DENTIUM CO., LTD. IMPLANTIUM by DENTIUM CO., LTD.

The Dentium Co., Ltd Implantium 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, and to restore the patient's chewing function. This may be accomplished by either a two-stage surgical procedure or a single surgical procedure. If a single surgical procedure is used, single or multiple implants may be inserted (type I, II or III bone) provided good initial stability (> 40 Ncm) is achieved. Not intended for immediate loading.

Device Description

The Dentium Co., Ltd Implantium is a device made of pure titanium metal and titanium alloy 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, and to restore the patient's chewing function. It consists of fixture, abutment, mount, mount screw, cover screw, impression coping, analog, impression coping screw and plastic impression cap. Its materials, dimensions, and intended use are similar to devices currently marketed worldwide. The Dentium Co., Ltd Implantium are available in four diameters (3.4, to 4.8 mm) and four lengths (8, 10, 12 and 14 mm)

AI/ML Overview

The provided text describes a 510(k) premarket notification for the Dentium Co., Ltd Implantium, a dental implant device. However, it does not contain information about acceptance criteria or a study proving the device meets specific acceptance criteria in the context of device performance metrics like accuracy, sensitivity, or specificity.

Instead, the document details the device's general information, indications for use, device description, and the FDA's determination of substantial equivalence to a legally marketed predicate device (Astra Tech Implants-Dental System K012965). The substantial equivalence determination is based on the primary function, technological characteristics, and a comparison to the predicate device, concluding that it "raises no new questions of safety and effectiveness."

Therefore, I cannot provide a table of acceptance criteria and reported device performance, nor details about a study that proves the device meets such criteria because this information is not present in the provided text.

Here is a breakdown of what can be inferred or directly stated from the text regarding the lack of such information:

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria: Not explicitly stated in the provided documents. The FDA's acceptance is based on "substantial equivalence" to a predicate device, meaning it performs as safely and effectively as the predicate, not necessarily against pre-defined quantitative performance metrics for the new device.
Reported Device Performance: No specific performance metrics (e.g., success rates, complication rates, osseointegration percentages) are reported for the Dentium Co., Ltd Implantium itself in this document. The equivalence claim infers its performance is similar to the predicate.

2. Sample size used for the test set and the data provenance:

Sample Size: Not applicable. No "test set" in the context of a performance study (e.g., clinical trial data) is mentioned or used for this 510(k) submission as described. The determination is based on comparison to a predicate.
Data Provenance: Not applicable. No study data (retrospective or prospective) from a particular country of origin is referenced for the Dentium Co., Ltd Implantium's performance.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not applicable. No "ground truth" establishment by experts is mentioned as part of this 510(k) submission for performance evaluation.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

Not applicable. There is no test set or adjudication process described.

5. 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:

Not applicable. This is a dental implant, not an AI-assisted diagnostic device, and no MRMC studies are mentioned.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:

Not applicable. This is a physical medical device (dental implant), not an algorithm or AI.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

Not applicable. No "ground truth" used for a performance evaluation study is mentioned. The ground for approval is substantial equivalence to a predicate device.

8. The sample size for the training set:

Not applicable. This is a physical medical device, not a machine learning model, so there is no "training set."

9. How the ground truth for the training set was established:

Not applicable. See point 8.

Summary

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I. GENERAL INFORMATION

Trade or (Proprietary) Name: Dentium Co., Ltd Implantium

Common or usual name:	Dental Implant
Classification Name:	Endosseous Dental Implant(21 C.F.R. § 872.3640)
Submitter's NameAnd Address:	Dentium Co., Ltd27-5 leui-dong, Yeongtong-gu, Suwon-si, Gyeonggi-do,Republic of Korea
Contact's Name:	Cathryn N. Cambria
Submission Date:	May 17, 2004
Legally Marketed DeviceTo Which Claim SubstantialEquivalence:	Astra Tech Implants-Dental SystemK012965

II. INDICATIONS FOR USE

III. DEVICE DESCRIPTION

The Dentium Co., Ltd Implantium are available in four diameters (3.4, to 4.8 mm) and four lengths (8, 10, 12 and 14 mm)

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Based on the indication for use, technological characteristics and comparison to the predicate device, the primary function of the Dentium Co., Ltd. Implantium is the same as the Astra Tech Implants-Dental System and raises no new questions of safety and effectiveness.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image is a seal for the Department of Health & Human Services - USA. The seal is circular and contains the department's logo in the center. The logo is a stylized image of an eagle with three stripes across its body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the top half of the circle.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL 2 9 2004

Dentium Company Limited C/O Ms. Cathryn N. Cambria Consultant Arkin Consulting Group, LLC 5536 Trowbridge Drive Dunwoody, Georgia 30338

Re: K041368

Trade/Device Name: Dentium Company Limited Implantium Regulation Number: 872.3640 Regulation Name: Endosseous Implant Regulatory Class: II Product Code: DZE Dated: July 20, 2004 Received: July 21, 2004

Dear Ms. Cambria:

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 Foderal 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 - Ms. Cambria

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 mount and regulations 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 and instile (s 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), 11 Joe contact the Office of Compliance at (301) 594-4613. 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,

Quls

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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Indications for Use

510(k) Number (if known): K041368 Dentium Co., Ltd Device Name: Indications for Use:

The Dentium Co., Ltd Implantium 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, and to restore the patient's chewing function.

This may be accomplished by either a two-stage surgical procedure or a single surgical procedure. If a single surgical procedure is used, single or multiple implants may be inserted (type I, II or III bone) provided good initial stability (> 40 Ncm) is achieved. Not intended for immediate loading.

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

ﺮ ﺳﺮ

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)

Angela Blackwell for MSR

Division of Anesthesiology, General Hospital, Infection Control, Dental Devices

510(k) Number:

Page 1 of

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.