The DIO 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. 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.

Device Description

The DIO Implant system includes one-stage fixture and two-stage fixture made of titanium. These implants are surgically inserted into the upper and/or lower jawbone, and serve as a substitute or replacement tooth root providing a stable foundation for restorations.

AI/ML Overview

The provided text describes a 510(k) premarket notification for the DIO Implant Systems, a dental implant device. It does not contain information about acceptance criteria or a study that proves the device meets specific acceptance criteria in the way typically expected for an AI/ML medical device.

The "Performance" section (14-8) states: "Laboratory testing was conducted to determine device functionality and conformance to design input requirements." However, it does not provide details about the specific acceptance criteria, method, sample size, or results of this laboratory testing.

The document primarily focuses on establishing substantial equivalence to a predicate device (SM® IMPLANT SYSTEMS) based on intended use, material, design, and technological characteristics.

Therefore, I cannot fulfill your request for the tables and detailed study information as the provided text lacks the necessary content for acceptance criteria, device performance metrics, study design, sample sizes, ground truth establishment, or expert-related information for an AI/ML device.

Summary

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APR 1 5 2008

510(K) SUMMARY DIO Implant Systems

14-1. Submitter	DIO Department, DSI, Inc.117 Kyo-Dong, Yangsan-CityKyungnam-Do, 626-210, South KoreaPhone: 82-55-363-3401Fax : 82-55-363-3404
14-2. US Agent /Contact Person	Dr. Steve Chang13340 E. Firestone Blvd. Suite JSanta Fe Springs, CA 90670Phone : 562-404-8466, Fax : 562-404-2757
14-3. Date Prepared	February 05, 2007
14-4. Device Name	DIO IMPLANT SYSTEMS
14-5. Classification Name	Endosseous Dental Implant System
14-6. Device Classification	Class IIDental Devices panel21 CFR § 872.3640Regulation Number:
14-7. Predicate Devices	SM® IMPLANT SYSTEMS
14-8. Performance	Laboratory testing was conducted to determine device functionalityand conformance to design input requirements.

14-9. Device Description

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

14-11. Indication for Use

The DIO 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. Implants can be placed with a conventional two stage surgical process with an option for transmucosal healing or thev 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.

14-12. Substantial Equivalence Comparison

	Subject Device	Predicate Device
Device Name	DIO DENTAL IMPLANT CO.LTD(DIO Implant System)	DIO DENTAL IMPLANT CO.LTD (K061797)(SM® Implant System)
Intended Use	Identical to predicate devices	DIO Dental implant is designedfor use in edentulous sites in themandible or maxilla for supportof a complete denture prosthesis,terminal or intermediateabutment for fixed bridgework,partial dentures, or single toothreplacements.
Material	Commercially pure titanium GR. 3and GR.4 (ASTM-F-67)	Commercially pure titanium GR.3 and GR.4 (ASTM-F-67)
Design	Morse Taper with Tread	Morse Taper with Tread
Screw Threads	YES	YES
Implant ThreadDiameter (mm)	3.5, 4.0, and 4.8 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

TECHNOLOGICAL CHARACTERISTIC COMPARISON

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Attachments

Screw-retainedrestoration system	YES	YES
Cemented restorationsystem	YES	YES
Overdenturerestoration	YES	YES
Instruments (surgicaland restorative)	YES	YES

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with its wings spread, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" arranged in a circular pattern around the eagle. The eagle is black, and the text is also black. The logo is simple and recognizable.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

APR 15 2008

DIO Department, DSI, Incorporated C/O Dr. Steve Chang Consultant/U.S Agent Kodent, Incorporated 13340 East Firestone Boulevard, Suite J Santa Fe Springs, California 90670

Re: K070570

Trade/Device Name: DIO Dental Implant System Regulation Number: 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: II Product Code: DZE, NHA Dated: April 4, 2008 Received: April 7, 2008

Dear Dr. 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 - Dr. Chang

Please be advised that FDA's issuance of a substantial equivalence determination docs 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 (240) 276-0115. 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/industry/support/index.html.

Sincerely vours.

Sutte Y. Michel Dors.

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

K070570 510(K) Number (if known):

DIO Dental Implant System Device Name:

Indications For Use:

Susan Russe

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

510(k) Number: K070520

Prescription Use X Over – The-Counter Use AND/OR (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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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.