The I-FIX System are intended to load immediately in partially or fully edentulous manidibles and maxillae to serve as temporary support for provisional prosthetic device during the healing phase of permanent endosseous dental implants.

Device Description

The I-FIX System is mini implant system, which serves temporary support for provisional prosthetic device during the healing phase of permanent endosseous dental implants. The I-FIX System is comprised in diameter of 2.0 - 3.0mm and range from 10 - 16 mm and is made of CP Titanium grade 4. The surface treatment of I-Fix System is of R.B.M (Resorbable Blasting Media).

AI/ML Overview

This is a 510(k) premarket notification for a dental implant system, not a device that uses AI or goes through an acceptance criteria study as understood in modern AI/ML medical devices. The document focuses on demonstrating substantial equivalence to a predicate device through material and mechanical performance testing, rather than clinical performance or AI algorithm validation.

Therefore, most of the requested information regarding acceptance criteria, AI performance, ground truth, and training/test sets is not applicable to this submission.

Here's a breakdown of what can be extracted and why other points are not applicable:

A table of acceptance criteria and the reported device performance

Acceptance Criteria	Reported Device Performance
Mechanical strength equivalent to predicate devices, consistent with FDA guidance (Root-form Endosseous Dental Implants and Endosseous Dental Implant Abutments, May 12, 2004)	"mechanical testing of the implants demonstrated that the I-Fix System possess mechanical strength at least equivalent to the predicate devices."

Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not applicable. The "test set" here refers to the device itself undergoing mechanical testing, not a dataset for an AI model.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not applicable. Ground truth, in the context of this submission, relates to establishing the substantial equivalence of material and mechanical properties, not clinical or diagnostic accuracy requiring expert consensus.
Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. This refers to adjudication of labels or outcomes in a clinical study, which is not described here.
If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- No. This is a traditional medical device submission, not an AI-powered device.
If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- No. This device does not involve an algorithm.
The type of ground truth used (expert concensus, pathology, outcomes data, etc)
- For the mechanical testing, the "ground truth" would be established by standardized mechanical testing methodologies and comparison data from the predicate device based on the FDA guidance document.
The sample size for the training set
- Not applicable. There is no AI model requiring a training set.
How the ground truth for the training set was established
- Not applicable. There is no AI model requiring a training set.

Summary

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1-Fix System 510(K) Submission

Dentis Co., Ltd.

K083586

APR 9 9 2009

1 87 2

510(K) Summary

Submitter

Dentis Co., Ltd. Shim Gi Bong #951, Woram-Dong, Dalseo-Gu, Daegu, South Korea Phone: 82-53-589-3530 Fax: 82-53-583-2806 Registration Number: 3007031098

Device Information

Product Name: I-Fix System

Common Name: Endosseous Dental Implant

Classification Name: Implant, Endosseous, Root-Form

Product Code: DZE

Regulation Number: 872.3640

Device Class: Class II

General Description

Indication for Use

Official Correspondent Kodent Inc. Jung Bae Bang 13340 E. Firestone Blvd. Suite J Santa Fe Springs, CA 90670 Email: kodentinc@kodent.co.kr

Phone: 562-404-8466

Fax: 562-404-2757

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K083586

2872

Materials

イ

This device are manufactured from TI6A1-4V ELI alloy following ASTM and ISO standards.

Predicate Devices

The subject device is substantially equivalent to the following predicate devices:

. Intermezzo™ Implant System (K051018) manufactured by Megagen Implant Co., Ltd.

Comparison to Predicate Devices

Testing and other comparisons have established that the subject of I-Fix System is substantially equivalent in design, materials, indications and intended use, packaging, labeling, and performance to other predicate devices of the type currently marketed in the U.S.

Performance Data

All of the data consistent with the recommendations in the FDA guidance document Root-form Endosseous Dental Implants and Endosseous Dental Implant Abutments, May 12, 2004, mechanical testing of the implants demonstrated that the I-Fix System possess mechanical strength at least equivalent to the predicate devices.

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

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features a stylized caduceus, a symbol often associated with medicine and healthcare, on the right side. On the left side of the seal, the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern. The seal is presented in black and white.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

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

APR 2 9 2009

Re: K083586

Trade/Device Name: I-Fix System Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: II Product Code: DZE, NHA Dated: April 13, 2009 Received: April 13, 2009

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 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.

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.

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Page 2- Mr. Bang

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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.

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 (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please contact the CDRH/Office of Surveillance and Biometrics/Division of Postmarket Surveillance at 240-276-3464. For more information regarding the reporting of adverse events, please go to http://www.fda.gov/cdrh/mdr/.

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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Susan Runner

Susan Runner, D.D.S., MA Acting 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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Dentis Co., Ltd.

1000

K083586

Indication for Use

510(K) Number (if known):

Device Name: I-Fix System

Indication for Use:

Prescription Use X

(Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter

(Per 21 CFR 801 Subpart C)

(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

sion of Anesthesiology, General Hospital
fection Control, Dental Devices

10(k) Number:	K083586
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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.