The SM 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. The SM Dental implant system is intended for immediate placement and function on singletooth and/or multiple tooth applications when good primary stability is achieved and with appropriate occlusal loading, to restore chewing function. Multiple tooth applications may be rigidly splinted. In the case of edentulous patients 4 or more implants must be used.

Device Description

SM® Implant System is a root-form threaded dental implant made of Grade 3 and 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 5.3mm, and lengths from 8mm to 14mm. It is placed via one or two stage surgery and the functional loading can be from immediate to delay.

AI/ML Overview

The provided text describes a 510(k) summary for the SM® Internal/External Implant Systems. This document is a premarket notification to the FDA to demonstrate that the device is substantially equivalent to a legally marketed predicate device. The information presented is typical for a medical device submission seeking regulatory clearance, focusing on comparison to existing devices rather than a detailed performance study with acceptance criteria and statistical analysis in the way modern AI/ML device submissions require.

Therefore, many of the requested elements for a performance study evaluating an AI/ML device will not be present in this document, as it pertains to a dental implant system.

Here's an analysis based on the information provided:

1. Table of Acceptance Criteria and Reported Device Performance

Criterion Type	Acceptance Criteria	Reported Device Performance
Intended Use	"The SM 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. The SM Dental implant system is intended for immediate placement and function on singletooth and/or multiple tooth applications when good primary stability is achieved and with appropriate occlusal loading, to restore chewing function. Multiple tooth applications may be rigidly splinted. In the case of edentulous patients 4 or more implants must be used." (Identical to predicate device's intended use.)	The submission states, "Identical to predicate devices" under the "Intended Use" comparison. This implies that the device meets the functional requirements for its intended use, as demonstrated by the predicate device's established performance. The "Performance" section explicitly states, "Laboratory testing was conducted to determine device functionality and conformance to design input requirements." This general statement indicates that the device's functional performance aligns with its design. However, specific quantitative performance metrics against pre-defined acceptance thresholds in a table format are not provided in this summary.
Material	Commercially pure titanium GR. 3 and GR.4 (ASTM-F-67)	Commercially pure titanium GR. 3 and GR.4 (ASTM-F-67)
Design	Morse Taper with Thread	Morse Taper with Thread
Screw Threads	YES	YES
Implant Thread	3.8, 4.5, and 5.3 mm	3.8, 4.5, and 5.3 mm
Collar Height	1.8 mm	1.8 mm
Lengths (External)	8-14 mm	8-14 mm
Surface Treatment	Machined	Machined
Sterilization	Gamma sterilized	YES
Attachments	Screw-retained, Cemented, Overdenture restoration, Instruments (surgical and restorative) supported	YES (for all listed attachment types)

2. Sample Size Used for the Test Set and Data Provenance

This document does not describe a "test set" in the context of an AI/ML device validation. The "Performance" section generically states, "Laboratory testing was conducted to determine device functionality and conformance to design input requirements." This likely refers to mechanical, material, and biocompatibility testing inherent to dental implants, not a data-driven validation. No specific sample sizes for such tests are provided in this summary, nor is the provenance of any "data" specified. It is a physical device, and testing would involve physical specimens, not a data set.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts

Not applicable. This is not an AI/ML device requiring expert-established ground truth for a test set.

4. Adjudication Method for the Test Set

Not applicable. This is not an AI/ML device with a test set requiring expert adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size

Not applicable. This document pertains to a physical dental implant, not an AI-assisted diagnostic tool that would typically undergo an MRMC study.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

Not applicable. This is not an AI algorithm.

7. The Type of Ground Truth Used

The concept of "ground truth" as used in AI/ML validation (e.g., pathology, outcomes data) is not applicable here. For this physical device, the "ground truth" would be established by validated engineering standards (e.g., ASTM-F-67 for materials), mechanical testing benchmarks (e.g., fatigue strength, torque), and biocompatibility assessments, which are not detailed in this summary. The submission focuses on demonstrating "substantial equivalence" to a predicate device based on identical materials, similar design, and intended use.

8. The Sample Size for the Training Set

Not applicable. This is not an AI/ML device, and therefore, there is no "training set."

9. How the Ground Truth for the Training Set Was Established

Not applicable. As there is no training set for an AI/ML model, there's no ground truth establishment for it.

Summary of the Study and Device Performance:

The provided 510(k) summary for the SM® Internal/External Implant Systems describes a submission to the FDA seeking clearance for a dental implant. The primary method for proving the device meets acceptance criteria is through demonstration of substantial equivalence to a previously cleared predicate device (SM® Implant System, K061797).

The study that supports the device meeting its acceptance criteria is not a "study" in the sense of a clinical trial or AI/ML validation. Instead, it relies on a comparison of technological characteristics and intended use to the predicate device, along with "Laboratory testing... to determine device functionality and conformance to design input requirements."

The acceptance criteria are implicitly met by showing that:

The Intended Use is "Identical to predicate devices."
The Material (Commercially pure titanium GR. 3 and GR.4 (ASTM-F-67)) is identical.
The Technological Characteristics such as design (Morse Taper with Thread), screw threads (YES), implant thread diameter (3.8, 4.5, and 5.3 mm), collar height (1.8 mm), lengths (8-14 mm), surface treatment (Machined), and sterilization (Gamma sterilized) are identical to or within the established parameters of the predicate device.
The types of Attachments supported are also identical.

The "reported device performance" is the direct correspondence and equivalency of these characteristics to the predicate device. The FDA's letter of clearance (K070569) signifies that the agency has reviewed this comparative information and determined the device is "substantially equivalent" to the predicate, thus deeming its performance acceptable for market entry based on the predicate's established safety and effectiveness. Specific quantitative results from the "laboratory testing" are not detailed in this summary.

Summary

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

Ko70569

510(K) SUMMARY

SM® Internal/External 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	NOV 0 8 2007
14-2. US Agent /Contact Person	Kenny Lim13340 E. Firestone Blvd. Suite JSanta Fe Springs, CA 90670Phone : 562-404-8466, Fax : 562-404-2757
14-3. Date Prepared	February 09, 2007
14-4. Device Name	SM® INTERNAL/EXTERNAL 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

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

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

14-11. Intended Use

14-12. Substantial Equivalence Comparison

	Subject Device	Predicate Device
Device Name	DIO DENTAL IMPLANT CO.LTD	DIO DENTAL IMPLANT CO.LTD (K061797)
	(SM® Internal/External ImplantSystem)	(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)

TECHNOLOGICAL CHARACTERISTIC COMPARISON

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

Design	Morse Taper with Thread	Morse Taper with Thread
Screw Threads	YES	YES
Implant ThreadDiameter (mm)	3.8, 4.5, and 5.3 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
Gamma sterilized	YES	YES

Attachments

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

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

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

Image /page/3/Picture/1 description: The image shows the logo for the Department of Health and Human Services (HHS) in the United States. The logo features a stylized depiction of an eagle or bird with three curved lines forming its body and wings. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" is arranged in a circular pattern around the bird symbol.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV 0 8 2007

DIO Department DSI, Incorporated C/O Mr. Hosup Shim KoDent, Incorporated 13340 East Firestone Boulevard, Suite J Santa Fe Springs, California 90670

Re: K070569

Trade/Device Name: SM Dental Implant System Regulation Number: 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: II Product Code: DZE Dated: October 29, 2007 Received: October 29, 2007

Dear Mr. Shim:

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 - Mr. Shim

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 (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 yours,

Nil Re Ogle

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}------------------------------------------------

Indication for Use

Koros69 510(K) Number (if known): ַ

Device Name: SM Dental Implant System

Indications For Use:

Prescription Use AND/OR Over - The-Counter Use (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)

		Page 1 of 1

(Division Sign-Off)
Division of Anesthesiology, General Hospital,Infection Control, Dental Devices
510(k) Number:	K070569

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.