SM IMPLANT SYSTEMS

K061797 · Dio Department Dsi, Inc. · DZE · Sep 1, 2006 · Dental

Device Facts

• Record ID: K061797
• Device Name: SM IMPLANT SYSTEMS
• Applicant: Dio Department Dsi, Inc.
• Product Code: DZE · Dental
• Decision Date: Sep 1, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3640
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The SM® Implant System is an endosseous dental implant is indicated 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. Patients must be subject for dental treatment with endosseous implants.

Device Story

SM Implant System is a root-form threaded dental implant; manufactured from Grade 4 titanium via machining, grit blasting, and cleaning. Available in diameters 3.8, 4.5, and 5.3 mm; lengths 8-14 mm. Used by dental professionals in clinical settings for surgical placement in jaw arches. Provides root-form foundation for prosthetic appliance attachment to restore chewing function. Supports conventional two-stage surgery or single-stage surgery with immediate loading (restricted to anterior mandible with four splinted implants). Benefits patients by restoring masticatory function through stable prosthetic support.

Clinical Evidence

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

Technological Characteristics

Material: Grade 4 titanium. Design: Root-form, threaded dental implant. Dimensions: 3.8, 4.5, 5.3 mm diameters; 8-14 mm lengths. Manufacturing: Machining, grit blasting, cleaning. Sterilization: Not specified. Connectivity: None (mechanical device).

Indications for Use

Indicated for patients requiring dental implants for prosthetic attachment to restore chewing function. Placement in upper or lower jaw arches via one or two-stage surgery. 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

• ANKYLOS® DENTAL IMPLANT SYSTEM (K012087)

Submission Summary (Full Text)

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SEP - 1 2006

## 13. 510(K) SUMMARY

DIO Department, DSI, Inc. 117 Kyo-Donq, Yangsan-City, Kyungnam-Do, 626-210, South Korea Phone: [phone] Fax: [phone]

#### 510(K) Summary

510(K) SUMMARY AND CERTIFICATION This summary of 510(K) safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR & 807.93

- 13-1. Submitter DIO Department, DSI, Inc. 117 Kyo-Dong, Yangsan-City, Kyungnam-Do, 626-210, South Korea Phone: [phone]
- 13-2. US Agent / Dae Kyu Chang Contact Person 13340 E. Firestone Blvd. Suite J Santa Fe Springs, CA 90670 Phone : [phone], Fax : [phone]
- 13-3. Date Prepared June 21, 2005
- 13-4. Device Name SM® IMPLANT SYSTEMS
- 13-5. Classification Name Endosseous Dental Implant System 13-6. Device Classification Class II

Dental Devices panel 21 CFR ≥ 872.3640 Regulation Number: 872.3640

- ANKYLOS® DENTAL IMPLANT SYSTEM (K012087) 13-7. Predicate Devices
Laboratory testing was conducted to determine device functionality and conformance to design input requirements. 13-8. Performance

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#### 13-9.Device Description

The SM Implant System is a root-form threaded dental implant made of 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 5.3 mm, and lengths from 8mm to 14 mm. It is placed via one or two 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®. SM ™ Implant Systems (SM ™ Implant Fixtures, SM Protective Cap, and SM Implant System Surgery Tray) will be packaged.

#### 13-11. Intended Use

The SM® Implant System is an endosseous dental implant is indicated 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 is restricted to the anterior mandible, based on four splinted interforminal placed implants, and not indicated for single, unsplinted implants. Patients must be subject for dental treatment with endosseous implants.

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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health and Human Services (HHS). The seal features the department's name in a circular arrangement around a symbol. The symbol consists of a stylized caduceus, a staff with two snakes entwined around it, which is a common symbol associated with medicine and healthcare.

#### Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP - 1 2006

DIO Department DSI, Incorporated C/O Mr. Dae Kyu Chang President/Manager Kodent, Incorporated 13340 East Firestone Boulevard, Suite J Santa Fe Springs, California 90670

Re: K061797

Trade/Device Name: SM Implant Systems Regulation Number: 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: II Product Code: DZE Dated: August 22, 2006 Received: August 28, 2006

Dear Mr. 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 - Mr. Chang

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/cdrl/industry/support/index.html.

Sincerely yours.

Suyte Y. Michael Tims.

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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K061797

# Indication for Use

510(K) Number (if known):

Device Name: SM Implant Systems

Indications for Use:

The SM® Implant System is an endosseous dental implant is indicated 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 Ruppert

of Anesthesiology, General Hospital, n Control. Dental Devices

1. Number.

Over - The-Counter Use Prescription Use AND/OR (Part 21 CFR 801 Subpart D) (21 CFR 807 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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