ONEPLANT DENTAL IMPLANT SYSTEM

K081748 · Warantec Co., Ltd. · DZE · Mar 27, 2009 · Dental

Device Facts

• Record ID: K081748
• Device Name: ONEPLANT DENTAL IMPLANT SYSTEM
• Applicant: Warantec Co., Ltd.
• Product Code: DZE · Dental
• Decision Date: Mar 27, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3640
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

ONEPLANT is designed for use in dental implant Surgery. These are intended for use in partially or fully edentulous mandibles and maxillae to support for single or multiple-unit restorations such as cemented retained, screw retained, or over denture restorations and terminal or intermediate abutment support for fixed bridgework.

Device Story

ONEPLANT Dental Implant System consists of titanium fixtures, abutments, and surgical instruments. Designed for surgical placement into upper or lower jaw bone to support prosthetic devices (artificial teeth) and restore chewing function. Used by dental surgeons in clinical settings. Fixtures are surgically implanted; abutments are attached to fixtures to support restorations. System utilizes internal connection, Morse taper, and internal octagon design. Benefits include restoration of oral function and aesthetics for edentulous patients.

Clinical Evidence

No clinical data provided. Substantial equivalence is based on design, material, and intended use comparisons to legally marketed predicate devices.

Technological Characteristics

Materials: Titanium G4 (fixture), Titanium G5 (abutment). Design: Internal connection, Morse taper, internal octagon. Dimensions: Fixture diameters 3.3, 3.6, 4.3, 5.3mm; lengths 8.5, 10, 11.5, 13, 15mm. Non-powered, mechanical dental implant system.

Indications for Use

Indicated for partially or fully edentulous adult patients requiring dental implants in the mandible or maxilla to support single or multiple-unit restorations (cemented, screw-retained, or overdenture) or fixed bridgework.

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

• DENTIUM Multiple (K070228, K052957, K060501, K052823, K041368)
• Osstem Implant (K051576)

Submission Summary (Full Text)

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

K081748

RYC

MAR 2 7 2009

510(K) Summary K08 WARANTEC Co., Ltd. 307, Sunil Technopia, #440, Sangdaewon-dong, Jungwon-gu, Sungnam-si, Gyeonggi-do, 462-726, Korea TEL. [phone]~8 FAX. [phone] Contact: Song, Chung-Hun/ President Date prepared: June 10, 2008

307, Sunil Technopia, #440, Sangdaewon-dong,
Jungwon-gu, Sungnam-si,
Gyeonggi-do, 462-726, Korea
TEL. [phone]~8
FAX. [phone]
Contact: Song, Chung-Hun/ President
Date prepared: June 10, 2008

1. Trade Name: ONEPLANT Dental Implant System

- 2. Common Name: Dental Implant
- 3. Classification Name and Device Class: implant, endosseous, root-form DZE and Abutment, implant, dental, endosseous NHA; Class II per regulations 872.3640 and 872.3630
- 4. The legally marketed device to which we are claiming equivalence [807.92(a)(3)) : DENTIUM Multiple: K070228; K052957; K060501; K052823; K041368; Osstem Implant K051576
- 5. Dental implant systems are devices made of a material such as Description of device: titanium 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 patients chewing function. Dental implant system consists of Fixture, Abutment and Implant surgical instruments.
- 6. Indications for use: ONEPLANT is designed for use in dental implant Surgery. These are intended for use in partially or fully edentulous mandibles and maxillae to support for single or multiple-unit restorations such as cemented retained, screw retained, or over denture restorations and terminal or intermediate abutment support for fixed bridgework.
- 7. Comparison Table: Below.

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

K081748

2 d 2

| Manufacturer/510(k)<br>Number | DENTIUM<br>Multiple: K070228;<br>K052957; K060501;<br>K052823; K041368 | Osstem Implant<br>K051576 | WARANTEC | |
|-------------------------------|-------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------|
| Website | www.implantium.com | www.osstem.com | www.oneplant.co.kr | |
| Type name | IMPLANTIUM | GS System | ONEPLANT | |
| Intended use | It is to provide support for<br>prosthetic device, such as<br>artificial teeth, and to<br>restore the patient's<br>chewing function | GS System is indicated for<br>use in partially or fully<br>edentulous mandibles and<br>maxillae, in support of<br>single or multiple-unit<br>restorations including;<br>cemented retained, screw<br>retained, or overdenture<br>restorations, and terminal<br>or intermediate abutment<br>support for fixed<br>bridgework. GS System is<br>for one stage surgical<br>procedures. It is not<br>intended for immediate<br>load. | ONEPLANT is designed<br>for use in dental implant<br>Surgery. These are<br>intended for use in<br>partially or fully<br>edentulous mandibles and<br>maxillae to support for<br>single or multiple-unit<br>restorations such as<br>cemented retained, screw<br>retained, or over denture<br>restorations and terminal<br>or intermediate abutment<br>support for fixed<br>bridgework. | |
| Design | Internal Connection<br>Morse Taper,<br>Internal Octagon | Internal Connection<br>Morse Taper,<br>Internal Octagon | Internal Connection<br>Morse Taper,<br>Internal Octagon | |
| Fixture | Material | Titanium G4 | Titanium G4 | Titanium G4 |
| | Platform<br>Dia. | 3.6, 4.0, 4.5, 5.0, 5.5mm | 3.5, 4.0, 4.5, 5.0mm | 3.3, 3.6, 4.3, 5.3mm |
| | Length | 8, 10, 12, 14mm | 7, 8.5, 10, 11.5, 13, 15mm | 8.5, 10, 11.5, 13, 15mm |
| Abutment | Material | Titanium G5 | Titanium G5 | Titanium G5 |
| | Type | Various | Various | Various |
| Certification | KGMP, CE, FDA 510k | KGMP, CE, FDA 510k | KGMP | |

- 8. Conclusion: In all respects, the Oneplant Dental Implant components are the equivalent of currently marked devices. They are made of the same materials and have similar dimensions and characteristics. This device is substantially equivalent in design, material, intended use and function to the products on the table above.
:

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

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized human figure with three arms, representing health, services, and people. The figure is positioned to the right of the text "DEPARTMENT OF HEALTH & HUMAN SERVICES · USA", which is arranged in a circular fashion.

Public Health Service

MAR 2 7 2009

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Warantec Company, Limited C/o Mr. Daniel Kamm, P.E. Kamm & Associates P.O. Box 7007 Deerfield. Illinois 60015

Re: K081748

> Trade/Device Name: Oneplant Dental Implant System Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: II Product Code: DZE Dated: March 16, 2009 Received: March 19, 2009

Dear Mr. Kamm:

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.

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

## Page 2 - Mr. Kamm

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 (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions 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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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/industry/support/index.html.

Sincerely yours.

Sugette Y. Michie Dues

Ginette Y. Michaud, M.D. Acting Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{4}------------------------------------------------

K081748

## Indications for Use

510(k) Number (if known):

Device Name: Oneplant Dental Implant System

## Indications For Use:

ONEPLANT is designed for use in dental implant Surgery. These are intended for use in partially or fully edentulous mandibles and maxillae to support for single or multiple-unit restorations such as cemented retained, screw retained, or over denture restorations and terminal or intermediate abutment support for fixed bridgework..

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

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)

Page 1 of 1

Susan Moore

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

510(k) Number: k081744

Page 15 of 740