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.

Device Description

The TS Implant System is a dental implant made of titanium metal intended to be surgically placed in the bone of the upper or lower jaw arches. Fixture is made of pure titanium metal and supplied sterile. The surface is SA, Sandblasting and Acid etching, treated. Abutment is device made of titanium alloy and Plastic and it is intended for use to make temporary prosthesis. It consists of Abutment and Abutment Screw.

AI/ML Overview

This document is a 510(k) premarket notification for the "TS Implant System" by OSSTEM Implant Co., Ltd. It seeks to establish substantial equivalence to previously marketed predicate devices, not to prove performance against specific acceptance criteria for a new AI/software-driven medical device. Therefore, the information typically required for an AI/software device's acceptance criteria and study proving its performance is not present in this document.

The document focuses on comparing the design, materials, and intended use of the TS Implant System to existing dental implants (predicate devices) to demonstrate that it is "substantially equivalent" and thus safe and effective.

Here's why the requested information cannot be extracted from this document:

Nature of the Device: The TS Implant System is a physical dental implant made of titanium metal and does not appear to incorporate artificial intelligence or sophisticated software for diagnosis or treatment.
Type of Submission: A 510(k) Pre-market Notification primarily assesses "substantial equivalence" to a predicate device, rather than requiring extensive clinical trials or performance studies against predefined acceptance criteria like a PMA (Pre-market Approval) or De Novo submission for novel AI/software devices.
Absence of Clinical Studies: The document explicitly states under "7. Summary of clinical testing": "No clinical studies are submitted." This confirms that no clinical data was presented to establish performance metrics against acceptance criteria.
Lack of AI/Software-Specific Information: There is no mention of algorithms, data sets (training or test), ground truth, expert readers, or adjudication methods, which are standard for AI/software device evaluations.

In summary, this document does not contain the information needed to answer your request regarding acceptance criteria and performance studies for an AI/software device because the device described is a physical dental implant, and the submission type does not necessitate such detailed performance data as would be required for a novel AI/software medical device.

Summary

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K 121585

Image /page/0/Picture/1 description: The image shows the logo for Osstem Implant. The logo is in black and white 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 it is likely used to represent a company that manufactures or sells dental implants.

OSSTEM Implant Co., Ltd

#507-8 Geoje3-Dong Yeonje-Gu Busan, 611-804 Republic of Korea Tel: +82 51 850-2500 Fax: +82 51 850-4341 www.osstem.com

JAN 0 7 2013

5 Summary

This summary of 510(k) safety and effectiveness information is being submitted in accordance with requirements of 21 CFR Part 807.92.

Date: April 20, 2012

Company and Correspondent making the submission:

Submitter's Name :
Address :
Contact :
Phone:
Correspondent's Name:
Address:
Contact:
Phone:

Device :

Trade or (Proprietary) Name : Common or usual name :

Classification Name :

OSSTEM Implant Co., Ltd. #507-8 Geoje3-Dong Yeonje-Gu Busan, 611-804, Republic of Korea Mr. Hee Kwon Son +82 51 850 2575

HIOSSEN Inc. 85 Ben Fairless Dr. Fairless Hills, PA 19030 Patrick Lim 888 678 0001

TS Implant System Dental Implant Endosseous Dental Implant 21CFR872.3640 Class II DZE

3. Predicate Device:

The HGII Short Fixture System, Osstem Implant Co., Ltd, K091678 The ETIII SA Fixture System, HIOSSEN Inc., K101096 The HS/HG Prosthetic System, Osstem Implant Co., Ltd, K100245 The NC Temporary Abutment, STRAUMANN USA, K072679 The RC Temporary Abutment, STRAUMANN USA, K093027

4. Description:

The TS Implant System is a dental implant made of titanium metal intended to be surgically placed in the bone of the upper or lower jaw arches.

Fixture is made of pure titanium metal and supplied sterile. The surface is SA, Sandblasting and Acid etching, treated.

QS-QI-505-3(Rev.0)

Letter(8.5 X 11in)

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Image /page/1/Picture/0 description: The image shows the logo for Osstem Implant. The logo is in black and white and features the word "OSSTEM" in a stylized font. Below the word "OSSTEM" is the word "IMPLANT" in a smaller, less bold font. The logo is simple and modern.

Abutment is device made of titanium alloy and Plastic and it is intended for use to make temporary prosthesis. It consists of Abutment and Abutment Screw

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

Fixture in the TS Implant System is substantially equivalent in design, function and intended use to the HGII Short Fixture System of Osstem Implant Co., Ltd(K091678) and the ETIII SA Fixture System of HIOSSEN Inc.(K101096)

Abutment in the TS Implant System is substantially equivalent in design, function and intended use to the HS/HG Prosthetic System of Osstem Implant Co., Ltd.(K100245) , the NC Temporary Abutment of STRAUMANN USA(K072679) and the RC Temporary Abutment of STRAUMANN USA(K093027)

- Substantial Equivalence Matrix

		Predicate devices
	TS Implant System	HG II Short FixtureSystem(K091678)	ETIII SA FixtureSystem(K101096)
Design	Image: TS Implant System	Image: HG II Short Fixture System	Image: ETIII SA Fixture System
Intended use	The TS Implant System isindicated for use in partiallyor fully edentulousmandibles and maxillae, insupport of single ormultiple-unit restorationsincluding; cementedretained, screw retained, oroverdenture restorations,and final or temporaryabutment support for fixedbridgework. It is intendedfor delayed loading. Theabutment is intended for usewith a dental implant fixtureto provide support forprosthetic restorations such	The HG II Short FixtureSystem is intended for use inpartially or fully edentulousmandibles and maxillae, insupport of single ormultiple-unit restorationsincluding; cementedretained, screw retained, oroverdenture restorations,and terminal or intermediateabutment support for fixedbridgework. It is not forimmediate load.	ETIII SA FixtureSystem is indicated for usein partially or fullyedentulous mandibles andmaxillae, in support ofsingle or multiple-unitrestorations including ;cemented retained, screwretained, or overdenturerestorations, and terminal orintermediate abutmentsupport for fixedbridgework. The ETIII SAFixture System is for singleand two stage surgicalprocedures. It is not forimmediate load. The Ultra

QS-QI-505-3(Rev.0)

Letter(8.5 X 11in)

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Image /page/2/Picture/0 description: The image shows the logo for OSSTEM IMPLANT. The word "OSSTEM" is in bold, black letters, with a degree symbol next to the "M". Below the word "OSSTEM" is the word "IMPLANT" in smaller, black letters. The logo is simple and professional.

OSSTEM Implant Co., Ltd.

#507-8 Geoje3-Dong Yeonje-Gu Busan, 611-804 Republic of Korea Tel: +82 51 850-2500 Fax: +82 51 850-4341 www.osstem.com

	as crowns, bridges, or		wide Fixture System is
	overdenture.		intended to be used in themolar region.
Surgery type	One and two stageSurgery	One and two stageSurgery	One and two stageSurgery
Structure	- Internal Hex-connected- Submerged Fixture- Tapered body shape and- cutting edge forself-tapping	- Internal Hex-connected- Submerged Fixture- Straight body shape and- 4 sided cutting edge withself-tapping	- Submerged Fixture- Self tapping- Internal Hexagonalconnection- Taper Body
BodyDiameter(D)	TSIII SA: 5.1TSIII SA Ultra Wide: 5.95,6.8	4.85~6.85	3.5~5.0
Length (mm)	6.2	6.2	7.0~15.0
Material ofFixture	Pure Titanium Grade 4(ASTM F67)	Pure Titanium Grade 4(ASTM F67)	Pure Titanium Grade 4(ASTM F67)
Surface	SA	RBM	SA
Sterilization	Radiation Sterile	Radiation Sterile	Radiation Sterile
Shelf life	8years	5 years	5 years
S. E.	The TS Implant System has the same material, indication for use and similar design as theThe HG II Short Fixture (K091678) except surface treatment. but the surface treatment ofTS Implant System is the same with surface treatment of ETIII SA Fixture System(K101096)

Indication for use :

TS Implant System is compatible with abutment in the ET/SS Implant System

1. Review :
  The TS Implant System has same material and indication for use and similar design and technological characteristics as the predicate device.

The TS Implant System has been subjected to safety, performance, and product validations prior to release. Safety tests including biocompatibility have been performed to ensure the devices comply with the applicable International and US regulations.

7. Summary of clinical testing

No clinical studies are submitted

QS-QI-505-3(Rev.0).

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Image /page/3/Picture/0 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized human figure with outstretched arms, representing care and protection. The figure is positioned to the right of the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA", which is arranged in a circular fashion around the left side of the logo.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

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

January 7, 2013

Osstem Implant Company, Limited C/O Mr. Patrick Lim Hiossen, Incorporated 85 Ben Fairless Drive FAIRLESS HILLS PA 19030

Re: K121585

Trade/Device Name: TS Implant System Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: II Product Code: DZE, NHA Dated: December 21, 2012 Received: December 26, 2012

Dear Mr. Lim:

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.

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Page 2 - Mr. Lim

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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Anthony Lo m

Anthony D. Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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OSSTEM Implant Co., Ltd.

#507-8 Geoje3-Dong Yeonje-Gu Busan, 611-804 Republic of Korea

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

510(k) Number	K 121585
---------------	----------

Device Name : TS Implant System

Indication for use : 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 abutiment 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.

TS Implant System is compatible with abutment in the ET/SS Implant i System

Prescription Use_ ਮ (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)

2013.01.04 Susan Runner DDS, MA 11:23:44 -05'00'

(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices

K121585 510(k) Number:

QS-Q1-505-2(Rev.0)

Letter(8.5 X 1 lin)

Regulation Number and Section

§ 872.3640 Endosseous dental implant.

(a)
Identification. An endosseous dental implant is a prescription device made of a material such as titanium or titanium alloy that is intended to be surgically placed in the bone of the upper or lower jaw arches to provide support for prosthetic devices, such as artificial teeth, in order to restore a patient's chewing function.(b)
Classification. (1) Class II (special controls). The device is classified as class II if it is a root-form endosseous dental implant. The root-form endosseous dental implant is characterized by four geometrically distinct types: Basket, screw, solid cylinder, and hollow cylinder. The guidance document entitled “Class II Special Controls Guidance Document: Root-Form Endosseous Dental Implants and Endosseous Dental Implant Abutments” will serve as the special control. (See § 872.1(e) for the availability of this guidance document.)(2)
Classification. Class II (special controls). The device is classified as class II if it is a blade-form endosseous dental implant. The special controls for this device are:(i) The design characteristics of the device must ensure that the geometry and material composition are consistent with the intended use;
(ii) Mechanical performance (fatigue) testing under simulated physiological conditions to demonstrate maximum load (endurance limit) when the device is subjected to compressive and shear loads;
(iii) Corrosion testing under simulated physiological conditions to demonstrate corrosion potential of each metal or alloy, couple potential for an assembled dissimilar metal implant system, and corrosion rate for an assembled dissimilar metal implant system;
(iv) The device must be demonstrated to be biocompatible;
(v) Sterility testing must demonstrate the sterility of the device;
(vi) Performance testing to evaluate the compatibility of the device in a magnetic resonance (MR) environment;
(vii) Labeling must include a clear description of the technological features, how the device should be used in patients, detailed surgical protocol and restoration procedures, relevant precautions and warnings based on the clinical use of the device, and qualifications and training requirements for device users including technicians and clinicians;
(viii) Patient labeling must contain a description of how the device works, how the device is placed, how the patient needs to care for the implant, possible adverse events and how to report any complications; and
(ix) Documented clinical experience must demonstrate safe and effective use and capture any adverse events observed during clinical use.