INTERMEZZO PLUS FIXTURE

K053354 · Megagen Co., Ltd. · DZE · Apr 13, 2006 · Dental

Device Facts

• Record ID: K053354
• Device Name: INTERMEZZO PLUS FIXTURE
• Applicant: Megagen Co., Ltd.
• Product Code: DZE · Dental
• Decision Date: Apr 13, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3640
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Intermezzo ™ Plus are designed for use in dental implant surgery and are intended to be used in a manner in which the implants integrate with the bone (osseointegration). The system is intended for use in partially or fully edentulous mandibles and maxillae, in support of overdentures.

Device Story

Intermezzo Plus is an endosseous dental implant system; threaded, root-form design; constructed of C.P. Titanium Grade 3. Used by dental professionals in implant surgery to achieve osseointegration; provides structural support for overdentures in partially or fully edentulous patients. Device is supplied sterile via gamma radiation. Clinical benefit derived from restoring dental function through stable prosthetic support.

Clinical Evidence

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

Technological Characteristics

Material: C.P. Titanium Grade 3. Design: Threaded, root-form endosseous dental implant. Dimensions: 2.5–3.1 mm diameter, 10.0–15.0 mm length. Sterilization: Gamma radiation. Packaging: Class 10,000 clean room, sealed in PET container with Tyvek.

Indications for Use

Indicated for use in dental implant surgery for osseointegration in partially or fully edentulous mandibles and maxillae to support overdentures.

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 Implant Systems (K051018)

Submission Summary (Full Text)

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### APR 1 3 2006

#### 12. 510(K) SUMMARY

Mega'Gen Co., Ltd. 114-8, Eupchun-Ri, Jain-Myun, Gyeongsan, Gyeongbuk South Korea Phone: [phone], Fax: [phone]

#### 510(K) Summary

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

| 13-1. Submitter | Mega'Gen Co., Ltd. |
|-----------------|--------------------------------------------|
| | 114-8, Eupchun-Ri, Jain-Myun, |
| | Gyeongsan, Gyeongbuk |
| | South Korea |
| | Phone: [phone], Fax: [phone] |

| 13-2. US Agent /<br>Contact Person | Dae Kyu Chang |
|------------------------------------|------------------------------------------------------------------------------------------------------------|
| | 13340 E. Firestone Blvd. Suite J<br>Santa Fe Springs, CA 90670<br>Phone : [phone], Fax : [phone] |

#### 13-3. Date Prepared November 30, 2005

- 13-4. Device Name Intermezzo TM Plus
- 13-5. Classification Name Endosseous Dental Implant System

| 13-6. Device Classification | Class II<br>Dental Devices panel<br>21 CFR § 872.3640<br>Regulation Number: 872.3640 |
|-----------------------------|--------------------------------------------------------------------------------------|
| 13-7. Predicate Devices | Intermezzo Implant Systems (K051018) |
| 13-8. Performance | Laboratory testing was conducted to determine device |

## functionality and conformance to design input requirements.

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#### 13-9. Device Description

Intermezzo ™ Plus Implant System is an integrated system of endosseous dental implants which are intended for use in partially or fully edentulous mandibles and maxillae in support of overdentures.

#### 13-10. Packing / Labeling / Product Information

In a clean room that is Class 10,000 or less, put the product into a capsule, and then put the capsule in a pet container, which is 45mm by 75mm, then sealed the pet container with PERFECSEAL CR27 1073B Coated Tyvek®. Intermezzo TM Plus will be packed.

#### 13-11. Intended Use

Intermezzo ™ Plus are designed for use in dental implant surgery and are intended to be used in a manner in which the implants integrate with the bone (osseointegration). The system is intended for use in partially or fully edentulous mandibles and maxillae, in support of overdentures.

#### 13-12. Substantial Equivalence Comparison

Intermezzo ™ Plus (Intermezzo ™ Fixtures ) and predicate implant systems share a substantially equivalent intended use. Intermezzo ™ Plus (Intermezzo ™ Implant Systems K051018 ) are similar in fundamental scientific technology in that they are all threaded, root form implants constructed of titanium. Any differences between the two devices do not raise new questions of safety and effectiveness. The subject and predicate devices are similar in size and materials. When compared with the predicate devices, no new questions of safety or effectiveness have been raised for the Intermezzo ™ Plus Fixture.

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### 13-13. Comparative Data

## Comparison between the Intermezzo ™ Plus and Intermezzo ™ Implant System,

| Characteristic | IntermezzoTM Plus | IntermezzoTM Implant Systems<br>(K051018) |
|--------------------------------|--------------------------------------------------------------|-----------------------------------------------------------------|
| Manufacturer | MegaGen Co., Ltd. | MegaGen Co., Ltd. |
| Indications for Use | Mandible and Maxilla<br>Endosseous Dental Implant<br>Fixture | Mandible and Maxilla Endosseous<br>Dental Implant & Accessories |
| Endosseous Implant<br>Material | C.P Titanium Gr.3 | C.P Titanium Gr.3 |
| Implant Sterile | Yes | Yes |
| Sterilization Method | Gamma | Gamma |
| Implant Diameters | 2.5 – 3.1 mm | 1.6 – 3.1 mm |
| Implant Lengths | 10.0 – 15.0 mm | 10.0 – 15.0 mm |
| Product Code | DZE | DZE |

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Image /page/3/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 three stripes representing the department's mission. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

APR 1 3 2006

Mega'Gen Company, Limited C/O Mr. Dac Kyu Chang President Kodent, Incorporated 13340 East Firestone Boulevard, Suite J Santa Fe Springs, California 90670

Re: K053354

Trade/Device Name: Intermezzo Plus Fixture Regulation Number: 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: II Product Code: DZE Dated: March 30, 2006 Received: April 3, 2006

Dear Mr. Chang:

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. Chang

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.

Chiu-Lin, 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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Ko53354

# Indication for Use

510(K) Number (if known): K053354

Device Name: Intermezzo Plus Fixture

Indications for Use:

Intermezzo ™ Plus are designed for use in dental implant surgery and are intended to be used in a manner in which the implants integrate with the bone (osseointegration). The system is intended for use in partially or fully edentulous mandibles and maxillae, in support of overdentures.

Prescription Use AND/OR Over -- The-Counter Use (Part 21 CFR 801 Subpart D) (21 CFR 807 Subpart C)

(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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Robert Burrows for Dr. Susan Kummer