US SYSTEM

K062030 · Osstem Implant Co., Ltd. · DZE · Nov 2, 2006 · Dental

Device Facts

• Record ID: K062030
• Device Name: US SYSTEM
• Applicant: Osstem Implant Co., Ltd.
• Product Code: DZE · Dental
• Decision Date: Nov 2, 2006
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 872.3640
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

US system and SSII mini are 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. US System is for two stage surgical procedures. It is not for one stage surgery or immediate load. The SSII mini is for one and two stage surgical procedures. It is not for immediate load.

Device Story

Dental implant system composed of titanium; surgically placed in upper or lower jaw arches to support dental restorations. US System utilizes two-stage surgical procedure; features R.B.M. (Resorbable Blasting Media) surface treatment. Used by dental professionals in clinical settings to restore masticatory function in edentulous patients. Device provides stable foundation for cemented, screw-retained, or overdenture restorations; acts as terminal or intermediate abutment for fixed bridges. Benefits include restoration of oral function and aesthetics.

Clinical Evidence

No clinical data provided. Safety and performance established via bench testing and product validation, including biocompatibility testing to ensure compliance with applicable regulations.

Technological Characteristics

Titanium dental implant; R.B.M. (Resorbable Blasting Media) surface treatment. Two-stage surgical design. Non-software device.

Indications for Use

Indicated for partially or fully edentulous patients requiring single or multiple-unit restorations (cemented, screw-retained, or overdenture) or fixed bridgework support in the mandible or maxilla. Contraindicated for immediate loading; US System contraindicated for one-stage surgery.

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

• AVANA Dental Implant System (K051576)

Submission Summary (Full Text)

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NUV - 2 2006

K062030

# 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: August 16, 2006

1. Company and Correspondent making the submission:

| - | Submitter's Name : | Osstem Implant Co., Ltd. |
|---|--------------------|-------------------------------------------------------------------|
| - | Address : | #507-8 Geoje3-Dong Yeonje-Gu<br>Busan, 611-804, Republic of Korea |
| - | Contact : | Song Seung Woo |

- 2. Device:

| Proprietary Name: | US System |
|----------------------|---------------------------------------------------------------------|
| Common Name -: | Dental Implant System |
| Classification Name: | Endosseous dental implant<br>21CFR 872.3640<br>Class II<br>DZE, NHA |

- 3. Predicate Device:
AVANA Dental Implant System, Osstem Co., Ltd, K051576

- 4. Description:
The US system is a dental implant system made of titanium metal intended to be surgically placed in the bone of the upper or lower jaw arches.

The US 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 differences between them are shape. The US system has two-stage surgery while AVANA Dental Implant System has one-stage-surgery. The US system has R.B.M (Resorbable Blasting Media).

The US system is substantially equivalent in design, function and intended use to the AVANA Dental Implant System of Osstem Implant Co., Ltd.

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## 5. Indication for use:

US system and SSII mini are 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. US System is for two stage surgical procedures. It is not for one stage surgery or immediate load. The SSII mini is for one and two stage surgical procedures. It is not for immediate load.

### 6. Review:

US System has similar material, indication for use, design and technological characteristics as the predicate device.

US 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. Conclusions:

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

510(k) Submission

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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 is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES, USA" around the perimeter. Inside the circle is an abstract image of an eagle with its wings spread.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV - 2 2006

Osstem Implant Company, Limited C/O Ms. Cathryn N. Cambria Consultant Cambria Regulatory Consulting, Incorporated 5536 Trowbridge Drive Dunwoody, Georgia 30338

Re: K062030

Trade/Device Name: US System Regulation Number: 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: II Product Code: DZE Dated: October 17, 2006 Received: October 23, 2006

Dear Ms. Cambria:

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 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. Cambria

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 (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.

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,

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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510(k) Number K062030

Device Name: US System

- Indication for use: US System and SSII mini are 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. US System is for two stage surgical procedures. It is not for one stage or immediate load. SSII mini is for one and two stage surgical procedures. It is not for immediate load.
Prescription Use______________________________________________________________________________________________________________________________________________________________ OR (Per 21CFR801 Subpart D)

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)

Susan Rnam

sthesiology, General Hospit

Osstem Implant Co., Ltd

Indication for Use Page 1 of 1