JNE IMPLANT SYSTEM

K072425 · GC America, Inc. · DZE · Mar 10, 2008 · Dental

Device Facts

• Record ID: K072425
• Device Name: JNE IMPLANT SYSTEM
• Applicant: GC America, Inc.
• Product Code: DZE · Dental
• Decision Date: Mar 10, 2008
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 872.3640
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The JNE Implant System is a titanium alloy screw-type endosseous dental implant and endosseous dental implant abutment, which is intended to be surgically placed in the bone of the upper or lower jaw arches to provide support for a prosthetic device, such as an artificial tooth, in order to restore a patient's chewing function.

Device Story

JNE Implant System is a screw-type endosseous dental implant and abutment system. Components are surgically placed into the upper or lower jaw bone by a dental professional to support prosthetic devices like artificial teeth. The system restores patient chewing function. The device is manufactured from Ti-6Al-4V ELI alloy; fixtures feature a sandblasted and acid-etched surface treatment. Abutments connect to fixtures via a tapered-joint interface.

Clinical Evidence

Bench testing only. No clinical data provided.

Technological Characteristics

Material: Ti-6Al-4V ELI alloy. Design: Screw-type fixture with tapered-joint abutment connection. Surface treatment: Sandblast and acid etching. Sterilization: Not specified (facility listed).

Indications for Use

Indicated for patients requiring dental restoration via endosseous implants in the upper or lower jaw arches to support prosthetic devices (artificial teeth) and restore chewing function.

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

• ENDOPORE ENDOSSEOUS DENTAL IMPLANT SYSTEM (K971196)
• ASTRA TECH IMPLANTS - DENTAL SYSTEM (K002513)
• STRAUMANN DENTAL IMPLANT SYSTEM (K033984)

Submission Summary (Full Text)

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

## MAR 1 0 2008

| | | wa | |
|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----|----------------------|
| 1<br>------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------<br>. | | THETY TO A LALLAAL A |

ग प

... ...

රි

7

8

9

, l

:

| | Regulation: 21 CFR 872.3640 and 21 CFR 872.3630 |
|------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | |
| Identification of<br>Predicates and Summary<br>of Substantial<br>Equivalence | The JNE Implant System is substantially equivalent with<br>respect to the intended use, design, risks, device<br>characteristics and performance aspects to numerous cleared<br>devices, including:<br>510(k) / Product / Manufacturer<br>- K971196 / ENDOPORE ENDOSSEOUS DENTAL<br>IMPLANT SYSTEM / INNOVA CORP.<br>- K002513 / ASTRA TECH IMPLANTS - DENTAL<br>SYSTEM / ASTRA TECH, INC. |
| | - K033984 / STRAUMANN DENTAL IMPLANT<br>SYSTEM / INSTITUT STRAUMANN AG |
| Device Description | The JNE Implant System is an endosseous dental implant<br>made of Ti-6Al-4V ELI alloy and consists of several<br>components. Geometrically, the fixture is screw-type. An<br>abutment is connected to the fixture through a tapered-joint.<br>Fixtures are treated with sandblast and acid etching using<br>scanning electron microscopy (SEM). |
| Intended Use and<br>Indications | The JNE Implant System is a titanium alloy screw-type<br>endosseous dental implant and endosseous dental implant<br>abutment, which is intended to be surgically placed in the<br>bone of the upper or lower jaw arches to provide support for a<br>prosthetic device, such as an artificial tooth, in order to restore<br>a patient's chewing function. |
| Performance Testing | Several tests were performed on the device. All tests<br>demonstrated that the device is safe and effective, performs<br>comparably to and is substantially equivalent to the predicate<br>devices. |

5. 510(k) Summary

:

Page 5.2 of 5.2

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

## 5. 510(k) Summary

| Submitter/Contact<br>Person | H. Carl Jenkins<br>The Wood Burditt Group<br>FDA Regulatory Counseling<br>1025 W. Everett Rd., Suite 100<br>Lake Forest, IL 60045<br>(ph) [phone] x 205<br>(fax) [phone]<br>(email) [e-mail] |
|-----------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Applicant | GC America, Inc.<br>3737 W. 127th Street<br>Alsip, IL 60803<br>800.323.3386 x4042<br>708.897.4042<br>708.897.4031 (fax) |
| Manufacturer | GC CORPORATION.<br>76 - 1 HASUNUMA - CHO,<br>ITABASHI - KU<br>TOKYO 174 - 8585 JAPAN |
| Sterilization Facility | RADIA INDUSTRY CO., LTD<br>168 OOYAGI, TAKASAKI<br>GUNNMA 370 - 0072 JAPAN |
| Device Name | JNE Implant System |
| Common Name | Root-form Endosseous Dental Implant and Endosseous<br>Dental Implant Abutment |
| Classification | Class II<br>Procode DZE and NHA |

5. 510(k) Summary

l

l

■

l

l

ili

მ

7

8

9

------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

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

Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of an eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

GC America, Incorporated C/O Mr. H. Carl Jenkins The Wood Burditt Group 1025 Everett Road, Suite 100 Lake Forest, Illinois 60045

MAR 1 0 2008

Re: K072425

Trade/Device Name: GC JNE Implant Regulation Number: 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: II Product Code: DZE Dated: January 28, 2008 Received: January 29, 2008

Dear Mr. Jenkins:

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.

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

## Page 2 - Mr. Jenkins

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.

Sydite Y. Michien 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

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

## Indications for Use

510(k) Number (if known):

Device Name: GC JNE Implant

Indications for Use:

The JNE Implant System is a titanium alloy screw-type endosseous dental implant and endosseous dental implant abutment, which is intended to be surgically placed in the bone of the upper or lower jaw arches to provide support for a prosthetic device, such as an artificial tooth, in order to restore a patient's chewing function.

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

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

| Concurrence of CDRH, Office of Device Evaluation (ODE) |
|--------------------------------------------------------|
|--------------------------------------------------------|

Susan Turner

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

510(k) Number:

4. Indications For Use

Page 4.1 of 4.1

רן )