DIO IMPLANT SYSTEM

K070570 · Dio Department Dsi, Inc. · DZE · Apr 15, 2008 · Dental

Device Facts

• Record ID: K070570
• Device Name: DIO IMPLANT SYSTEM
• Applicant: Dio Department Dsi, Inc.
• Product Code: DZE · Dental
• Decision Date: Apr 15, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3640
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The DIO Dental Implant system is an endosseous dental implant that is indicated to use for surgical placement in the upper and lower jaw arches, to provide a root form means for single or multiple units' prosthetic appliance attachment to restore a patient's chewing function. Implants can be placed with a conventional two stage surgical process with an option for transmucosal healing or they can be placed in a single stage surgical process for immediate loading. Immediate loading is restricted to the anterior mandible, based on four splinted interforminal placed implants, and not indicated for single, unsplinted implants.

Device Story

DIO Implant System consists of titanium fixtures (one-stage or two-stage) surgically inserted into jawbone; serves as artificial tooth root foundation for prosthetic restorations. Used by dentists/oral surgeons in clinical settings. Fixtures provide stable base for single/multiple unit prosthetic appliances, including fixed bridgework, partial dentures, or complete dentures. Immediate loading protocol limited to anterior mandible with four splinted implants. Benefits include restoration of chewing function and stable prosthetic support.

Clinical Evidence

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

Technological Characteristics

Commercially pure titanium Grade 3 and Grade 4 (ASTM-F-67). Morse Taper design with screw threads. Implant diameters: 3.5, 4.0, 4.8 mm. Collar height: 1.8 mm. Lengths: 8-14 mm. Machined surface. Supports screw-retained, cemented, and overdenture restorations.

Indications for Use

Indicated for patients requiring dental restoration in upper or lower jaw arches. Used for single or multiple unit prosthetic attachment to restore chewing function. Immediate loading restricted to anterior mandible using four splinted interforminal implants; not for single, unsplinted 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

• SM® IMPLANT SYSTEMS (K061797)

Submission Summary (Full Text)

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# APR 1 5 2008

### 510(K) SUMMARY DIO Implant Systems

| 14-1. Submitter | DIO Department, DSI, Inc.<br>117 Kyo-Dong, Yangsan-City<br>Kyungnam-Do, 626-210, South Korea<br>Phone: [phone]<br>Fax : [phone] |
|------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------|
| 14-2. US Agent /<br>Contact Person | Dr. Steve Chang<br>13340 E. Firestone Blvd. Suite J<br>Santa Fe Springs, CA 90670<br>Phone : [phone], Fax : [phone] |
| 14-3. Date Prepared | February 05, 2007 |
| 14-4. Device Name | DIO IMPLANT SYSTEMS |
| 14-5. Classification Name | Endosseous Dental Implant System |
| 14-6. Device Classification | Class II<br>Dental Devices panel<br>21 CFR § 872.3640<br>Regulation Number: |
| 14-7. Predicate Devices | SM® IMPLANT SYSTEMS |
| 14-8. Performance | Laboratory testing was conducted to determine device functionality<br>and conformance to design input requirements. |

14-9. Device Description

The DIO Implant system includes one-stage fixture and two-stage fixture made of titanium. These implants are surgically inserted into the upper and/or lower jawbone, and serve as a substitute or replacement tooth root providing a stable foundation for restorations.

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14-10. 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®. DIO Implant Systems (DIO Implant Fixtures, DIO Protective Cap, and DIO Implant System Surgery Tray) will be packaged.

14-11. Indication for Use

The DIO Dental Implant system is an endosseous dental implant that is indicated to use for surgical placement in the upper and lower jaw arches, to provide a root form means for single or multiple units' prosthetic appliance attachment to restore a patient's chewing function. Implants can be placed with a conventional two stage surgical process with an option for transmucosal healing or thev can be placed in a single stage surgical process for immediate loading. Immediate loading is restricted to the anterior mandible, based on four splinted interforminal placed implants, and not indicated for single, unsplinted implants.

14-12. Substantial Equivalence Comparison

| | Subject Device | Predicate Device |
|---------------------------------|----------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Name | DIO DENTAL IMPLANT CO.<br>LTD<br>(DIO Implant System) | DIO DENTAL IMPLANT CO.<br>LTD (K061797)<br>(SM® Implant System) |
| Intended Use | Identical to predicate devices | DIO Dental implant is designed<br>for use in edentulous sites in the<br>mandible or maxilla for support<br>of a complete denture prosthesis,<br>terminal or intermediate<br>abutment for fixed bridgework,<br>partial dentures, or single tooth<br>replacements. |
| Material | Commercially pure titanium GR. 3<br>and GR.4 (ASTM-F-67) | Commercially pure titanium GR.<br>3 and GR.4 (ASTM-F-67) |
| Design | Morse Taper with Tread | Morse Taper with Tread |
| Screw Threads | YES | YES |
| Implant Thread<br>Diameter (mm) | 3.5, 4.0, and 4.8 mm | 3.8, 4.5, and 5.3 mm |
| Collar Height (mm) | 1.8 | 1.8 |
| Lengths (External) | 8-14 mm | 8-14 mm |
| Surface Treatment | Machined | Machined |

#### TECHNOLOGICAL CHARACTERISTIC COMPARISON

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|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | | -----------------------------------------------------------------------------------------------------------------------------------------------<br>------------------------------------------------------------------------------------------------------------------------------------------------------------------------------<br>------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ |

## Attachments

| Screw-retained<br>restoration system | YES | YES |
|-------------------------------------------|-----|-----|
| Cemented restoration<br>system | YES | YES |
| Overdenture<br>restoration | YES | YES |
| Instruments (surgical<br>and restorative) | YES | YES |

:

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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 consists of a stylized eagle with its wings spread, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" arranged in a circular pattern around the eagle. The eagle is black, and the text is also black. The logo is simple and recognizable.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

## APR 15 2008

DIO Department, DSI, Incorporated C/O Dr. Steve Chang Consultant/U.S Agent Kodent, Incorporated 13340 East Firestone Boulevard, Suite J Santa Fe Springs, California 90670

Re: K070570

Trade/Device Name: DIO Dental Implant System Regulation Number: 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: II Product Code: DZE, NHA Dated: April 4, 2008 Received: April 7, 2008

Dear Dr. 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 - Dr. Chang

Please be advised that FDA's issuance of a substantial equivalence determination docs 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 vours.

Sutte Y. Michel Dors.

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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## Indication for Use

K070570 510(K) Number (if known):

DIO Dental Implant System Device Name:

#### Indications For Use:

The DIO Dental Implant system is an endosseous dental implant that is indicated to use for surgical placement in the upper and lower jaw arches, to provide a root form means for single or multiple units' prosthetic appliance attachment to restore a patient's chewing function. Implants can be placed with a conventional two stage surgical process with an option for transmucosal healing or they can be placed in a single stage surgical process for immediate loading. Immediate loading is restricted to the anterior mandible, based on four splinted interforminal placed implants, and not indicated for single, unsplinted implants.

Susan Russe

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

510(k) Number: k070520

Prescription Use X Over – The-Counter Use AND/OR (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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