DIO STEADY EXTERNAL IMPLANT SYSTEM

K100100 · Dio Corporation · DZE · Nov 10, 2010 · Dental

Device Facts

• Record ID: K100100
• Device Name: DIO STEADY EXTERNAL IMPLANT SYSTEM
• Applicant: Dio Corporation
• Product Code: DZE · Dental
• Decision Date: Nov 10, 2010
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3640
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The DIO STEADY External Implant System is an endosseous dental implant is indicated 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. Implants can be placed with a conventional two stage surgical process with an option for transmucosal healing or they can be placed in a single stage surgical process for immediate loading. Immediate loading is restricted to the anterior mandible, based on four interforaminal placed implants, and not indicated for single unsplinted implants. Patients must be subject for dental treatment with endosseous implants.

Device Story

Endosseous dental implant system; includes implants and superstructures. Used in dental surgery for edentulous mandibles/maxillae. Surgically placed by dentists; supports single or multiple-unit restorations. Implants integrate with bone to provide root-form foundation for prosthetic appliances. Supports two-stage surgical process with transmucosal healing or single-stage process with immediate loading (anterior mandible only). Benefits patient by restoring chewing function.

Clinical Evidence

Bench testing only. Fatigue testing conducted per FDA guidance for Class II Special Controls for Root-form Endosseous Dental Implants. Results compared to predicate devices to confirm functionality and design conformance.

Technological Characteristics

Material: CP Ti Gr4 (ASTM F67). Surface treatment: RBM (Resorbable Blast Media, TiO2 100%). Design: External Hex type with screw threads. Sterilization: Gamma radiation. Dimensions: Diameters 3.3-6.0mm; Lengths 8.5-16mm.

Indications for Use

Indicated for patients requiring dental implants in upper or lower jaw arches for single or multiple unit prosthetic attachment to restore chewing function. Immediate loading restricted to anterior mandible using four interforaminal implants; not for single unsplinted implants.

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

• SM Internal/External Implant System (K070569)

Submission Summary (Full Text)

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

K100100

.

NOV 1 0 2010

### Traditional 510(k) Submission

.

.

. .- - -- -- ---- -- ------ -

. .

- ----------------------------------------------------------------------------------------------------------------------------------------------------------------------------

Attachment 4

.

..

# 510(k) Summary

DIO STEADY External Implant System

| 1. Submitter | DIO Corporation<br>1464 U-dong, Haeundae-gu, Busan, 612-020, Korea<br>Tel.: [phone]<br>Fax.: [phone] |
|---------------------------------|---------------------------------------------------------------------------------------------------------------------------------|
| 2. US Agent /<br>Contact Person | DIO, USA<br>Tim C.J. Lee<br>3540 Wilshire Blvd. #1104 Los Angeles,<br>CA 90010, USA<br>Tel.: [phone]<br>Fax.: [phone] |
| 3. Device Name | DIO STEADY External Implant System |
| 4. Classification Name | Endosseous Dental Implant System |
| 5. Device Classification | Class II<br>Dental Devices panel<br>Regulation Number: 21 CFR 872.3640 |
| 6. Predicate Devices | SM Internal/External Implant System(510(k) No: K070569) |
| 7. Performance | Laboratory testing was conducted to determine device functionality and conformance to design input requirements. |
| 8. Purpose | The purpose of this 510(k) is to modify the prior 510(k) submission for the DIO STEADY External Implant System. |

..

- 36 ---

11. 11. 11.

.

.

· .

...

. .

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

#### DIO STEADY External Implant System

### 9. Device Description

The DIO STEADY External Implant System is comprised of dental implants, and superstructures.

::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::

The DIO STEADY External Implant System is specially designed for use in dental implant surgery. A successfully osseointegrated implant will achieve a firm implant when surgically implanted under controlled conditions, per well known clinical studies. There are intended for use in partially or fully edentulous mandibles and maxillae, in support of single or multiple-unit restorations.

### 10. Packing / Labeling / Product Information

DIO STEADY External Implant System follows the guidance of the 21 CFR872.3640.

11. Intended Use ·

The DIO STEADY External Implant System is an endosseous dental implant is indicated 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. Implants can be placed with a conventional two stage surgical process with an option for transmucosal healing or they can be placed in a single stage surgical process for immediate loading. Immediate loading is restricted to the anterior mandible, based on four interforaminal placed implants, and not indicated for single unsplinted implants. Patients must be subject for dental treatment with endosseous implants.

37 -

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

# DIO STEADY External Implant System

## 12. Substantial Equivalence Comparison

| | Subject Device | Predicate Device |
|--------------------------|---------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Manufacturer<br>Name | DIO Corporation | DIO DENTAL IMPLANT CO.,<br>LTD |
| Device Name | DIO STEADY External Implant<br>System | SM Internal/External Implant<br>System |
| 510(k) Number | Not available yet | K070569 |
| Intended Use | Same with predicate device | The DIO Dental Implant is and designed for use in edentulous sites in the mandible or maxilla for support of a complete denture prosthesis, terminal or intermediate abutment for fixed bridgework partial dentures, or single tooth replacements. |
| Material | CP Ti Gr4 (ASTM F67) | CP Ti Gr4 (ASTM F67) |
| Design | External Hex Type | Internal Type, Morse Tapered and External Hex Type |
| Screw Threads | YES | YES |
| Implant<br>Diameters(mm) | 3.3/3.75/4.0/4.5/5.0/6.0 | 3.8/4.5/5.3 |
| Implant<br>Lengths(mm) | 8.5/10/11.5/13/15/16 | 8/10/12/14 |
| Surface<br>Treatment | RBM (Resorbable Blast Media :<br>TiO2 100%) | RBM (Resorbable Blast Media) |
| Sterilization<br>Method | Gamma | Gamma |
| Attachments | Various abutments and components | Various abutments and components |
| Product Code | DZE | DZE |

Technological Characteristic Comparison

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

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

#### DIO STEADY External Implant System

### 13. Review

The DIO STEADY External Implant System has same material and indication for use and similar design and technological characteristics as the predicate device.

The DIO STEADY External Implant System has been subjected to safety, performance and product validation prior to release. Safety tests including biocompatibility has been performed to ensure the devices comply with the applicable International and US regulations.

### 14. Summary of nonclinical testing

Fatigue testing was conducted according to the "Guidance for industry and FDA staff Class II Special Controls Guidance Document Root-form Endosseous Dental Implants and Endosseous Dental Abutment" with the worst case scenario of the DIO STEADY External Fixture and an angled abutment.

The fatigue test results were similar to previously cleared predicate devices.

#### 15. Conclusion

The evaluation of the DIO STEADY External Implant System demonstrates that it may be considered substantially equivalent to its predicate device.

Date: October/ 30/ 2009

Date: October/ 30/ 2009

Signature

Gabmoon,Jeong/ DIO Corporation RA Staff

signature

Tim C.J. Lee/ DIO, USA Manager

- 39 -

Comments and I. B. B. B.

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

Image /page/4/Picture/1 description: The image shows a logo for the Department of Health & Human Services. The logo consists of a stylized eagle with three curved lines representing its wings. The text "DEPARTMENT OF HEALTH & HUMAN" is arranged in a circular fashion around the left side of the eagle. The logo is black and white.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

Dio Corporation C/O Mr. Timothy Lee Manager Dio USA 3540 Wilshire Boulevard, Suite 1104 Los Angeles, California 90010

NOV 1 0 2010

Re: K100100

Trade/Device Name: DIO STEADY External Implant System Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: II Product Code: DZE Dated: October 7, 2010 Received: October 19, 2010

Dear Mr. Lee:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

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.

{5}------------------------------------------------

Page 2- Mr. Lee

· 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); 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 go to

http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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 go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours.

Susan Tunne

Anthony D. Watson, B.S., M.S., M.B.A. Director

Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and

Radiological Health

Enclosure

{6}------------------------------------------------

Traditional 510(k) Submission

DIO STEADY External Implant System

Attachment 2

# Indications for Use Statement

NOV 1 0 2010

K100100 510(K) Number (if known):

Device Name: DIO STEADY External Implant System

Indications For Use:

KOGION

The DIO STEADY External Implant System is an endosseous dental implant is indicated 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. Implants can be placed with a conventional two stage surgical process with an option for transmucosal healing or they can be placed in a single stage surgical process for immediate loading. Immediate loading is restricted to the anterior mandible, based on four interforaminal placed implants, and not indicated for single unsplinted implants. Patients must be subject for dental treatment with endosseous implants.

Prescription Use -----------S 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)

un m Concurrence of CDRH, Office of Device Evaluation (ODE) (Division Sign-Off) Page 1 of 1 Division of Anesthestology, General Hospital Infection Control, Dental Devices

510(k) Number:

- 34