HS II SHORT FIXTURE SYSTEM

K083633 · Osstem Implant Co., Ltd. · DZE · May 1, 2009 · Dental

Device Facts

• Record ID: K083633
• Device Name: HS II SHORT FIXTURE SYSTEM
• Applicant: Osstem Implant Co., Ltd.
• Product Code: DZE · Dental
• Decision Date: May 1, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3640
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The HS II Short 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 HS II Short Fixture System is for one and two stage surgical procedures. It is not for immediate load.

Device Story

HS II Short Fixture System is a titanium dental implant surgically placed into the upper or lower jaw bone. Used by dental clinicians in surgical procedures (one or two-stage) to support prosthetic restorations; including single/multiple-unit crowns, bridges, or overdentures. Device provides stable foundation for dental prosthetics; improving patient masticatory function and aesthetics. Not intended for immediate loading.

Clinical Evidence

No clinical data provided; substantial equivalence is based on design, material, and intended use similarities to legally marketed predicate devices.

Technological Characteristics

Titanium metal endosseous dental implant. Designed for surgical placement in jaw arches. Supports one and two-stage surgical protocols.

Indications for Use

Indicated for partially or fully edentulous adult patients requiring dental implants in mandibles or maxillae for single/multiple-unit restorations (cemented, screw-retained, or overdenture) or fixed bridgework 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

• HS I Fixture System (K080387)
• Straumann Standard Implant (K033922)

Submission Summary (Full Text)

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K083633

Image /page/0/Picture/1 description: The image shows the logo for Osstem. The logo consists of a stylized circular design above the word "osstem" in lowercase letters. A line is drawn underneath the word "osstem".

# SSTEM 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

MAY - 1 2009

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

Date: November 20, 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 :

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

- 3. Predicate Device :
The HS I Fixture System, HIOSSEN Inc., Ltd. K080387 The Straumann Standard Implant, Institut Straumann Ag., K033922

- 4. Description :
The HS II Short 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 HS I Short 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 HS II Short Fixture System is substantially equivalent in design, function and intended use to the HS II Fixture System (K080387) of HIOSSEN Inc. and Straumann Standard Implant (K033922) of Institut Straumann Ag.

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Image /page/1/Picture/1 description: The image shows the logo for Osstem. The logo consists of a circular design with two crescent shapes facing each other within the circle. Below the logo, the word "osstem" is written in lowercase letters.

# 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 HS I Short 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 HS II Short Fixture System is for one and two stage surgical procedures. It is not for immediate load.

### 6. Review :

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

## 7. Conclusion :

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

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### DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the seal for the Department of Health & Human Services - USA. The seal is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or other bird-like figure.

#### Public Health Service

MAY - 1 2009

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OSSTEM Implant Company, Limited C/O Mr. MinJoo Kim Manager Hiossen Incorporated 85 Ben Fairless Drive Fairless Hills, Pennsylvania 19030

Re: K083633

Trade/Device Name: HS II Short Fixture System Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: II Product Code: DZE Dated: May 1, 2009 Received: May 1, 2009

#### 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 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- Ms. 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) 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 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 the reporting of adverse events under the MDR regulation (21 CFR Part 803), please contact the CDRH/Office of Surveillance and Biometrics/Division of Postmarket Surveillance at 240-276-3464. For more information regarding the reporting of adverse events, please go to http://www.fda.gov/cdrh/mdr/.

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,

Susan Runner, D.D.S., MA

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

510(k) Number K 083433

osstem

Device Name : HS I Short Fixture System

Indication for use : The HS II Short 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 HS II Short Fixture System is for single and two stage surgical procedures. It is not for immediate load.

Prescription Use X (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)

Kein Mibley for MSR
(Division Sign-Off)

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Division of Anesthesiology, General Hospital Infection Control, Dental Devices

510(k) Number: K083633

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

Letter(8.5 X 1 in)