maxFit II Dental Implant System

K151588 · Taiwan Implant Technology Company, Ltd. · DZE · Apr 25, 2016 · Dental

Device Facts

• Record ID: K151588
• Device Name: maxFit II Dental Implant System
• Applicant: Taiwan Implant Technology Company, Ltd.
• Product Code: DZE · Dental
• Decision Date: Apr 25, 2016
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3640
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

maxFiT II Dental Implant System is for single-stage or two-stage surgical procedures and cemented or screw retained restorations. maxFiT II Dental Implant System is intended for immediate placement and function on single tooth and/or multiple tooth applications when good primary stability is achieved, with appropriate occlusal loading, in order to restore chewing function. Multiple tooth applications may be splinted with a bar.

Device Story

Endosseous dental implant system consisting of threaded, self-tapping implants, screws, and various abutments (healing, temporary, ball, angled, transfer, locator). Implants placed surgically into mandible or maxilla by dental professionals. System provides foundation for cemented or screw-retained dental prostheses. Implants feature SLA surface treatment to promote osseointegration. Abutments connect to implants via tapered connection (hex or non-hex) to support crowns, bridges, or overdentures. Device restores chewing function for patients with missing teeth. Clinical benefit derived from stable prosthetic support.

Clinical Evidence

No clinical test data was used to support the decision of substantial equivalence. Bench testing only, including biocompatibility, corrosion resistance (ASTM F746, F2129), and fatigue testing (ISO 14801).

Technological Characteristics

Implants: CP Titanium Grade 4 (ASTM F67, ISO 5832-2) with SLA surface treatment. Abutments/Screws: Ti-6Al-4V ELI (ASTM F136, ISO 5832-3). Connection: Tapered, hex or non-hex. Sterilization: Gamma irradiation.

Indications for Use

Indicated for patients requiring single or multiple tooth replacement via single-stage or two-stage surgical procedures, including immediate placement and function when primary stability is achieved. Used for cemented or screw-retained restorations to restore chewing function. Contraindications not specified.

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

• ANKYLOS® C/X Dental Implant System (K083805)

Submission Summary (Full Text)

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a symbol of three stylized human profiles facing to the right, with three wave-like lines below them.

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

April 25,2016

Taiwan Implant Technology Company, Ltd. Kaohsiung Science Park Branch Huang Ching-Chieh Assistant Manager 5f., No.63, Luke 2nd Rd., Luzhu Dist Kaohsiung, 82151 TAIWAN

Re: K151588

Trade/Device Name: maxFiT II Dental Implant System Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: Class II Product Code: DZE, NHA Dated: March 16, 2016 Received: March 25, 2016

Dear Huang Ching-Chieh:

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,

Susan Runno DDS, MA

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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maxFiT II Dental Implant System 510(k) Notification

## Indications for Use

510(k) Number (if known): K151588

Device Name: maxFiT II Dental Implant System

### Indications for Use:

maxFiT II Dental Implant System is for single-stage or two-stage surgical procedures and cemented or screw retained restorations. maxFiT II Dental Implant System is intended for immediate placement and function on single tooth and/or multiple tooth applications when good primary stability is achieved, with appropriate occlusal loading, in order to restore chewing function. Multiple tooth applications may be splinted with a bar.

Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 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)

Page 1 of 1

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maxFiT II Dental Implant System 510(k) Notification, K151588/S002

## 510(k) Summary

| 5.1 | Type of Submission: | Traditional |
|-----|----------------------|-------------------------------------------------------------------------|
| 5.2 | Date of Summary: | 04/19/2016 |
| 5.3 | Submitter: | Taiwan Implant Technology Company, Ltd. |
| | Address: | Kaohsiung Science Park Branch<br>5F., No.63, Luke 2nd Rd., Luzhu Dist., |
| | | Kaohsiung City 82151, Taiwan |
| | Phone: | [phone] |
| | Fax: | [phone] |
| | Contact: | Ching-Chieh, Huang |
| | | ([e-mail]) |
| | Registration number: | — |

#### 5.4 Identification of the Device:

| Proprietary/Trade name: | maxFiT II Dental Implant System |
|-------------------------|---------------------------------|
| Classification Name: | Endosseous Dental Implant |
| Review Panel: | Dental |
| Regulation Number: | 872.3640 |
| Primary Product Code: | DZE |
| Secondary Product Code | NHA |
| Device Classification: | II |

#### ર્ રંડ Identification of the Predicate Device:

| Predicate Device Name: | ANKYLOS® C/X Dental Implant System |
|------------------------|------------------------------------|
| Manufacturer: | DENTSPLY International |
| Regulation Number: | 872.3640 |
| Product Code: | DZE |
| Device Classification: | II |
| 510(k) Number: | K083805 |

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# 5.6 Intended Use and Indications for Use of the subject device.

maxFiT II Dental Implant System is for single-stage or two-stage surgical procedures and cemented or screw retained restorations. maxFiT II Dental Implant System is intended for immediate placement and function on single tooth and/or multiple tooth applications when good primary stability is achieved, with appropriate occlusal loading, in order to restore chewing function. Multiple tooth applications may be splinted with a bar.

# 5.7 Device Description

The maxFiT II Dental Implant System includes implant, screw and abutment. The maxFiT II Dental Implant System is designed for single-stage or two-stage surgical procedures and cemented or screw retained restorations.

#### . Implant

The maxFiT II Dental Implant System consists of solid threaded, self-tapping dental implants in Ø3.5."604."70."5.6mm diameters with 8."32."34."14mm lengths. The implant of maxFiT II Dental Implant System is made from CP titanium Grade 4 which complies with ISO 5832-2 and ASTM F67. The implant surface treatment is SLA (Sand-blasted, Large grit, Acid -etched) technology which involves sandblasting with large grit and acid etching techniques, creates micron and macrosubmicron pores morphology.

#### Abutment Models .

The abutments are made of Ti6A14V Eli, which complies with ISO 5832-3 and ASTM F136.

| Item | Description | Specification |
|--------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------|
| Healing Abutment | To protect the inner configuration of the implant, and help the soft tissue of gum naturally formed during the healing process. | D: 4.0mm、4.5mm、<br>5.0mm、5.5mm<br>AH: 1.0mm、3.0mm<br>GH: 1.0mm、2.0mm、<br>3.0mm、4.0mm、5.0mm |
| Temporary<br>Abutment | To manufacture temporary<br>prostheses. For the temporary<br>crowns and bridges. The abutment<br>height can be modified for clinical<br>cases. The allowable abutment<br>height range is between 4.5 ~ 17mm.<br>And its diameter, wall thickness and<br>angulation cannot be modified. | D: 4.0mm、5.0mm<br>AH: 17mm<br>GH: 1.0mm |
| Ball Abutment | Used for implant retained<br>mucosa-supported restorations, such<br>as overdentures for fully edentulous<br>patients. | D: 4.0mm<br>GH: 2.0mm、4.0mm |
| Angled Abutment /<br>Non-hex Angled<br>Abutment | Intended for use in partially or fully<br>edentulous mandibles and maxillae,<br>to support for single or multiple-unit<br>cement retained restorations. It is<br>used when the prosthetic angulation<br>of implant correction is required for<br>bite direction. | D: 4.0mm、4.5mm<br>AH: 7.0mm<br>GH: 2.0mm、4.0mm<br>Angle: 15°、25°<br>Type: A、B (For Angled<br>abutment) |
| Transfer<br>Abutment /<br>Non-hex Transfer<br>Abutment | Used as an aid in prosthetic<br>restoration, such as cement-retained<br>crowns and bridges. | D: 4.0mm、4.5mm、<br>5.0mm、5.5mm<br>AH: 4.0mm、5.5mm<br>GH: 1.0mm、2.0mm、<br>3.0mm、4.0mm、5.0mm、<br>6.0mm、7.0mm |
| Locator Abutment | Appropriate for use with<br>overdentures or partial dentures<br>retained in whole or in part by<br>endosseous implants in the mandible<br>or maxilla. | D: 3.5mm<br>H: 1.0mm、2.0mm、3.0mm<br>、4.0mm、5.0mm、6.0mm |

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maxFiT II Dental Implant System 510(k) Notification, K151588/S002

| Hex | The hex abutment is the external hexagonal design for<br>preventing implant/abutment rotation. The hexagonal cone<br>could ensure optimum stability. |
|---------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Non-hex | The non-hex abutment is no anti-rotation, but it still be<br>positioned as desired. The abutment and implant are completely<br>friction-locked by the cone in order to prevent rotation. |

#### . Abutment connection platforms

#### 5.8 Non-clinical Testing

A series of tests were performed on the proposed device, maxFiT II Dental Implant System.

- . Sterilization Test
- . Shelf Life Test
- . Biocompatibility Test
- In vitro Cytotoxicity Study <>
- や Intracutaneous Reactivity Study
- ゃ Skin Sensitization Study
- や Acute Systemic Toxicity (Systemic Injection) Study
- ゃ Pyrogenicity Study
- や In vitro Bacterial Reverse Mutation (AMES) Study
- ゃ In vitro Chromosome Aberration Study
- や In vitro Mammalian Cell Gene Mutation Study
- ゃ 14-Day Repeated Exposure Systemic Toxicity Study
- や 90-Day Bone Implantation Study
- Performance Test ●
- や Corrosion test
- < Fatigue test

Corrosion test has been conducted on SLA-surface treated CP4 dental implant and Ti-6Al-4V abutment. The study is complied with ASTM F746, ASTM F2129 and "Guidance for Industry and Staff - Class II Special Controls Guidance Document:

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Endosseous Dental Implants and Root-form Endosseous Dental Implant Abutments". The results could prove the maxFiT II Dental Implant System is corrosion resistance.

Fatigue evaluation was performed for demonstrating substantial equivalence under worst case scenario in accordance with ISO 14801 and "Guidance for Industry and Staff - Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Implant Abutments".

All the test results demonstrate that maxFiT II Dental Implant System meets the requirements of its pre-defined acceptance criteria, and is substantially equivalent to the predicate device.

#### 5.9 Clinical Testing

No clinical test data was used to support the decision of substantial equivalence.

# 5.10 Substantial Equivalence Determination

The maxFiT II Dental Implant System submitted in this 510(k) file is substantially equivalent in intended use, technology/principles of operation, materials and performance to the cleared ANKYLOS® C/X Dental Implant System. Differences between the devices cited in this section do not raise any new issues of substantial equivalence.

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| | maxFiT II<br>Dental Implant System | ANKYLOS® C/X Dental Implant<br>System |
|---------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) Number | – | K083805 |
| Primary<br>Product Code | DZE | DZE |
| Secondary<br>Product Code | NHA | – |
| Intended use | maxFiT II Dental Implant System is for<br>single-stage or two-stage surgical<br>procedures and cemented or screw<br>retained restorations. maxFiT II Dental<br>Implant System is intended for<br>immediate placement and function on<br>single tooth and/or multiple tooth<br>applications when good primary<br>stability is achieved, with appropriate<br>occlusal loading, in order to restore<br>chewing function. Multiple tooth<br>applications may be splinted with a bar. | The ANKYLOS® C/X Dental Implant<br>System is for single-stage or two-stage<br>surgical procedures and cemented or<br>screw retained restorations. The<br>ANKYLOS® C/X Dental Implant<br>System is intended for immediate<br>placement and function on single tooth<br>and/or multiple tooth applications when<br>good primary stability is achieved, with<br>appropriate occlusal loading, in order to<br>restore chewing function. Multiple tooth<br>applications may be splinted with a bar. |
| Surgery Type | One or two stage surgery | One or two stage surgery |

| Implant | | |
|---------|---------------|---------------|
| Drawing | Image: Thread | Image: Thread |
| Design | Thread | Thread |

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| Material | Pure Titanium Grade 4<br>(ASTM F67 \ DIN ENISO5832-2) | Pure Titanium Grade 2<br>(DIN ENISO5832-2) |
|--------------------------------|-------------------------------------------------------|-----------------------------------------------------|
| Body Diameter (D) | Ø3.5mm - Ø5.6mm | Ø3.5mm - Ø7.0mm |
| Length (L) | 8mm - 14mm | 8mm - 14mm |
| Surface treatment | Sandblasted and acid-etched (SLA) | FRIADENT Surface.<br>(Sandblasted and acid-etched ) |
| Implant-Abutment<br>Connection | Tapered | Tapered |
| Sterilization | Sterile - Gamma Irradiation | Sterile - Gamma Irradiation |

| Screw | | |
|---------------|--------------------------------------------------------------------------|-------------------------------------------|
| | Cover Screw | Spare part ANKYLOS C/X cover<br>screw |
| Design | The cover screw locked into the implant | The cover screw locked into the implant |
| Material | Titanium alloy (Ti-6A1-4V ELI, meets<br>ASTM F-136) | Titanium alloy (Ti-6A1-4V ELI) |
| Specification | Ø1.8mm | Ø1.0mm |
| Sterilization | Sterile _ Gamma Irradiation<br>Non-sterile _ Steam Sterilization by user | Non-sterile _ Steam Sterilization by user |
| | Screw | ANKYLOS Fixation Screw |
| Design | To connect abutment to fixture | To connect abutment to fixture |
| Material | Titanium alloy (Ti-6A1-4V ELI, meets<br>ASTM F-136) | Titanium alloy (Ti-6A1-4V ELI) |
| Specification | Ø1.8mm | Ø1.4mm、Ø1.6mm |
| Sterilization | Sterile _ Gamma Irradiation<br>Non-sterile _ Steam Sterilization by user | Non-sterile _ Steam Sterilization by user |

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| Abutment | | | | | | |
|----------------------------------------------|-----------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|
| Abutments<br>Connection part with<br>fixture | | | 1.Internal connection<br>2. Have “Hex” & “Non-hex” two size of<br>connection | | 1.Internal connection<br>2.Have “C/” & “/X” two size of<br>connection (non-indexed & indexed<br>prosthetics) | |
| | Hex | The hex abutment is the<br>external hexagonal design for<br>preventing implant/abutment<br>rotation. | | /X | Are indexed. The index is used to<br>position the abutments in the<br>implants in one of six possible<br>positions. | |
| | Non-hex | The non-hex abutment is no<br>anti-rotation, but it still be<br>positioned as desired. The<br>abutment and implant are<br>completely friction-locked by<br>the cone in order to prevent<br>rotation. | | C/ | Only use the cone for the<br>connection and are not indexed.<br>The abutment components can be<br>positioned as desired and are<br>completely friction-locked by the<br>cone in order to prevent rotation. | |
| Design | Healing abutment | | | Sulcus Former / Gingiva Former | | |
| | To protect the inner configuration of the<br>implant, and help the soft tissue of gum<br>naturally formed | | | To protect the inner configuration of the<br>implant, and help the soft tissue of gum<br>naturally formed | | |
| Material | Titanium alloy (Ti-6A1-4V ELI, meets<br>ASTM F-136) | | | Titanium alloy (Ti-6A1-4V ELI) | | |
| Specification | D: 4.0mm 、4.5mm 、5.0mm 、5.5mm<br>AH: 1.0mm 、3.0mm<br>GH: 1.0mm 、2.0mm 、3.0mm 、4.0mm 、<br>5.0mm | | | (1)ANKYLOS Gingiva Former C<br>D: 4.2mm<br>GH: 0.75mm 、1.5mm 、3.0mm 、4.5mm<br>(2) ANKYLOS Standard C/ Sulcus<br>Former<br>D: 3.3mm 、4.5mm<br>AH: 4.0mm 、6.0mm | | |

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| | | GH: 1.0mm 、 3.0mm 、 4.5mm 、 6.0mm |
|---------------|----------------------------------------------------------------------------------------------------|------------------------------------------------------------------------|
| Sterilization | Sterile _ Gamma Irradiation<br>Non-sterile _ Steam Sterilization by user | Non-sterile _ Steam Sterilization by user |
| | <b>Temporary abutment</b> | <b>Temporary abutment</b> |
| Design | To manufacture temporary prostheses | To manufacture temporary prostheses |
| | For the temporary crowns and bridges | For the temporary crowns and bridges |
| Material | Titanium alloy (Ti-6Al-4V ELI, meets<br>ASTM F-136) | Titanium alloy (Ti-6Al-4V ELI, meets<br>ASTM F-136) |
| Specification | D: 4.0mm 、 5.0mm | D: 5.5mm 、 7.0mm |
| | AH: 17mm | AH: 6.0mm 、 7.5mm |
| | GH: 1.0mm | GH: 1.5mm 、 3.0mm |
| | | Angle: 0° 、 15° |
| Sterilization | Sterile _ Gamma Irradiation<br>Non-sterile _ Steam Sterilization by user | zirconia-reinforced PEEK |
| | <b>Ball abutment</b> | ANKYLOS® Snap Attachment C/ |
| Design | Implant retained mucosa-supported<br>restorations | Implant retained mucosa-supported<br>restorations |
| Material | Titanium alloy (Ti-6Al-4V ELI, meets<br>ASTM F-136) | Titanium alloy (Ti-6Al-4V ELI) |
| Specification | D: 4.0mm | D: 2.7mm |
| | GH: 2.0mm 、 4.0mm | GH: 1.5mm 、 3.0mm 、 4.5mm |
| Sterilization | Sterile _ Gamma Irradiation<br>Non-sterile _ Steam Sterilization by user | Non-sterile _ Steam Sterilization by user |
| | <b>Angled abutment 、 Non-hex Angled<br/>abutment</b> | <b>ANKYLOS Regular /X Abutment 、<br/>ANKYLOS Regular C/ Abutment</b> |
| Design | To support for single or multiple-unit<br>cement retained restorations | To support for single or multiple-unit<br>cement retained restorations |
| Material | Titanium alloy (Ti-6Al-4V ELI, meets<br>ASTM F-136) | Titanium alloy (Ti-6Al-4V ELI) |
| Specification | D: 4.0mm 、 4.5mm | D: 5.7mm |
| | AH: 7.0mm | Head height: 6.6mm 、 7.0mm 、 7.4mm |
| | GH: 2.0mm、4.0mm | 7.7mm、8.0mm |
| | Angle: 15°、25° | GH: 0.75mm、1.5mm、3.0mm、4.5mm |
| | Type: A、B (For Angled abutment) | Angle: 7.5°、15°、22.5°、30°、37.5° |
| Sterilization | Sterile _ Gamma Irradiation<br>Non-sterile _ Steam Sterilization by user | Non-sterile _ Steam Sterilization by user |
| | Transfer abutment、Non-hex Transfer<br>abutment | ANKYLOS Regular /X Abutment 、<br>ANKYLOS Regular C/ Abutment |
| Design | Aid in prosthetic restoration | Aid in prosthetic restoration |
| Material | Titanium alloy (Ti-6Al-4V ELI, meets<br>ASTM F-136) | Titanium alloy (Ti-6Al-4V ELI) |
| Specification | D: 4.0mm、4.5mm、5.0mm、5.5mm<br>AH: 4.0mm、5.5mm<br>GH: 1.0mm、2.0mm、3.0mm、4.0mm、<br>5.0mm、6.0mm、7.0mm | D: 5.7mm<br>Head height: 6.6mm<br>GH: 0.75mm、1.5mm、3.0mm、4.5mm |
| Sterilization | Sterile _ Gamma Irradiation<br>Non-sterile _ Steam Sterilization by user | Non-sterile _ Steam Sterilization by user |
| | Locator abutment | ANKYLOS LOCATOR Abutment C |
| Design | Use with overdentures or partial<br>dentures retained restoration | Use with overdentures or partial<br>dentures retained restoration |
| Material | Titanium alloy (Ti-6Al-4V ELI, meets<br>ASTM F-136) | Titanium alloy (Ti-6Al-4V ELI) |
| Specification | D: 3.5mm | D: 3.8mm |
| | H: 1.0mm、2.0mm、3.0mm、4.0mm、 | GH: 2.0mm、3.0mm、4.0mm、5.0mm、 |
| | 5.0mm、6.0mm | 6.0mm |
| Sterilization | Sterile _ Gamma Irradiation<br>Non-sterile _ Steam Sterilization by user | Non-sterile _ Steam Sterilization by user |

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maxFiT II Dental Implant System 510(k) Notification, K151588/S002

## 5.11 Similarity and differences

The differences between the proposed device and predicate device are the Grade of Titanium and the design of abutments connection part. The proposed device has tested on safety and performance tests and the results were complied with the test requests. Therefore, the differences of proposed device and predicate device did not raise any problems of substantial equivalence. The proposed device is substantially equivalent to the predicate device in intended use, main materials, safety and performance claims.

## 5.12 Conclusion

After analyzing bench tests, device description and intended use/indications for use, it can be concluded that maxFiT II Dental Implant System is substantially equivalent to the predicate device.