ROYAL-DENT EUREKA DENTAL IMPLANT SYSTEM

K122804 · Intai Technology Corp. · DZE · May 20, 2013 · Dental

Device Facts

• Record ID: K122804
• Device Name: ROYAL-DENT EUREKA DENTAL IMPLANT SYSTEM
• Applicant: Intai Technology Corp.
• Product Code: DZE · Dental
• Decision Date: May 20, 2013
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3640
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Royal-Dent Eureka Dental Implant System is indicated for use in partially or fully edentulous mandibles and maxillae, in support of single or multiple-unit restorations including: cemented retained, screw retained or overdenture restorations, and terminal or intermediate abutment support for fixed bridgework. Royal-Dent Eureka Dental Implant System is for one and two stage surgical procedures. It's not for immediate load.

Device Story

Royal-Dent Eureka Dental Implant System comprises endosseous dental implants and abutments; used as replacement for missing teeth; provides stable foundation for restorations. Implants inserted into upper/lower jawbone; surgeon-operated in clinical setting. System includes Eureka and Eureka Plus sub-types; differing in outer design configuration; identical inner hole features for screw/abutment compatibility. Implants provided sterile; other components require sterilization before use. Device supports cemented, screw-retained, or overdenture restorations; fixed bridgework. Not for immediate load. Benefits patient by restoring dental function and aesthetics.

Clinical Evidence

Bench testing only. Testing included fatigue testing per ISO 14801 and biocompatibility testing per ISO 10993-3 (genotoxicity), ISO 10993-5 (cytotoxicity), ISO 10993-6 (implantation), ISO 10993-10 (sensitization), and ISO 10993-11 (systemic injection).

Technological Characteristics

Materials: CP Ti (implants), Ti-6Al-4V (abutments, screws, healing caps). Energy source: None (mechanical). Dimensions: Diameters 3.5-5.0mm, Lengths 8.5-15mm. Sterilization: Gamma (implants), non-sterile (abutments/accessories). Connectivity: None. Software: None.

Indications for Use

Indicated for partially or fully edentulous patients (mandibles and maxillae) requiring single or multiple-unit restorations (cemented, screw-retained, or overdenture) or fixed bridgework support. Suitable for one or two-stage surgical procedures. Contraindicated for immediate load.

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

• GS System (K063861)
• GS III System (K091208)

Submission Summary (Full Text)

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## 510(k) Summary (K122804)

The summary of 510(k) safety and effectiveness information is being submitted in accordance with requirement of 21 CFR Part 807.92

| Date : | May 20, 2013 |
|-------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Submitter : : | INTAI TECHNOLOGY CORP. |
| Address : | No.9, Jingke Rd., Nantun Dist .<br>Taichung City,<br>Taiwan<br>Tel : [phone]<br>Fax: [phone] |
| Contact Person : | Kevin Wang, Regulatory Affairs Specialist |
| Trade Name : | Royal-Dent Eureka Dental Implant System |
| Device Classification : | Class II |
| Classification Name : | Endosseous dental implant, Endosseous dental implant abutment |
| Regulation Number : | 872.3640, 872.3630 |
| Product Code : | DZE, NHA |
| Predicate Devices : | GS System (K063861)<br>GS III System (K091208) |
| Device Description : | Royal-Dent Eureka Dental Implant System is a multiple component device,<br>made from CP Ti and Ti-6Al-4V, which allow the surgeon to build an<br>implant system to fit the patient's requirements. The system is a set of<br>implants designed to be inserted into the upper and/or lower jawbone and<br>serves as a replacement for patient's tooth providing a stable foundation<br>for restorations. The system is provided with simplified main implants, but<br>with a variety of different styles of components. Eureka and Eureka Plus<br>implant series are the sub-types incorporated into Royal-Dent Dental<br>Implant System. The major difference between two implant sub-types is<br>outer design configuration. The design configuration and features of inner<br>hole for the sake of fitness to various screws and abutments are identical.<br>The Implants are provided sterile, the remaining components must be<br>sterilized prior to use. The size information is as below. |

| Eureka Implant |
|---------------------------------------------------|
| Dia. 3.5mm x (L) 8.5mm, 10mm, 11.5mm, 13mm, 15mm. |
| Dia. 4.0mm x (L) 8.5mm, 10mm, 11.5mm, 13mm, 15mm. |
| Dia. 4.5mm x (L) 8.5mm, 10mm, 11.5mm, 13mm, 15mm. |
| Dia. 5.0mm x (L) 8.5mm, 10mm, 11.5mm, 13mm, 15mm. |

| Eureka Plus Implant |
|---------------------------------------------------|
| Dia. 3.5mm x (L) 8.5mm, 10mm, 11.5mm, 13mm, 15mm. |
| Dia. 4.3mm x (L) 8.5mm, 10mm, 11.5mm, 13mm, 15mm. |
| Dia. 5.0mm x (L) 8.5mm, 10mm, 11.5mm, 13mm, 15mm. |

| Abutments |
|-----------|
|-----------|

: 3.5mm~6mm Diameter Vertical High : 2.5mm~10mm

.

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Indication for Use :

Royal-Dent Eureka Dental Implant System is indicated for use in partially or fully edentulous mandibles and maxillae, in support of single or multiple-unit restorations including: cemented retained, screw retained or overdenture restorations, and terminal or intermediate abutment support for fixed bridgework.

Royal-Dent Eureka Dental Implant System is for one and two stage surgical procedures. It's not for immediate load.

### Technological Characteristics :

| | Subject Device | Predicate Devices |
|----------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device | | GS System (K063861) |
| Name | Royal-Dent Eureka Dental Implant System | GS III System (K091208) |
| Indication<br>for use | Royal-Dent Eureka Dental Implant System is<br>indicated for use in partially or fully edentulous<br>mandibles and maxillae, in support of single or<br>multiple-unit restorations including: cemented<br>retained, screw retained or overdenture<br>restorations, and terminal or intermediate abutment<br>support for fixed bridgework. Royal-Dent Eureka<br>Dental Implant System is for one and two stage<br>surgical procedures. It's not for immediate load. | GS System and GS III System are indicated for use<br>in partially or fully edentulous mandibles and<br>maxillae, in support of single or multiple-unit<br>restorations including: cemented retained, screw<br>retained or overdenture restorations, abutments<br>support for fixed bridgework. GS and GS III System<br>is for one stage surgical procedures. It's not for<br>immediate load. |
| | CP Ti : dental implant | CP Ti: dental implant, cover screw, healing abutment. |
| Material(s) | Ti6Al4V: abutments, screws, healing caps, clix. | Ti6Al4V: abutments, screws, healing caps, clix.<br>Gold alloy + plastic: casting abutment, cylinder. |
| Use | Single use | Single use |
| Dimension<br>of Implants | Diameter: 3.5, 4.0, 4.3, 4.5, 5.0mm<br>Length: 8.5, 10,11.5,13,15mm | Diameter: 3.5, 4.0,4.3, 4.5, 5.0mm<br>Length: 7.0,8.5,10,11.5,13,15mm |
| Method of<br>sterilization | Gamma sterilization: implant<br>Abutments and accessories : non-sterile | Gamma sterilization: implant<br>Abutments and accessories : non-sterile |

Performance Data :

Pre-clinical testing of Royal-Dent Eureka Dental Implant System

- ♦ Bench testing per ISO 14801
- Genotoxicity Testing per ISO 10993-3
- Cytotoxicity testing per ISO 10993-5
- Implantation testing per ISO 10993-6
- Sensitization testing per ISO10993-10
- System Injection testing per ISO10993-11

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Conclusion :

The comparisons of Royal-Dent Eureka Dental Implant System and predicate devices show that the devices are manufactured from same or similar materials, and have the same indication for use and similar design characteristics. Performance Testing were also conducted to demonstrate safety and effectiveness of the proposed devices. Based on the similarities between the Royal-Dent Eureka Dental Implant System and the predicate devices, the safety and effectiveness of the Royal-Dent Eureka Dental Implant System is substantially equivalent to the predicate devices.

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### DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image is a black and white seal for the Department of Health & Human Services - USA. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract symbol that resembles a person embracing another person.

#### Public Health Service

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

### May 20, 2013

Mr. Kevin Wang Regulatory Affairs Specialist INTAI Technology Corporation No.9, Jingke Road, Nantun District Taichung City, Taiwan 40852

Re: K122804

Trade/Device Name: Royal-Dent Eureka Dental Implant System Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: II Product Code: DZE, NHA Dated: May 16, 2013 Received: May 16, 2013

Dear Mr. Wang:

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.

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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 devicerelated 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 Division of Small Manufacturers, International and Consumer Assistance at its tollfree number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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,

Image /page/4/Picture/8 description: The image shows the name "Kwame O. Ulmer-S" in a bold, sans-serif font. The text is arranged in two lines, with "Kwame O." on the top line and "Ulmer-S" on the bottom line. There is a design to the right of the name that looks like a triangle.

for

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

Division of Anesthesiology, General Hospital, Respiratory, 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): K122804 Device Name: Royal-Dent Eureka Dental Implant System Indications for Use:

Royal-Dent Eureka Dental Implant System is indicated for use in partially or fully edentulous mandibles and maxillae, in support of single or multiple-unit restorations including: cemented retained, screw retained or overdenture restorations, and terminal or intermediate abutment support for fixed bridgework.

Royal-Dent Eureka Dental Implant System is for one and two stage surgical procedures. It's not for immediate load.

| Prescription Use<br>(Part 21 CFR 801 Subpart D) | X | | AND/OR | Over-The-Counter Use<br>(21 CFR 801 Subpart C) |
|-------------------------------------------------|---|--|--------|------------------------------------------------|
|-------------------------------------------------|---|--|--------|------------------------------------------------|

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Digitally signed by Mary S. Runner -S

DN: c=US, o=U.S. Government, ou=HHS, ou=FDA, ou=People, cn=Mary S. Runner

0.9.2342.19200300.100.1.1=1300087950

Date: 2013.05.20 12:09:36 -04'00'

Concurrence of CDRH, Office of Device Evaluation (ODE)

Page 1 of 1

(Division Sign-Off)

Division of Anesthesiology, General Hospital

Infection Control, Dental Devices

| 510(k) Number: | K122804 |
|----------------|---------|
|----------------|---------|

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510(k) Number._