Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The document describes a physical dental implant made of titanium and does not mention any software, algorithms, or data processing that would indicate the use of AI/ML.

Therapeutic

Yes.
The device is a dental implant intended to support restorations and treat edentulism in patients, directly addressing a medical condition.

Diagnostic

No

The device is a dental implant, which is a restorative medical device, not one used for diagnosis.

SaMD (Software as a Medical Device)

No

The device description explicitly states it is a dental implant made of titanium metal intended for surgical placement, which is a physical hardware device, not software.

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 for supporting dental restorations in the jawbone. This is a surgical implant, not a test performed on a sample taken from the body to diagnose a condition.
Device Description: The device is described as a dental implant made of titanium, surgically placed in the bone. This aligns with a medical device, not an IVD.
Lack of IVD characteristics: There is no mention of analyzing biological samples, detecting analytes, or providing diagnostic information.

Therefore, the TS Fixture System is a medical device, specifically a dental implant, and not an In Vitro Diagnostic device.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The TS 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 final or temporary abutment support for fixed bridgework. It is intended for delayed loading.

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

DZE

Device Description

The TS Fixture 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 available in various lengths 7.0 to 15.0mm and diameters 3.5 to 6.8mm (TSII SA Fixture : 3.5, 4.2, 4.4, 4.9 / TSIII SA Fixture: 3.75, 3.77, 4.2, 4.25, 4.6, 4.63, 4.65, 5.05, 5.08, 5.1 / TSIII SA Ultra-Wide Fixture : 5.92, 5.95, 6, 6.8) according to the anatomical situation.

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

The TS Fixture 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.

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)

Fatigue testing was considered according to the "Guidance for industry and FDA staff Class II Special Controls Guidance Document Root-form Endosseous Dental Implants and Endosseous Dental Abutment" with the worst case scenario of the GSIII Fixture/ the HGII Fixture and an angled abutment in support of the TSIII SA Fixture and TSII SA Fixture. TS Fixture System has same material and similar design as the GSIII Fixture and the HGII Fixture . Therefore, submitted fatigue test result can be used as a proof of TS Fixture system.

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.

K090237, K101096, K091208, K103537

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

0

K121995

OSSTEM Implant Co.,

#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

NOV 2 9 2012

510(k) Summary

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

Date: June 15, 2012

Company and Correspondent making the submission:

Submitter's Name :
Address :
Contact :
Phone:
Correspondent's Name:
Address:
Contact:
Phone:
1. 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 Fixture System Dental Implant Endosseous Dental Implant 21CFR872.3640 Class II DZE

3. Predicate Device:

The HGII Fixture System, HIOSSEN Inc., Ltd. K090237 The ETIII SA Fixture System, HIOSSEN Inc., K101096 The GSIII System, Osstem Implant Co., Ltd, K091208 The ETIII SA Ultra wide Fixture, HIOSSEN Inc., K103537

4. Description:

The TS Fixture 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 available in various lengths 7.0 to 15.0mm and diameters 3.5 to 6.8mm (TSII SA Fixture : 3.5, 4.2, 4.4, 4.9 / TSIII SA Fixture: 3.75, 3.77, 4.2, 4.25, 4.6, 4.63, 4.65, 5.05,

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 word "OSSTEM" is in bold, sans-serif font, with the letters slightly overlapping. Below "OSSTEM" is the word "IMPLANT" in a smaller, lighter font. There is a small circle to the upper right of the word "OSSTEM".

OSSTEM Implant Co., Lt #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

5.08, 5.1 / TSIII SA Ultra-Wide Fixture : 5.92, 5.95, 6, 6.8) according to the anatomical situation.

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

The TS Fixture 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.

The TS Fixture System is substantially equivalent in design, function and intended use to the HGII Fixture System of HIOSSEN Inc. (K090237), the ETIII SA Fixture System of HIOSSEN Inc.(K101096), The GSIII System of Osstem Implant Co., Ltd(K091208) and The ETIII SA Ultra wide Fixture of HIOSSEN Inc.(K103537)

- Substantial Equivalence Matrix

		Predicate devices				TSIII SA Ultra-Wide Fixture	Predicate devices
	TS Fixture System	HGII Fixture
System	GSIII System	ETIII SA
Fixture System			ETIII SA Ultra wide Fixture
Design					Design	Image: TSIII SA Ultra-Wide Fixture	Image: ETIII SA Ultra wide Fixture
510(K) No.	New Device	K090237	K091208	K101096	510(K) No.	New Device	K103537
Intended use	The TS Fixture System
is designed for dental
implant surgery; it is
placed on the maxillary
or mandibular alveolar
bone through a surgical
procedure, and after
osseointegration with
the alveolar bone, it can
replace a lost tooth by
connecting the
abutment post. The TS
Fixture System is
indicated for use in
partially or fully
edentulous mandibles	The HG II 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	The GS III 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	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	Intended use	The TSIII SA Ultra-Wide Fixture 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 ETIII SA Ultra wide 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.
	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.	for fixed
bridgework.
The HG II Fixture
System is for single
and two stage
surgical
procedures. It is not
for
immediate load.	for fixed
bridgework.
The GS III System
is for single and
two stage surgical
procedures. It is not
for immediate
load.	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 wide
Fixture System is
intended to be used
in the molar region.	Surgery type	One or two stage Surgery	One or two stage Surgery
Surgery type	One or two stage
Surgery	One or two stage
Surgery	One or two stage
Surgery	One or two stage
Surgery	Structure	- Internal Hex-connected

Submerged Fixture
Tapered body shape and straight body shape
4 sided cutting edge with self-tapping | - Internal Hex-connected
Submerged Fixture
Tapered body shape and straight body shape
4 sided cutting edge with self-tapping |
| Structure | - Internal Hex-
connected
Submerged Fixture
Tapered body shape
and straight body shape
4 sided cutting edge
with self-tapping | - Internal Hex-
connected
Submerged
Fixture
Straight body
shape
4 sided cutting
edge with self-
tapping | - Internal Hex-
connected
Submerged
Fixture
Tapered body
shape and
4 sided cutting
edge with self-
tapping | - Submerged
Fixture
Self tapping
Internal
Hexagonal
connection
Taper Body | Body Diameter (D) | 5.92, 5.95, 6, 6.8 | 5.96.82 |
| Body
Diameter
(D) | TSII SA Fixture:
3.5, 4.2, 4.4, 4.9
TSIII SA Fixture:
3.75, 3.77, 4.2, 4.25,
4.6, 4.63, 4.65, 5.05,
5.08, 5.1 | 3.54.85 | 3.75.1 | 3.755.05 | Length (mm) | 7.012.5 | 7.212.7 |
| Length (mm) | 7.015 | 7.215.2 | 7.015.0 | 7.215.2 | Material of Fixture | Pure Titanium Grade 4 (ASTM F67) | Pure Titanium Grade 4 (ASTM F67) |
| Material of
Fixture | Pure Titanium Grade 4
(ASTM F67) | Pure Titanium
Grade 4
(ASTM F67) | Pure Titanium
Grade 4
(ASTM F67) | Pure Titanium
Grade 4
(ASTM F67) | Surface | SA (Sandblasting and Acid etching) | SA (Sandblasting and Acid etching) |
| Surface | SA | RBM | RBM | SA | Sterilization | Radiation Sterile | Radiation Sterile |
| Sterilization | Radiation Sterile | Radiation Sterile | Radiation Sterile | Radiation Sterile | Shelf life | 8years | 5years |
| Shelf life | 8years | 5 years | 5 years | 5 years | S E | The TSIII SA Ultra-Wide Fixture has the same material, surface treatment, indication for use and similar design as the ETIII SA Ultra wide Fixture (K103537) | |
| S. E. | The TS Fixture System has the same material, indication for use and similar design as the
HGII Fixture System (K090237) and GSIII System (K091208) except surface treatment. but
the surface treatment of TS Fixture System is the same with surface treatment of ETIII SA
Fixture System (K101096) | | | | | | |

OS-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 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, simpler font. There is a circle above and to the right of the word "OSSTEM".

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

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

Letter(8.5 X 11in)

.

3

OSSTEM® IMPLANT

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

A The School States States of Article

(6)

--

4

Image /page/4/Picture/0 description: The image shows the logo for OSSTEM IMPLANT. The logo is in black and white, with the word "OSSTEM" in large, bold letters. Below the word "OSSTEM" is the word "IMPLANT" in smaller letters. There is a degree symbol to the right of the word OSSTEM.

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

5. Indication for use :

The TS 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 final or temporary abutment support for fixed bridgework. It is intended for delayed loading.

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

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

The TS Fixture 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 nonclinical testing

Fatigue testing was considered according to the "Guidance for industry and FDA staff Class II Special Controls Guidance Document Root-form Endosseous Dental Implants and Endosseous Dental Abutment" with the worst case scenario of the GSIII Fixture/ the HGII Fixture and an angled abutment in support of the TSIII SA Fixture and TSII SA Fixture. TS Fixture System has same material and similar design as the GSIII Fixture and the HGII Fixture . Therefore, submitted fatigue test result can be used as a proof of TS Fixture system

Summary of clinical testing No clinical studies are submitted

9. 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 Implant Co., Ltd. concludes that the TS Fixture System is substantially equivalent to the predicate devices as described herein

5

Image /page/5/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles a stylized caduceus or a bird-like figure, composed of three curved lines.

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002

November 29, 2012

Osstem Implant Company, Limited C/O Mr. Patrick Lim Hiossen, Incorporated 85 Ben Fairless Drive Fairless Hills, Pennsylvania 19030

Re: K121995

Trade/Device Name: TS Fixture System Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: II · Product Code: DZE Dated: November 9, 2012 . Received: November 23, 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.

6

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 device-related 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/ResourcesforYou/Industry/default.htm.

Sincerely vours.

Kwame O. Ulmer

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

7

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 121995

Device Name : TS Fixture System

Indication for use : The TS 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 final or temporary abutment support for fixed bridgework. It is intended for delayed loading.

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

Prescription Use X (Per 21CFR801 Subpart D)

Over-The-Counter Use OR (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)

Susan Runner DDS, MA
2012.11.29
12:46:27 -05'00'

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

510(k) Number:

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

Letter(8.5 X 1 l in)

11