TS IMPLANT SYSTEM

• K Number: K121585
• Device Name: TS IMPLANT SYSTEM
• Manufacturer: OSSTEM IMPLANT CO.,LTD
• Date Cleared: 2013-01-07 ( 221 days)
• Product Code: DZE NHA
• Regulation Number: 872.3640

Intended 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 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.

Predicate Devices

K091678, K101096, K100245, K072679, K093027

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The summary describes a dental implant system made of titanium and plastic, with no mention of software, algorithms, or any technology related to AI or ML.

Therapeutic

No
The device is a dental implant system used for supporting prosthetic restorations. It does not actively treat or resolve a disease or condition in a therapeutic manner beyond supporting a physical structure.

Diagnostic

No
The TS Implant System is a dental implant intended for surgical placement to support restorations, not for diagnosing conditions.

SaMD (Software as a Medical Device)

No

The device description clearly states it is a dental implant made of titanium metal and includes physical components like fixtures and abutments. This indicates it is a hardware medical device, not software-only.

IVD (In Vitro Diagnostic)

No, this device is not an IVD (In Vitro Diagnostic).

Here's why:

• IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health. This testing is done outside of the body (in vitro).
• Device Description and Intended Use: The description clearly states that the TS Implant System is a dental implant made of titanium metal intended to be surgically placed in the bone of the jaw. It is used to support dental restorations. This is an in vivo (within the body) application, not an in vitro test.

The device is a surgically implanted medical device, not a diagnostic tool that analyzes samples outside the body.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications 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 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.

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

DZE, NHA

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

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

mandibles and maxillae

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)

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.

K091678, K101096, K100245, K072679, K093027

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.

Not Found

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

§ 872.3640 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.

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: [phone] Fax: [phone] 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

1. Company and Correspondent making the submission:

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

2. 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 [phone]

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)

1

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 Fixture
System
(K091678)	ETIII SA Fixture
System
(K101096)
Design	Image: TS Implant System	Image: HG II Short Fixture System	Image: ETIII SA Fixture System
Intended 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
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	The HG II Short Fixture
System is intended 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 terminal or intermediate
abutment support for fixed
bridgework. It is not for
immediate load.	ETIII SA Fixture
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 terminal or
intermediate abutment
support for fixed
bridgework. The ETIII SA
Fixture System is for single
and two stage surgical
procedures. It is not for
immediate load. The Ultra

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

Letter(8.5 X 11in)

2

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: [phone] Fax: [phone] www.osstem.com

	as crowns, bridges, or		wide Fixture System is
	overdenture.		intended to be used in the
molar region.
Surgery type	One and two stage
Surgery	One and two stage
Surgery	One and two stage
Surgery
Structure	- Internal Hex-connected

• Submerged Fixture
• Tapered body shape and
• cutting edge for
  self-tapping | - Internal Hex-connected
• Submerged Fixture
• Straight body shape and
• 4 sided cutting edge with
  self-tapping | - Submerged Fixture
• Self tapping
• Internal Hexagonal
  connection
• Taper Body |
  | Body
  Diameter(D) | TSIII SA: 5.1
  TSIII SA Ultra Wide: 5.95,
  6.8 | 4.856.85 | 3.55.0 |
  | Length (mm) | 6.2 | 6.2 | 7.0~15.0 |
  | Material of
  Fixture | 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 the
  The HG II Short Fixture (K091678) except surface treatment. but the surface treatment of
  TS Implant System is the same with surface treatment of ETIII SA Fixture System
  (K101096) | | |

5. 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 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.

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

• 6. 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).

3

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.

4

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 [phone] or [phone] 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

5

OSSTEM Implant Co., Ltd.

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

Tel: [phone] Fax: [phone] 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)