ANKER DENTAL IMPLANT SYSTEM

K131165 · Alliance Global · DZE · Nov 14, 2013 · Dental

Device Facts

• Record ID: K131165
• Device Name: ANKER DENTAL IMPLANT SYSTEM
• Applicant: Alliance Global
• Product Code: DZE · Dental
• Decision Date: Nov 14, 2013
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3640
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Anker Dental Implant System 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. It is intended for delayed loading.

Device Story

Anker Dental Implant System consists of a titanium (grade IV) fixture with an SLA (sand-blasted, large grit, acid-etched) surface, various abutments (healing, fixed, dual, angle, o-ring, temporary), and a cover screw. Fixtures range from 3.4-5.0 mm in diameter and 7.0-15.0 mm in length. Abutments are primarily titanium alloy, with temporary abutments made of SUS316 stainless steel. The system is surgically placed in the jaw bone by a dental professional to support prosthetic devices like artificial teeth. It is designed for delayed loading to restore chewing function. All components are provided sterile.

Clinical Evidence

No clinical data. Safety and effectiveness were established through non-clinical bench testing, including compressive force and fatigue testing (ISO 14801), corrosion testing (ASTM G3-89), and comprehensive biocompatibility testing (ISO 10993 series).

Technological Characteristics

Fixture: Grade IV pure titanium with SLA surface. Abutments: Titanium alloy (temporary: SUS316 stainless steel). Dimensions: 3.4-5.0 mm diameter, 7.0-15.0 mm length. Sterilization: Gamma irradiation. Standards: ISO 14801 (fatigue), ASTM G3-89 (corrosion), ISO 10993 (biocompatibility), ISO 11137-1 (sterilization), ASTM F88/F1140/F1929 (shelf life).

Indications for Use

Indicated for patients requiring dental implants in the upper or lower jaw arches to support prosthetic devices and restore chewing function. Intended for delayed 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

• Dentium Co., Ltd Implantium (K041368)
• Osstem GS-III system (K091208)

Submission Summary (Full Text)

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Image /page/0/Picture/1 description: The image shows the logo for Alliance Global Technology Co. Ltd. The logo features the word "Alliance" in large, bold letters, with the words "Global Technology Co. Ltd" in smaller letters underneath. Above the word "Alliance" is a graphic of a globe. The logo is black and white.

# 510(k) SUMMARY

## Anker Dental Implant system

Company Name: Alliance Global Technology Co., Ltd. 2F., No.92, Luke 5th Rd., Luzhu Dist., Kaohsiung City 821, Taiwan (R.O.C.) Telephone: [phone] Fax: [phone]

Contact Person: Ms. Yayuan Chang Telephone: [phone] Fax: [phone] E-mail: [e-mail]

Date prepared: Sep 12nd, 2013

Trade Name: Anker Dental Implant System

Common Name: Dental Implant

Classification Name: Root-form endosseous dental implant

Device Classification: Class II

Regulation Number: 21 CFR 872.3640

Panel: Dental

Product Code: DZE

#### Predicate Device:

(1)Predicate Device Name: Dentium Co., Ltd Implantium Manufacturer: Dentium Company Limited 510(k) Number: K041368 (2)Predicate Device Name: Osstem GS-III system Manufacturer: OSSTEM Implant Co., Ltd.

510(k) Number: K091208

510(k) K131165-Anker Dental Implant System Section 5 - Page 5-1

**NOV** 14 2019

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Image /page/1/Picture/0 description: The image shows the logo for ALLIANCE GLOBAL TECHNOLOGY CO. LTD. The logo features the word "ALLIANCE" in large, bold, black letters. Above the word "ALLIANCE" is a graphic of a globe. Below the word "ALLIANCE" is the text "GLOBAL TECHNOLOGY CO. LTD." in smaller, black letters.

#### Device Description:

Anker Dental Implant System consists of fixture, abutment (healing abutment, fixed abutment, dual abutment, angle abutment, o-ring abutment, temporary abutment) and cover screw. Fixture is made of pure titanium (grade IV) and its surface was treated by SLA (Sand-blasted, Large grit, Acid-etched) process. Diameters of fixtures are including 3.4 to 5.0 mm and lengthes are including 7.0 to 15.0 mm. Most abutments are made of titanium alloy and their diameters are including 4.0 to 7.0 mm. Temporary abutment is made of SUS316 stainless steel instead of titanium alloy. All products are sterilized as finished products.

### Indications for Use:

Anker Dental Implant System 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. It is intended for delayed loading.

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Image /page/2/Picture/0 description: The image shows the logo for ALLIANCE GLOBAL TECHNOLOGY CO., LTD. The word "ALLIANCE" is in large, bold, black letters. Below that is the text "GLOBAL TECHNOLOGY CO., LTD." in smaller, thinner, black letters. Above the word "ALLIANCE" is a black and white image of a globe.

## Substantial Equivalence:

| Item | | Anker Dental Implant<br>System | Osstem GS-III system | Dentium Co., Ltd<br>Implantium |
|------|-----------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 1. | Classification | Class II | Class II | Class II |
| 2. | Code or<br>Federal<br>Regulations | 872.3640 | 872.3640 | 872.3640 |
| 3. | 510K No. | K131165 | K091208 | K041368 |
| 4. | Design | Image: Anker Dental Implant | Image: Osstem GS-III system | Image: Dentium Co., Ltd Implantium |
| 5. | Intended Use | Anker Dental Implant<br>System is intended to be<br>surgically placed in the bone<br>of the upper or lower jaw<br>arches to provide support for<br>prosthetic devices, such as<br>artificial teeth, and to restore<br>the patient's chewing<br>function. It is intended for<br>delayed loading. | The GS III System is<br>indicated for use in<br>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. The GS III<br>System is for single and<br>two stage surgical<br>procedures. It is not for<br>immediate load. | The Dentium Co., Ltd<br>Implantium is intended to<br>be surgically placed in the<br>bone of the upper or<br>lower jaw arches to<br>provide support for<br>prosthetic devices, such<br>as artificial teeth, and to<br>restore the patient's<br>chewing function. |
| 6. | Body<br>Diameter | 3.4mm, 3.5mm, 3.8mm,<br>4.0mm, 4.3mm, 4.5mm,<br>4.8mm, 5.0mm | 3.7 mm,4.2 mm,4.6 mm,<br>5.1mm | 3.4mm, 3.8mm, 4.3mm,<br>4.8mm |
| 7. | Length | 7mm, 8 mm, 8.5mm, 10mm,<br>11.5mm, 12mm, 13mm,<br>14mm,<br>15mm | 7 mm, 8.5 mm, 10mm,<br>11.5 mm, 13mm, 15mm | 8 mm, 10 mm, 12mm,<br>14mm |
| 8. | Surface | S.L.A. (Sand-blasted, Large<br>grit, Acid-etched surface) | RBM (Resorbable<br>Blasting Media) | S.L.A. (Sandblasting with<br>large grit and acid<br>etching) |
| 9. | Sterilization | y-ray (Radiation) | y-ray (Radiation) | y-ray (Radiation) |
| 10. | Material | Titanium | Titanium | Titanium |
| 11. | Abutment<br>angulations | 0. 17 deg | 0. 17 deg | 0. 15, 25 deg |
| 12. | Material of<br>Abutments | Titanium Vanadium Alloy | Titanium Vanadium Alloy | Titanium Vanadium Alloy |

510(k) K131165-Anker Dental Implant System Section 5 - Page 5-3

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Image /page/3/Picture/0 description: The image shows the logo for ALLIANCE GLOBAL TECHNOLOGY CO., LTD. The word "ALLIANCE" is written in large, bold, black letters. Above the word "ALLIANCE" is a black and white image of a globe. Below the word "ALLIANCE" is the text "GLOBAL TECHNOLOGY CO., LTD" in smaller, black letters.

Comparing to the predicate devices, Dentium Co., Ltd Implantium (510K No. K041368) and Osstem GS-III system (510K No. K091208), Anker Dental Implant System is equivalent in surface treatment, intended use, method of operation, material and design.

### Non-clinical Testing:

Non-clinical test was used to support the decision of safety and effectiveness.

Non-clinical testing consisted of performance of testing in accordance with the FDA guidance "Class II Special Controls Guidance Document Root-form Endosseous Dental Implants and Endosseous Dental Implant Abutments." The results of the non-clinical testing demonstrate that the Anker Dental Implant System is substantially equivalent to the predicate devices.

| Testing Item | Reference |
|------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------|
| Compressive forces and Fatigue tests | ISO14801 |
| Compatibility test of dental implant/abutment<br>interface | N/A |
| Corrosion test | ASTM G3-89 |
| Residual of Acidic Substances Test | ISO10993-12 |
| Biocompatibility test | ISO10993-3<br>ISO10993-5<br>ISO10993-6<br>ISO10993-10<br>ISO10993-11<br>Pharmacopeia US<br>OECD guideline #473 |

Overview for all non-clinical testing:

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Image /page/4/Picture/0 description: The image shows the logo for ALLIANCE GLOBAL TECHNOLOGY CO., LTD. The word "ALLIANCE" is written in large, bold, black letters. Above the word "ALLIANCE" is a black and white image of the earth. Below the word "ALLIANCE" is the text "GLOBAL TECHNOLOGY CO., LTD" in smaller, black letters.

| | OECD guideline #474 |
|-----------------------------------------------|---------------------|
| Sterilization Validation of Gamma Irradiation | ISO11137-1 |
| Shelf life Validation | ASTM F88/F88M-09 |
| | ASTM F1140-07 |
| | ASTM F1929-98 |
| | ISO11737-2 |

## Clinical Testing:

Non-clinical test was used to support the decision of safety and effectiveness.

## Conclusion:

The evaluation of the Anker Dental Implant system does not raise any additional . concerns regarding safety and effectiveness and Anker Dental Implant system may therefore be considered substantially equivalent to their predicate device.

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#### DEPARTMENT OF HEALTH & HUMAN SERVICES

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Public Health Service

Food and Drug Administration 0903 New Hampshire Avenue Document Control Center - WO66-G60 Silver Spring, MD 20993-0002

November 14, 2013

Alliance Global Company Technology Company, Limited Ms. Yayuan Chang Manager 2F., No.92, Luke 5th Road Luzhu District, Kaohsiung City 82151 TAIWAN (R.O.C.)

Re: K131165

Trade/Device Name: Anker Dental Implant System Regulation Number: 21 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: II Product Code: DZE, NHA Dated: October 4, 2013 Received: October 7, 2013

Dear Ms. Chang:

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 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 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/ResourcesforYou/Industry/default.htm.

Sincerely yours,

MaryFDAmer-S

Kwame Ulmer M.S. Acting Division Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Evaluation Center for Devices and Radiological Health

Enclosure

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Image /page/7/Picture/0 description: The image shows the logo for ALLIANCE GLOBAL TECHNOLOGY CO., LTD. The logo is in black and white and features the word "ALLIANCE" in large, bold letters. Below the word "ALLIANCE" is the text "GLOBAL TECHNOLOGY CO., LTD." in smaller letters. Above the word "ALLIANCE" is an abstract design.

# Indications for Use

510(k) Number: K131165

Device Name: Anker dental implant system

Indications for Use:

Anker Dental Implant System 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. It is intended for delayed loading,

Prescription Use ____________ Over-The-Counter Use _ AND/OR (Part 21 CFR 801 Subpart D) (2) CFR 801 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

## Concurrence of CDRH, Office of Device Evaluation (ODE)

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510(k) K131165-Anker Dental Implant System Section 4 - Page 4-1

Andrew I. Steen -S - . - . 2013.11.13 11:25:52 -05'00'