HU/HS/HG PROSTHETIC SYSTEM

K081575 · Osstem Implant Co., Ltd. · NHA · Sep 2, 2008 · Dental

Device Facts

• Record ID: K081575
• Device Name: HU/HS/HG PROSTHETIC SYSTEM
• Applicant: Osstem Implant Co., Ltd.
• Product Code: NHA · Dental
• Decision Date: Sep 2, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3630
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

HU/HS/HG Prosthetic System is intended for use with a dental implant to provide support for prosthetic restorations such as crowns, bridges, or overdentures.

Device Story

HU/HS/HG Prosthetic System consists of abutments, protect caps, and abutment screws; used as aid in prosthetic restoration. Device components interface with dental implants to support crowns, bridges, or overdentures. Used in clinical dental settings by licensed practitioners. System provides mechanical support for dental prosthetics; benefits patient by restoring oral function and aesthetics. No software or automated processing involved.

Clinical Evidence

Bench testing only. Safety and performance validations, including biocompatibility testing, were performed to ensure compliance with applicable International and US regulations.

Technological Characteristics

Materials: titanium, titanium alloy, polyoxymethylene (POM), and polycarbonate (PC). Components: abutment, protect cap, abutment screw. Surface treatment: partial titanium nitride (TiN) coating. Mechanical dental abutment system; no energy source, no software, no connectivity.

Indications for Use

Indicated for patients requiring dental implant-supported prosthetic restorations, including crowns, bridges, or overdentures.

Regulatory Classification

Identification

An endosseous dental implant abutment is a premanufactured prosthetic component directly connected to the endosseous dental implant and is intended for use as an aid in prosthetic rehabilitation.

Special Controls

*Classification.* Class II (special controls). 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.)

Predicate Devices

• US System (K062030)
• SS System (K062051)
• GS System (K063861)
• US/SS/GS System (K073247)

Submission Summary (Full Text)

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OSSTEM Implant Co., Ltd

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

SEP - 2 2008

# 510(k) Summary

KC81575

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

Date: May 21, 2008

1. Company and Correspondent making the submission:

- Submitter's Name :
- Address :

OSSTEM Implant Co., Ltd.

HU/HS/HG Prosthetic System

Mr. JongHyuk Seo

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

- Contact :

Classification Name :

- 2. Device :
Trade or (Proprietary) Name : Common or usual name :

Dental Device Abutment, implant, dental, endosseous 21CFR872.3630 Class II NHA

# 3. Predicate Device :

The US System, Osstem Implant Co., Ltd, K062030 The SS System, Osstem Implant Co., Ltd, K062051 The GS System, Osstem Implant Co., Ltd, K063861 The US/SS/GS System, Osstem Implant Co., Ltd, K073247

# 4. Description :

The HU/HS/HG Prosthetic System is device made of titanium, titanium alloy, POM and PC intended for use as an aid in prosthetic restoration. It consists of Abutment, Protect Cap and Abutment Screw. Its surfaces are partially Tin coated and uncoated.

The HU/HS/HG Prosthetic 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 HU/HS/HG Prosthetic System is substantially equivalent in design, function and intended use to the US System(K062030), SS System(K062051), GS System(K063861) and US/SS/GS System(K073247) of Osstem Implant Co., Ltd.

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### 5. Indication for use :

HU/HS/HG Prosthetic System is intended for use with a dental implant to provide support for prosthetic restorations such as crowns, bridges, or overdentures.

- 6. Review :
The HU/HS/HG Prosthetic System has similar material, indication for use, design and technological characteristics as the predicate device.

The HU/HS/HG Prosthetic 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 HU/HS/HG Prosthetic 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

## SEP - 2 - 2008

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

Re: K081575 Trade/Device Name: HU/HS/HG Prosthetic System Regulation Number: 21 CFR 872.3630 Regulation Name: Regulatory Class: II Product Code: NHA Dated: May 21, 2008 Received: June 5, 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 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 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.

Thmmuels Leudims. forji

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 and contact information for OSSTEM Implant Co., Ltd. The logo is on the left, with the company name and address on the right. The address is #507-8 Geoje3-Dong Yeonje-Gu Busan, 611-804 Republic of Korea. The phone number is [phone], the fax number is [phone], and the website is www.osstem.com.

510(k) Number K ______________________________________________________________________________________________________________________________________________________________

Device Name: HU/HS/HG Prosthetic System

Indication for use : HU/HS/HG Prosthetic System is intended for use with a dental implant to provide support for prosthetic restorations such as crowns, bridges, or overdentures.

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)

Susan Runnes

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

510(k) Number: 60 8 1575