MS SYSTEM (PROVISIONAL)

K072871 · Osstem Implant Co., Ltd. · DZE · Jan 10, 2008 · Dental

Device Facts

• Record ID: K072871
• Device Name: MS SYSTEM (PROVISIONAL)
• Applicant: Osstem Implant Co., Ltd.
• Product Code: DZE · Dental
• Decision Date: Jan 10, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3640
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The MS system (Provisional) is intended to be loaded immediately in partially or fully edentulous mandibles and maxilla to serve as temporary support for provisional prosthetic device during the healing phase of permanent endosseous dental implants.

Device Story

MS system (Provisional) is a one-piece dental implant system; functions as temporary support for provisional prosthetic devices during healing phase of permanent endosseous implants. Device consists of screw-formed fixture and abutment; fabricated from Titanium Alloy Ti-6AL-4V. Used in partially or fully edentulous mandibles and maxilla. Operated by dental professionals in clinical settings. Provides immediate loading capability to support temporary prosthetics. Benefits patient by maintaining prosthetic function during osseointegration of permanent implants.

Clinical Evidence

No clinical data. Safety and performance established via bench testing and literature review regarding biocompatibility and mechanical integrity.

Technological Characteristics

One-piece screw-formed fixture and abutment; material: Titanium Alloy Ti-6AL-4V (ASTM F 136) ELI; diameters: 1.8mm, 2.5mm; lengths: 10mm, 13mm, 15mm; surface: machined; supplied sterile.

Indications for Use

Indicated for patients with partially or fully edentulous mandibles and maxilla requiring temporary support for provisional prosthetic devices during the healing phase of permanent endosseous dental implants. Contraindicated in cases of insufficient alveolar bone width or height, poor bone quality, poor oral hygiene, heavy smoking, tobacco abuse, or medical conditions such as blood disorders or uncontrolled diabetes.

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™ OS Implant Dentatus Transitional Implants, MTI-MPTM

Submission Summary (Full Text)

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K072871

Image /page/0/Picture/1 description: The image shows the logo and contact information for OSSTEM Implant Co., Ltd. The logo features a stylized image of two interlocking circles above the word "osstem". The text provides the company's address as #507-8 Geoje3-Dong Yeonje-Gu Busan, 611-804 Republic of Korea, along with the phone number [phone], fax number [phone], and website www.osstem.com.

*JAN*

10 2008

# 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: ________________________________________________________________________________________________________________________________________________________________________

1. Company and Correspondent making the submission:

| | Company |
|-------------------------|-------------------------------------------------------|
| Name | Osstem Implant Co., Ltd. |
| Address | #507-8 Geoje3-Dong Yeonje-GuBusan, 611-<br>804, Korea |
| Phone<br>Fax<br>Contact | [phone]<br>[phone]<br>Sung Ryul, Kim |

### 2. Device:

Proprietary Name - MS system (Provisional) Common Name - Dental Implant Classification Name - Endosseous dental implant

- 3. Predicate Device:
The Maximus™ OS Implant Dentatus Transitional Implants, MTI-MPTM

- 4. Classifications Names & Citations:
21CFR 872.3640, DZE, Endosseous dental implant, Class II

- 5. Description:
The MS system (Provisional) is a dental implant system made of titanium metal intended to be loaded immediately in partially or fully edentulous mandibles and maxilla to seve as temporary support for provisional prosthetic device during the healing phase of permanent endosseous dental implants.

It has a screw-formed one piece of fixture and abutment made of Titanium Alloy Ti-6AL-4V (ASTM F 136) ELI with diameter 1.8, 2.5mm and length 10, 13, 15mm It has machined surface, and is supplied sterile.

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Image /page/1/Picture/0 description: The image shows the logo and contact information for OSSTEM Implant Co., Ltd. The logo consists of the word "osstem" in lowercase letters, with a stylized graphic above it. The contact information includes the address, phone number, fax number, and website. 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.

It is similar to other commercially available products based on the intended use, the technology used, the claims, the material composition employed and performance characteristics. It is substantially equivalent in design, function and intended use to the predicate devices.

#### 6. Indication for use:

The MS system (Provisional) is intended to be loaded immediately in partially or fully edentulous mandibles and maxilla to serve as temporary support for provisional prosthetic device during the healing phase of permanent endosseous dental implants.

## 7. Contra-indications:

MS system (Provisional) should not be used in cases where the remaining alveolar bone is too diminished to provide adequate width or height to surround the implant. Lack of osseointegration or subsequent implant failure may occur in cases where there is insufficient available bone, poor bone quality, poor oral hygiene, heavy smoking, tobacco abuse, or medical conditions such as blood disorder or uncontrolled diabetes.

- 8. Review:
MS system (Provisional) has the same device characteristics as the predicate device. Material, design and use concept is similar.

MS system (Provisional) has been subjected to extensive safety, performance, and product validations prior to release. Safety tests have been performed to ensure the devices comply to applicable industry and US regulations.

An extensive review of literature pertaining to the safety and biocompatibility of MS system (Provisional) has been conducted. Appropriate safeguards have been incorporated in the design of MS system (Provisional).

### 9. Conclusions:

In accordance with the Federal Food, Drug and Cosmetic Act, 21 CFR Part 807, and based on the information provided in this premarket notification Osstem Implant Con, and Ltd. concludes that MS system (Provisional) is safe and effective and substantially equivalent to predicate devices as described herein.

- Osstem Implant Co., Ltd. will update and include in this summary any other 10. information deemed reasonably necessary by the FDA.
- END

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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health and Human Services (HHS) of the United States. The seal features a stylized eagle with three lines forming its body and wings, symbolizing health, services, and people. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA" is arranged in a circular pattern around the eagle.

JAN 10 2008

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

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

Re: K072871

Trade/Device Name: MS System (Provisional) Regulation Number: 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: II Product Code: DZE Dated: December 17 2007 Received: December 18, 2007

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 (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 yours,

Suyate Y. Michael O.M.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 K _072871

Device Name: MS system (Provisional)

Indication for use: The MS system (Provisional) is intended to be loaded immediately in partially or fully edentulous mandibles and maxilla to serve as temporary support for provisional prosthetic device during the healing phase of permanent endosseous dental implants.

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 Bunse |
|--|------------------------------------------|
| | Jan of Anestnentningy, General Hospital, |
| | sction Corol, Deal Device |
| | cher. K07287) |