Predicate Devices

Reference Devices

K221684, K163634, K161689, K161604, K120847

AI/ML (Artificial Intelligence / Machine Learning)

No
The summary describes a physical dental abutment system made of titanium alloy and focuses on its material composition, intended use, and performance characteristics through non-clinical testing and comparison to predicate devices. There is no mention of software, algorithms, image processing, or any terms related to AI/ML.

Therapeutic

No
The device is an abutment system used to support dental prosthetic restorations, not to treat a disease or condition.

Diagnostic

No

Explanation: The device description states it is an "Abutment system ... intended for use with a dental implant to provide support for prosthetic restorations." This describes a supportive, restorative function, not a diagnostic one.

SaMD (Software as a Medical Device)

No

The device description explicitly states the device is made of titanium alloy and is a physical component (abutment) intended for use with a dental implant. It also details non-clinical testing related to materials, sterilization, and fatigue, which are characteristic of hardware devices.

IVD (In Vitro Diagnostic)

Based on the provided information, the OSSTEM Abutment system is not an In Vitro Diagnostic (IVD) device.

Here's why:

Intended Use: The intended use is to provide support for prosthetic restorations (crowns, bridges, overdentures) with a dental implant. This is a mechanical function within the body.
Device Description: The device is a physical component made of titanium alloy, designed to be implanted and support a prosthesis.
Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing samples from the human body (blood, urine, tissue, etc.).
- Providing information about a patient's health status, diagnosis, or treatment.
- Using reagents or other substances to perform tests.

The OSSTEM Abutment system is a medical device (specifically, a dental prosthetic component), but it operates in vivo (within the body) rather than in vitro (in a test tube or laboratory setting).

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The OSSTEM Abutment system is intended for use with a dental implant to provide support for prosthetic restorations such as crowns, bridges, or overdentures.

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

NHA

Device Description

TS Abutment System is made of titanium alloy. TS Abutment System is intended for use with a dental implant to provide support for prosthetic restorations such as crowns, bridges, or overdentures. TS Abutment System is similar to other commercially available products based on the intended use, technology used, material composition employed and performance characteristics.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

edentulous mandibles and maxillae, upper or lower jaw

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Not Found

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

Not Found

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

Not Found

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

Non-clinical Performance Testing:
Non-clinical testing data were referenced by prior clearances to demonstrate substantial equivalence.
Biocompatibility Evaluation:
Biocompatibility testing was considered followed the FDA Guidance Document Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process, " The TS Abutment System has same materials, manufacturer, manufacturing process, surface treatment etc., as primary predicate and reference devices. Therefore, we didn't conduct additional biocompatibility test.
Sterilization Validation and Shelf-life:
Validation of the gamma irradiation process was previously conducted for the predicated device. The processes of prediates since the clearance and the change in dimensions of the subject devices do not create the new worst case scenario or sterilization; therefore, additional validation is not required. In addition, TS Abutment System are made with titanium and titanium alloy we don't consider about shelf life of material by itself because this metal is widely known that it generally has no adversely affect by aging. Therefore we certify that product such like metal has no shelf life.
Pvrogen Test:
Bacterial Endotoxin Test Report on implants according to ISO 10993-11:2006 and USP referenced in K161604.
Mechanical Properties:
Fatigue testing was considered according to the FDA Guidance Document Guidance for Industry and FDA Staff Class II Special Controls Guidance Document Root-form Endosseous Dental Implants and Endosseous Dental Abutment and ISO 14801 standard. Processes of predicates since the clearance and the change in dimensions of the subject device do not create the new worst case scenario or bench testing.
MR Compatibility:
Non-clinical worst-case MRI review was performed to evaluate the Subject device components in the MRI environment using scientific rationale and published literature (e.g., Woods, Terry O., Jana G. Delfino, and Sunder Rajan, "Assessment of Magnetically Induced Displacement Force and Torque on Metal Alloys Used in Medical Devices." Journal of Testing and Evaluation 49.2 (2019): 783-795), based on the entire system including all variations (all compatible implant bodies, abutments, and fixation screws) and material composition. Rationale addressed parameters per the FDA guidance "Testing and Labeling Medical Devices for Safety in the Magnetic Resonance (MR) Environment," including magnetically induced displacement force and torque.
Clinical Testing:
No clinical studies are submitted.

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

Not Found

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

K182091

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

K221684, K163634, K161689, K161604, K120847

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

Regulation Number and Section

§ 872.3630 Endosseous dental implant abutment.

(a)
Identification. An endosseous dental implant abutment is a premanufactured prosthetic component directly connected to the endosseous dental implant and is intended for use as an aid in prosthetic rehabilitation.(b)
Classification. Class II (special controls). 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.)

Summary

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

February 20, 2024

Osstem Implant Co., Ltd. % Peter Lee RA/QA Manager Hiossen Inc. 85 Ben Fairless Dr. Fairless Hills, Pennsylvania 19030

Re: K233194

Trade/Device Name: TS Abutment System Regulation Number: 21 CFR 872.3630 Regulation Name: Endosseous dental implant abutment Regulatory Class: Class II Product Code: NHA Dated: November 22, 2023 Received: November 22, 2023

Dear Peter Lee:

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

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

1

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

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

2

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

Sincerely.

Andrew I. Steen -S

Andrew I. Steen Assistant Director DHT1B: Division of Dental and ENT Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K233194

Device Name TS Abutment System

Indications for Use (Describe)

The OSSTEM Abutment system is intended for use with a dental implant to provide support for prosthetic restorations such as crowns, bridges, or overdentures.

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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510(k) Summary K233194

Date: February 16, 2024

1. Company and Correspondent making the submission

Submitter's Name	: Osstem Implant Co., Ltd.
Address	: 66-16, Bansong-ro 513beon-gil, Haeundae-gu, Busan,
48002, Republic of Korea
Contact	: Ms. Seungju Kang
Phone	: +82-51-850-2500
Correspondent's Name	: Hiossen Inc.
Address	: 85 Ben Fairless Dr. Fairless Hills, PA 19030
Contact	: Mr. Peter Lee
Phone	: +1-267-759-7031

2. Proposed Device

Trade or (Proprietary) Name	: TS Abutment System
Classification Name	: Endosseous dental implant Abutment
Regulation Number	: 21 CFR 872.3630
Devce Classification	: Class II
Classification Product Code	: NHA

3. Predicated Device

Primary Predicate
K182091	Osstem Abutment System
Reference Device
K221684	Osstem Abutment System
K163634	External Hex Implants
K161689	OSSTEM Implant System - Abutment
K161604	OSSTEM Implant System
K120847	ET/SS IMPLANT SYSTEM

4. Indication for use

The OSSTEM Abutment system is intended for use with a dental implant to provide support for prosthetic restorations such as crowns, bridges, or overdentures.

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Image /page/5/Picture/2 description: The image contains the logo for Osstem Implant. The logo is in orange and the word "Osstem" is in a larger font than the word "Implant." The logo is simple and modern.

5. Device Description

TS Abutment System is made of titanium alloy. TS Abutment System is intended for use with a dental implant to provide support for prosthetic restorations such as crowns, bridges, or overdentures. TS Abutment System is similar to other commercially available products based on the intended use, technology used, material composition employed and performance characteristics.

Device	Content
Rigid Abutment	Description	It is used for making general cement-type prosthesis.
	Material	Ti-6Al-4V (ASTM F136)
	Dimension (mm)	D(Ø)
4.0
4.6
5.0	G/H
6.0, 7.0
6.0, 7.0
6.0, 7.0
Transfer Abutment	Description	It is used for making general cement-type prosthesis.
	Material	Ti-6Al-4V (ASTM F136)
	Dimension (mm)	D(Ø)
4.0
4.6
5.0
6.0
7.0	G/H
1.0, 2.0, 3.0, 4.0, 5.0, 6.0, 7.0
1.0, 2.0, 3.0, 4.0, 5.0, 6.0, 7.0
1.0, 2.0, 3.0, 4.0, 5.0, 6.0, 7.0
1.0, 2.0, 3.0, 4.0, 5.0, 6.0, 7.0
1.0, 2.0, 3.0, 4.0, 5.0, 6.0, 7.0
	Angled Abutment	Description	It is used for making general cement-type prosthesis.
		Material	Ti-6Al-4V (ASTM F136)
Dimension (mm)		D(Ø)
4.0
4.5
5.0
6.0	G/H
2.0, 4.0
2.0, 4.0
2.0, 4.0
2.0, 4.0
Angle(°)		17
FreeForm ST Abutment		Description	It is used for making general cement-type prosthesis.
		Material	Ti-6Al-4V (ASTM F136)
	Dimension (mm)	D(Ø)
5.5	G/H
1.5, 3.0
	Description	It is used temporarily to maintain esthetic appearance and chew ability until final prosthesis is made.
Temporary Abutment	Material	Titanium Gr.3 (ASTM F67)
	Dimension (mm)	D(Ø)	G/H	Post
		4.0	7.0	10.0
		4.5	7.0	10.0
Multi Abutment	Description	It is used for edentulous mandible or maxilla and usually used to make full denture.
	Material	Ti-6Al-4V (ASTM F136)
	Dimension (mm)	D(Ø)	G/H	Post
		4.8	1.0, 2.0, 3.0, 4.0, 5.0, 6.0, 7.0	2.3
Multi Angled Abutment	Description	TS Multi Angled Abutment is used to adjust the path of prosthesis in the case where the path is misaligned. It is provided as a set product composed with abutment, screw, and carrier to the end users for their convienience.
	Material	Ti-6Al-4V (ASTM F136)
	Dimension (mm)	D(Ø)	G/H	Post
		4.9	2.5, 3.0, 3.5, 4.0, 5.0	2.3
	Angle( °)	17°, 30°
Convertible Abutment	Description	It is used for creating bridge case prosthesis with dislocated path.
	Material	Ti-6Al-4V (ASTM F136)
	Dimension (mm)	D(Ø)	G/H	Post
		4.0	1.0, 2.0, 3.0, 4.0	1.0
		4.8	1.0, 2.0, 3.0, 4.0, 5.0	1.2
		6.0	1.0, 2.0, 3.0, 4.0, 5.0	1.2
Ti Cylinder Screw	Description	It is used to make final prosthesis using Convertible Abutment.
	Material	Ti-6Al-4V (ASTM F136)
	Dimension (mm)	D(Ø)	L
		2.2	4.35
		2.5	4.9
Port Abutment	Description	It is used for prosthetic restoration. It is for implant retained overdenture at maxilla/mandible in case of the patient has no teeth.
	Material	Ti-6Al-4V (ASTM F136)
	Dimension
(mm)	D(Ø)	G/H	Post
Stud Abutment	Dimension
(mm)	3.7	1.0, 2.0, 3.0, 4.0, 5.0,
6.0, 7.0	1.5
	Description	It is used for prosthetic restoration. It is used for making stud
type overdenture prosthetics.
	Material	Ti-6Al-4V (ASTM F136)
	Dimension
(mm)	D(Ø)
3.5	G/H
1.0, 2.0, 3.0, 4.0, 5.0,
6.0	Post
2.5, 3.35
	Description	It is used to make a natural soft tissue shape before setting up
prosthetics and removing cover screw after osseointegration.
	Material	Titanium Gr.4 (ASTM F67)
Healing Abutment	Dimension
(mm)	D(Ø)
4.3
4.8
5.3
6.3
7.3
8.3
9.3	L
2.0, 6.0, 8.0
6.0, 8.0, 10.0
6.0, 8.0, 10.0, 11.0, 12.0
6.0, 8.0
6.0, 8.0
6.0, 8.0
5.0, 6.0, 8.0

The specifications of the proposed device are as follow;

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Image /page/6/Picture/2 description: The image shows the logo for Osstem Implant. The logo is orange and features the word "OSSTEM" in a stylized font. Below the word "OSSTEM" is the word "IMPLANT" in a smaller, sans-serif font. The logo is simple and modern.

OSSTEM Implant Co., Ltd.
66-16, Bansong-n 513beon-gil, Haeundae-gu, Busan, Republic of Korea
Tel: +82 51 850 2500 Fax: +82 51 861 4693 www.osstem.com.

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Image /page/7/Picture/2 description: The image shows the logo for Osstem Implant. The logo is orange and features the word "OSSTEM" in a stylized font. Below the word "OSSTEM" is the word "IMPLANT" in a smaller, sans-serif font. The logo is simple and modern.

OSSTEM Implant Co., Ltd.
66-16, Bansong-n 513beon-gil, Haeundae-gu, Busan, Republic of Korea
Tel: +82 51 850 2500 Fax: +82 51 861 4693 www.osstem.com.

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Image /page/8/Picture/2 description: This image shows the logo and contact information for OSSTEM Implant Co., Ltd. The address is 66-16, Bansong-ro 513beon-gil, Haeundae-gu, Busan, Republic of Korea. The telephone number is +82 51 850 2500, the fax number is +82 51 861 4693, and the website is www.osstem.com.

6. Substantial Equivalence Matrix

These subject devices are modifications to are cleared in past 510(k); therefore, indication for use, shape, comection structure, material, surface treatment, manufacturer and etc. are the same with predicated devices except dimension of additional products.

1.1 Non-Sterile Device

Rigid Abutment

	Subject Device	Reference Device	Primary Predicate	Remark
Device Name	Rigid Abutment	Rigid Abutment	Transfer Abutment	Same
510(k) Number	-	K161689	K182091	-
Manufacturer	Osstem Implant Co., Ltd	Osstem Implant Co., Ltd	Osstem Implant Co., Ltd	Same
Design	Image: Subject Device Design	Image: Reference Device Design	Image: Primary Predicate Design	Same
Indication for Use	The OSSTEM Abutment system is
intended for use with a dental implant to
provide support for prosthetic
restorations such as crowns, bridges, or
overdentures.	The OSSTEM Implant System -
Abutment is intended for use with a
dental implant to provide support for
prosthetic restorations such as crowns,
bridges, or overdentures.	Osstem Abutment System is intended for
use with a dental implant to provide
support for prosthetic restorations such
as crowns, bridges, or overdentures.	Same
Principle of
Operation	Using making for general cement-type
prosthesis.	Using making for general cement-type
prosthesis.	Using making for general cement-type
prosthesis.	Same

Dimension (mm)	D(Ø)	G/H	Post
	4.0	6.0, 7.0	5.5
	4.6	6.0, 7.0	5.5
	5.0	6.0, 7.0	4.0, 5.5

	D(Ø)	G/H	Post
	4.0	1.0, 2.0, 3.0,
4.0, 5.0	4.0, 5.5,
7.0
	4.6	1.0, 2.0, 3.0,
4.0, 5.0	4.0, 5.5,
7.0
	5.0	1.0, 2.0, 3.0,
4.0, 5.0	4.0, 5.5,
7.0
	6.0	1.0, 2.0, 3.0,
4.0, 5.0	4.0, 5.5,
7.0
	7.0	1.0, 2.0, 3.0,
4.0, 5.0	5.5

	D(Ø)	G/H	Post
	4.0	1.0, 2.0, 3.0,
4.0, 5.0, 6.0,
7.0	5.5, 7.0	Different
	4.6	1.0, 2.0, 3.0,
4.0, 5.0, 6.0,
7.0	5.5, 7.0
	5.0	1.0, 2.0, 3.0,
4.0, 5.0, 6.0,
7.0	4.0, 5.5,
7.0
	6.0	1.0, 2.0, 3.0,
4.0, 5.0, 6.0,
7.0	4.0, 5.5,
7.0
	7.0	1.0, 2.0, 3.0,
4.0, 5.0, 6.0,
7.0	4.0, 5.5
Material	Titanium Alloy (ASTM F136)			Titanium Alloy (ASTM F136)	Same
Surface
Treatment	N/A			N/A	Same
S.E.	Similarities
Proposed Rigid Abutment has same design, function and indication for use; and is made with same material with same manufacturing process by same manufacturer compared to that of the reference device Rigid Abutment, K161689.
Differences
The added lengths differ from the dimension range of the reference device because new length combination is added to the same diameter range as primary predicate. However, proposed device has same design, function, connection and platform as reference device. Also, primary predicate for the increased gingival height of 6mm and 7mm is already cleared in Transfer Abutment, K182091.
In addition, since proposed device is straight type and the distance between the embedding plane and the centre of the hemispherical loading member always is 11mm according to the ISO 14801, it has same moment arm.
As a result, the fatigue of the proposed device is considered to be equal to or greater than that of the reference device. Therefore, we don't conduct additional fatigue testing.

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Page 6 of 31

OSSTEM® IMPLANT

OSSTEM Implant Co., Ltd.

OSSTEM Implant Co., Ltd.
66-16, Bansong-o 513beon-gil, Haunda-gu, Busan, Republic of Korea
Tel: +82 51 850 250 Fax: +82 51 861 4693 www.osstem.com

10

OSSTEM
IMPLANT

OSSTEM Implant Co., Ltd.

66-16, Bansong-ro 513beon-gil, Haeundae-gu, Busan, Republic of Korea Tel: +82 51 850 2500 Fax: +82 51 861 4693 www.osstem.com

: Proposed Rigid Abutment and the reference device have common in design, for use, material, manufacturing process, manufacturer, etc.; therefore, the proposed device is substantially equivalent to the reference device.

Page 7 of 31

11

66-16, Bansong-ro 513beon-gil, Haeundae-gu, Busan, Republic of Korea
Tel: +82 51 850 2500 Fax: +82 51 861 4693 www.osstem.com

2) Transfer Abutment

	Subject Device	Primary Predicate	Remark
Device Name	Transfer Abutment	Transfer Abutment	Different
510(k) Number	-	K182091	-
Manufacturer	Osstem Implant Co., Ltd	Osstem Implant Co., Ltd	Same
Design	Image: Subject Device Design	Image: Primary Predicate Design	Different
Indication for Use	The OSSTEM Abutment system is intended for use with a dental implant to provide support for prosthetic restorations such as crowns, bridges, or overdentures.	Osstem Abutment System is intended for use with a dental implant to provide support for prosthetic restorations such as crowns, bridges, or overdentures.	Same
Principle of Operation	Using making for general cement-type prosthesis.	Using making for general cement-type prosthesis.	Same
Dimension (mm)	D(Ø)	G/H	Post	D(Ø)	G/H	Post	Different
	4.0	1.0, 2.0, 3.0, 4.0, 5.0, 6.0, 7.0	4.0 , 5.5, 7.0	4.0	1.0, 2.0, 3.0, 4.0, 5.0, 6.0, 7.0	5.5, 7.0
	4.6	1.0, 2.0, 3.0, 4.0, 5.0, 6.0, 7.0	4.0, 5.5, 7.0	4.6	1.0, 2.0, 3.0, 4.0, 5.0, 6.0, 7.0	5.5, 7.0
	5.0	1.0, 2.0, 3.0, 4.0, 5.0, 6.0, 7.0	4.0, 5.5, 7.0	5.0	1.0, 2.0, 3.0, 4.0, 5.0, 6.0, 7.0	4.0, 5.5, 7.0
	6.0	1.0, 2.0, 3.0, 4.0, 5.0, 6.0, 7.0	4.0, 5.5, 7.0	6.0	1.0, 2.0, 3.0, 4.0, 5.0, 6.0, 7.0	4.0, 5.5, 7.0
7.0	1.0, 2.0, 3.0, 4.0, 5.0, 6.0, 7.0	4.0 , 5.5, 7.0	7.0	1.0, 2.0, 3.0, 4.0, 5.0, 6.0, 7.0	4.0, 5.5
Material	Titanium Alloy (ASTM F136)			Titanium Alloy (ASTM F136)			Same
Feature	Image: Subject Device Feature			Image: Primary Predicate Feature			Different
Surface Treatment	N/A			N/A			Same
S.E.	Similarities
Proposed Transfer Abutment has same design, function and indication for use; and is made

12

Image /page/12/Picture/2 description: The image contains the logo for Osstem Implant. The logo is in orange and consists of the word "OSSTEM" in a bold, sans-serif font, with the superscript symbol for a registered trademark. Below the word "OSSTEM" is the word "IMPLANT" in a smaller, less bold font. The logo is simple and modern, and the orange color is eye-catching.

OSSTEM Implant Co., Ltd.
66-16, Bansong-o 513beon-gil, Haeundae-gu, Busan, Republic of Korea
Tel: +82 51 850 2500 Fax: +82 51 861 4693 www.osstem.com.

| with same material with same manufacturing process by same manufacturer compared to that

of the primary predicate Transfer Abutment, K182091.
Differences
The added lengths differ from the dimension range of the primary predicate because new
length combination is added to the same diameter range as primary predicate. Also, proposed
device differs in feature from the primary predicate because it has a guide to support
connecting with the implant body. However, this change in connection features was
evaluated and determined that is not a new worst case for bench testing.
In addition, since proposed device is straight type and the distance between the embedding
plane and the centre of the hemispherical loading member always is 11mm according to the
ISO 14801, it has same moment arm.
As a result, the fatigue of the proposed device is considered to be equal to or greater than that
of the primary predicate. Therefore, we don't conduct additional fatigue testing.
.: Proposed Transfer Abutment and the primary predicate have common in design, function,
indication for use, material, manufacturing process, manufacturer, etc.; therefore, the
proposed device is substantially equivalent to the primary predicate.

3) Angled Abutment

	Subject Device	Primary Predicate	Remark
Device Name	Angled Abutment	Angled Abutment	Same
510(k) Number	-	K182091	-
Manufacturer	Osstem Implant Co., Ltd	Osstem Implant Co., Ltd	Same
Design	Image: Angled Abutment	Image: Angled Abutment	Different
Indication for
Use	The OSSTEM Abutment system is
intended for use with a dental implant
to provide support for prosthetic
restorations such as crowns, bridges, or
overdentures.	Osstem Abutment System is intended
for use with a dental implant to provide
support for prosthetic restorations such
as crowns, bridges, or overdentures.	Same
Principle of
Operation	Using making general cement-type
prosthesis when a prosthetic's path
adjustment is necessary.	Using making general cement-type
prosthesis when a prosthetic's path
adjustment is necessary.	Same

13

Image /page/13/Picture/2 description: The image shows the logo for Osstem Implant. The logo is orange and features the word "OSSTEM" in a bold, sans-serif font. Below the word "OSSTEM" is the word "IMPLANT" in a smaller, sans-serif font. There is a small circle in the upper right corner of the logo.

OSSTEM Implant Co., Ltd.

OSSTEM Implant Co., Ltd.
66-16, Bansong-n 513beon-gil, Haeunda-gu, Busan, Republic of Korea
Tel: +82 51 850 2500 Fax: +82 51 861 4693 www.osstem.com.

	D(Ø)	G/H	Post	D(Ø)	G/H	Post
Dimension
(mm)	4.0	2.0, 4.0	8.0	4.0	2.0, 4.0	8.0	Same
	4.5	2.0, 4.0	8.0	4.5	2.0, 4.0	8.0
	5.0	2.0, 4.0	8.0	5.0	2.0, 4.0	8.0
	6.0	2.0, 4.0	8.0	6.0	2.0, 4.0	8.0
Angled( °)	17			17			Same
Material	Titanium Alloy (ASTM F136)			Titanium Alloy (ASTM F136)			Same
Feature	Image: Feature 1			Image: Feature 2			Different
Surface
Treatment	N/A			N/A			Same
S.E.	Similarities
Proposed Angled Abutment has same design, function and indication for use; and is made
with same material with same manufacturing process by same manufacturer compared to that
of the primary predicate Angled Abutment, K182091.
Differences
The proposed device differs in feature from the primary predicate because it has a guide to
support connecting with the implant body. However, proposed device has same design,
function, connection and platform as primary predicate.
As a result, the fatigue of the proposed device is considered to be equal to or greater than that
of the primary predicate. Therefore, we don't conduct additional fatigue testing.
∴ Proposed Angled Abutment and the primary predicate have common in design, function,
indication for use, material, manufacturing process, manufacturer, etc.; therefore, the
proposed device is substantially equivalent to the primary predicate.

4) FreeForm ST Abutment

	Subject Device	Reference Device	Remark
Device Name	FreeForm ST Abutment	FreeForm ST Abutment	Same
510(k) Number	-	K161689	-
Manufacturer	Osstem Implant Co., Ltd	Osstem Implant Co., Ltd	Same
Design	Image: Subject Device	Image: Reference Device	Same

14

Image /page/14/Picture/2 description: The image shows the logo for Osstem Implant. The word "OSSTEM" is written in orange, with a registered trademark symbol next to it. Below the word "OSSTEM" is the word "IMPLANT" written in a smaller, darker font.

OSSTEM Implant Co., Ltd.

OSSTEM Implant Co., Ltd.
66-16, Bansong-n 513beon-gil, Haeundae-gu, Busan, Republic of Korea
Tel: +82 51 850 2500 Fax: +82 51 861 4693 www.osstem.com.

Indication for Use	The OSSTEM Abutment system is intended for use with a dental implant to provide support for prosthetic restorations such as crowns, bridges, or overdentures.			The OSSTEM Implant System - Abutment is intended for use with a dental implant to provide support for prosthetic restorations such as crowns, bridges, or overdentures.			Same
Principle of Operation	Use for making general cement-type prosthesis.			Use for making general cement-type prosthesis.			Same
Dimension (mm)	D(Ø)	G/H	Post	D(Ø)	G/H	Post
	5.5	1.5, 3.0	8.0	4.0
5.0
6.0
7.0	1.5, 3.0
1.5, 3.0
1.5, 3.0
1.5, 3.0	9.0, 10.5
9.0, 10.5
9.0, 10.5
9.0, 10.5	Different
Material	Titanium Alloy (ASTM F136)			Titanium Alloy (ASTM F136)			Same
Surface Treatment	N/A			N/A			Same
S.E.	Similarities
Proposed FreeForm ST Abutment has same design, function and indication for use; and is made with same material with same manufacturing process by same manufacturer compared to that of the reference device FreeForm ST Abutment, K161689.
Differences
The added diameter Ø 5.5 and length 8mm differs from reference device; but it is included in the dimension range of the reference device. In addition, since proposed device is straight type and the distance between the embedding plane and the centre of the hemispherical loading member always is 11mm according to the ISO 14801, it has same moment arm.
As a result, the fatigue of the proposed device is considered to be equal to or greater than that of the reference device. Therefore, we don't conduct additional fatigue testing.
Proposed FreeForm ST Abutment and the reference device have common in design, function, indication for use, material, manufacturing process, manufacturer, etc.; therefore, the proposed device is substantially equivalent to the reference device.

15

OSSTEM® IMPLANT

OSSTEM Implant Co., Ltd.

66-16, Bansong-ro 513beon-gil, Haeundae-gu, Busan, Republic of Korea

Tel: +82 51 850 2500 Fax: +82 51 861 4693 www.osstem.com

5) Temporary Abutment

	Subject Device	Reference Device	Primary Predicate	Primary Predicate	Remark
Device Name	Temporary Abutment	Temporary Abutment	Temporary Abutment	Transfer Abutment	Same
510(k) Number	-	K221684	K182091	K182091	-
Manufacturer	Osstem Implant Co., Ltd	Osstem Implant Co., Ltd	Osstem Implant Co., Ltd	Osstem Implant Co., Ltd	Same
Design	Image: Subject Device Design	Image: Reference Device Design	Image: Primary Predicate Design	Image: Primary Predicate Design	Same
Indication for Use	The OSSTEM Abutment
system is intended for use
with a dental implant to
provide support for prosthetic
restorations such as crowns,
bridges, or overdentures.	The OSSTEM Abutment
System is intended for use
with a dental implant to
provide support for prosthetic
restorations such as crowns,
bridges, or overdentures.	Osstem Abutment System is
intended for use with a dental
implant to provide support for
prosthetic restorations such as
crowns, bridges, or
overdentures.	Osstem Abutment System is
intended for use with a dental
implant to provide support for
prosthetic restorations such as
crowns, bridges, or
overdentures.	Same
Principle of
Operation	Using making temporary
prosthesis to maintain
aesthetic appearance until
final prosthesis is made.	Using making temporary
prosthesis to maintain
aesthetic appearance until
final prosthesis is made.	Using making temporary
prosthesis to maintain
aesthetic appearance until
final prosthesis is made.	Using making for general
cement-type prosthesis.	Same
Dimension (mm)	D(Ø)
G/H
Post	D(Ø)
G/H
Post	D(Ø)
G/H
Post	D(Ø)
G/H
Post
	4.0
7.0
10.0	4.0
1.0, 3.0
10	4.0
1.0, 3.0
10	4.0
1.0, 2.0,
3.0, 4.0,
5.0, 6.0,
7.0
5.5, 7.0	Different
	4.5
7.0
10.0	4.5
1.0, 3.0
10	4.5
1.0, 3.0
10	4.6
1.0, 2.0,
3.0, 4.0,
5.0, 6.0,
7.0
5.5, 7.0
				5.0
1.0, 2.0,
3.0, 4.0,
5.0, 6.0,
7.0
4.0, 5.5,
7.0
				6.0
1.0, 2.0,
3.0, 4.0,
5.0, 6.0,
7.0
4.0, 5.5,
7.0
				7.0
1.0, 2.0,
3.0, 4.0,
5.0, 6.0,
7.0
4.0, 5.5
Material	Titanium Gr.3 (ASTM F67)	Titanium Gr.3 (ASTM F67)	Titanium Gr.3 (ASTM F67)	Titanium Alloy (ASTM F136)	Same
Surface
Treatment	N/A	N/A	N/A	N/A	Same
S.E.	Similarities
Proposed Temporary Abutment has same design, function and indication for use; and is made with same material with same manufacturing
process by same manufacturer compared to that of the reference device and primary predicate Temporary Abutment, K221684 and K182091.
Differences
Temporary Abutment is used to make temporary prosthesis for esthetic purpose for healing placement of implant, so the length of
gingiva height does not affect the any performance.
Also, the proposed gingiva height 7mm differs from predicate and reference device; but the proposed diameter is same as reference
device, and primary predicate for the increased gingival height of 7mm is already cleared in Transfer Abutment, K182091.

16

Page 13 of 31

OSSTEM®

OSSTEM Implant Co., Ltd.
66-16, Bansong-ro 513beon-gil, Haundae-gu, Busan, Republic of Korea
Tel: +82 51 850 250 Fax: +82 51 861 4693 www.osstem.com

17

OSSTEM® IMPLANT

OSSTEM Implant Co., Ltd.

OSSTEM Implant Co., Ltd.
66-16, Bansong-ro 513beon-gil, Haundae-gu, Busan, Republic of Korea
Tel: +82 51 850 2500 Fax: +82 51 861 4693 www.osstem.com.

Proposed device is used for temporary use and also has primary predicate for the increased gingival height. Therefore, we don't conduct additional performance test.
: Proposed Temporary Abutment and the primary predicate have common in design, function, indication for use, material, manufacturing process, manufacturer, etc.; therefore, the proposed device is substantially equivalent to the primary predicate.

6) Multi Abutment

	Subject Device	Reference Device	Primary Predicate	Remark
Device Name	Multi Abutment	Multi Abutment	Transfer Abutment	Same
510(k) Number	-	K161689	K182091	-
Manufacturer	Osstem Implant Co., Ltd	Osstem Implant Co., Ltd	Osstem Implant Co., Ltd	Same
Design	Image: Multi Abutment	Image: Multi Abutment	Image: Transfer Abutment	Same
Indication for Use	The OSSTEM Abutment system is
intended for use with a dental implant to
provide support for prosthetic
restorations such as crowns, bridges, or
overdentures.	The OSSTEM Implant System -
Abutment is intended for use with a
dental implant to provide support for
prosthetic restorations such as crowns,
bridges, or overdentures.	Osstem Abutment System is intended for
use with a dental implant to provide
support for prosthetic restorations such
as crowns, bridges, or overdentures.	Same
Principle of
Operation	Using for edentulous mandible or
maxilla. Usually use to make full denture
screw-retained restoration.	Using for edentulous mandible or
maxilla. Usually use to make full denture
screw-retained restoration.	Using making for general cement-type
prosthesis.	Same

Page 14 of 31

18

Page 15 of 31

OSSTEM® IMPLANT

OSSTEM Implant Co., Ltd.
66-16, Bansong-o 513beon-gil, Haunda-gu, Busan, Republic of Korea
Tel: +82 51 850 250 Fax: +82 51 861 4693 www.osstem.com

		D(Ø)	G/H
		4.0	1.0, 2.0, 3.0,
4.0, 5.0, 6.0,
7.0	5.5, 7.0
		4.6	1.0, 2.0, 3.0,
4.0, 5.0, 6.0,
7.0	5.5, 7.0
Dimension (mm)	D(Ø)
4.8	G/H
6.0, 7.0	Post
2.3
		D(Ø)
4.8	G/H
1.0, 2.0, 3.0,
4.0, 5.0	Post
2.3
		5.0	1.0, 2.0, 3.0,
4.0, 5.0, 6.0,
7.0	4.0, 5.5,
7.0	Different
		6.0	1.0, 2.0, 3.0,
4.0, 5.0, 6.0,
7.0	4.0, 5.5,
7.0
		7.0	1.0, 2.0, 3.0,
4.0, 5.0, 6.0,
7.0	4.0, 5.5
Material	Ti-6Al-4V (ASTM F136)		Titanium Alloy (ASTM F136)	Same
Surface
Treatment	N/A		N/A	Same
S.E.	Similarities
Proposed Multi Abutment has same design, function, dimension range and indication for use; and is made with same material with same manufacturing process by same manufacturer compared to that of the reference device Multi Abutment, K161689.
Differences
The proposed gingiva height 6mm and 7mm differ from reference device; but the proposed diameter is same as reference device, and primary predicate for the increased gingival height of 6mm and 7mm is already cleared in Transfer Abutment, K182091. In addition, since proposed device is straight type and the distance between the embedding plane and the centre of the hemispherical loading member always is 11mm according to the ISO 14801, it has same moment arm.
As a result, the fatigue of the proposed device is considered to be equal to or greater than that of the reference device. Therefore, we don't conduct additional fatigue testing.
∴ Proposed Multi Abutment and the reference device have common in design, function, indication for use, material, manufacturing process, manufacturer, etc .; therefore, the proposed device is substantially equivalent to the reference device.

19

66-16, Bansong-ro 513beon-gil, Haeundae-gu, Busan, Republic of Korea
Tel: +82 51 850 2500 Fax: +82 51 861 4693 www.osstem.com

7) Ti Cylinder Screw

	Subject Device	Primary Predicate	Remark
Device Name	Ti Cylinder Screw	EbonyGold Cylinder Screw	Same
510(k) Number	-	K182091	-
Manufacturer	Osstem Implant Co., Ltd	Osstem Implant Co., Ltd	Same
Design	Image: Ti Cylinder Screw	Image: EbonyGold Cylinder Screw	Different
Indication for
Use	The OSSTEM Abutment system is
intended for use with a dental implant
to provide support for prosthetic
restorations such as crowns, bridges,
or overdentures.	Osstem Abutment System is intended
for use with a dental implant to
provide support for prosthetic
restorations such as crowns, bridges,
or overdentures.	Same
Principle of
Operation	Using to connect a cylinder to the
abutment.	Using to connect a cylinder to the
abutment.	Same
Dimension (mm)	D(Ø)
2.2
2.5	L
4.35
4.9	D(Ø)
2.2
2.5
		L
4.35
4.9	Same
Material	Ti-6Al-4V (ASTM F136)	Ti-6Al-4V (ASTM F136)	Same
Surface
treatment	N/A	WC Coating	Different
S.E.	Similarities
Proposed Ti Cylinder Screw has same design, function, dimension range and indication for
use; and is made with same material with same manufacturing process by same
manufacturer compared to that of the primary predicate EbonyGold Cylinder Screw,
K182091.
Differences
The only difference is surface treatment. The primary predicate has WC coating surface, but
the proposed device has no surface treatment. However, since the proposed device is a
component using with cylinder, we don't consider fatigue testing. In addition, the proposed
device has a difference in surface coating from the primary predicate, but there is no
difference in biocompatibility because it has the same raw material as the Abutments made
of titanium alloy already cleared in K182091.
Proposed Ti Cylinder Screw and the primary predicate have common in design, function,
indication for use, material, manufacturing process, manufacturer, etc.; therefore, the
proposed device is substantially equivalent to the primary predicate.

1.2 Sterile Device

Transfer Abutment

20

Image /page/20/Picture/2 description: The image shows the logo for Osstem Implant. The logo is in orange and features the word "OSSTEM" in a stylized font. Below the word "OSSTEM" is the word "IMPLANT" in a smaller, sans-serif font. The logo is simple and modern.

OSSTEM Implant Co., Ltd.
66-16, Bansong-n 513beon-gil, Haeundae-gu, Busan, Republic of Korea
Tel: +82 51 850 2500 Fax: +82 51 861 4693 www.osstem.com.

	Subject Device		Primary Predicate		Remark
Device Name	Transfer Abutment		Transfer Abutment		Different
510(k) Number	-		K182091		-
Manufacturer	Osstem Implant Co., Ltd		Osstem Implant Co., Ltd		Same
Design	Image: Subject Device Design		Image: Primary Predicate Design		Different
Indication for
Use	The OSSTEM Abutment system is
intended for use with a dental implant
to provide support for prosthetic
restorations such as crowns, bridges, or
overdentures.		Osstem Abutment System is intended
for use with a dental implant to provide
support for prosthetic restorations such
as crowns, bridges, or overdentures.		Same
Principle of
Operation	Using making for general cement-type
prosthesis.		Using making for general cement-type
prosthesis.		Same
	D(Ø)	G/H	Post	D(Ø)	G/H	Post
Dimension
(mm)	4.0	1.0, 2.0, 3.0,
4.0, 5.0, 6.0,
7.0	4.0, 5.5,
7.0	4.0	1.0, 2.0, 3.0,
4.0, 5.0, 6.0,
7.0	5.5, 7.0
	4.6	1.0, 2.0, 3.0,
4.0, 5.0, 6.0,
7.0	4.0, 5.5,
7.0	4.6	1.0, 2.0, 3.0,
4.0, 5.0, 6.0,
7.0	5.5, 7.0
	5.0	1.0, 2.0, 3.0,
4.0, 5.0, 6.0,
7.0	4.0, 5.5,
7.0	5.0	1.0, 2.0, 3.0,
4.0, 5.0, 6.0,
7.0	4.0, 5.5,
7.0
	6.0	1.0, 2.0, 3.0,
4.0, 5.0, 6.0,
7.0	4.0, 5.5,
7.0	6.0	1.0, 2.0, 3.0,
4.0, 5.0, 6.0,
7.0	4.0, 5.5,
7.0
	7.0	1.0, 2.0, 3.0,
4.0, 5.0, 6.0,
7.0	4.0, 5.5,
7.0	7.0	1.0, 2.0, 3.0,
4.0, 5.0, 6.0,
7.0	4.0, 5.5
Material	Titanium Alloy (ASTM F136)		Titanium Alloy (ASTM F136)		Same
Feature	Image: Subject Device Feature		Image: Primary Predicate Feature		Different
Sterilization	Provided sterile
(Radiation Sterile for Identifier
TSTAWH and TSTATH)		Sterile by end users		Different
Shelf-life	8 years		N/A		Different
Surface
Treatment	N/A		N/A		Same

21

Image /page/21/Picture/1 description: The image shows the alphanumeric string "K233194" in a clear, sans-serif font. The characters are uniformly sized and spaced, making the string easily readable. The black text stands out against the white background, providing high contrast.

0

OSSTEM Implant Co., Ltd.
66-16, Bansong-n 513beon-gil, Haeunda-gu, Busan, Republic of Korea
Tel: +82 51 850 2500 Fax: +82 51 861 4693 www.osstem.com.

| | Similarities
Proposed Transfer Abutment has same design, function and indication for use; and is made
with same material with same manufacturing process by same manufacturer compared to that
of the primary predicate Transfer Abutment, K182091. |
|------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Differences
The added lengths differ from the dimension range of the primary predicate because new
length combination is added to the same diameter range as primary predicate. Also, proposed
device differs in feature from the primary predicate because it has a guide to support
connecting with the implant body. However, proposed device has same design, function,
connection and platform as primary predicate. |
| S.E. | In addition, since proposed device is straight type and the distance between the embedding
plane and the centre of the hemispherical loading member always is 11mm according to the
ISO 14801, it has same moment arm. |
| | As a result, the fatigue of the proposed device is considered to be equal to or greater than that
of the primary predicate. Therefore, we don't conduct additional fatigue testing. |
| | Proposed device, identifier TSTAWH and TSTATH, differs in sterilization process.
The proposed device is sterilized compared to the primary predicate; but it has same raw
material, design, manufacturing process, etc. as that of the primary predicate. |
| | ∴ Proposed Transfer Abutment and the primary predicate have common in design, function,
indication for use, material, manufacturing process, manufacturer, etc., except sterilization
process: therefore, the proposed device is substantially equivalent to the primary predicate. |

2) Angled Abutment

	Subject Device	Primary Predicate	Remark
Device Name	Angled Abutment	Angled Abutment	Same
510(k) Number	-	K182091	-
Manufacturer	Osstem Implant Co., Ltd	Osstem Implant Co., Ltd	Same
Design	Image: Angled Abutment	Image: Angled Abutment	Different
Indication for
Use	The OSSTEM Abutment system is
intended for use with a dental implant
to provide support for prosthetic
restorations such as crowns, bridges, or	Osstem Abutment System is intended
for use with a dental implant to provide
support for prosthetic restorations such
as crowns, bridges, or overdentures.	Same

22

Image /page/22/Picture/1 description: The image shows the alphanumeric string "K233194" in a clear, sans-serif font. The characters are uniformly sized and spaced, creating a balanced and easily readable sequence. The text is presented in black against a white background, providing high contrast and enhancing visibility.

OSSTEM® IMPLANT

OSSTEM Implant Co., Ltd.
66-16, Bansong-n 513beon-gil, Haeundae-gu, Busan, Republic of Korea
Tel: +82 51 850 2500 Fax: +82 51 861 4693 www.osstem.com.

	overdentures.
Principle of
Operation	Using making general cement-type
prosthesis when a prosthetic's path
adjustment is necessary.				Using making general cement-type
prosthesis when a prosthetic's path
adjustment is necessary.			Same
	D(Ø)	G/H	Post		D(Ø)	G/H	Post
Dimension
(mm)	4.0	2.0, 4.0	8.0		4.0	2.0, 4.0	8.0	Same
	4.5	2.0, 4.0	8.0		4.5	2.0, 4.0	8.0
	5.0	2.0, 4.0	8.0		5.0	2.0, 4.0	8.0
	6.0	2.0, 4.0	8.0		6.0	2.0, 4.0	8.0
Angled( °)	17				17			Same
Material	Titanium Alloy (ASTM F136)				Titanium Alloy (ASTM F136)			Same
Feature	Image: abutment feature				Image: abutment feature			Different
Sterilization	Provided sterile
(Radiation Sterile for Identifier
TSAAWH and TSAATH)				Sterile by end users			Different
Shelf-life	8 years				N/A			Different
Surface
Treatment	N/A				N/A			Same
S.E.	Similarities
Proposed Angled Abutment has same design, function and indication for use; and is made
with same material with same manufacturing process by same manufacturer compared to that
of the primary predicate Angled Abutment, K182091.
Differences
The only difference is sterilization process. The proposed device is sterilized compared to the
primary predicate; but it has same raw material, design, manufacturing process, etc. as that of
the primary predicate.
∴ Proposed Angled Abutment and the primary predicate have common in design, function,
indication for use, material, manufacturing process, manufacturer, etc., except sterilization
process; therefore, the proposed device is substantially equivalent to the primary predicate.

23

Image /page/23/Picture/1 description: The image shows the logo for Osstem Implant. The word "OSSTEM" is written in orange, with a registered trademark symbol next to it. Below the word "OSSTEM" is the word "IMPLANT" in a smaller, gray font.

OSSTEM Implant Co., Ltd.

66-16, Bansong-ro 513beon-gil, Haundae-gu, Busan, Republic of Korea
Tel: +82 51 850 250 Fax: +82 51 861 4693 www.osstem.com

66-16, Bansong-ro 513beon-gil, Haeundae-gu, Busan, Republic of Korea
Tel: +82 51 850 2500 Fax: +82 51 861 4693 www.osstem.com

3) Multi Abutment
	Subject Device	Reference Device	Primary Predicate	Remark
Device Name	Multi Abutment	Multi Abutment	Transfer Abutment	Same
510(k) Number	-	K161689	K182091	-
Manufacturer	Osstem Implant Co., Ltd	Osstem Implant Co., Ltd	Osstem Implant Co., Ltd	Same
Design	Image: Multi Abutment	Image: Multi Abutment	Image: Transfer Abutment	Same
Indication for Use	The OSSTEM Abutment system is
intended for use with a dental implant to
provide support for prosthetic
restorations such as crowns, bridges, or
overdentures.	The OSSTEM Implant System -
Abutment is intended for use with a
dental implant to provide support for
prosthetic restorations such as crowns,
bridges, or overdentures.	Osstem Abutment System is intended for
use with a dental implant to provide
support for prosthetic restorations such
as crowns, bridges, or overdentures.	Same
Principle of
Operation	Using for edentulous mandible or
maxilla. Usually use to make full denture
screw-retained restoration.	Using for edentulous mandible or
maxilla. Usually use to make full denture
screw-retained restoration.	Using making for general cement-type
prosthesis.	Same
Dimension (mm)	D(Ø) G/H Post 4.8 1.0, 2.0, 3.0,
4.0, 5.0, 6.0,
7.0 2.3					D(Ø) G/H Post 4.8 1.0, 2.0, 3.0,
4.0, 5.0 2.3					D(Ø) G/H Post 4.0 1.0, 2.0, 3.0,
4.0, 5.0, 6.0,
7.0 5.5, 7.0 4.6 1.0, 2.0, 3.0,
4.0, 5.0, 6.0,
7.0 5.5, 7.0 5.0 1.0, 2.0, 3.0,
4.0, 5.0, 6.0,
7.0 4.0, 5.5,
7.0						Different

Page 20 of 31

24

Page 21 of 31

Image /page/24/Picture/2 description: The image contains the logo for "OSSTEM IMPLANT". The word "OSSTEM" is in orange and has a registered trademark symbol next to it. The word "IMPLANT" is in a smaller, gray font and is located below the word "OSSTEM".

OSSTEM Implant Co., Ltd.
66-16, Bansong-ro 513beon-gil, Haeundae-gu, Busan, Republic of Korea
Tel: +82 51 850 2500 Fax: +82 51 861 4693 www.osstem.com

| | | | 6.0
1.0, 2.0, 3.0,
4.0, 5.0, 6.0,
7.0 | 4.0, 5.5,
7.0 |
|-------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------|------------------------------------------------|------------------|
| | | | 7.0
1.0, 2.0, 3.0,
4.0, 5.0, 6.0,
7.0 | 4.0, 5.5 |
| Material | Ti-6Al-4V (ASTM F136) | Ti-6Al-4V (ASTM F136) | Titanium Alloy (ASTM F136) | Same |
| Sterilization | Provided sterile
(Radiation Sterile for Identifier
TSMASP) | Sterile by end users | Sterile by end users | Different |
| Shelf-life | 8 years | N/A | N/A | Different |
| Surface Treatment | N/A | N/A | N/A | Same |
| S.E. | Similarities
Proposed Multi Abutment has same design, function, dimension range and indication for use; and is made with same material with same
manufacturing process by same manufacturer compared to that of the reference device Multi Abutment, K221684 and K182091.
Differences
The proposed gingiva height 6mm and 7mm differ from reference device; but the proposed diameter is same as reference device, and primary
predicate for the increased gingival height of 6mm and 7mm is already cleared in Transfer Abutment, K182091.
In addition, since proposed device is straight type and the distance between the embedding plane and the centre of the hemispherical loading
member always is 11mm according to the ISO 14801, it has same moment arm.
As a result, the fatigue of the proposed device is considered to be equal to or greater than that of the reference device. Therefore, we don't
conduct additional fatigue testing.
Proposed device, identifier TSMASP, differs in sterilization process. The proposed device is sterilized compared to the reference device;
but it has same raw material, design, manufacturing process, etc. as that of the reference device.
.: Proposed Multi Abutment and the reference device have common in design, function, indication for use, material, manufacturing process,
manufacturer, etc. except sterilization process; therefore, the proposed device is substantially equivalent to the reference device. | | | |

25

Image /page/25/Picture/1 description: The image contains the logo for Osstem Implant. The logo is orange and has the word "OSSTEM" in all caps. Below the word "OSSTEM" is the word "IMPLANT" in smaller letters.

OSSTEM Implant Co., Ltd.

66-16, Bansong-ro 513beon-gil, Haeundae-gu, Busan, Republic of Korea Tel: +82 51 850 2500 Fax: +82 51 861 4693 www.osstem.com

4) Multi Angled Abutment

	Subject Device	Reference Device	Primary Predicate	Remark
Device Name	Multi Angled Abutment	Multi Angled Abutment	Multi Angled Abutment	Same
510(k) Number	-	K221684	K182091	-
Manufacturer	Osstem Implant Co., Ltd	Osstem Implant Co., Ltd	Osstem Implant Co., Ltd	Same
Design	Image: Multi Angled Abutment	Image: Multi Angled Abutment	Image: Multi Angled Abutment	Same
Indication for Use	The OSSTEM Abutment system is
intended for use with a dental implant to
provide support for prosthetic
restorations such as crowns, bridges, or
overdentures.	The OSSTEM Abutment System is
intended for use with a dental implant to
provide support for prosthetic
restorations such as crowns, bridges, or
overdentures.	Osstem Abutment System is intended
for use with a dental implant to provide
support for prosthetic restorations such
as crowns, bridges, or overdentures.	Same
Principle of
Operation	Using making screw-retained type
prosthesis in multiple cases by using
with Esthetic-low cylinder when path
adjustment is necessary.	Using making screw-retained type
prosthesis in multiple cases by using
with Esthetic-low cylinder when path
adjustment is necessary.	Using making screw-retained type
prosthesis in multiple cases by using
with Esthetic-low cylinder when path
adjustment is necessary.	Same
Dimension (mm)	D(Ø) G/H Post 4.9 2.5, 3.0, 3.5,
4.0, 5.0 2.3					D(Ø) G/H Post 4.9 5.0 2.3	D(Ø) G/H Post 4.9 2.5,
3.0,
3.5,
4.0,
5.0 2.3					Same
Angled( °)	17, 30	17	17, 30	Same
Material	Ti-6Al-4V (ASTM F136)	Ti-6Al-4V (ASTM F136)	Ti-6Al-4V (ASTM F136)	Same

26

Page 23 of 31

Image /page/26/Picture/2 description: The image contains the logo for "OSSTEM IMPLANT". The word "OSSTEM" is in a bold, sans-serif font and is colored orange. The word "IMPLANT" is in a smaller, sans-serif font and is located below the word "OSSTEM". The logo is simple and clean, and it is likely used to represent a company that manufactures or sells dental implants.

OSSTEM Implant Co., Ltd.
66-16, Bansong-ro 513beon-gil, Haeundae-gu, Busan, Republic of Korea
Tel: +82 51 850 2500 Fax: +82 51 861 4693 www.osstem.com

| Sterilization | Provided sterile
(Radiation Sterile) | Sterile by end users | Sterile by end users | Different |
|----------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------|----------------------|-----------|
| Shelf-life | 8 years | N/A | N/A | Different |
| Surface
Treatment | N/A | N/A | N/A | Same |
| S.E. | Similarities
Proposed Multi Angled Abutment has same design, function, dimension range and indication for use; and is made with same material with same manufacturing process by same manufacturer compared to that of the primary predicate Multi Angled Abutment, K221684 and K182091.

Differences
The only difference is sterilization process. The proposed device is sterilized compared to the primary predicate; but it has same raw material, design, manufacturing process, etc. as that of the primary predicate.

.: Proposed Multi Angled Abutment and the primary predicate are exactly same except sterilization process; therefore, the proposed device is substantially equivalent to the primary predicate. | | | |

27

Image /page/27/Picture/2 description: The image shows the logo for Osstem Implant. The logo is orange and features the word "OSSTEM" in a bold, sans-serif font. Below the word "OSSTEM" is the word "IMPLANT" in a smaller, sans-serif font. The logo is simple and modern.

OSSTEM Implant Co., Ltd.

66-16, Bansong-o 513beon-gil, Haeundae-gu, Busan, Republic of Korea
Tel: +82 51 850 2500 Fax: +82 51 861 4693 www.osstem.com.

66-16, Bansong-ro 513beon-gil, Haeundae-gu, Busan, Republic of Korea
Tel: +82 51 850 2500 Fax: +82 51 861 4693 www.osstem.com

5) Convertible Abutment

	Subject Device	Reference Device	Remark
Device Name	Convertible Abutment	Convertible Abutment	Same
510(k) Number	-	K120847	-
Manufacturer	Osstem Implant Co., Ltd	Osstem Implant Co., Ltd	Same
Design	Image: Convertible Abutment	Image: Convertible Abutment	Same
Indication for
Use	The OSSTEM Abutment system is
intended for use with a dental implant
to provide support for prosthetic
restorations such as crowns, bridges,
or overdentures.	The ET/SS Implant System is
indicated for use in partially or fully
edentulous mandibles and maxillae, in
support of single or multiple-unit
restorations including; cemented
retained, screw retained, or
overdenture restorations, and final or
temporary abutment support for fixed
bridgework. It is intended for delayed
loading. The abutment is intended for
use with a dental implant fixture to
provide support for prosthetic
restorations such as crowns, bridges,
or overdenture.	Same
Principle of
Operation	Use for cereating bridge case
prosthesis with dislocated path.	Use for cereating bridge case
prosthesis with dislocated path.	Same
	D(Ø)	G/H	Post	D(Ø)	G/H	Post
	4.0	1.0, 2.0, 3.0,
4.0	1.0	4.0	1.0, 2.0, 3.0,
4.0	1.0
Dimension (mm)	4.8	1.0, 2.0, 3.0,
4.0, 5.0	1.2	4.8	1.0, 2.0, 3.0,
4.0, 5.0	1.2	Same
	6.0	1.0, 2.0, 3.0,
4.0, 5.0	1.2	6.0	1.0, 2.0, 3.0,
4.0, 5.0	1.2
Material	Ti-6Al-4V (ASTM F136)			Ti-6Al-4V (ASTM F136)			Same
Sterilization	Provided sterile
(Radiation Sterile)			Sterile by end users			Different
Shelf-life	8 years			N/A			Different
Surface
Treatment	N/A			N/A			Same
S.E.	Similarities
Proposed Convertible Abutment has same design, function, dimension range and indication
for use; and is made with same material with same manufacturing process by same
manufacturer compared to that of the reference device Convertible Abutment, K120847.

28

Image /page/28/Picture/1 description: The image shows the text 'K233194' in a simple, sans-serif font. The text is presented in a straightforward manner, with each character clearly legible. The arrangement of the characters is linear, forming a single string of alphanumeric characters.

TEM®

OSSTEM Implant Co., Ltd.
66-16, Bansong-n 513beon-gil, Haeunda-gu, Busan, Republic of Korea
Tel: +82 51 850 2500 Fax: +82 51 861 4693 www.osstem.com.

| Differences
The only difference is sterilization process. The proposed device is sterilized compared to
the reference device; but it has same raw material, design, manufacturing process, etc. as

that of the reference device.
.: Proposed Convertible Abutment and the reference device are exactly same except
sterilization process; therefore, the proposed device is substantially equivalent to the
reference device.

6) Port Abutment

	Subject Device	Primary Predicate	Remark
Device Name	Port Abutment	Port Abutment	Same
510(k) Number	-	K182091	-
Manufacturer	Osstem Implant Co., Ltd	Osstem Implant Co., Ltd	Same
Design	Image: Subject Device Design	Image: Primary Predicate Design	Same
Indication for Use	The OSSTEM Abutment system is intended for use with a dental implant to provide support for prosthetic restorations such as crowns, bridges, or overdentures.	Osstem Abutment System is intended for use with a dental implant to provide support for prosthetic restorations such as crowns, bridges, or overdentures.	Same
Principle of Operation	Using making implant retained overdenture at maxilla/mandible.	Using making implant retained overdenture at maxilla/mandible.	Same
Dimension (mm)	D(Ø) G/H Post 3.7 1.0, 2.0, 3.0, 4.0, 5.0, 6.0, 7.0 1.5			D(Ø) G/H Post 3.7 1.0, 2.0, 3.0, 4.0, 5.0, 6.0, 7.0 1.5	Same
Material	Ti-6Al-4V (ASTM F136)	Ti-6Al-4V (ASTM F136)	Same
Sterilization	Provided sterile (Radiation Sterile)	Sterile by end users	Different
Shelf-life	8 years	N/A	Different
Surface Treatment	N/A	N/A	Same
S.E.	Similarities
Proposed Port Abutment has same design, function, dimension range and indication for use; and is made with same material with same manufacturing process by same manufacturer compared to that of the primary predicate Port Abutment, K182091.

29

OSSTEM® IMPLANT

OSSTEM Implant Co., Ltd.

66-16, Bansong-n 513beon-gil, Haeundae-gu, Busan, Republic of Korea
Tel: +82 51 850 2500 Fax: +82 51 861 4693 www.osstem.com.

66-16, Bansong-ro 513beon-gil, Haeundae-gu, Busan, Republic of Korea
Tel: +82 51 850 2500 Fax: +82 51 861 4693 www.osstem.com

Differences
The only difference is sterilization process. The proposed device is sterilized compared to
the primary predicate; but it has same raw material, design, manufacturing process, etc. as
that of the primary predicate.
: Proposed Port Abutment and the primary predicate are exactly same except sterilization
process; therefore, the proposed device is substantially equivalent to the primary predicate.

30

Image /page/30/Picture/1 description: The image contains the logo for "OSSTEM IMPLANT". The word "OSSTEM" is in orange and is in a larger font than the word "IMPLANT", which is in black. There is a registered trademark symbol next to the word "OSSTEM".

OSSTEM Implant Co., Ltd.

66-16, Bansong-ro 513beon-gil, Haeundae-gu, Busan, Republic of Korea
Tel: +82 51 850 2500 Fax: +82 51 861 4693 www.osstem.com

7) Stud Abutment
	Subject Device	Primary Predicate	Reference Device	Remark
Device Name	Stud Abutment	Stud Abutment	Stud Abutment	Same
510(k) Number	-	K182091	K161689	-
Manufacturer	Osstem Implant Co., Ltd	Osstem Implant Co., Ltd	Osstem Implant Co., Ltd	Same
Design	Image: Stud Abutment	Image: Stud Abutment	Image: Stud Abutment	Same
Indication for Use	The OSSTEM Abutment system is
intended for use with a dental implant to
provide support for prosthetic
restorations such as crowns, bridges, or
overdentures.	Osstem Abutment System is intended for
use with a dental implant to provide
support for prosthetic restorations such
as crowns, bridges, or overdentures.	The OSSTEM Implant System -
Abutment is intended for use with a
dental implant to provide support for
prosthetic restorations such as crowns,
bridges, or overdentures.	Same
Principle of
Operation	Using making stud type overdenture
prosthetics	Using making stud type overdenture
prosthetics	Using making stud type overdenture
prosthetics	Same
Dimension (mm)	D(Ø)	G/H	Post	Same
	3.5	1.0, 2.0, 3.0,
4.0, 5.0, 6.0	2.5, 3.35
	D(Ø)	G/H	Post
	3.5	1.0,
2.0,
3.0,
4.0,
5.0,
6.0	2.5
	D(Ø)	G/H	Post
	3.5	1.0, 2.0, 3.0,
4.0, 5.0, 6.0	3.35
Material	Ti-6Al-4V (ASTM F136)	Ti-6Al-4V (ASTM F136)	Ti-6Al-4V (ASTM F136)	Same
Sterilization	Provided sterile
(Radiation Sterile)	Sterile by end users	Sterile by end users	Different
Shelf-life	8 years	N/A	N/A	Different
Surface
Treatment	N/A	N/A	N/A	Same
S.E.	Similarities
Proposed Stud Abutment has same design, function, dimension range and indication for use; and is made with same material with same manufacturing process by same manufacturer compared to that of the primary predicate and reference device Stud Abutment, K182091 and K161689.
Differences
The only difference is sterilization process. The proposed device is sterilized compared to the primary predicate; but it has same raw material, design, manufacturing process, etc. as that of the primary predicate.
	.: Proposed Stud Abutment and the primary predicate are exactly same except sterilization process; therefore, the proposed device is substantially equivalent to the primary predicate.

Page 27 of 31

31

Page 28 of 31

OSSTEM® IMPLANT

OSSTEM Implant Co., Ltd.
66-16, Bansong-ro 513beon-gil, Haundae-gu, Busan, Republic of Korea
Tel: +82 51 850 250 Fax: +82 51 861 4693 www.osstem.com

8) Healing Abutment

	Subject Device	Reference Device	Reference Device	Remark
Device Name	Healing Abutment	Healing Abutment	Healing Abutment	Same
510(k) Number	-	K161604	K163634	-
Manufacturer	Osstem Implant Co., Ltd	Osstem Implant Co., Ltd	Southern Implants (Pty) Ltd.	Same
Design	Image: Healing Abutment	Image: Healing Abutment	N/A	Same
Indication for Use	The OSSTEM Abutment system is	The Osstem Implant System is indicated	Southern Implants' External Hex	Same

32

Image /page/32/Picture/1 description: The image contains the logo for "OSSTEM IMPLANT". The word "OSSTEM" is in a larger, orange font with a registered trademark symbol. Below it, the word "IMPLANT" is written in a smaller, black font.

OSSTEM Implant Co., Ltd.
66-16, Bansong-ro 513beon-gil, Haeundae-gu, Busan, Republic of Korea
Tel: +82 51 850 2500 Fax: +82 51 861 4693 www.osstem.com

| | intended for use with a dental implant to
provide support for prosthetic
restorations such as crowns, bridges, or
overdentures. | for use in partially or fully edentulous
mandibles and maxillae, in support of
single or multiple-units restorations
including; cemented retained, screw
retained, or overdenture restorations, and
final or temporary abutment support for
fixed bridgework. It is intended for
delayed loading. Ultra wide Fixture
System is intended to be used in the
molar region.
Products with diameter of less than
3.25mm should be used exclusively for
the laterl incisor in the maxilla and a
central or lateral incisor in the mandible. | Implants are intended for surgical
placement in the upper or lower jaw to
provide a means for prosthetic
attachment of crowns, bridges or
overdentures utilizing delayed or
immediate loading. Southern Implants'
External Hex Implants are intended for
immediate function when good primary
stability with appropriate occlusal
loading is achieved. | | | | |
|---------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------|------|------------------------------------|-----------|
| Principle of
Operation | Used to make a natural soft tissue shape
until setting up prosthetics. It is intended
use to combine with implanted implant
after osseointegration then removing
cover screw. | Used to make a natural soft tissue shape
until setting up prosthetics. It is intended
use to combine with implanted implant
after osseointegration then removing
cover screw. | N/A | Same | | | |
| | | | | | | | |
| | | D(Ø) | L | D(Ø) | L | D(Ø) | L |
| Dimension (mm) | 4.3 | 2.0, 6.0, 8.0 | 4.3 | 3.0, 4.0, 5.0, 7.0, 9.0 | 4.5 | 2.2, 3.0, 4.0, 5.0, 6.0, 8.0 | Different |
| | 4.8 | 6.0, 8.0, 10.0 | 4.8 | 3.0, 4.0, 5.0, 7.0, 9.0 | 5.5 | 2.2, 3.0, 4.0, 5.0, 6.0, 8.0, 12.0 | |
| | 5.3 | 6.0, 8.0, 10.0, 11.0, 12.0 | 5.3 | 3.0, 4.0, 5.0, 7.0, 9.0 | 6.5 | 2.2, 3.0, 4.0, 5.0, 6.0, 8.0, 12.0 | |
| | 6.3 | 6.0, 8.0 | 6.3 | 3.0, 4.0, 5.0, 7.0, 9.0 | 7.5 | 2.2, 3.0, 4.0, 5.0, 6.0, 8.0, 12.0 | |
| | 7.3 | 6.0, 8.0 | 7.3 | 3.0, 4.0, 5.0, 7.0, 9.0 | | | |
| | 8.3 | 6.0, 8.0 | 8.3 | 5.0 | | | |
| | 9.3 | 5.0, 6.0, 8.0 | | | | | |
| | Material | Titanium Gr.4 (ASTM F67) | Titanium Gr.4 (ASTM F67) | CPTi, Titanium alloy, Gold, CoCr | Same | | |
| Sterilization | Provided sterile
(Radiation Sterile) | Provided sterile
(Radiation Sterile) | N/A | Same | | | |
| | Shelf-life | 8 years | 8 years | N/A | Same | | |

Page 29 of 31

33

Page 30 of 31

Image /page/33/Picture/2 description: The image contains the logo for Osstem Implant. The logo is in orange and consists of the word "OSSTEM" in a stylized font, with a small circle above the "M". Below the word "OSSTEM" is the word "IMPLANT" in a smaller, sans-serif font. The logo is simple and modern.

OSSTEM Implant Co., Ltd.
66-16, Bansong-o 513beon-gil, Haunda-gu, Busan, Republic of Korea
Tel: +82 51 850 250 Fax: +82 51 861 4693 www.osstem.com

| Surface
Treatment | Mini Connection: Anodizing
Regular Connection : N/A | Mini Connection: Anodizing
Regular Connection : N/A | N/A | Same |
|----------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------|
| S.E. | Similarities
Proposed Healing Abutment has same design, function and indication for use; and is made with same material with same manufacturing process
by same manufacturer compared to that of the reference device Healing Abutment, K161604. | Differences
The added diameter and length differ from the dimension range of the reference device. However, since Healing Abutment is used temporarily to make natural soft tissue shape until setting up prosthetics, it does not required any performance. In addition, proposed lengths are within in dimension range of reference device, already cleared in K163634. Therefore, we don't consider additional performance testing. | : Proposed Healing Abutment and the reference device have common in design, function, indication for use, material, manufacturing process,
manufacturer, etc.; therefore, the proposed device is substantially equivalent to the reference device. | |

34

Image /page/34/Picture/21 description: The image contains the logo for Osstem Implant. The logo is in orange and consists of the word "OSSTEM" in all caps, with the word "IMPLANT" underneath in a smaller font. There is a degree symbol to the right of the word "OSSTEM".

66-16, Bansong-ro 513beon-gil, Haeundae-gu, Busan, Republic of Korea Tel: +82 51 850 2500 Fax: +82 51 861 4693 www.osstem.com

Summary of Non-clinical Performance Testing

Non-clinical testing data were referenced by prior clearances to demonstrate substantial equivalence.

Biocompatibility Evaluation

Biocompatibility testing was considered followed the FDA Guidance Document Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process, " The TS Abutment System has same materials, manufacturer, manufacturing process, surface treatment etc., as primary predicate and reference devices. Therefore, we didn't conduct additional biocompatibility test.

Sterilization Validation and Shelf-life

Validation of the gamma irradiation process was previously conducted for the predicated device. The processes of prediates since the clearance and the change in dimensions of the subject devices do not create the new worst case scenario or sterilization; therefore, additional validation is not required. In addition, TS Abutment System are made with titanium and titanium alloy we don't consider about shelf life of material by itself because this metal is widely known that it generally has no adversely affect by aging. Therefore we certify that product such like metal has no shelf life.

Pvrogen Test

Bacterial Endotoxin Test Report on implants according to ISO 10993-11:2006 and USP referenced in K161604.

Mechanical Properties

Fatigue testing was considered according to the FDA Guidance Document Guidance for Industry and FDA Staff Class II Special Controls Guidance Document Root-form Endosseous Dental Implants and Endosseous Dental Abutment and ISO 14801 standard. Processes of predicates since the clearance and the change in dimensions of the subject device do not create the new worst case scenario or bench testing.

MR Compatibility

Non-clinical worst-case MRI review was performed to evaluate the Subject device components in the MRI environment using scientific rationale and published literature (e.g., Woods, Terry O., Jana G. Delfino, and Sunder Rajan, "Assessment of Magnetically Induced Displacement Force and Torque on Metal Alloys Used in Medical Devices." Journal of Testing and Evaluation 49.2 (2019): 783-795), based on the entire system including all variations (all compatible implant bodies, abutments, and fixation screws) and material composition. Rationale addressed parameters per the FDA guidance "Testing and Labeling Medical Devices for Safety in the Magnetic Resonance (MR) Environment," including magnetically induced displacement force and torque.

7. Summary of Clinical Testing

No clinical studies are submitted.

8. 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. Osstem Implant Co., Ltd. concludes that TS Abutment System is substantially equivalent to the predicated devices as herein.