HS/HG PROSTHETIC SYSTEM

K100245 · Osstem Implant Co., Ltd. · NHA · Aug 17, 2010 · Dental

Device Facts

• Record ID: K100245
• Device Name: HS/HG PROSTHETIC SYSTEM
• Applicant: Osstem Implant Co., Ltd.
• Product Code: NHA · Dental
• Decision Date: Aug 17, 2010
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 872.3630
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

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

HS/HG Prosthetic System consists of abutments, protective caps, and abutment screws; used as an aid in prosthetic restoration. Components are fabricated from titanium alloy, POM, and PC; surfaces are partially Tin-coated. Device functions as an interface between dental implants and prosthetic restorations (crowns, bridges, overdentures). Used in dental clinics by dental professionals. Provides mechanical support for dental prosthetics. Benefits include restoration of dental function and aesthetics for patients with missing teeth.

Clinical Evidence

No clinical data. Evidence consists of bench testing, including fatigue testing conducted in accordance with the FDA guidance document for Class II Special Controls for Root-form Endosseous Dental Implants and Endosseous Dental Abutments. Results demonstrated performance comparable to predicate devices.

Technological Characteristics

Materials: Titanium alloy, POM, PC. Surface treatment: Partial Tin coating. Components: Abutment, protective cap, abutment screw. Sterilization: Healing abutments are radiation sterile; other abutments are non-sterile. Shelf life: 5 years. Packaging: Polymeric ampoule in foil-backed peel-open blister pack.

Indications for Use

Indicated for use with dental implants to support prosthetic restorations including crowns, bridges, or overdentures in patients requiring dental prosthetic rehabilitation.

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

• HU/HS/HG Prosthetic System (K081575)
• Ziocera & Convertible System (K081786)

Submission Summary (Full Text)

{0}------------------------------------------------

# 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: January 8, 2010

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 - Telephone No. : 82-51-850-2574 - Contact : Mr. JongHyuk Seo
- 2. Device :

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

HS/HG Prosthetic System Dental Device Abutment, implant, dental, endosseous 21CFR872.3630 Class II NHA

#### 3. Predicate Device :

The HU/HS/HG Prosthetic System, Osstem Implant Co., Ltd. K081575 The Ziocera & Convertible System, Osstem Implant Co., Ltd, K081786

#### 4. Description :

- l ) The HS/HG Prosthetic System is device made of 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.
- 2) The 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.
- 3) The HS/HG Prosthetic System is substantially equivalent in design, function and intended use to the HU/HS/HG Prosthetic System (K081575) and Ziocera & Convertible System (K081786) of Osstem Implant Co., Ltd.

QS-Q1-505-3(Rev.0)

Letter(8.5 X 11in),

{1}------------------------------------------------

Image /page/1/Picture/1 description: The image shows the logo for OSSTEM IMPLANT. The logo is in black and white and features the word "OSSTEM" in a bold, sans-serif font. Below the word "OSSTEM" is the word "IMPLANT" in a smaller, sans-serif font. There is a small degree symbol to the right of the word "OSSTEM".

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

### - Substantial Equivalence Matrix

| | HS/HG Prosthetic<br>System | HU/HS/HG Prosthetic<br>System (K081575) | Ziocera & Convertible<br>System (K081786) |
|------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Manufacturer | Osstem Implant Co., Ltd | Osstem Implant Co., Ltd | Osstem Implant Co., Ltd |
| 510(k)<br>Number | New | K081575 | K081786 |
| Intended use | HS/HG Prosthetic<br>System is intended for<br>use with a dental<br>implant to provide<br>support for prosthetic<br>restorations such as<br>crowns, bridges, or<br>overdentures. | HU/HS/HG Prosthetic<br>System is intended for<br>use with a dental<br>implant to provide<br>support for prosthetic<br>restorations such as<br>crowns, bridges, or<br>overdentures. | Ziocera & Convertible<br>System is intended for<br>use with a dental<br>implant to provide<br>support for prosthetic<br>restorations such as<br>crowns, bridges, or<br>overdentures. |
| Packaging | Polymeric Ampoule in a<br>foil backed peel open<br>blister pack | Polymeric Ampoule in a<br>foil backed peel open<br>blister pack | Polymeric Ampoule in a<br>foil backed peel open<br>blister pack |
| Sterilization | Healing Abutment -<br>Radiation Sterile<br>Abutment -- Non-Sterile | Healing Abutment -<br>Radiation Sterile<br>Abutment - Non-Sterile | Non-Sterile |
| Shelf life | 5 years | 5 years | |

#### 5. Indication for use :

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 HS/HG Prosthetic System has similar material, indication for use, design and technological characteristics as the predicate device.

The 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. Summary of nonclinical testing

Fatigue testing was conducted according to the "Guidance for industry and FDA staff Class II Special Controls Guidance Document Root-form Endosseous Dental Implants and Endosseous Dental Abutment" with the worst case scenario. The fatigue test result were Similar to previously cleared predicate device.

{2}------------------------------------------------

Image /page/2/Picture/1 description: The image shows the logo for OSSTEM IMPLANT. The word "OSSTEM" is in bold, black letters, with a small circle above the "M". Below "OSSTEM" is the word "IMPLANT" in smaller, black letters. The logo is simple and professional.

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

## 8. Conclusion :

Based on the information provided in this premarket notification Osstem concludes that the HS/HG Prosthetic System is substantially equivalent to the predicate device as described herein.

{3}------------------------------------------------

#### DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image contains the text 'Public Health Service'. The text is in a simple, sans-serif font and is horizontally aligned. The text appears to be part of a document or sign.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

Osstem Implant Company, Limited C/O Mr. Patrick Lim Hiossen, Incorporated 85 Ben Fairless Drive Fairless Hills, Pennsylvania 19030

AUG 17 2010

Re: K100245

Trade/Device Name: HS/HG Prosthetic System Regulation Number: 21 CFR 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: II Product Code: NHA Dated: August 11, 2010 Received: August 13, 2010

Dear Mr. Lim:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

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.

Image /page/3/Picture/10 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal features the HHS logo, which is a stylized caduceus, a symbol often associated with medicine and healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the logo.

{4}------------------------------------------------

#### Page 2- Mr. Lim

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 (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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to

http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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 go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

h for

Anthony D. Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology, and General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{5}------------------------------------------------

K100245

#### OSSTEM Implant Co., Ltd. OSSTEM #507-8 Geoje3-Dong Yeonje-Gu Busan, 611-804 Republic of Korea

Tel: [phone] Fax: [phone] www.osstem.com

510(k) Number K LOO 245

Device Name : HS/HG Prosthetic System

Indication for use : 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)

ASBatz DDS for Dri. RPMuly

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

510(k) Number: K100245

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