SM INTERNAL./EXTERNAL IMPLANT SYSTEM

K070569 · Dio Department Dsi, Inc. · DZE · Nov 8, 2007 · Dental

Device Facts

• Record ID: K070569
• Device Name: SM INTERNAL./EXTERNAL IMPLANT SYSTEM
• Applicant: Dio Department Dsi, Inc.
• Product Code: DZE · Dental
• Decision Date: Nov 8, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3640
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The SM 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. The SM Dental implant system is intended for immediate placement and function on singletooth and/or multiple tooth applications when good primary stability is achieved and with appropriate occlusal loading, to restore chewing function. Multiple tooth applications may be rigidly splinted. In the case of edentulous patients 4 or more implants must be used.

Device Story

Root-form threaded dental implant; manufactured from Grade 3 and Grade 4 titanium via machining, grit blasting, and cleaning. Placed surgically in upper or lower jaw arches by dental professionals. Provides foundation for prosthetic appliance attachment (single/multiple units, fixed bridgework, partial dentures, overdentures). Supports immediate or delayed functional loading; requires rigid splinting for multiple tooth applications. Benefits patient by restoring chewing function.

Clinical Evidence

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

Technological Characteristics

Material: Grade 3 and Grade 4 titanium (ASTM-F-67). Design: Root-form, threaded, Morse taper. Dimensions: 3.8, 4.5, 5.3mm diameter; 8-14mm length. Sterilization: Gamma. Packaging: Class 10,000 clean room, Tyvek sealed.

Indications for Use

Indicated for patients requiring dental restoration in upper or lower jaw arches; suitable for single or multiple tooth replacement, including edentulous patients (requiring 4+ implants). Supports immediate or delayed functional loading when primary stability is achieved.

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 System (K061797)

Submission Summary (Full Text)

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Ko70569

## 510(K) SUMMARY

## SM® Internal/External 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] | NOV 0 8 2007 |
|------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------|--------------|
| 14-2. 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] | |
| 14-3. Date Prepared | February 09, 2007 | |
| 14-4. Device Name | SM® INTERNAL/EXTERNAL 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

SM® Implant System is a root-form threaded dental implant made of Grade 3 and Grade 4 titanium. The implant is produced by machining process, followed by grit blasting and cleaning. It is available in diameters 3.8, 4.5 and 5.3mm, and lengths from 8mm to 14mm. It is placed via one or two stage surgery and the functional loading can be from immediate to delay.

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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®. SM TM Implant Systems (SM TM Implant Fixtures, SM Protective Cap, and SM Implant System Surgery Tray) will be packaged.

### 14-11. Intended Use

The SM 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. The SM Dental implant system is intended for immediate placement and function on singletooth and/or multiple tooth applications when good primary stability is achieved and with appropriate occlusal loading, to restore chewing function. Multiple tooth applications may be rigidly splinted. In the case of edentulous patients 4 or more implants must be used.

### 14-12. Substantial Equivalence Comparison

| | Subject Device | Predicate Device |
|--------------|----------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Name | DIO DENTAL IMPLANT CO.<br>LTD | DIO DENTAL IMPLANT CO.<br>LTD (K061797) |
| | (SM® Internal/External Implant<br>System) | (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) |

## TECHNOLOGICAL CHARACTERISTIC COMPARISON

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| Design | Morse Taper with Thread | Morse Taper with Thread |
|---------------------------------|-------------------------|-------------------------|
| Screw Threads | YES | YES |
| Implant Thread<br>Diameter (mm) | 3.8, 4.5, and 5.3 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 |
| Gamma sterilized | YES | YES |

# 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 |

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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Image /page/3/Picture/1 description: The image shows the logo for the Department of Health and Human Services (HHS) in the United States. The logo features a stylized depiction of an eagle or bird with three curved lines forming its body and wings. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" is arranged in a circular pattern around the bird symbol.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV 0 8 2007

DIO Department DSI, Incorporated C/O Mr. Hosup Shim KoDent, Incorporated 13340 East Firestone Boulevard, Suite J Santa Fe Springs, California 90670

Re: K070569

Trade/Device Name: SM Dental Implant System Regulation Number: 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: II Product Code: DZE Dated: October 29, 2007 Received: October 29, 2007

Dear Mr. Shim:

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 - Mr. Shim

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,

Nil Re Ogle

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

Koros69 510(K) Number (if known): ַ

Device Name: SM Dental Implant System

#### Indications For Use:

The SM 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. The SM Dental implant system is intended for immediate placement and function on singletooth and/or multiple tooth applications when good primary stability is achieved and with appropriate occlusal loading, to restore chewing function. Multiple tooth applications may be rigidly splinted. In the case of edentulous patients 4 or more implants must be used.

Prescription Use AND/OR Over - The-Counter Use (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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| Division of Anesthesiology, General Hospital,<br>Infection Control, Dental Devices | | |
| 510(k) Number: | K070569 | |