Chang Gung ComMed Series Dental Implant System

K142751 · Chang Gung Medical Technology Co., Ltd. · DZE · Jun 15, 2015 · Dental

Device Facts

• Record ID: K142751
• Device Name: Chang Gung ComMed Series Dental Implant System
• Applicant: Chang Gung Medical Technology Co., Ltd.
• Product Code: DZE · Dental
• Decision Date: Jun 15, 2015
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3640
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

ComMed Series Dental Implant System is intended for surgical placement in the maxilla or mandible to provide means for prosthetic attachment to restore a patient's chewing function. ComMed Series Dental Implants are intended only for delayed loading.

Device Story

The ComMed Series Dental Implant System consists of threaded, root-form endosseous dental implants and associated abutments. The system is used by dental clinicians to replace missing teeth. The implant (Grade 4 pure titanium) is surgically placed into the maxilla or mandible; it serves as a substitute for the tooth root. After osseointegration, a healing abutment is attached for gingival forming, followed by a standard or angle abutment (Ti6Al4V) to support a prosthetic restoration. The device features an internal hex with an 8° Morse taper connection, platform switching, and micro-threads at the neck. The implant surface is blasted with aluminum oxide and acid-etched, then anodized. The system restores chewing function by providing a stable foundation for artificial teeth. The device is intended for delayed loading only.

Clinical Evidence

Bench testing only. No clinical data provided. Testing included static and dynamic fatigue loading (ISO 14801), comprehensive biocompatibility testing (ISO 10993 series), sterilization validation (ISO 11737, ISO 17665), and packaging shelf-life validation (ASTM F1140, F1929, F88, F1608, F1980) for up to 5 years.

Technological Characteristics

Implant: Grade 4 Pure Titanium; Abutment: Ti6Al4V. Connection: Internal hex with 8° Morse taper. Surface: Blasted with aluminum oxide, acid-etched, and anodized. Dimensions: 3.5-6.0mm diameter, 10-16mm length. Sterilization: Gamma irradiation (implant), moist heat (abutment). Standards: ISO 10993 (biocompatibility), ISO 14801 (fatigue), ISO 11737/17665 (sterilization), ASTM F1140/F1929/F88/F1608/F1980 (packaging).

Indications for Use

Indicated for surgical placement in the maxilla or mandible to restore chewing function in patients requiring prosthetic attachment. Intended for delayed loading only.

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

• STRAUMANN DENTAL IMPLANT SYSTEM (K033984)

Reference Devices

• FRIADENT Implant Systems – XiVE® S Plus Dental Implant System (K073075)
• MIS DENTAL IMPLANT SYSTEM (K040807)

Submission Summary (Full Text)

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

June 15, 2015

Chang Gung Medical Technology Co., Ltd. Mr. Chao-Chun Chiu Manager 11F., No. 201-4, DungHua North Rd., Song Shan District Taipei City, Taiwan 10508 REPUBLIC OF CHINA

Re: K142751 Trade/Device Name: Chang Gung "ComMed" Series Dental Implant System Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: II Product Code: DZE, NHA Dated: May 11, 2015 Received: May 13, 2015

Dear Mr. Chiu:

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 Industry and Consumer Education at its toll-free 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" (21 CFR 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 Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

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

Sincerely yours,

Tina
Kiang -S

for Erin I. Keith, M.S. 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) K142751

Device Name

Chang Gung "ComMed" Series Dental Implant System

Indications for Use (Describe)

"ComMed" Series Dental Implant System is intended for surgical placement in the maxilla or mandible to provide for prosthetic attachment to restore a patient's chewing function. "ComMed" Series Dental Implants are intended only for delayed loading.

Type of Use (Select one or both, as applicable)> Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

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# Chang Gung Medical Technology Co., Ltd.

## Chapter 4 510(k) Summary

| Type of Submission | Original Application - Traditional 510(k) |
|--------------------|-----------------------------------------------------|
| Device Name | Chang Gung "ComMed" Series<br>Dental Implant System |
| Validated Date | 2015.06.12 |
| Version | 1.4 |

11F., No. 201-4, Dunghua N. Rd., Song Shan Dist. Taipei City, TAIWAN 10508 Tel: [phone] Fax: [phone]

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### 4.1 Applicant Information

| Type of Submission | Original Application- Traditional 510(k) |
|--------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Applicant Name | Chang Gung Medical Technology Co., Ltd. |
| Address | Office : Chang Gung Medical Technology Co., Ltd.<br>11F., No. 201-4, Dunghua N. Rd., Song Shan Dist.<br>Taipei City, TAIWAN 10508<br>Factory: Chang Gung Medical Technology Co., Ltd. Linkou<br>Factory<br>2F., No. 118, Nanlin Rd., Taishan Dist., New Taipei<br>City 24352, Taiwan (R.O.C.) |
| Phone | [phone] |
| Fax | [phone] |
| Contact Person | Heng-Liang Liu |
| Contact Title | Project Manager |
| Contact E-mail | [e-mail] |

### 4.2 Device Description

| Common Name | Dental Implant |
|---------------------|--------------------------------------------------|
| Trade Name | Chang Gung "ComMed" Series Dental Implant System |
| Classification Name | Implant, Endosseous, Root-form |
| Regulation Number | 872.3640 |
| Product Code | DZE, NHA |
| Device Class | Class II |

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### 4.3 Technological Characteristics of Device

| Product Name | Chang Gung "ComMed" Series Dental Implant System |
|----------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Regulation Number | 872.3640 |
| Product Code | DZE, NHA |
| Intended Use | "ComMed" Series Dental Implant System is intended<br>for surgical placement in the maxilla or mandible to<br>provide means for prosthetic attachment to restore a<br>patient' s chewing function. "ComMed" Series Dental<br>Implants are intended only for delayed loading. |
| Material | Implant: Grade 4 Pure Titanium<br>Abutment: Ti6Al4V |
| Connection | Internal Hex with Morse Taper 8° |
| Platform Switching | YES |
| Fine thread in Neck | YES |
| Diameter (mm) | 3.5, 4.0, 4.5, 5.0, 5.5, 6.0 |
| Length (mm) | 10, 11, 12, 13, 14, 15,16 |
| Angle Abutment | YES (15°) |
| Surface Treatment | Blasted with Aluminum Oxide and Acid Etched. |
| Anodized Treatment | YES |
| Sterilization method | Implant : Gamma irradiation<br>Abutment : Moist heat sterilization before use by<br>clinicians. |

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## Components

| Name | Function | Accessories |
|-------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------|
| Standard Implant<br>(Fixture) | A cylindrical and tapered post that<br>serves as a substitute for the tooth root. | Cover Screw<br>Mount<br>Mount Screw |
| Healing Abutment | Attached to the fixture for gingival<br>forming. | N/A |
| Standard Abutment | A connector built into the top of the<br>fixture to straightly attach the implant to<br>the replacement tooth. | Abutment Screw |
| Angle Abutment | A connector built into the top of the<br>fixture to obliquely attach the implant to<br>the replacement tooth. | Abutment Screw |
| Accessories | | |
| Cover Screw | A screw placed on the superior part of a<br>fixture during osseointegration period.<br>The Cover Screw size depends on the<br>corresponding Standard Implant. | N/A |
| Mount | A temporary part to connect fixture to<br>driver for placement. The Mount size<br>depends on the corresponding Standard<br>Implant. | N/A |
| Mount Screw | Connection implant with mount. The<br>Mount Screw size depends on the<br>corresponding Standard Implant. | N/A |
| Abutment Screw | Connection implant with standard<br>abutment or angle abutment. The<br>Abutment Screw size depends on the<br>corresponding Abutment. | N/A |

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# Specification

- Standard Implant : .

| Model Type | Model No. | Ø/L(mm) | Model Type | Model No. | Ø/L(mm) | Model Type | Model No. | Ø/L(mm) |
|------------|-----------|----------------|------------|-----------|----------------|------------|-----------|----------------|
| | UTAA3510 | Ø 3.5 / L 10.0 | | UTAA4510 | Ø 4.5 / L 10.0 | | UTAA5510 | Ø 5.5 / L 10.0 |
| | UTAA3511 | Ø 3.5 / L 11.0 | | UTAA4511 | Ø 4.5 / L 11.0 | | UTAA5511 | Ø 5.5 / L 11.0 |
| | UTAA3512 | Ø 3.5 / L 12.0 | | UTAA4512 | Ø 4.5 / L 12.0 | | UTAA5512 | Ø 5.5 / L 12.0 |
| | UTAA3513 | Ø 3.5 / L 13.0 | | UTAA4513 | Ø 4.5 / L 13.0 | | UTAA5513 | Ø 5.5 / L 13.0 |
| | UTAA3514 | Ø 3.5 / L 14.0 | | UTAA4514 | Ø 4.5 / L 14.0 | | UTAA5514 | Ø 5.5 / L 14.0 |
| | UTAA3515 | Ø 3.5 / L 15.0 | | UTAA4515 | Ø 4.5 / L 15.0 | | UTAA5515 | Ø 5.5 / L 15.0 |
| Standard | UTAA3516 | Ø 3.5 / L 16.0 | Standard | UTAA4516 | Ø 4.5 / L 16.0 | Standard | UTAA5516 | Ø 5.5 / L 16.0 |
| Implant | UTAA4010 | Ø 4.0 / L 10.0 | Implant | UTAA5010 | Ø 5.0 / L 10.0 | Implant | UTAA6010 | Ø 6.0 / L 10.0 |
| | UTAA4011 | Ø 4.0 / L 11.0 | | UTAA5011 | Ø 5.0 / L 11.0 | | UTAA6011 | Ø 6.0 / L 11.0 |
| | UTAA4012 | Ø 4.0 / L 12.0 | | UTAA5012 | Ø 5.0 / L 12.0 | | UTAA6012 | Ø 6.0 / L 12.0 |
| | UTAA4013 | Ø 4.0 / L 13.0 | | UTAA5013 | Ø 5.0 / L 13.0 | | UTAA6013 | Ø 6.0 / L 13.0 |
| | UTAA4014 | Ø 4.0 / L 14.0 | | UTAA5014 | Ø 5.0 / L 14.0 | | UTAA6014 | Ø 6.0 / L 14.0 |
| | UTAA4015 | Ø 4.0 / L 15.0 | | UTAA5015 | Ø 5.0 / L 15.0 | | UTAA6015 | Ø 6.0 / L 15.0 |
| | UTAA4016 | Ø 4.0 / L 16.0 | | UTAA5016 | Ø 5.0 / L 16.0 | | UTAA6016 | Ø 6.0 / L 16.0 |

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- Healing Abutment : .

| Model Type | Model No. | Specification | Model Type | Model No. | Specification |
|---------------------|-----------|----------------|---------------------|----------------|----------------|
| Healing<br>Abutment | UTAB3501 | Ø 3.5mm / GH 1 | Healing<br>Abutment | UTAB5001 | Ø 5.0mm / GH 1 |
| | UTAB3503 | Ø 3.5mm / GH 3 | | UTAB5003 | Ø 5.0mm / GH 3 |
| | UTAB3505 | Ø 3.5mm / GH 5 | | UTAB5005 | Ø 5.0mm / GH 5 |
| | UTAB4001 | Ø 4.0mm / GH 1 | | UTAB5501 | Ø 5.5mm / GH 1 |
| | UTAB4003 | Ø 4.0mm / GH 3 | | UTAB5503 | Ø 5.5mm / GH 3 |
| | UTAB4005 | Ø 4.0mm / GH 5 | | UTAB5505 | Ø 5.5mm / GH 5 |
| | UTAB4501 | Ø 4.5mm / GH 1 | | UTAB6001 | Ø 6.0mm / GH 1 |
| | UTAB4503 | Ø 4.5mm / GH 3 | | UTAB6003 | Ø 6.0mm / GH 3 |
| | UTAB4505 | Ø 4.5mm / GH 5 | UTAB6005 | Ø 6.0mm / GH 5 | |

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- Standard Abutment : .

| Model Type | Model No. | Specification | Model Type | Model No. | Specification |
|----------------------|-----------|----------------|----------------------|-----------|----------------|
| Standard<br>Abutment | UTBA3501 | Ø 3.5mm / GH 1 | Standard<br>Abutment | UTBA5001 | Ø 5.0mm / GH 1 |
| | UTBA3503 | Ø 3.5mm / GH 3 | | UTBA5003 | Ø 5.0mm / GH 3 |
| | UTBA3505 | Ø 3.5mm / GH 5 | | UTBA5005 | Ø 5.0mm / GH 5 |
| | UTBA4001 | Ø 4.0mm / GH 1 | | UTBA5501 | Ø 5.5mm / GH 1 |
| | UTBA4003 | Ø 4.0mm / GH 3 | | UTBA5503 | Ø 5.5mm / GH 3 |
| | UTBA4005 | Ø 4.0mm / GH 5 | | UTBA5505 | Ø 5.5mm / GH 5 |
| | UTBA4501 | Ø 4.5mm / GH 1 | | UTBA6001 | Ø 6.0mm / GH 1 |
| | UTBA4503 | Ø 4.5mm / GH 3 | | UTBA6003 | Ø 6.0mm / GH 3 |
| | UTBA4505 | Ø 4.5mm / GH 5 | | UTBA6005 | Ø 6.0mm / GH 5 |

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## ●

| Model Type | Model No. | Specification | Model Type | Model No. | Specification |
|----------------|---------------------|---------------------|----------------|---------------------|---------------------|
| Angle Abutment | UTBB3501 | Ø 3.5mm / 15°/ GH 1 | Angle Abutment | UTBB5001 | Ø 5.0mm / 15°/ GH 1 |
| | UTBB3503 | Ø 3.5mm / 15°/ GH 3 | | UTBB5003 | Ø 5.0mm / 15°/ GH 3 |
| | UTBB3505 | Ø 3.5mm / 15°/ GH 5 | | UTBB5005 | Ø 5.0mm / 15°/ GH 5 |
| | UTBB4001 | Ø 4.0mm / 15°/ GH 1 | | UTBB5501 | Ø 5.5mm / 15°/ GH 1 |
| | UTBB4003 | Ø 4.0mm / 15°/ GH 3 | | UTBB5503 | Ø 5.5mm / 15°/ GH 3 |
| | UTBB4005 | Ø 4.0mm / 15°/ GH 5 | | UTBB5505 | Ø 5.5mm / 15°/ GH 5 |
| | UTBB4501 | Ø 4.5mm / 15°/ GH 1 | | UTBB6001 | Ø 6.0mm / 15°/ GH 1 |
| UTBB4503 | Ø 4.5mm / 15°/ GH 3 | | UTBB5001 | Ø 6.0mm / 15°/ GH 1 | |
| UTBB4505 | Ø 4.5mm / 15°/ GH 5 | | UTBB5003 | Ø 6.0mm / 15°/ GH 3 | |

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| | Subject Device | Predicate device | Reference device<br>#1 | Reference device<br>#2 |
|------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k)<br>Number | - | K033984 | K073075 | K040807 |
| Indication for<br>use | "ComMed" Series<br>Dental Implant<br>System is<br>intended for<br>surgical<br>placement in the<br>maxilla or<br>mandible to<br>provide means for<br>prosthetic<br>attachment to<br>restore a<br>patient's<br>chewing function.<br>"ComMed" Series<br>Dental Implants<br>are intended only<br>for delayed<br>loading. | The ITI Dental<br>System implants<br>are for<br>single-stage or<br>two-stage surgical<br>procedures. The<br>implants are<br>intended for<br>immediate<br>placement and<br>function on<br>single-tooth<br>and/or multiple<br>tooth applications<br>when good<br>primary stability is<br>achieved and with<br>appropriate<br>occlusal loading,<br>to restore chewing<br>function. Multiple<br>tooth applications<br>may be rigidly<br>splinted. In the<br>case of<br>edentulous<br>patients, 4 or<br>more implants<br>must be used in<br>immediately | The FRIADENT<br>Implant systems<br>are for<br>single-stage or<br>two-stage surgical<br>procedures and<br>cemented or<br>screw retained<br>restorations. The<br>FRIADENT Implant<br>Systems are<br>intended for<br>immediate<br>placement and<br>function on single<br>tooth and/or<br>multiple tooth<br>applications when<br>good primary<br>stability is<br>achieved, with<br>appropriate<br>occlusal loading,<br>in order to restore<br>chewing function.<br>Multiple tooth<br>applications may<br>be splinted with a<br>bar. | The MIS Dental<br>Implant System is<br>indicated for use<br>in surgical and<br>restorative<br>applications for<br>placement in the<br>bone of the upper<br>or lower jaw to<br>provide support<br>for prosthetic<br>devices, such as<br>artificial teeth, in<br>order to restore<br>the patient's<br>chewing function. |
| | | loaded cases. | | |
| Trade name | Chang Gung<br>"ComMed " Seri<br>es Dental Implant<br>System | STRAUMANN<br>DENTAL IMPLANT<br>SYSTEM | FRIADENT Implant MIS DENTAL<br>Systems - XiVE® S<br>Plus Dental<br>Implant System | IMPLANT SYSTEM |
| Material | Implant: Grade 4<br>Pure Titanium<br>Abutment:<br>Ti-6Al-4V | Implant: Grade 4<br>Pure Titanium<br>Abutment: Grade<br>4 Pure Titanium | Implant: Grade 2<br>Pure Titanium<br>Abutment:<br>Ti-6Al-4V / Grade<br>2 Pure Titanium | Implant: Grade 4<br>Pure Titanium<br>Abutment:<br>Ti-6Al-4V |
| Connection<br>type | Internal hex with<br>Morse taper 8° | Internal hex with<br>Morse taper | Internal hex | Internal hex with<br>Morse taper,<br>internal octa with<br>Morse taper |
| Platform<br>switching | Yes | Yes | No | No |
| Micro-thread<br>at implant<br>neck | Yes | No | No | Yes |
| Diameter<br>(mm) | 3.5, 4.0, 4.5, 5.0,<br>5.5, 6.0 | 3.3~4.8 | 3.0~5.5 | 3.3~6.0 |
| Length (mm) | 10, 11, 12, 13, 14,<br>15, 16 | 8~14 | 8~18 | 6~16 |
| Angle<br>abutment | Yes (15°) | Yes (15°) | Yes (15°) | Yes (15°) |
| Surface<br>modification | Blasted with<br>aluminum oxide<br>and acid etched | Blasted with<br>aluminum oxide<br>and acid etched | Blasted with<br>aluminum oxide<br>and acid etched | Blasted with<br>aluminum oxide<br>and acid etched |
| Anodizing | Yes | Yes | Yes | Yes |
| Sterilization<br>method | Gamma<br>irradiation | Gamma<br>irradiation | Gamma<br>irradiation | Gamma<br>irradiation |

### 4.4 Predicate and Reference Devices

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### 4.5 Substantial Equivalence

Substantially equivalence is claimed to the following legally marketed predicate device: STRAUMANN DENTAL IMPLANT SYSTEM (K033984) and reference device: FRIADENT Implant Systems – XiVE® S Plus Dental Implant System (K073075) and MIS DENTAL IMPLANT SYSTEM (K040807). The above comparison table lists the primary technological characteristics and specifications that are pertinent to Dental Implant Systems. Based on the comparison analysis, the proposed device is identical to the predicate and reference devices in terms of intended use, materials, surface treatment, sterilization method, and comparable technological characteristics and general design features.

All minor differences in design features (connection type, platform switching and micro-thread at implant neck) exist between the subject and the predicate and reference devices have been evaluated per the testing described in section 4.6 (non-clinical testing) following the recommendations in the "Class II Special Controls Guidance Document: Root-form Endosseous Dental Implant and Endosseous Dental Implant Abutments" . The results of non-clinical testing support that these minor differences do not raise any new questions of safety and effectiveness.

It is concluded that the Chang Gung "ComMed" Series Dental Implant System is substantially equivalent to the predicate and reference devices.

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### 4.6 Non-clinical Testing

Performance testing was conducted to support the substantial equivalence of the subject device. This testing included Static and Dynamic fatigue loading, Biocompatibility, Packaging Shelf Life Validation and Sterilization Validation (Table 1).

| | Device | Test | Relevant<br>standard |
|------------------|------------------------------------------------|-----------------------------------------------------|----------------------|
| Biocompatibility | Implant | In vitro cytotoxicity study | ISO 10993-5 |
| | | Intracutaneous reactivity study | ISO 10993-10 |
| | | Skin sensitization study | ISO 10993-10 |
| | | Acute systemic toxicity | ISO 10993-11 |
| | | Pyrogenicity study | ISO 10993-11 |
| | | 14-day repeated dose systemic toxicity<br>study | ISO 10993-11 |
| | | In vitro haemolysis study | ISO 10993-4 |
| | | In vitro bacterial reverse mutation (AMES)<br>study | ISO 10993-3 |
| | In vitro chromosome aberration study | ISO 10993-3 | Abutment |
| | In vitro mammalian cell gene mutation<br>study | ISO 10993-3 | |
| | Bone formation and histological study | ISO 10993-6 | |
| | Abutment | In vitro cytotoxicity study | ISO 10993-5 |
| | | Intracutaneous reactivity study | ISO 10993-10 |
| | | Skin sensitization study | ISO 10993-10 |

Table 1. Tests and relevant standards

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| Static and dynamic<br>fatigue loading | | | |
|---------------------------------------|----------------------------------------|-------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------|
| | Implant<br>and<br>standard<br>abutment | Static and dynamic fatigue test | ISO 14801 |
| | Implant<br>and angle<br>abutment | Static and dynamic fatigue test | ISO 14801 |
| Sterilization validation | Implant | Sterilization validation of Gamma<br>irradiation | ISO 11737-1<br>ISO 11737-2 |
| | Abutment | Moist heat validation- microbiological<br>performance qualification | ISO 11737-1<br>ISO 11737-2<br>ISO 17665-1 |
| Packaging shelf life validation | Implant | Burst and creep tests | ASTM F1140 |
| | | Dye penetration test | ASTM F1929 |
| | | Seal peel test | ASTM F88/F88M |
| | | Microbial ranking test | ASTM F1608 |
| | | Burst, creep, dye penetration, seal peel,<br>and microbial ranking tests after 2 years<br>accelerated aging | ASTM F1980<br>ASTM F1140<br>ASTM F1929<br>ASTM F88/F88M<br>ASTM F1608 |
| | | Burst, creep, dye penetration, seal peel,<br>and microbial ranking tests after 3 years<br>accelerated aging | ASTM F1980<br>ASTM F1140<br>ASTM F1929<br>ASTM F88/F88M<br>ASTM F1608 |
| | | Burst, creep, dye penetration, seal peel,<br>and microbial ranking tests after 5 years<br>accelerated aging | ASTM F1980<br>ASTM F1140<br>ASTM F1929<br>ASTM F88/F88M<br>ASTM F1608 |

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### 4.7 Conclusion

This submission is seeking marketing clearance for the Chang Gung "ComMed" Series Dental Implant System which includes threaded root-form endosseous dental implants as well as dental implant abutments. These devices have been evaluated using non-clinical performance and bench testing. This testing included static and dynamic mechanical loading, biocompatibility testing, sterilization validation, and packaging life validation. The technological characteristics of this device system do not raise different questions of safety and effectiveness. The information included in this submission supports the substantial equivalence of the Chang Gung "ComMed" Series Dental Implant System to the identified predicate and reference devices for its intended use.