The Rescue® 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.

Device Description

Rescue® Implant System is an integrated system of endosseous dental implants which designed to support prosthetic devices for partially or fully edentulous patients. Rescue® implant Fixture Systems consist of two-stage, root-form dental implants, associated with abutment systems, which provide the clinician with screw and cement retained restoration for multi-mount, screw retained restoration for octa abutment, and cement retained restoration for solid abutment restorative options. The devices covered by this submission are Rescue® Implant Fixtures, Retained Restoration Abutment System.

AI/ML Overview

The provided 510(k) summary for the Mega'Gen Co., Ltd. Rescue® Implant System does not contain acceptance criteria or a study that evaluates device performance against such criteria in the manner typically expected for AI/ML-based diagnostic devices.

This document describes a dental implant system, which is a physical medical device. The "performance" section refers to "Laboratory testing was conducted to determine device functionality and conformance to design input requirements," but it does not specify what those requirements were, what the test outcomes were, or any quantitative acceptance criteria.

The submission focuses on establishing substantial equivalence to predicate devices (BICON Implant Systems). This is a common pathway for physical medical devices where the manufacturer demonstrates that their new device is as safe and effective as a legally marketed predicate device. This typically involves comparing design, materials, indications for use, and manufacturing processes, rather than conducting a clinical study with detailed performance metrics against a defined ground truth.

Therefore, I cannot fulfill the request to provide the requested information for acceptance criteria and a study proving device performance as the provided document does not contain this type of data for this specific device.

Here's why the requested information isn't present in the context of this 510(k) for a dental implant system:

Type of Device: Dental implants are physical devices, not AI/ML-based diagnostic tools. Their performance is typically assessed through mechanical testing, biocompatibility testing, and comparison of design features to established standards and predicate devices, rather than through metrics like sensitivity, specificity, or AUC based on AI model outputs.
Submission Type: A 510(k) submission for this type of device aims to demonstrate "substantial equivalence" to a predicate device. This often means showing similar design, materials, and intended use, rather than conducting new clinical trials to prove efficacy against specific performance criteria as might be required for a novel diagnostic.
"Performance" Section: The single line "Performance Laboratory testing was conducted to determine device functionality and conformance to design input requirements" is very generic and doesn't provide specific criteria or results.

If this were a submission for an AI/ML diagnostic device, the requested information would be crucial and would typically be found in detailed performance studies.

Summary

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K053353

APR 1 9 2006

13. 510(K) SUMMARY

Mega'Gen Co., Ltd. 114-8, Eupchun-Ri, Jain-Myun, Gyeongsan, Gyeongbuk South Korea Phone: 82-53-857-5770, Fax: 82-53-857-5432

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

13-9. Device Description

13-1. Submitter
114-8, Eupchun-Ri, Jain-Myun, Gyeongsan, Gyeongbuk South Korea Phone : 82-53-857-5770, Fax : 82-53-857-5432

Mega'Gen Co., Ltd.

13-2. US Agent / Dae Kyu Chang Contact Person 13340 E. Firestone Blvd. Suite J Santa Fe Springs, CA 90670 Phone : 562-404-8466, Fax : 562-404-2757
13-3. Date Prepared November 30, 2005
13-4. Device Name RESCUE® IMPLANT SYSTEMS
13-5. Classification Name Endosseous Dental Implant System Class II 13-6. Device Classification Dental Devices panel 21 CFR & 872.3640 Regulation Number: 872.3640
13-7. Predicate Devices BICON Implant Systems (K01085, K050712)
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

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

13-11. Intended Use

13-12. Substantial Equivalence Comparison

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13-13. Comparative Data

Comparison between the Rescue® Implant System, and BICON Implant

Characteristic	Rescue Dental Implant Systems	BICON Dental Implant SystemK010185, K050712
Manufacturer	MegaGen Co., Ltd.	BICON Dental Implants
Indications for Use	Mandible and MaxillaEndosseous Dental Implant &Accessories	Mandible and MaxillaEndosseous Dental Implant &Accessories
Design:	External Hex andMorse Taper	External Hex andMorse Taper
EndosseousImplant Material	C.P Titanium and It's Alloy	C.P Titanium and It's Alloy
Implant Sterile	Yes	Same
Sterilization Method	Gamma	Gamma
Implant Diameters	6.0, 6.5, 7.0,8.0	4.5, 6.0
Implant Lengths	7.0 - 10.0 mm	5.7-6.0mm
Attachments	Various abutments andcomponents	Equivalent
Product Code	DZE & NHA	Same

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Image /page/3/Picture/1 description: The image shows the logo for the Department of Health and Human Services. The logo consists of a stylized eagle with three lines representing its body and wings. The eagle is facing right. The words "DEPARTMENT OF HEALTH AND HUMAN SERVICES USA" are arranged in a circle around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

2PR 1 0 2006

Mega'Gen Company, Limited C/O Mr. Dae Chang Kodent, Incorporated 13340 E. Firestone Boulevard, Suite J Santa Fe Springs, California 90670

Re: K053353

Trade/Device Name: Rescue Dental Implant System Regulation Number: 872.3640 Regulation Name: Endosseous dental implant Regulatory Class: II Product Code: DZE Dated: March 30, 2006 Received: April 3, 2006

Dear Mr. Chang:

We have reviewed your Scction 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. Dae 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 vour 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 (301) 594-4618. 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 (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Quetta y. Michie Davis

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): K053353

Device Name: Rescue Dental Implant System

Indications for Use:

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

Over – The-Counter Use (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)

Shari Ruan

. General Hosp

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Regulation Number and Section

§ 872.3640 Endosseous dental implant.

(a)
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.(b)
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.