US/GS ULTRA WIDE SYSTEM

K073465 · Osstem Implant Co., Ltd. · DZE · Apr 7, 2008 · Dental

Device Facts

• Record ID: K073465
• Device Name: US/GS ULTRA WIDE SYSTEM
• Applicant: Osstem Implant Co., Ltd.
• Product Code: DZE · Dental
• Decision Date: Apr 7, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3640
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The US/GS 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. The US/GS Ultra Wide System is for single and two stage surgical procedures. It is not for immediate load. The US/GS Ultra Wide System is intended to be used in the molar region.

Device Story

The US/GS Ultra Wide System is a titanium dental implant surgically placed into the upper or lower jaw arches. Designed for use in the molar region, it provides support for single or multiple-unit restorations, including cemented, screw-retained, or overdenture prosthetics, and serves as a terminal or intermediate abutment for fixed bridgework. The device is intended for one or two-stage surgical procedures and is not indicated for immediate loading. It is used by dental professionals in a clinical setting to restore patient dentition in edentulous areas.

Clinical Evidence

Bench testing only. No clinical data provided. Safety and performance were verified through product validation and biocompatibility testing to ensure compliance with applicable international and US regulations.

Technological Characteristics

Titanium dental implant; endosseous design; intended for molar region; one or two-stage surgical procedure compatibility. No software or electronic components.

Indications for Use

Indicated for partially or fully edentulous patients requiring single or multiple-unit restorations (cemented, screw-retained, or overdenture) or fixed bridgework in the molar region. Suitable for one or two-stage surgical procedures. Contraindicated for immediate load.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

• US System (K062030)
• GS System (K063861)

Submission Summary (Full Text)

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K073465

Image /page/0/Picture/1 description: The image shows the logo for Osstem. The logo consists of a circular design with two curved lines that intertwine to form a ring-like shape. Below the circular design, the word "osstem" is written in lowercase letters.

Osstem, Inc. One Ben Fairless Dr. Fairless Hills, PA 19030 Tel: [phone] / Fax: [phone] www.osstem.com

APR - 7 2008

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: December 3, 2007

1. Company and Correspondent making the submission:

- Submitter's Name : OSSTEM Implant Co., Ltd.

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

- Contact : Mr. JongHyuk Seo

2. Device :

.

| Trade or (Proprietary) Name : | US/GS Ultra Wide System |
|-------------------------------|---------------------------|
| Common or usual name : | Dental Implant |
| Classification Name : | Endosseous Dental Implant |
| | 21CFR872.3640 |
| | Class II |
| | DZE |

## 3. Predicate Device :

The US System, Osstem Implant Co., Ltd, K062030 The GS System, Osstem Implant Co., Ltd, K063861

4. Description :

The US/GS Ultra Wide System is a dental implant made of titanium metal intended to be surgically placed in the bone of the upper or lower jaw arches.

The US/GS Ultra Wide System is similar to other commercially available products based on the intended use, the technology used, the claims, the material composition employed and

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Image /page/1/Picture/0 description: The image shows the Osstem logo. The logo consists of a circular design with two curved lines that do not fully connect, creating an open, flowing shape. Below the circular design, the word "osstem" is written in lowercase letters, using a simple, sans-serif font.

Osstem, Inc. One Ben Fairless Dr. Fairless Hills, PA 19030 Tel: [phone] / Fax: [phone] www.osstem.com

performance characteristics.

The US/GS Ultra Wide System is substantially equivalent in design, function and intended use to the US System(K062030) and GS System(K063861) of Osstem Implant Co., Ltd.

- 5. Indication for use :
The US/GS 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. The US/GS Ultra Wide System is for one and two stage surgical procedures. It is not for immediate load. The US/GS Ultra Wide System is intended to be used in the molar region.

- 6. Review :
The US/GS Ultra Wide System has similar material, indication for use, design and technological characteristics as the predicate device.

The US/GS Ultra Wide 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. Conclusion :

Based on the information provided in this premarket notification Osstem concludes that the US/GS Ultra Wide System is safe and effective and substantially equivalent to the predicate device as described herein

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Image /page/2/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 an eagle or bird-like figure with three stylized wings or feathers.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

## APR - 7 2008

OSSTEM Implant Company, Limited C/O Mr. MinJoo Kim Manager Osstem, Incorporated One Ben Fairless Drive Fairless Hills, Pennsylvania 19030

Re: K073465

Trade/Device Name: US/GS Ultra Wide System Regulation Number: 21CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: II Product Code: DZE Dated: March 17, 2008 Received: March 17, 2008

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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting vour 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. Kim

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); 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.

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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/cdrh/industry/support/index.html.

Sincerely yours,

Sayite Y. Michael DMD.

Chiu Lin, Ph.D. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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K073465

Image /page/4/Picture/1 description: The image shows the Osstem logo. The logo consists of a stylized circular design above the word "osstem" in lowercase letters. The circular design appears to be made of two curved shapes that partially overlap, creating a sense of depth and movement. The overall design is simple and modern.

Osstem, Inc. One Ben Fairless Dr. Fairless Hills, PA 19030 Tel: [phone] / Fax: [phone] www.osstem.com

Attachment V

## Indications for Use

510(k) Number K

US/ GS Ultra Wide System Device Name:

Indication for use : The US/GS 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. The US/GS Ultra Wide System is for single and two stage surgical procedures. It is not for immediate load. The US/GS Ultra Wide System is intended to be used in the molar region.

| Prescription Use | X |
|------------------|---|
|------------------|---|

(Per 21CFR801 Subpart D)

Use

OR Over-The-Counter

(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)

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

| 510(k) Number: | K073465 |
|----------------|---------|
|----------------|---------|