ATLAS IMPLANT SYSTEM

K071148 · Cowellmedi Co., Ltd. · DZE · Feb 6, 2008 · Dental

Device Facts

• Record ID: K071148
• Device Name: ATLAS IMPLANT SYSTEM
• Applicant: Cowellmedi Co., Ltd.
• Product Code: DZE · Dental
• Decision Date: Feb 6, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3640
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Atlas Implant Systems are designed for use in dental implant surgery. They are intended for use in partially or fully edentulous mandibles and maxillae, in support of single or multiple-unit restorations including, cement retained, screw retained, or overdenture restorations, and terminal or intermediate abutment support for fixed bridgework. They are not intended for use of immediate loading.

Device Story

Atlas Implant Systems consist of precision-machined titanium fixtures surgically inserted into the jawbone to replace tooth roots. These fixtures provide a stable foundation for dental restorations, including single/multiple-unit crowns, bridges, and overdentures. Used in dental clinics by oral surgeons or dentists; the device acts as a mechanical anchor for prosthetic attachments. Benefits include restoration of masticatory function and aesthetics for edentulous patients. The system includes various diameters and lengths to accommodate anatomical requirements.

Clinical Evidence

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

Technological Characteristics

Materials: Commercially pure titanium (Grade 3 and 4). Design: Internal, external, and submerged types. Surface treatment: Anodic Spark Deposition (ASD). Dimensions: Diameters 3.3-5.0 mm; lengths 8-14 mm. Sterilization: Gamma radiation. Packaging: Sealed in Tyvek/PET containers in Class 10,000 clean room.

Indications for Use

Indicated for partially or fully edentulous patients requiring dental implants in the mandible or maxilla to support single or multiple-unit restorations (cement-retained, screw-retained, or overdentures) or fixed bridgework. Contraindicated for immediate loading.

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

• ALLFIM IMPLANT SYSTEM (K050635)

Submission Summary (Full Text)

{0}------------------------------------------------

K071148

# FEB -6 2008

### 510(K) SUMMARY

## Atlas Implant Systems

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

| 14-1. Submitter | Cowell Medi Co., Ltd |
|------------------------------------|---------------------------------------------------------------------------------------------------------------------|
| | #155-4 Gamjeon-2Dong, Sasang-Gu, Busan, South Korea<br>Phone: [phone]<br>Fax : [phone] |
| 14-2. US Agent /<br>Contact Person | Dr. Chang Dae Kyu |
| | 3340 E. Firestone Blvd. Suite J, Santa Fe Springs, CA 90670 |
| | Phone : [phone], Fax : [phone] |
| 14-3. Date Prepared | April 18, 2007 |
| 14-4. Device Name | ATLAS 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, Regulation Number:872-3640 |
| 14-7. Predicate Devices | ALLFIM IMPLANT SYSTEM(K050635) |
| 14-8. Performance | Laboratory testing was conducted to determine device functionality<br>and conformance to design input requirements. |

#### 14-9. Device Description

{1}------------------------------------------------

The Atlas Implant System includes a variety of precision-machined fixtures manufactured from titanium. These implants are surgically inserted into the upper and/or lower jawbone and serve as a replacement for a patient's tooth root providing a stable foundation for restorations.

#### 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®.

#### 14-11. Intended Use

Atlas Implant Systems are designed for use in dental implant surgery. They are intended for use in partially or fully edentulous mandibles and maxillae, in support of single or multiple-unit restorations including, cement retained, screw retained, or overdenture restorations, and terminal or intermediate abutment support for fixed bridgework. They are not intended for use of immediate loading.

#### 14-12. Substantial Equivalence Comparison

| | Subject Device | Predicate Device |
|--------------------------|--------------------------------------------------------------------|--------------------------------------------------------------------|
| Manufacturer | Cowell Medi Co. Ltd. | Cowell Medi. Co. Ltd. |
| Device Name | Atlas Implant System | Allfim Implant System |
| 510(k) Number | N/A | K050635 |
| Indications for Use | Mandible and Maxilla Endosseous<br>Dental Implant & Accessories | Mandible and Maxilla<br>Endosseous Dental Implant &<br>Accessories |
| Material | Commercially pure titanium<br>GR. 3 and GR.4 | Commercially pure titanium GR. 4 |
| Design | Internal, External and Submerged | External |
| Screw Threads | YES | YES |
| Implant Diameter<br>(mm) | Internal Type: 3.5, 4.0, 5.0 mm<br>External Type: 3.3, 4.0, 5.0 mm | External: 3.3, 4.0, and 5.0 mm |

#### TECHNOLOGICAL CHARACTERISTIC COMPARISON

{2}------------------------------------------------

| | Submerged Type: 3.5, 4.0, 5.0 mm | |
|--------------------|----------------------------------|----------|
| Lengths (External) | 8-14 mm | 8-14 mm |
| Surface Treatment | ASD (Anodic Spark Deposition) | Machined |
| Gamma sterilized | YES | YES |

## Attachments

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

{3}------------------------------------------------

DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal features an abstract eagle design with three stylized stripes representing the department's mission. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.

Public Health Service

FEB - 6 2008

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Cowell Medi Company, Limited C/O Dr. Chang Dae Kyu KoDent, Incorporated 13340 East Firestone Boulevard, Suite J Santa Fe Springs, California 90670

Re: K071148

Trade/Device Name: Atlas Implant System Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: II Product Code: DZE Dated: January 24, 2008 Received: January 25, 2008

Dear Dr. Kyu:

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.

{4}------------------------------------------------

Page 2 - Dr. Kyu

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 (OS) 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,

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

{5}------------------------------------------------

K071148

## Indication for Use

510(K) Number (if known): _

Device Name: Atlas Implant System

Indications for Use:

Atlas Implant Systems are designed for use in dental implant surgery. They are intended for use in partially or fully edentulous mandibles and maxillae, in support of single or multiple-unit restorations including, cement retained, screw retained, or overdenture restorations, and terminal or intermediate abutment support for fixed bridgework. They are not intended for use of immediate loading.

Prescription Use AND/OR (Part 21 CFR 801 Subpart D)

VOR

5

(Per 21 CFR 801.109)

Over - The-Counter Use

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

Susan Burns

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

510(k) Number: k071148