RESCUE EXTERNAL IMPLANT SYSTEM

K081302 · Megagen Implant Co., Ltd. · DZE · Aug 15, 2008 · Dental

Device Facts

• Record ID: K081302
• Device Name: RESCUE EXTERNAL IMPLANT SYSTEM
• Applicant: Megagen Implant Co., Ltd.
• Product Code: DZE · Dental
• Decision Date: Aug 15, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3640
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Rescue External Implant System consists of machined titanium, screw-form, root-form endosseous dental implants. It is intended to be surgically placed in the maxillary or mandibular molar areas for the purpose of providing prosthetic support for dental restorations (Crown, bridges, and overdentures) in partially or fully edentulous individuals. These implants can be used where smaller implants have failed.

Device Story

Rescue External Implant System comprises machined titanium, screw-form, root-form endosseous dental implants; designed for surgical placement in maxillary or mandibular molar regions. System provides prosthetic support for crowns, bridges, and overdentures in partially or fully edentulous patients; specifically indicated for use where smaller implants have failed. Clinicians perform surgical implantation; system includes fixtures, abutments, and surgical instruments. Abutment options include screw-retained (UCLA) and cement-retained configurations. Device replaces missing teeth; restores oral function and aesthetics.

Clinical Evidence

No clinical data provided; substantial equivalence based on design, material, and intended use comparisons to previously cleared predicate devices.

Technological Characteristics

Machined titanium, screw-form, root-form endosseous dental implants. Two-stage surgical system. Includes fixtures, abutments (screw and cement-retained), and surgical instruments. No software or electronic components.

Indications for Use

Indicated for partially or fully edentulous individuals requiring prosthetic support for dental restorations (crowns, bridges, overdentures) in maxillary or mandibular molar areas, including cases where smaller implants have failed.

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

• Rescue Dental Implant System (K063216)
• Rescue Dental Implant System (K053353)
• Rescue Internal Implant System (K073058)

Submission Summary (Full Text)

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Kosi302

AUG 1 5 2008

Rescue External Implant System

## 510(K) PREMARKET NOTIFICATION SUMMARY

#### 1. Submitter:

Mega'Gen Co., Ltd. Dong—Guk Hah 114-8, Eupchun-Ri, Jain-Myun, Gyeongsan, Gyeongbuk South Korea Phone: [phone], Fax : [phone]

### 2. US Agent/Contact:

.

Kodent Inc. Jung Bae Bang 13340 East Firestone Blvd., Suite J Santa Fe Springs, CA 90670 [e-mail] Phone: [phone], Fax: [phone]

#### 3. Date Prepared:

May 5, 2008

#### 4. Device Name:

Rescue External Implant System

#### 5. Device Classification:

Status: Class II Name: Endosseous Implant and Accessories Regulation Number: 21 CFR 872.3640 and 21 CFR 872.3630

#### 6. Purpose:

The purpose of this 510(k) is to include the components that are to be used with the external method in joining the fixtures and prosthetics to the prior 510(k) submission for the Rescue External Implant System.

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#### 7. Intended Use:

Rescue External Implant System consists of machined titanium, screw-form, root-form endosseous dental implants. It is intended to be surgically placed in the maxillary or mandibular molar areas for the purpose of providing prosthetic support for dental restorations (Crown, bridges, and overdentures) in partially or fully edentulous individuals. These implants can be used where smaller implants have failed.

#### 8. Performance Standards:

FDA has not established a performance standard applicable to endosseous implants. The materials in the Rescue Implant System meet applicable standards.

#### 9. Device Description:

The Rescue External Implant System consists of machined titanium, screw-form, rootform endosseous dental implants are used to replace missing teeth in various situations ranging from a single missing tooth to the completely edentulous individual. The wide ranges of size are provided to be in conformance with each patient, or to cover up in case of due to deficiency in implant operation. The system is used as two stage, root-form dental implants, associated with abutment systems, which provide the clinician with the screw (for UCLA abutments) and cement (for solid abutments) retained for multi-mount options. Fixtures, the prosthetics, and the surgical instruments are produced and packaged separately. All included devices in the system are covered by this submission.

#### 10. Packing / Labeling / Product Information:

Rescue External Implant System follows the guidance of the 21 CFR 872.3640 and 21 CFR 872.3630.

#### 11. Substantial Equivalence Comparison:

Rescue External Implant System is essentially an addition to the predicate device previously cleared for marketing by FDA, Rescue Dental Implant System (K063216, K053353) and Rescue Internal Implant System (K073058). The noted difference in the design and material does not effectively change the performance of the device and Rescue External Implant System is substantially equivalent to predicate devices.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

## AUG 1 5 2008

Megagen Implant Company, Limited C/O Mr. Jung Bae Bang Kodent Incorporated 13340 East Firestone Boulevard, Suite J Santa Fe Springs, California 90670

Re: K081302

Trade/Device Names: Rescue External Implant System Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: II Product Code: DZE Dated: July 24, 2008 Received: July 24, 2008

Dear Mr. Bang:

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. Bang

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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions reearding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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.

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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Rescue External Implant System

# Indication for Use

510(K) Number (if known):

Device Name: Rescue External Implant System

Indications For Use:

The Rescue External Implant System is intended to be surgically placed in the maxillary or mandibular molar areas for the purpose providing prosthetic support for dental restorations (Crown, bridges, and overdentures) in partially or fully edentulous individuals. These implants are intended to be used where smaller implants have failed.

Susan Ruane

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

510(k) Number:

| Prescription Use | X |
|------------------|---|
|------------------|---|

(Part 21 CFR 801 Subpart D)

AND/OR

Over – The-Counter Use

(21 CFR 807 Subpart C)

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Concurrence of CDRH, Office of Device Evaluation (ODE)