EZ PLUS IMPLANT SYSTEM

K070562 · Megagen Co., Ltd. · NHA · May 18, 2007 · Dental

Device Facts

• Record ID: K070562
• Device Name: EZ PLUS IMPLANT SYSTEM
• Applicant: Megagen Co., Ltd.
• Product Code: NHA · Dental
• Decision Date: May 18, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3630
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The EZ Plus Implant Systems are intended to be surgically placed in the upper or lower jaw to support prosthetic devices, such as artificial teeth, and to restore a patient's chewing function. This may be accomplished using either a two stage surgical procedure or a single stage surgical procedure. Large angle abutments (e.g. 25°) on small diameter implants of the EZ Plus internal connection system are intended for the anterior region of the mouth and not intended for use in the posterior region of the mouth due to limited strength of the implant.

Device Story

EZ Plus Implant System comprises machined, screw-form, root-form endosseous dental implants; includes fixtures, abutments, and surgical instruments. Used by clinicians in dental surgery to support prosthetic devices (artificial teeth) in upper or lower jaw. Supports single or two-stage surgical procedures. Provides screw-retained (UCLA) or cement-retained restoration options. Benefits patient by restoring chewing function. Device is non-active; no software or algorithms involved.

Clinical Evidence

Bench testing only. No clinical data provided.

Technological Characteristics

Material: Commercial pure titanium. Design: Screw-form, root-form endosseous dental implant with internal and external hex connections. Sterilization: Gamma radiation. Packaging: Clean room (Class 10,000) with Tyvek sealing. No software or electronic components.

Indications for Use

Indicated for patients requiring endosseous dental implants in the mandible or maxilla to support prosthetic devices and restore chewing function. Contraindicated for large angle abutments on small diameter internal connection implants in the posterior region of the mouth due to limited implant strength.

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

• EXFEEL IMPLANT SYSTEM (K052369)

Submission Summary (Full Text)

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

## 13. 510(K) SUMMARY

MAY 1 8 2007

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]. US Agent / Dae Kyu Chang Contact Person 13340 E. Firestone Blvd. Suite J Santa Fe Springs, CA 90670 Phone : [phone], Fax : [phone]. Date Prepared May 1, 2007 EZ PLUS ® IMPLANT SYSTEMS 13-4. Device Name 13-5. Classification Name Endosseous Dental Implant System 13-6. Device Classification Class II Dental Devices panel 21 CFR & 872.3640 Regulation Number: 872.3640 13-7. Predicate Devices EXFEEL IMPLANT SYSTEM(K052369) 13-8. Performance Laboratory testing was conducted to determine device functionality and conformance to design input requirements.

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

### 13-9. Device Description

The EZ Plus Implant system consists of machined titanium, screw-form, root-form endosseous dental implant. The system is used as two stage, root-form dental implants, associated with abutment systems, which provide the clinician with the screw (for UCLA abutments) and cement (for solid abutments) retained restoration for multi-mount options. Fixtures, the prosthetics, and the surgical instruments are produced and packaged separately. All included devices in the system are covered by this submission.

### 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®. EZ PLUS™ Implant Systems (EZ Plus™ Implant Fixtures, EZ Plus Protective Cap and EZ Plus Implant system surgery tray) will be packed.

### 13-11. Intended Use

The EZ Plus Implant Systems are intended to be surgically placed in the upper or lower jaw to support prosthetic devices, such as artificial teeth, and to restore a patient's chewing function. This may be accomplished using either a two stage surgical procedure or a single stage surgical procedure. Large angle abutments (e.g. 25°) on small diameter implants of the EZ Plus internal connection system are intended for the anterior region of the mouth and not intended for use in the posterior region of the mouth due to limited strength of the implant.

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

# 13-12. Substantial Equivalence Comparison

# 13-12-1. Comparative data

| Content | Subject Device | Precedent Device |
|--------------------------------|----------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------|
| 510(K) Number | Not available yet | K052369 |
| Characteristic | EZ Plus Implant System | ExFeel Implant System |
| Manufacturer | MegaGen Co., Ltd. | MegaGen Co., Ltd. |
| Indications for Use | Mandible and Maxilla Endosseous Dental Implant &<br>Accessories | Mandible and Maxilla Endosseous Dental<br>Implant & Accessories |
| Design: | Internal and External Hex | Internal and External Hex |
| Endosseous<br>Implant Material | Commercial pure titanium | Commercial pure titanium |
| Implant Sterile | Yes | Yes |
| Sterilization<br>Method | Gamma | Gamma |
| Implant Diameters | - Internal Type Implant: 3.3,4.0, 5.0mm<br>- External Type Implant 3.3, 4.0, 5.0mm | 3.5, 4.1, 4.8mm(Internal)<br>3.30, 3.75, 4.0, 5.0mm(External) |
| Implant Lengths | -Internal Type Implant : 8.0, 10.0,11.0, 13.0,15.0,<br>18.0mm<br>- External Type Implant : 8.0,10.0, 11.0, 13.0, 15.0,<br>18.0mm | - Internal Type Implant: 7.0, 8.5, 10.0, 11.5,<br>3.0mm<br>- External Type Implant:<br>8.5, 10.0, 11.5, 13.0,<br>15.0, 18.0mm |
| Attachments | Various abutments and components | Various abutments and components |
| Product Code | DZE | DZE |

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

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three overlapping wings, representing the department's commitment to health, human services, and well-being. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle, emphasizing the department's role within the United States.

#### Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY 1 8 2007

Mega'Gen Company, Limited C/O Mr. Dae Kyu Chang Kodent Incorporation 13340 E. Firestone Boulevard, Suite J Santa Fe Springs, California 90670

Re: K070562

Trade/Device Name: EZ Plus Implant System Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: II Product Code: NHA Dated: May 1, 2007 Received: May 4, 2007

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.

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

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,

Senite Y. Michael Omd.

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

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

# Indication for Use

510(K) Number (if known): ____________________________________________________________________________________________________________________________________________________

Device Name: EZ Plus Implant System

Indications For Use:

The EZ Plus Implant Systems are intended to be surgically placed in the upper or lower jaw to support prosthetic devices, such as artificial teeth, and to restore a patient's chewing function. This may be accomplished using either a two stage surgical procedure or a single stage surgical procedure. Large angle abutments (e.g. 25°) on small diameter implants of the EZ Plus internal connection system are intended for the anterior region of the mouth and not intended for use in the posterior region of the mouth due to limited strength of the implant.

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

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

Susan Rumsey

Concurrence of

: 2(k) Number: RO 105

Page 1 of _1_