HG II FIXTURE SYSTEM

K080744 · Osstem Implant Co., Ltd. · DZE · Jul 17, 2008 · Dental

Device Facts

• Record ID: K080744
• Device Name: HG II FIXTURE SYSTEM
• Applicant: Osstem Implant Co., Ltd.
• Product Code: DZE · Dental
• Decision Date: Jul 17, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3640
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

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 abutment support for fixed bridgework. The HG II Fixture System is for single and two stage surgical procedures. It is not for immediate load.

Device Story

HG II Fixture System is a titanium dental implant surgically placed into upper or lower jaw bone; supports single/multiple-unit restorations or fixed bridgework. Used in clinical dental settings by trained professionals; supports single or two-stage surgical procedures. Device provides structural foundation for prosthetic restorations; not indicated for immediate load. Benefits include restoration of oral function and aesthetics in edentulous patients.

Clinical Evidence

Bench testing only. Safety and performance validated through biocompatibility and product validation testing to ensure compliance with international and US regulations.

Technological Characteristics

Titanium dental implant; endosseous design; intended for single or two-stage surgical placement. No software or electronic components.

Indications for Use

Indicated for partially or fully edentulous patients (mandible/maxilla) requiring single/multiple-unit restorations (cemented, screw-retained, overdenture) or fixed bridgework abutment support. 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

• GS System, Osstem Implant Co., Ltd (K063861)
• OsseoSpeed™, Astra tech Inc (K053384)

Submission Summary (Full Text)

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JUL 1 7 2008

Image /page/0/Picture/1 description: The image shows a logo with the word "osstem" in lowercase letters below a circular graphic. The graphic is composed of two curved lines that form an incomplete circle, with the top curve being thicker than the bottom curve. The logo is in black and white.

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) Summary

K080744

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

Date: March 10, 2008

1. Company and Correspondent making the submission:

- Submitter's Name :
- Address :

OSSTEM Implant Co., Ltd.

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

- Contact :

Mr. JongHyuk Seo

2. Device :

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

HG II Fixture System Dental Implant Endosseous Dental Implant 21CFR872.3640 Class II DZE

# 3. Predicate Device :

The GS System, Osstem Implant Co., Ltd, K063861 The OsseoSpeed™, Astra tech Inc, K053384

# 4. Description :

The HG II 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.

The HG II 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 HG II Fixture System is substantially equivalent in design, function and intended use to the GS System(K063861) of Osstem Implant Co., Ltd and OsseoSpeed™ (K053384) of Astra tech Inc.

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Image /page/1/Picture/0 description: The image shows a logo with a circular design at the top and the word "osstem" in lowercase letters below it. The circular design consists of two curved shapes that resemble crescent moons facing each other, creating a sense of enclosure. The word "osstem" is written in a simple, sans-serif font, and the overall design is clean and modern.

OSSTEM Implant Co., Ltd. #507-8 Geoje3-Dong Yeonje-Gu Busan, 611-804 Republic of Korea Tel: [phone] Fax: [phone] www.osstem.com

## 5. Indication for use :

The HG I 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 HG II Fixture System is for single and two stage surgical procedures. It is not for . immediate load.

#### 6. Review :

The HG II Fixture System has similar material, indication for use, design and technological characteristics as the predicate device.

The HG II 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. Conclusion :

Based on the information provided in this premarket notification Osstem concludes that the HG II Fixture System is safe and effective and substantially equivalent to the predicate device as described herein.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

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

JUL 1 7 200

Re: K080744

Trade/Device Name: HG H Fixture System Regulation Number: 21CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: II Product Code: DZE Dated: July 11, 2008 Received: July 14, 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 prematket 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 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. 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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. You may obtain other general information on vour 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,

Susan
Chiu Lin, Ph.D.

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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Image /page/4/Picture/0 description: The image shows the logo for Osstem. The logo consists of the word "osstem" in lowercase letters, with a horizontal line underneath. Above the word is a circular graphic with a swirling design inside.

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 O80744

Device Name: HG II Fixture System

Indication for use : 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 abutment support for fixed bridgework.

> The HG II Fixture System is for single and two stage surgical procedures. It is not for immediate load.

Prescription Use 文 (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)

Susar Runne

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

510(k) Number. k080744

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