I-FIX SYSTEM

K083586 · Dentis Co., Ltd. · DZE · Apr 29, 2009 · Dental

Device Facts

• Record ID: K083586
• Device Name: I-FIX SYSTEM
• Applicant: Dentis Co., Ltd.
• Product Code: DZE · Dental
• Decision Date: Apr 29, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3640
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The I-FIX System are intended to load immediately in partially or fully edentulous manidibles and maxillae to serve as temporary support for provisional prosthetic device during the healing phase of permanent endosseous dental implants.

Device Story

I-Fix System is a mini endosseous dental implant; diameter 2.0-3.0mm; length 10-16mm. Used as temporary support for provisional prosthetic devices during healing phase of permanent implants. Implanted in partially or fully edentulous mandibles and maxillae. Operated by dental professionals. Provides mechanical stability for provisional prosthetics.

Clinical Evidence

No clinical data. Substantial equivalence supported by mechanical bench testing consistent with FDA guidance document 'Root-form Endosseous Dental Implants and Endosseous Dental Implant Abutments' (May 12, 2004).

Technological Characteristics

Mini endosseous dental implant; diameter 2.0-3.0mm; length 10-16mm. Material: TI6A1-4V ELI alloy per ASTM/ISO standards (also noted as CP Titanium grade 4). Surface treatment: Resorbable Blasting Media (RBM).

Indications for Use

Indicated for patients with partially or fully edentulous mandibles and maxillae requiring temporary support for provisional prosthetic devices during the healing phase of permanent endosseous dental implants.

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 System (K051018)

Submission Summary (Full Text)

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#### 1-Fix System 510(K) Submission

Dentis Co., Ltd.

K083586

APR 9 9 2009

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# 510(K) Summary

#### Submitter

-

Dentis Co., Ltd. Shim Gi Bong #951, Woram-Dong, Dalseo-Gu, Daegu, South Korea Phone: [phone] Fax: [phone] Registration Number: 3007031098

#### Device Information

Product Name: I-Fix System

Common Name: Endosseous Dental Implant

Classification Name: Implant, Endosseous, Root-Form

Product Code: DZE

Regulation Number: 872.3640

Device Class: Class II

### General Description

The I-FIX System is mini implant system, which serves temporary support for provisional prosthetic device during the healing phase of permanent endosseous dental implants. The I-FIX System is comprised in diameter of 2.0 - 3.0mm and range from 10 - 16 mm and is made of CP Titanium grade 4. The surface treatment of I-Fix System is of R.B.M (Resorbable Blasting Media).

#### Indication for Use

The I-FIX System are intended to load immediately in partially or fully edentulous manidibles and maxillae to serve as temporary support for provisional prosthetic device during the healing phase of permanent endosseous dental implants.

## Official Correspondent Kodent Inc. Jung Bae Bang 13340 E. Firestone Blvd. Suite J Santa Fe Springs, CA 90670 Email: [e-mail]

Phone: [phone]

Fax: [phone]

48

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K083586

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### Materials

イ

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This device are manufactured from TI6A1-4V ELI alloy following ASTM and ISO standards.

#### Predicate Devices

The subject device is substantially equivalent to the following predicate devices:

- . Intermezzo™ Implant System (K051018) manufactured by Megagen Implant Co., Ltd.
#### Comparison to Predicate Devices

Testing and other comparisons have established that the subject of I-Fix System is substantially equivalent in design, materials, indications and intended use, packaging, labeling, and performance to other predicate devices of the type currently marketed in the U.S.

### Performance Data

All of the data consistent with the recommendations in the FDA guidance document Root-form Endosseous Dental Implants and Endosseous Dental Implant Abutments, May 12, 2004, mechanical testing of the implants demonstrated that the I-Fix System possess mechanical strength at least equivalent to the predicate devices.

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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# DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features a stylized caduceus, a symbol often associated with medicine and healthcare, on the right side. On the left side of the seal, the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern. The seal is presented in black and white.

#### Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Dentis Company, Limited C/o Mr. Jung Bae Bang Kodent, Incorporated 13340 East Firestone Boulevard Suite J Santa Fe Springs, California 90670

APR 2 9 2009

Re: K083586

Trade/Device Name: I-Fix System Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: II Product Code: DZE, NHA Dated: April 13, 2009 Received: April 13, 2009

Dear Mr. Bang:

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 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.

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.

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Page 2- Mr. Bang

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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please contact the CDRH/Office of Surveillance and Biometrics/Division of Postmarket Surveillance at 240-276-3464. For more information regarding the reporting of adverse events, please go to http://www.fda.gov/cdrh/mdr/.

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,

Susan Runner

Susan Runner, D.D.S., MA Acting 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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Dentis Co., Ltd.

1000

K083586

Indication for Use

510(K) Number (if known):

Device Name: I-Fix System

Indication for Use:

The I-FIX System are intended to load immediately in partially or fully edentulous manidibles and maxillae to serve as temporary support for provisional prosthetic device during the healing phase of permanent endosseous dental implants.

Prescription Use X

(Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter

(Per 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)

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| sion of Anesthesiology, General Hospital |
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| fection Control, Dental Devices |

| 10(k) Number: | K083586 |
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