SECURE IMPLANT SYSTEM (2.5/3.0MM)

K080129 · Dio Department Dsi, Inc. · DZE · May 30, 2008 · Dental

Device Facts

• Record ID: K080129
• Device Name: SECURE IMPLANT SYSTEM (2.5/3.0MM)
• Applicant: Dio Department Dsi, Inc.
• Product Code: DZE · Dental
• Decision Date: May 30, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3640
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Secure Implant System(2.5/3.0mm) is designed for use in dental implant surgery and is intended for use in a manner in which the implants integrate with the bone(osseointegration). It is intended to provide immediate transitional splinting stability or intrabony long-term fixation of new or existing crown, bridge and denture installations in partially or fully edentulous patients

Device Story

Secure Implant System is a root-form threaded dental implant; manufactured from titanium alloy via machining, grit blasting, and cleaning. Available in 2.5mm and 3.0mm diameters; lengths 8mm to 16mm. Used by dental surgeons in clinical settings to achieve osseointegration. Provides structural support for dental prosthetics (crowns, bridges, dentures) in edentulous patients. Device is packaged in plastic ampoules within sealed PET containers; sterilized via gamma radiation. Clinical benefit includes restoration of dental function and stability for prosthetic installations.

Clinical Evidence

Bench testing only. Laboratory testing conducted to determine device functionality and conformance to design input requirements.

Technological Characteristics

Titanium alloy root-form threaded dental implant; diameters 2.5/3.0mm; lengths 8.0-16.0mm. Surface treatment: grit blasted. Sterilization: Gamma radiation. Packaging: Class 10,000 clean room, plastic ampoule in PET container sealed with Tyvek.

Indications for Use

Indicated for partially or fully edentulous patients requiring dental implant surgery for osseointegration, providing immediate transitional splinting stability or long-term fixation for crowns, bridges, and dentures.

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

• INTERMEZZO TM Plus (K053354)
• Zimmer One-Piece Implant System (K052997)

Submission Summary (Full Text)

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Traditional 510(k) Submission

Secure Implant System(2.5/3.0mm)

MAY 3 0 2008

## 510(K) SUMMARY Secure Implant System (2.5/3.0mm)

14-1. Submitter DSI Jin Choel, Kim(President) Eun Jin, Kim(Regulatory affair staff) 117 Kyo-Dong, Yangsan-City Kyungnam-Do, 626-210, Korea Phone: [phone] Fax : [phone] Hyungick Kim/ Timothy Lee 14-2. US Agent / 3540 Wilshire Blvd. #1104 Los Angeles, Contact Person CA 90010, USA Phone : [phone], Fax : [phone] January 08, 2008 14-3. Date Prepared SECURE IMPLANT SYSTEM(2.5/3.0MM) 14-4. Device Name Endosseous Dental Implant System 14-5. Classification Name Class II 14-6. Device Classification Dental Devices panel Regulation Number: 21 CFR & 872.3640 INTERMEZZO TM Plus(510(k) No.: K053354) 14-7. Predicate Devices Zimmer One-Piece Implant System (510(k) No .: K052997) Laboratory testing was conducted to determine device functionality 14-8. Performance and conformance to design input requirements.

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#### 14-9. Device Description

Sccure Implant System(2.5/3.0mm) is a root-form threaded dental implant made of titanium alloy. The implant is produced by machining process, followed by grit blasting and cleaning. It is available in diameters 2.5 and 3.0mm, and lengths from 8mm to 16mm.

#### 14-10. Packing / Labeling / Product Information

In a clean room that is Class 10,000 or less, put the product into a plastic ampoule, and then put the plastic ampoule in a pet container, then sealed the pet container with Tyvek®. Secure Implant System(2.5/3.0mm) will be packaged.

### 14-11. Intended Use

Secure Implant System(2.5/3.0mm) is designed for use in dental implant surgery and is intended for use in a manner in which the implants integrate with the bone(osseointegration). It is intended to provide immediate transitional splinting stability or intrabony long-term fixation of new or existing crown, bridge and denture installations in partially or fully edentulous patients

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## 14-12. Substantial Equivalence Comparison

| | Subject Device | Predicate Device II |
|--------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Manufacturer<br>Name | DSI | Mega'Gen Co., Ltd. |
| Device Name | Secure Implant System (2.5/3.0mm) | IntermezzoTM Plus (K053354) |
| Intended Use | Secure Implant System(2.5/3.0mm) is<br>designed for use in dental implant surgery<br>and is intended for use in a manner in<br>which the implants integrate with the<br>bone(osseointegration). It is intended to<br>provide immediate transitional splinting<br>stability or intrabony long-term fixation of<br>new or existing crown, bridge and denture<br>installations in partially or fully<br>edentulous patients | IntermezzoTM Plus are gned for use in dental implant surgery and are<br>intended to be used in a manner in<br>which the implants integrate with the<br>bone (osseointegration). The system is<br>intended for use in partially or fully<br>edentulous mandibles and maxillae, in<br>support of overdentures. |
| Material | Titanium Alloy | CP-Ti Gr3 |
| Screw Threads | YES | YES |
| Implant Thread<br>Diameter(mm) | 2.5/3.0 | 2.5-3.1 |
| Lengths(mm) | 8.0-16.0 | 10.0-15.0 |
| Surface<br>Treatment | Yes | No |
| Sterilized | GAMMA | GAMMA |

# TECHNOLOGICAL CHARACTERISTIC COMPARISON

This summary of 510(K) safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR & 807.93

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle with its wings spread, symbolizing protection and care. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES . USA" is arranged in a circular pattern around the eagle emblem. The logo is presented in black and white.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

### MAY 8 0 2008

DIO Department, DSI, Incorporated C/O Mr. Hyungick Kim Manager DIO, USA 3540 Wilshire Boulevard, Suite 1104 Los Angeles, California 90010

Re: K080129

Trade/Device Name; Secure Implant System (2.5/3.0mm) Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: II Product Code: DZE Dated: May 8, 2008 Received: May 12, 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 (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 Liu, 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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Secure Implant System(2.5/3.0mm)

# Indication for Use

510(K) Number (if known):

Device Name: Secure Implant System (2.5/3.0mm)

### Indications For Use:

Secure Implant System(2.5/3.0mm) is designed for use in dental implant surgery and is intended for use in a manner in which the implants integrate with the bone(osseointegration). It is intended to provide immediate transitional splinting stability or intrabony long-term fixation of new or existing crown, bridge and denture installations in partially or fully edentulous patients

Susa Cuomo

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

510(k) Number: k060129

Prescription Use AND/OR Over -- The-Counter Use (Part 21 CFR 801 Subpart D) (Per 21 CFR 801.109)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

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