MS SYSTEM (DENTURE)

K072959 · Osstem Implant Co., Ltd. · DZE · Feb 4, 2008 · Dental

Device Facts

• Record ID: K072959
• Device Name: MS SYSTEM (DENTURE)
• Applicant: Osstem Implant Co., Ltd.
• Product Code: DZE · Dental
• Decision Date: Feb 4, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3640
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The MS System (Denture) is intended to be place in the bone of the upper or lower jaw arches to provide support the prosthetic devices to restore the patient's chewing function, including the denture stabilization. MS System (Denture) is intended for single use only.

Device Story

The MS System (Denture) is a Ti-6Al-4V dental implant surgically placed into the upper or lower jaw bone. It provides structural support for prosthetic devices, specifically aiding in denture stabilization and restoration of chewing function. The device features a Resorbable Blasting Media (RBM) surface treatment. It is intended for single-use application by dental professionals. The device functions as a mechanical anchor for dental prosthetics, benefiting patients by improving denture retention and oral function.

Clinical Evidence

No clinical data. Safety and performance were established through bench testing and product validations, including biocompatibility testing, to ensure compliance with international and US regulations.

Technological Characteristics

Material: Ti-6Al-4V. Surface treatment: Resorbable Blasting Media (RBM). Form factor: Endosseous dental implant. Intended for surgical placement in jaw arches. Single-use device.

Indications for Use

Indicated for patients requiring dental prosthetic support in the upper or lower jaw arches to restore chewing function and stabilize dentures. Single use only.

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

• Maximus TM OS Implant, BioHorizons Implant Systems, Inc. (K041938)
• Intermezzo TM PLUS, Mega'Gen Co., Ltd. (K053354)

Submission Summary (Full Text)

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K072959

Image /page/0/Picture/1 description: The image shows the logo and contact information for OSSTEM Implant Co., Ltd. The logo features a stylized circular design with the word "osstem" below it. The contact information includes the address: #507-8 Geoje3-Dong Yeonje-Gu Busan, 611-804 Republic of Korea, as well as the telephone number: [phone], fax number: [phone], and website: www.osstem.com.

# 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: October 8 , 2007

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 : | Mr. JongHyuk Seo |
| - Device : | |
| Trade or (Proprietary) Name : | MS System (Denture) |
| Common or usual name : | Dental Implant |
| Classification Name : | Endosseous Dental Implant<br>21CFR872.3640<br>Class II<br>DZE |
| | FEB - 4 2006 |

- 3. Predicate Device :
The Maximus TM OS Implant, BioHorizons Implant Systems, Inc. K041938 The Intermezzo TM PLUS, Mega'Gen Co., Ltd. K053354

## 4. Description :

2.

The MS System (Denture) is a dental implant made of Ti-6Al-4V metal intended to be surgically placed in the bone of the upper or lower jaw arches,

The MS System (Denture) 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 surface treatment of MS System is of R.B.M (Resorbable Blasting Media).

The MS System (Denture) is substantially equivalent in design, function and intended use to the The Maximus TM OS Implant of BioHorizons Implant Systems, Inc. K041938 and Intermezzo TM PLUS of Mega'Gen Co., Ltd. K053354.

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Image /page/1/Picture/0 description: The image shows a logo with the word "osstem" written in lowercase letters. Above the word is a circular symbol that appears to be two overlapping or intertwined circles. The logo is simple and modern, with a focus on the circular symbol and the clean typography of the word "osstem".

## 5. Indication for use :

The MS System (Denture) is intended to be place in the bone of the upper or lower jaw arches to provide support the prosthetic devices to restore the patient's chewing function, including the denture stabilization. MS System (Denture) is intended for single use only.

### 6. Review :

The MS System (Denture) has similar material, indication for use, design and technological characteristics as the predicate device.

The MS System (Denture) 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 MS System (Denture) is safe and effective and substantially equivalent to the predicate device as described herein

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with its wings spread, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle. The eagle is black, and the text is in a smaller, sans-serif font.

Public Health Service

Image /page/2/Picture/3 description: The image shows the text "FEB - 4 2008". The text indicates a date in February of 2008. The day of the month is the 4th.

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

Re: K072959

Trade/Device Name: MS System (Denture) Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: II Product Code: DZE Dated: January 22, 2008 Received: January 22, 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 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 vours.

Clues

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 features a stylized image of three circles intertwined. The text provides the company's address as #507-8 Geoje3-Dong Yeonje-Gu Busan, 611-804 Republic of Korea, along with their phone number ([phone]), fax number ([phone]), and website (www.osstem.com).

510(k) Number K 070950

Device Name: MS System (Denture)

Indication for use : The MS System (Denture) is intended to be place in the bone of the upper or lower jaw arches to provide support the prosthetic devices to restore the patient's chewing function, including the denture stabilization. MS System (Denture) is intended for single use only.

Prescription Use X (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)

OR

Concurrence of CDRH, Office of Device Evaluation (ODE)

Suse Rumar

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

510(k) Number: KC72159

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