DIO PROTEM IMPLANT SYSTEM

K070568 · Dio Department Dsi, Inc. · DZE · May 25, 2007 · Dental

Device Facts

• Record ID: K070568
• Device Name: DIO PROTEM IMPLANT SYSTEM
• Applicant: Dio Department Dsi, Inc.
• Product Code: DZE · Dental
• Decision Date: May 25, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3640
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

DIO Protem Implant Systems is threaded one-piece implants designed for orthodontic one-stage surgical procedures in upper and lower jaw to provide a means of prosthetic attachment to restore a patient's chewing function. DIO Protem Implant System consists of single-stage, root-form dental implants. The system is designed to provide immediate provisional implant to provide temporary support for prosthetic devices during the healing phase of permanent root form implants. DIO Protem Fixtures are to be removed within six to ten weeks after the surgery depending on a patient's bone condition. The system is intended for immediate placement in partially or fully edentulous mandibles and maxillae, in support of single or multiple-unit restorations including; cement retained, screw retained, or overdenture restorations.

Device Story

DIO Protem Implant System is a root-form threaded dental implant; manufactured from titanium alloy via machining, grit blasting, and cleaning. Device is placed via one-stage surgery in upper or lower jaw; provides immediate provisional support for prosthetic devices (cement/screw-retained or overdenture) during healing of permanent implants. Intended for removal within six to ten weeks post-surgery. Used by dental clinicians in clinical settings. Benefits include immediate prosthetic attachment and temporary restoration of chewing function during the healing period.

Clinical Evidence

Bench testing only. No clinical data provided.

Technological Characteristics

Titanium alloy root-form threaded dental implant; diameters 2.0 and 2.5mm; lengths 8-14mm. Surface treatment: machined and grit-blasted. Sterilized. No software or electronic components.

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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510(k) Submission

K070568

DIO Protem Implant System

# 510(K) SUMMARY DIO Protem Implant Systems

MAY 2 5 2007

| 13-1. Submitter | DIO Department, DSI, Inc.<br>117 Kyo-Dong, Yangsan-City<br>Kyungnam-Do, 626-210, South Korea<br>Phone: [phone]<br>Fax : [phone] |
|-----------------|-----------------------------------------------------------------------------------------------------------------------------------------------|
|-----------------|-----------------------------------------------------------------------------------------------------------------------------------------------|

| 13-2. US Agent /<br>Contact Person | Kenny Lim<br>13340 E. Firestone Blvd. Suite J<br>Santa Fe Springs, CA 90670<br>Phone : [phone], Fax : [phone] | |
|------------------------------------|-------------------------------------------------------------------------------------------------------------------------|--|
| 13-3. Date Prepared | February 09, 2007 | |
| 13-4. Device Name | DIO PROTEM IMPLANT SYSTEMS | |

13-5. Classification Name Endosseous Dental Implant System

- 13-6. Device Classification Class II Dental Devices panel 21 CFR ξ 872.3640
INTERMEZZO ™ IMPLANT SYSTEM 13-7. Predicate Devices

Regulation Number:

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

DIO Protem Implant System is a root-form threaded dental implant made of titanium alloy. The implant is produced by machining process, followed by grit blasting and cleaning. It is available in diameters 2.0 and 2.5mm, and lengths from 8mm to 14mm. It is placed via one stage surgery and the functional loading can be from immediate to delay.

### 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 . DIO Protem Implant Systems will be packaged.

## 13-11. Intended Use

DIO Protem Implant Systems is threaded one-piece implants designed for orthodontic one-stage surgical procedures in upper and lower jaw to provide a means of prosthetic attachment to restore a patient's chewing function. DIO Protem Implant System consists of single-stage, root-form dental implants. The system is designed to provide immediate provisional implant to provide temporary support for prosthetic devices during the healing phase of permanent root form implants. DIO Protem Fixtures are to be removed within six to ten weeks after the surgery depending on a patient's bone condition. The system is intended for immediate placement in partially or fully edentulous mandibles and maxillae, in support of single or multiple-unit restorations including; cement retained, screw retained, or overdenture restorations.

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## 13-12. Substantial Equivalence Comparison

| | Subject Device | Predicate Device |
|---------------------------------|--------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Name | DIO DENTAL IMPLANT CO.<br>LTD | Mega'Gen Co., Ltd. |
| | (DIO Protem Implant System) | (Intermezzo ™ Implant System) |
| | | K051018 |
| Intended Use | Identical to predicate devices | Immediate Provisional Implants<br>are placed in upper or lower jaw<br>to function for six to ten weeks<br>temporary use period and then,<br>removed. The implants can be<br>placed quickly and efficiently,<br>with little or no discomfort or<br>inconvenience to the patient. |
| Material | Titanium alloy | Commercially pure titanium GR.<br>3 (ASTM-F-67) |
| Screw Threads | YES | YES |
| Implant Thread<br>Diameter (mm) | 2.0 and 2.5 | 1.6, 2.0, 2.5, 3.1 |
| Lengths(mm) | 8-14 mm | 10.0, 13.0, 15.0 |
| Surface Treatment | Machined | Machined |
| Sterilized | YES | YES |

# TECHNOLOGICAL CHARACTERISTIC COMPARISON

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/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread.

Public Health Service

MAY 2 5 2007

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DIO Department, DSI, Incorporated C/O Mr. Kenny Lim Consultant/U.S Agent Kodent, Incorporated 13340 E. Firestone Boulevard, Suite J Santa Fe Springs, California 90670

Re: K070568

Trade/Device Name: DIO Protem Implant System Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: II Product Code: DZE Dated: February 23, 2007 Received: March 3, 2007

Dear Mr. Lim:

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 vour 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. Lim

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.

Suitte Y. Michaelms

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

510(K) Number (if known): K 0 7 05 68

Device Name: DIO Protem Implant System

Indications For Use:

The DIO Protem Implant Systems are intended to load immediately in partially or fully edentulous mandibles and maxillae to serve as temporary support for provisional prosthetic device during the healing phase of permanent endosseous dental implants.

| Prescription Use | <span></span> |
|-----------------------------|---------------|
| (Part 21 CFR 801 Subpart D) | <span></span> |
| AND/OR | <span></span> |
| Over - The-Counter Use | <span></span> |
| (Per 21 CFR 801.109) | <span></span> |

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

Kei Muluy for MSR

(Sign-Off)
Concurrence of CDRH, Anesthesiology Devices General Hospital, (QDE)
Section Control, Dental Devices
510(k) Number: K070568
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