Predicate Devices

Reference Devices

K120847, K081786, K121585, K063861, K110308, K100245, K140507, K062051

AI/ML (Artificial Intelligence / Machine Learning)

No
The summary describes a dental implant abutment and its components, with no mention of AI, ML, image processing, or any software-driven analytical capabilities.

Therapeutic

No.
A therapeutic device is one that treats a disease or condition; this device is explicitly described as providing support for prosthetic restorations.

Diagnostic

No

The device is an abutment for dental implants, intended to support prosthetic restorations. Its purpose is structural and restorative, not diagnostic.

SaMD (Software as a Medical Device)

No

The device description explicitly states it consists of "Abutments, components and Abutment Screws," which are physical hardware components.

IVD (In Vitro Diagnostic)

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

Here's why:

Intended Use: The intended use is to provide support for prosthetic restorations in the mouth, which is a mechanical function within the body.
Device Description: The device is described as components used in prosthetic restoration, not for analyzing samples from the body.
Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific substances, or providing diagnostic information based on in vitro testing.
Focus on Mechanical Function: The description and intended use clearly point to a device with a structural and mechanical role in dental restoration.

IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for diagnosis, monitoring, or screening. This device does not fit that description.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

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.

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

NHA

Device Description

The OSSTEM Implant System - Abutment is intended for use as an aid in prosthetic restoration. It consists of Abutments, components and Abutment Screws.

The OSSTEM Implant System - Abutment is similar to other commercially available products based on the intended use, the technology used, the claims, the material composition employed and performance characteristics.

The OSSTEM Implant System - Abutment is substantially equivalent in design, function and intended use to the Predicate Devices as above.

This submission includes straight abutments only that are not intended for any divergence/implant body angulation correction. The abutments are to be used with the TS SA Fixtures cleared in K121995.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Not Found

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)

Nonclinical Testing:
Biocompatibility: As the material of construction, manufacturing process, chemical composition, and body contact are same as the predicate devices, no additional testing is necessary.

Sterilization Validation: For Custom Healing Abutment, the sterilization validation report is leveraged from K140507 (conducted according to ISO 11137-1, ISO 11137-2 and ISO 11137-3) and shelf life testing leveraged from K062051 (tensile test (ASTM F882), seal peel test (ASTM F88/EN868-5), burst test (ASTM F1140), dye penetration (ASTM F1929), bubble test (ASTM F2096), and sterility testing (ISO 11737-2)). No additional testing is required.
Except for Custom Healing Abutment, the rest are non-sterile devices and steam sterilization validation was conducted according to ISO 17665-1 and ISO 17665-2.

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.

K130662

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.

K120847, K081786, K121585, K063861, K110308, K100245, K140507, K062051

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

0

Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes entwined around it. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus symbol. The logo is black and white.

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

May 22, 2017

OSSTEM Implant Co., Ltd. c/o Mr. David Kim Manager HiOSSEN Inc. 85 Ben Fairless Dr. Fairless Hills, Pennsylvania 19030

Re: K161689

Trade/Device Name: OSSTEM Implant System - Abutment Regulation Number: 21 CFR 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: Class II Product Code: NHA Dated: April 21, 2017 Received: April 21, 2017

Dear Mr. Kim:

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

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

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 (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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

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

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

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

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

Sincerely,

Image /page/1/Picture/8 description: The image contains a signature of a person named Tina Kiang. The signature is written in cursive and is accompanied by a dash and the letter 's' below the last name. The signature is placed over a light blue watermark of the letters 'FDA'.

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

Enclosure

2

Image /page/2/Picture/1 description: This image contains the logo and contact information for OSSTEM Implant Co., Ltd. The logo features the company name in bold, black letters, with the word "OSSTEM" in orange on the left. Below the company name is the address: 66-16, Bansong-ro 513beon-gil, Haeundae-gu, Busan, Republic of Korea. The image also includes the telephone number (+82 51 850-2500), fax number (+82 51 850-4341), and website address (www.osstem.com).

Indications for Use Statement

161689 510(k) Number K

Device Name: OSSTEM Implant System - Abutment

Indication for use:

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.

Prescription Use X (Per 21CFR801 Subpart D) OR

Over-The-Counter Use (Per 21CFR807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

3

OSSTEM
IMPLANT

66-16, Bansong-ro 513beon-gil, Haeundae-gu, Busan, Republic of Korea Tel: +82 51 850-2500 Fax: +82 51 850-4341 www.osstem.com

510(k) Summary

1. Date: May 19, 2017
- Submitter's Name:
- Address:
- Contact:
- Phone:
- Correspondent's Name:
- Address:
- Contact:
- Phone:
1. Device:

Trade or (Proprietary) Name: Common or usual name: Classification Name: Regulation Number: Device Classification: Subsequent Product Code:

OSSTEM Implant Co., Ltd. 66-16, Bansong-ro 513beon-gil, Haeundae-gu, Busan, 48002 Republic of Korea Mr. Hee Kwon Son +82 51 850 2575

HIOSSEN Inc. 85 Ben Fairless Dr. Fairless Hills, PA 19030 DAVID KIM 267 759 7031

OSSTEM Implant System - Abutment Dental Abutment Endosseous dental implant abutment 21CFR872.3630 Class II NHA

1. Predicate Device:
  Substantial equivalence is claimed to the following devices:

Primary Predicate K130662, ET Prosthetic System, OSSTEM IMPLANT CO., LTD

Reference predicate K120847, ET SS Implant System, OSSTEM IMPLANT CO., LTD K081786, Ziocera & Convertible System, OSSTEM IMPLANT CO., LTD K121585, TS Implant System, OSSTEM IMPLANT CO., LTD K063861, GS System, OSSTEM IMPLANT CO., LTD K110308, Prosthrtic System K100245, HS, HG Prosthetic System K140507, Hiossen Prosthetic system K062051, SS System

1. Description:
  The OSSTEM Implant System - Abutment is intended for use as an aid in prosthetic restoration. It consists of Abutments, components and Abutment Screws.

4

Image /page/4/Picture/1 description: The image shows the logo for Osstem Implant. The logo is orange and black. The word "OSSTEM" is in orange, and the word "IMPLANT" is in black. The logo is simple and modern.

Tel: +82 51 850-2500 Fax: +82 51 850-4341 www.osstem.com

The OSSTEM Implant System - Abutment is similar to other commercially available products based on the intended use, the technology used, the claims, the material composition employed and performance characteristics.

The OSSTEM Implant System - Abutment is substantially equivalent in design, function and intended use to the Predicate Devices as above.

This submission includes straight abutments only that are not intended for any divergence/implant body angulation correction. The abutments are to be used with the TS SA Fixtures cleared in K121995.

	Items	Content
1)	Transfer Abutment	Material	Titanium Alloy (Ti-6Al-4V)
		Diameter (mm)	4.6, 5.0, 6.0, 7.0
		Length(mm)	7.5, 8.5, 9, 9.1, 9.5, 10, 10.1, 10.5, 10.6, 11, 11.1,
11.5, 11.6, 12, 12.1, 12.5, 12.6, 13, 13.1, 13.5,
13.6, 14, 14.5, 14.6
		Angulation	-
		Device
Description	Used for making general cement-type prosthesis.
2)	ZioCera Abutment	Material	Zirconia
		Diameter (mm)	4.5, 5.5, 6.5
		Length(mm)	12.3, 12.7, 12.75, 13, 14.2, 14.4, 14.5, 14.75, 14.8
		Angulation	-
		Device
Description	Used for making general cement-type prosthesis.
3)	Quick Temporary
Abutment	Material	Titanium Alloy(Ti-6Al-4V) +
PEEK (Polyetherethereketone)
		Diameter (mm)	4, 4.5
		Length(mm)	11.5
		Angulation	-
		Device
Description	Used temporary until final prosthesis is made.
4)	FreeForm ST
Abutment	Material	Titanium Alloy (Ti-6Al-4V)
		Diameter (mm)	4.0, 5.0, 5.5, 6.0, 7.0
		Length(mm)	14, 14.5, 14.6
		Angulation	-
		Device
Description	Used for making general cement-type prosthesis.
Used when an abutment's path must be altered or a
prosthetic's margin area must be customized.
5)	Multi Abutment	Material	Titanium Alloy (Ti-6Al-4V)
		Diameter (mm)	4.8
		Length(mm)	8.3,8.7, 9.3, 9.7, 10.3, 10.7, 11.3, 11.7, 12.3, 12.7
		Angulation	-
		Device
Description	Used for edentulous mandible or maxilla to make
full denture.
		Material	Titanium Alloy (Ti-6Al-4V)
6)	Stud Abutment	Diameter (mm)	3.5
		Length(mm)	9.35, 9.75, 10.35, 10.75, 11.35, 11.75, 12.35, 12.75, 13.35, 13.75, 14.35, 14.75
		Angulation	-
		Device Description	Used in creating stud type overdenture prosthetics.
			Material
7)	Rigid Protect Cap	Diameter (mm)	4.4, 5.0, 5.5, 6.6, 7.4
		Length(mm)	5.5, 5.7, 5.8, 5.9, 7.0, 7.2, 7.3, 8.5, 8.7, 8.8
		Angulation	-
		Device Description	Used for the protection of the Rigid Abutment in the oral cavity.
		Material	POM (Polyoxymethylene)
		Diameter (mm)	4.8, 6.0, 6.6, 7.7, 8.7
8)	Rigid Retraction Cap	Length(mm)	5.5, 7.0, 8.5
		Angulation	-
		Device Description	Used for the protection of the Rigid Abutment on the oral cavity.
		Material	PEEK ( Polyetherethereketone)
		Diameter (mm)	7.05
9)	Custom Healing Abutment	Length(mm)	7, 7.5, 9, 9.5, 11, 11.5
		Angulation	-
		Device Description	Used to make a soft tissue shape before setting up prosthetics.
		Material	Titanium Alloy (Ti-6Al-4V)
		Diameter (mm)	4.0, 4.6, 5.0, 6.0, 7.0
	Rigid Abutment	Length(mm)	10, 10.4, 11, 11.4, 11.5, 11.9, 12, 12.4, 12.5, 12.9, 13, 13.4, 13.5, 13.9, 14, 14.4, 14.5, 14.9, 15, 15.4, 15.5, 15.9, 16, 16.4, 17, 17.4
10)			Angulation
			Device
Description
			Material
			Diameter (mm)
	Temporary Abutment	Length(mm)	13, 13.5, 13.6, 15, 15.5, 15.6
11)			Angulation
			Device Description
			Material
			Diameter (mm)
12)	O-ring
Retainer Cap Set	Length(mm)	Retainer Cap: 3.9/ O-Ring: 1.5mm
			Angulation
			Device Description
			Material
			Diameter (mm)
13)		O-ring Retainer Set	Length(mm)
	Angulation	-
	Device	Used for making stud-type overdenture.
	Description	Retainer + O-ring
	Material	Acrylonitrile & Butadiene Polymer
	Diameter (mm)	4.6
14)	O-ring Set	Length(mm) 1.5
	Angulation	-
	Device	Used for making stud-type overdenture.
	Description
	Material	Titanium Alloy (Ti-6Al-4V)
	Diameter (mm)	2.0, 2.05, 2.2, 2.3, 2.5
15)	Abutment Screw	Length(mm) 3.35, 5.6, 7.5, 8.35, 9.6, 10.2
	Angulation	-
	Device	Used to connect an abutment with fixture.
	Description

5

Image /page/5/Picture/0 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, italicized font. To the right of the word "OSSTEM" is a small superscript symbol.

6

Image /page/6/Picture/1 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, italicized font. The logo is simple and modern, and the orange color is eye-catching.

66-16, Bansong-ro 513beon-gil, Haeundae-gu, Busan, Republic of Korea Tel: +82 51 850-2500 Fax: +82 51 850-4341 www.osstem.com

The OSSTEM Implant System - Abutment is compatible with TS Fixture System, K121995.

TS Fixture System (TSII SA Fixture, TSIII SA Fixture, TSIII Ultra-Wide Fixture) has two types of connection, Mini type and Regular type that are same as OSSTEM Implant System - Abutment connection structure as below dimension table.

| TS Fixture System
(K121995) | Design | Nominal
Diameter | Diameter | Connection |
|--------------------------------|------------------------------------|---------------------|-----------------------|------------|
| TSII SA Fixture | Image: TSII SA Fixture | 3.5 | 3.5mm | Mini |
| | | 4.0 | 4.2mm | Regular |
| | | 4.5 | 4.4mm | Regular |
| | | 5.0 | 4.9mm | Regular |
| TSIII SA Fixture | Image: TSIII SA Fixture | 3.5 | 3.75mm, 3.77mm | Mini |
| | | 4.0 | 4.2mm, 4.25mm | Regular |
| | | 4.5 | 4.6mm, 4.63mm, 4.65mm | Regular |
| | | 5.0 | 5.05mm, 5.08mm, 5.1mm | Regular |
| TSIII SA Ultra-Wide
Fixture | Image: TSIII SA Ultra-Wide Fixture | 6.0 | 5.92mm, 5.95mm, 6.0mm | Regular |
| | | 7.0 | 6.8mm | Regular |

Indications for Use:

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.

1. Substantial Equivalence Matrix:
  Proposed devices in the this submission were all predicated by 510(k); therefore, indication for use, shape, connection structure, material, surface treatment, manufacturer and etc. are

7

Image /page/7/Picture/1 description: The image shows the logo and contact information for OSSTEM Implant Co., Ltd. The logo includes the company name in bold, along with the company's address, phone number, fax number, and website. The address is 66-16, Bansong-ro 513beon-gil, Haeundae-gu, Busan, Republic of Korea. The phone number is +82 51 850-2500, the fax number is +82 51 850-4341, and the website is www.osstem.com.

the same with predicated devices except dimension of additional products and new compatibility with TS SA Fixtures – K121995.

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

- Substantial Equivalence Matrix

Part Name	ZioCera Abutment	ZioCera Abutment	Identity
	Proposed	Predicate
510K	-	K081786
Material	Zirconia	Zirconia	Identical
Design	Image: ZioCera Abutment Proposed	Image: ZioCera Abutment Predicate	Connection
structure is
different (Hex and
Non-Hex) but
Design is
Substantial
Equivalence
Dimension
Diameter (mm)	4.5, 5.5, 6.5	4.5, 5.5, 6.5	Diameter is
identical
Length of post
(mm)	7	7	Identical
Indication for
use	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.	Ziocera & Convertible Systems
are intended for use as an aid in
prosthetic restoration.	Indication for use
of subject device
is slight
differences in
phrase with
predicate but
fundamental
Indication is same
Technological
Characteristics	Use for making general cement-
type prosthesis.	Use for making general cement-
type prosthesis.	Identical
SE	ZioCera Abutment has cleared with K081786, Ziocera & Convertible System. Therefore
ZioCera Abutment is resubmitted to add Hex type ZioCera Abutment
Proposed ZioCera Abutment are exactly same with predicate ZioCera abutment except
connection structure (diameter and Length of post are also same)
We state ZioCera Abutment is substantial Equivalence from predicate, ZioCera Abutment
(K081786)

	Proposed Device	Predicate Device
Part Name	Quick Temporary Abutment	Quick Temporary Abutment
510K	-	K121585
Material	Titanium Alloy
PEEK	Titanium Alloy
PEEK	Identical

8

Image /page/8/Picture/0 description: The image shows the logo for Osstem Implant. The logo is in orange and gray. The word "OSSTEM" is in orange, and the word "IMPLANT" is in gray. There is a superscript "6" next to the word "OSSTEM".

Manufacturer	OSSTEM Implant Co., Ltd.	OSSTEM Implant Co., Ltd.	Identical
Description
(Intended for use)	used to make temporary
prosthesis	used to make temporary prosthesis	Identical
Dimension
(Diameter)	4mm, 4.5mm	4.5mm, 5.5mm	Diameter
4.0mm is
added
Connection	Internal Hex Connection	Internal Hex Connection	Identical
Technological
Characteristics	Cement retained restoration.
Capable of altering/removing
shape of plastic material.
Two piece (Abutment + Screw)	Cement retained restoration.
Capable of altering/removing
shape of plastic material.
Two piece (Abutment + Screw)	Identical
Indication for use	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. | The TS 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. | Phrase
highlighted
Is Identical |
| Design | Image: Abutment | Image: Abutment | Shape of
Plastic
section
(PEEK) is
different.
Connection
structure is
same |
| SE | The Quick Temporary Abutment had been cleared with K121585 but it is being
resubmitted to add revised shape therefore Quick Temporary Abutment and Predicate
devices have same function, material, Connection structure, characteristic and intended use
We state Quick Temporary Abutment is substantial Equivalence from predicate, Quick
Temporary Abutment (K121585). | | |

Part Name	Proposed Device	Predicate Device	Identity
	FreeForm ST Abutment	FreeForm ST Abutment
510K	-	K120847
Material	Titanium Alloy (Ti-6Al-4V),
ASTM F 136	Titanium Alloy (Ti-6Al-4V),
ASTM F 136	Identical
Manufacturer	OSSTEM Implant Co., Ltd.	OSSTEM Implant Co., Ltd.	Identical
Description	Use for the path adjustment of	Use for the path adjustment of	Identical

9

Image /page/9/Picture/0 description: The image shows the alphanumeric string "K161689" in a clear, sans-serif font. The characters are uniformly sized and spaced, creating a balanced visual appearance. The string is presented in a straightforward manner, without any additional graphical elements or stylistic enhancements.

Image /page/9/Picture/1 description: The image contains the logo for Osstem Implant. The logo is in two lines, with the word "OSSTEM" in orange on the top line and the word "IMPLANT" in gray on the bottom line. There is a small orange circle with a white number 6 in the upper right corner of the logo.

| (Intended for use) | abutment or customization of
prosthetic margin. | abutment or customization of
prosthetic margin. | |
|----------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------|
| Indication for use | 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. | 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. | Phrase highlighted
Is Identical |
| Technological
Characteristics | Use for making general cement-
type prosthesis. | Use for making general cement-
type prosthesis. | Identical |
| Dimension
(Diameter) | 5 | 4.0, 5.0, 5.5, 6.0, 7.0 | Diameter 5mm is
included dimension
range of predicate |
| Lenth of post
(mm) | 9, 10.5 | 9, 10.5 | Identical |
| Connection | Internal Hex Connection | Internal Hex Connection | Identical |
| Design | Image: Two abutments | Image: Three abutments with the first one highlighted with a red box | Design is
Substantial
Equivalence
With highlighted
predicate with red
Box |
| SE | No changes in function and intended use
Diameter and length of post are also included dimension range of predicate
We state FreeForm ST Abutment is substantial Equivalence with predicate, FreeForm ST
Abutment (K120847) | | |

Part Name	Rigid Protect Cap	Rigid Protect Cap	Identity
	Proposed	Predicate
510K	-	K100245
Material	PC (PolyCarbonate Polymer)	PC (PolyCarbonate Polymer)	Identical
Design	Image: Rigid Protect Cap	Image: Rigid Protect Cap	Identical
Dimension
(Diameter)	4.4, 5.0, 5.5, 6.6, 7.4	4.4, 5.0, 5.4, 6.6, 7.4	5.4mm diameter is
changed to 5.5mm

10

Image /page/10/Picture/0 description: The image shows the logo for Osstem Implant. The logo is orange and gray. The word "OSSTEM" is in orange, and the word "IMPLANT" is in gray. There is a superscript "6" next to the word "OSSTEM".

| Intended for
use | Use for the protection of the rigid
abutment in the oral cavity | Use for the protection of the rigid
abutment in the oral cavity | Identical |
|---------------------|---------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------|-----------|
| S.E | No changes in function and intended use
Rigid Protect Cap is substantial Equivalence with predicate, Rigid Protect Cap | | |

Part Name	Multi Abutment	Multi Abutment	Identity
	Proposed	Predicate
510K	-	K130662
Material	Titanium Alloy (TiN coating)	Titanium Alloy (TiN coating)	Identical
Design	Image: Multi Abutment Proposed	Image: Multi Abutment Predicate	Identical
Dimension
(Diameter)	4.8	4.8	Identical
Intended for use	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	Identical
S.E	No changes in function and intended use
Therefore Multi Abutment is substantial Equivalence with predicate, Multi Abutment

Product name	Identity
Transfer Abutment	- Transfer Abutment has cleared with K130662

Only article numbering change.
No other modifications (e.g. coating changes, design changes, addition
of other models, etc.) | | |
| | Stud Abutment | - Stud Abutment has cleared with K110308.
Only article numbering change.
No other modifications (e.g. coating changes, design changes, addition
of other models, etc.) | |
| | | Rigid Retraction Cap | - Rigid Retraction Cap has cleared with K100245.
Only article numbering change.
No other modifications (e.g. design changes, addition of other models,
etc.) |
| | | | Custom Healing Abutment |

11

Image /page/11/Picture/1 description: The image shows the logo for Osstem Implant. The logo is orange and gray. The word "OSSTEM" is in orange, and the word "IMPLANT" is in gray. The logo is simple and modern.

6-16, Bansong-ro 513beon-gil, Haeundae-gu, Busan, Republic of Korea 'el: +82 51 850-2500 Fax: +82 51 850-4341 www.osstem.com

| Rigid Abutment | - Rigid Abutment has cleared with K130662.

Only article numbering change.
No other modifications (e.g. coating changes, design changes, addition of other models, etc.) |
|--------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Temporary Abutment | - Temporary Abutment has cleared with K110308.
Only article numbering change.
No other modifications (e.g. coating changes, design changes, addition of other models, etc.) |
| O-ring Retainer Cap Set
O-ring Retainer Set
O-ring Set | - O-ring Retainer Cap Set, O-ring Retainer Set and O-ring Set has cleared with K140507.
Only article numbering change.
No other modifications (e.g. coating changes, design changes, addition of other models, etc.) |
| Abutment Screw | - The Abutment Screw has a cleared with 510(k), K110308 and K081786.
Only article numbering change.
No other modifications (e.g. coating changes, design changes, addition of other models, etc.) |

7. Summary of nonclinical testing:

The following nonclinical testing data were provided or relied upon in support of the substantial equivalence determination.

Biocompatibility

As the material of construction, manufacturing process, chemical composition, and body contact are same as the predicate devices, ET Prosthetic System, OSSTEM Implant Co., Ltd., K130662; ET SS Implant System, OSSTEM Implant Co., Ltd., K120847; Ziocera & Convertible System, OSSTEM Implant Co., Ltd., K081786; TS Implant System, OSSTEM Implant Co., Ltd., K121585; GS System, OSSTEM Implant Co., Ltd., K063861; Prosthetic System, K110308; HS, HG Prosthetic System, K100245; and Hiossen Prosthetic System, K140507. Therefore, no additional testing is necessary. .

Sterilization Validation

For Custom Healing Abutment, it is same in material, dimension, and manufacturer with predicated Custom Healing Abutment in Hiossen Prosthetic System, K140507; and result of the sterilization validation report is leveraged that was conducted according to ISO 11137-1. ISO 11137-2 and ISO 11137-3, as well as the shelf life testing which was leveraged from K062051: tensile test (ASTM F882), seal peel test (ASTM F88/EN868-5), burst test (ASTM F1140), dye penetration (ASTM F1929), bubble test (ASTM F2096), and sterility testing (ISO 11737-2). Therefore, no additional testing is required.

Except for Custom Healing Abutment, the rest are non-sterile devices and steam sterilization validation was conducted according to ISO 17665-1 and ISO 17665-2.

8. Summary of clinical testing:

No clinical studies are submitted.

12

Image /page/12/Picture/1 description: The image shows the logo for Osstem Implant. The logo is comprised of the word "OSSTEM" in orange, stacked on top of the word "IMPLANT" in gray. A small orange superscript "6" is located to the right of the word "OSSTEM".

1. Conclusions:
  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 CO., LTD. concludes that OSSTEM Implant System - Abutment is substantially equivalent to the predicate devices as described herein.