DENTIUM CO., LTD. IMPLANTIUM

K041368 · Dentium Co., Ltd. · DZE · Jul 29, 2004 · Dental

Device Facts

• Record ID: K041368
• Device Name: DENTIUM CO., LTD. IMPLANTIUM
• Applicant: Dentium Co., Ltd.
• Product Code: DZE · Dental
• Decision Date: Jul 29, 2004
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 872.3640
• Device Class: Class 2
• Attributes: Therapeutic

Intended 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.

Device Story

Endosseous dental implant system; consists of fixture, abutment, mount, mount screw, cover screw, impression coping, analog, impression coping screw, and plastic impression cap. Surgically placed in upper or lower jaw bone by dental professionals. Provides structural support for prosthetic devices (artificial teeth) to restore chewing function. Available in diameters 3.4-4.8 mm and lengths 8-14 mm. Pure titanium and titanium alloy construction. Operates as mechanical support for dental prosthetics; no electronic or software components.

Clinical Evidence

Bench testing only. No clinical data provided.

Technological Characteristics

Materials: Pure titanium and titanium alloy. Form factor: Endosseous dental implant with fixture, abutment, and associated hardware. Diameters: 3.4-4.8 mm. Lengths: 8-14 mm. Mechanical fixation principle. No energy source, software, or connectivity.

Indications for Use

Indicated for patients requiring dental implants for prosthetic support and restoration of chewing function. Suitable for placement in upper or lower jaw bone via one or two-stage surgery. Requires type I, II, or III bone and initial stability > 40 Ncm for single-stage procedures. Contraindicated for immediate loading.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

• Astra Tech Implants-Dental System (K012965)

Submission Summary (Full Text)

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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<br>(21 C.F.R. § 872.3640) |
| Submitter's Name<br>And Address: | Dentium Co., Ltd<br>27-5 leui-dong, Yeongtong-gu, Suwon-si, Gyeonggi-do,<br>Republic of Korea |
| Contact's Name: | Cathryn N. Cambria |
| Submission Date: | May 17, 2004 |
| Legally Marketed Device<br>To Which Claim Substantial<br>Equivalence: | Astra Tech Implants-Dental System<br>K012965 |

## II. 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.

## III. 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)

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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.

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 [phone]. 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 [phone] or [phone] 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:

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