous mandible or maxillato makefull denture.
ConnectionType	Screw & External Hex-Connected	Screw & External Hex-Connected	Screw & External Hex-Connected
Diameter (D)	4.8	4.8	4.8
ConnectionDiameter (Ø)	2.88, 3.43	3.43	2.88, 3.43
G/H Length(mm)	1.5/2.5/3.5/4.5	1.5/2.5/3.5/4.5	1/2/3/4/5

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

Image /page/8/Picture/1 description: The image shows the logo for SEWONMEDIX Dental Implant System. The logo features a geometric design on the left, composed of orange and blue triangles arranged in a circular pattern. To the right of the geometric design, the text "SEWONMEDIX" is displayed in a bold, blue sans-serif font. Above the company name, the words "DENTAL IMPLANT SYSTEM" are written in a smaller, gray font.

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

Material	Titanium Alloy (ASTM F 136)	Titanium Alloy (ASTM F 136)	Titanium Alloy (ASTM F 136)
Surface	None	None	Partial TiN coated

IH Multi-unit Abutment (Straight, Angled) is as previously cleared in K153521 except added New models of angled type of gingival height 3, 4, 5 and Mini type.

Item	Subject device	Primary predicate device	Reference device
Device name	IH Multi-unit Abutment(Angled type)	IH Multi-unit Abutment(Angled type)	Multi Angled Abutment
510(k) No.	N/A	K153521	K123755
Design	Image: IH Multi-unit Abutment (Angled type)	Image: IH Multi-unit Abutment (Angled type)	Image: Multi Angled Abutment
Description	A pre-manufactured dentalimplant abutment to be directlyconnected to an endosseousdental implant intended for use asan aid in prosthetic rehabilitation.The IH Multi-unit Abutment ismade of titanium alloy.	IH Multi-Unit Abutment is usedfor screw retained multiple case.	The Multi Angled Abutment isdevice made of titanium alloyintended for use as an aid inprostrhtic restoration.
ConnectionType	Screw & External Hex-Connected	Screw & External Hex-Connected	Screw & External Hex-Connected
Diameter (Ø)	4.8	4.8	4.8
ConnectionDiameter (Ø)	2.88, 3.43	3.43	2.88, 3.43
G/H Length(mm)	2.5/3/3.5/4/4.5/5	2.5/3.5/4.5	2.5/3/3.5/4/4.5/5
Angle(°)	17, 30	17, 30	17, 30
Material	Titanium Alloy (ASTM F 136)	Titanium Alloy (ASTM F 136)	Titanium Alloy (ASTM F 136)
Surface	None	Partial TiN coated	None

IH Multi-unit Abutment (Straight, Angled) is as previously cleared in K153521 except added New models of angled type of gingival height 3, 4, 5

. Substantial Equivalence Review:

Subject devices in this submission are substantially equivalent to the identified prior clearances , therefore, manufacturing process including raw material, machining, cleaning and similar design and technological characteristics as the primary predicate device (K153521).

Type	Product name	Identity
FixtureSystem	IH2 SLA Fixture	- It was cleared under K153521- New models of diameter 5.95 or length 7.0 are added.- New packaging types (IH2 Fixture with Pre-Mount type) is added.
	IH Cover Screw	It was cleared under K153521 except with added new models of length5.2mm.

Refer to the difference of additional products for detail as below table.

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

Image /page/9/Picture/1 description: The image shows the logo for SEWONMEDIX Dental Implant System. The logo features a stylized, geometric shape in blue and orange on the left. To the right of the shape, the words "SEWONMEDIX" are written in large, bold, blue letters. Above the company name, the words "DENTAL IMPLANT SYSTEM" are written in smaller, gray letters.

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

IHProstheticSystem	IH Healing Abutment	- It was cleared under K153521- New models of diameter 9 and height 6.5, 8.5, 10.5, 11.5mm is added.
	IH Cement Abutment	- It was cleared under K153521- New model with a diameter of 4.5 x G/H x 4 &7mm is added.
	IH Multi-unit Abutment(Straight, Angled)	- It was cleared under K153521- New models of angled type of gingival height 3, 4, 5 and Mini type is added.
	IH Multi-unit AbutmentScrew	Add length 7.5, 8, 9.1 or diameter 2, 2.05 of existing device

IH Implant System has been subjected to performance and product validations prior to release. The differences between the subject device and predicate devices are detailed shape and detailed dimension of diameter and length.

8 Summary of non-clinical testing

The subject device was tested to evaluate its substantial equivalence according to the following standards.

Endotoxin testing on the Subject device or suitable test specimens was performed following USP<85> and ● USP<161> according to the endotoxin sampling plan
Biological Evaluation of the Subject device was performed according to ISO 10993-1. Cytotoxicity Testing per ISO . 10993-5. Biocompatibility information is also leveraged from primary predicate device(K153521).
· Fatigue Testing according to ISO 14801:2016 under the worst-case scenario
· Gamma sterilization validation Test Report according to ISO 11137-1 and ISO 11137-2
· End User Sterilization Validation Test Report according to ANSVAAMI ST79, ISO 17665-2, ISO 11737-1, ISO 11737-2, ISO 11138-1 and ISO 11138-3
· Shelf Life Test according to ASTM F1140, ASTM F1929, and ASTM F2096, ASTM F1980 and ISO 11607

The non-clinical testing results demonstrate that the subject device is substantially equivalent to the predicate devices. Non-clinical worst-case MRI review was performed to evaluate the metallic devices in the MRI environment using scientific rationale and published literature (i.e., 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 to include all variations (all compatible implant bodies, dental abutments, and fixation screws) and material compositions. The 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.

9 Conclusion

The comparison of similarities and differences between the proposed devices and the respective predicate devices demonstrate that the subject device is substantially equivalent to the identified predicate devices.

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.