Anker Dental Implant System - SB-III, ST and AT series

K142557 · Alliance Global Technology Co., Ltd. · DZE · Sep 21, 2015 · Dental

Device Facts

• Record ID: K142557
• Device Name: Anker Dental Implant System - SB-III, ST and AT series
• Applicant: Alliance Global Technology Co., Ltd.
• Product Code: DZE · Dental
• Decision Date: Sep 21, 2015
• 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 alveolar bone of upper or lower jaw arches to provide support for prosthetic devices, such as artificial teeth, and to restore the patient's chewing function. Anker Dental Implant System is intended for delayed loading. No matter placing implants in anterior or posterior region, we recommend choosing the diameter of implants as large as possible. The prosthetic restorations used are single crowns, bridges and partial or full dentures, which are connected to the implants through the corresponding components (abutments). Specific indications for small diameter (Ø3.3mm) and short (length < 7mm) dental implants: Because of their reduced mechanical stability, small diameter and short implants are only used in cases with a low mechanical load. We recommend only used in the mandibular anterior region and maxillary lateral incisor.

Device Story

Anker Dental Implant System consists of endosseous fixtures and various abutments; used by dental surgeons to replace missing teeth. Fixtures are surgically placed into alveolar bone; delayed loading protocol. System includes Bone Level (SB-III) and Tissue Level (ST, AT) series. Fixtures feature SLA (sand-blasted, large grit, acid-etched) surface treatment. Abutments connect to fixtures to support prosthetic restorations. Device provides mechanical foundation for artificial teeth; restores chewing function. Used in clinical dental settings.

Clinical Evidence

No clinical data. Bench testing only, including fatigue/compressive testing (ISO 14801), corrosion testing (ASTM G3-89), and biocompatibility testing (ISO 10993 series).

Technological Characteristics

Fixtures: Grade IV pure titanium, SLA surface. Abutments: Titanium alloy, SUS316L stainless steel. Dimensions: 3.3-5.0mm diameter, 7.0-15.0mm length. Connections: Internal hex (SB-III) or octa (ST/AT) with morse taper. Sterilization: Gamma irradiation. Standards: ISO 14801, ASTM G3-89, ISO 10993, ISO 11137-1, ASTM F88/F1140/F1929.

Indications for Use

Indicated for patients requiring endosseous dental implants in upper or lower jaw arches to support prosthetic devices (single crowns, bridges, partial/full dentures) and restore chewing function. Small diameter (Ø3.3mm) and short (<7mm) implants are indicated only for low mechanical load cases in the mandibular anterior region and maxillary lateral incisor.

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

• Anker Dental Implant System (K131165)
• Straumann Dental Implant System SLA & SLActive & Roxolid Product Families (K123784)

Reference Devices

• Straumann healing abutments, healing caps, closure screws (K130808)
• Straumann CARES Variobase Abutments (K120822)
• Osstem TS Implant System (K121585)
• Dentium Implantium Prosthetics (K052957)

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

September 21,2015

Alliance Global Technology Co., Ltd. Yayuan Chang 2F., No.92, Luke 5th Rd., Luzhu Dist., Kaohsiung City 82151. Taiwan

Re: K142557

Trade/Device Name: Anker Dental Implant System - SB-III, ST and AT Series Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: Class II Product Code: DZE Dated: August 21, 2015 Received: August 25, 2015

Dear Yayuan 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.

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

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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 Keith 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: K142557

Device Name: Anker Dental Implant System - SB-III, ST and AT series

Indications for Use:

Anker Dental Implant System is intended to be surgically placed in the alveolar bone of upper or lower jaw arches to provide support for prosthetic devices, such as artificial teeth, and to restore the patient's chewing function.

Anker Dental Implant System is intended for delayed loading. No matter placing implants in anterior or posterior region, we recommend choosing the diameter of implants as large as possible. The prosthetic restorations used are single crowns, bridges and partial or full dentures, which are connected to the implants through the corresponding components (abutments).

Specific indications for small diameter ( \$ 3.3mm) and short (length < 7mm) dental implants:

Because of their reduced mechanical stability, small diameter and short implants are only used in cases with a low mechanical load. We recommend only used in the mandibular anterior region and maxillary lateral incisor.

Prescription Use AND/OR Over-The-Counter Use (Part 21 CFR 801 Subpart D) (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)

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#### K142557 510(k) SUMMARY

### Anker Dental Implant System – SB-III, ST and AT series

1. 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]

- 2. Contact Person: Ms. Yayuan Chang E-mail: [e-mail]
- 3. Date prepared: Sep. 5th, 2014
- 4. Trade Name: Anker Dental Implant System SB-III, ST and AT series Common Name: Dental Implant Classification Name: Root-form endosseous dental implant
- 5. Device Classification: Class II
- 6. Regulation Number: 21 CFR 872.3640 Panel: Dental Product Code: DZE

### 7. Predicate Devices:

| K131165 | Anker Dental Implant System (Primary Predicate for proposed fixtures SB-III, ST, and proposed abutments SB-III) |
|---------|-----------------------------------------------------------------------------------------------------------------------------|
| K123784 | Straumann Dental Implant System SLA & SLActive & Roxolid Product Families (Reference Predicate for proposed fixture AT, ST) |
| K130808 | Straumann healing abutments, healing caps, closure screws (Reference Predicate for proposed abutments of ST and AT) |
| K120822 | Straumann CARES Variobase Abutments (Reference Predicate for proposed abutments of ST and AT) |
| K121585 | Osstem TS Implant System (Reference Predicate for proposed abutment SB-III) |
| K052957 | Dentium Implantium Prosthetics (Reference Predicate for proposed abutment SB-III) |

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Image /page/4/Picture/0 description: The image shows the logo for Alliance Global Technology Co., LTD. The logo features a green globe with the company name in large, bold, green letters below it. Underneath the company name, the words "GLOBAL TECHNOLOGY CO., LTD." are written in smaller letters.

### 8. Device Description:

Anker Dental Implant System is an integrated system which includes Bone Level (SB-III series) and Tissue Level (ST and AT series) dental implants.

Anker Dental Implant System SB-III series consists of fixture, abutments (healing abutment, fixed abutment, dual abutment, angle abutment, o-ring abutment,

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temporary abutment, convertible abutment, convertible protect cap, convertible combination cylinder, convertible angled cylinder, convertible temporary cylinder, angled screw abutment, temporary cylinder) and cover screw.

Anker Dental Implant System ST and AT series consist of fixture, abutments (healing cap, solid abutment, cementable abutment, angled abutment, temporary restoration screw, screw retained abutment, locator abutment) and closure screw.

Fixtures are made of pure titanium (grade IV) and there surface was treated by SLA (Sand-blasted, Large grit. Acid-etched) process. Diameters of fixtures are including 3.3 to 5.0 mm and lengthes are including 7.0 to 15.0 mm. Cover screw, closure screw and most abutments are made of titanium alloy. Temporary abutment and convertible temporary cylinder (SB-III series) are made of SUS316L stainless steel instead of titanium alloy. All products are sterilized as finished products.

Fixture of Anker Dental Implant System SB-III series is substantially equivalent in design, function and intended use to the Anker Dental Implant System (K131165). Fixture of AT series is substantially equivalent in design, function and intended use to the Straumann Dental Implant System (K123784). And fixture of ST series is substantially equivalent in design, function and intended use to the Anker Dental Implant System (K131165) and Straumann Dental Implant System (K123784).

Abutment of Anker Dental Implant System SB-III series is substantially equivalent in design, function and intended use to the Anker Dental Implant System (K131165), TS Implant System (K121585) of Osstem Implant Co., Ltd. and Implantium Prosthetics (K052957) of Dentium Co., Ltd. Abutment of ST and AT series are substantially equivalent in design, function and intended use to the Straumann healing abutments, healing caps, closure screws (K130808) and Straumann CARES Variobase Abutments (K120822).

### 9. Indications for Use:

Anker Dental Implant System is intended to be surgically placed in the alveolar bone of upper or lower jaw arches to provide support for prosthetic devices, such as artificial teeth, and to restore the patient's chewing function.

Anker Dental Implant System is intended for delayed loading. No matter placing implants in anterior or posterior region, we recommend choosing the diameter of implants as large as possible. The prosthetic restorations used are single crowns, bridges and partial or full dentures, which are connected to the implants through the corresponding components (abutments).

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Image /page/6/Picture/0 description: The image shows the logo for Alliance Global Technology Co., LTD. The logo features a green globe above the word "ALLIANCE" in large, green, bold letters. Below the word "ALLIANCE" is the text "GLOBAL TECHNOLOGY CO., LTD." in a smaller font size.

Specific indications for small diameter (Ø3.3mm) and short (length < 7mm) dental implants:

Because of their reduced mechanical stability, small diameter and short implants are only used in cases with a low mechanical load. We recommend only used in the mandibular anterior region and maxillary lateral incisor.

### 10. Substantial Equivalence:

The following tables list the proposed devices Anker Dental Implant System – SB-III, ST and AT series and the respective predicate which Anker is claiming substantial equivalence to.

| | Item | Anker Dental Implant System<br>SB-III, ST and AT series | Anker Dental Implant System | Straumann Dental Implant<br>System SLA, SLActive and<br>Roxolid Product Families |
|---------------------------------|------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 1 | 510K No. | | K131165 | K123784 |
| 2 | Design | Image: SB-III<br>Image: ST<br>Image: AT-I<br>Image: AT-II<br>Image: AT-III | Image: Anker Dental Implant System | Image: Straumann Dental Implant System |
| 3 | Intended Use | Anker Dental Implant System is<br>intended to be surgically placed in<br>the alveolar bone of upper or<br>lower jaw arches to provide<br>support for prosthetic devices,<br>such as artificial teeth, and to<br>restore the patient's chewing<br>function. Anker Dental Implant<br>System is intended for delayed<br>loading. No matter placing<br>implants in anterior or posterior<br>region, we recommend choosing<br>the diameter of implants as large<br>as possible. The prosthetic<br>restorations used are single<br>crowns, bridges and partial or<br>full dentures, which are<br>connected to the implants<br>through the corresponding<br>components (abutments).<br>Specific indications for small<br>diameter ( $Ø$ 3.3mm) and short<br>(length < 7mm) dental implants: | Anker Dental Implant System is<br>intended to be surgically placed<br>in the bone of the upper or lower<br>jaw arches to provide support for<br>prosthetic devices, such as<br>artificial teeth, and to restore the<br>patient's chewing function. | Straumann® Dental implants<br>are indicated for oral endosteal<br>implantation in the upper and<br>lower jaw arches for the<br>functional and aesthetic oral<br>rehabilitation of edentulous and<br>partially dentate patients.<br>Straumann® Dental implants<br>are also indicated for immediate<br>or early implantation following<br>extraction or loss of natural<br>teeth. Implants can be placed<br>with immediate function on<br>single-tooth and/or multiple<br>tooth applications when good<br>primary stability is achieved and<br>with appropriate occlusal<br>loading to restore chewing<br>function. The prosthetic<br>restorations used are single<br>crowns, bridges and partial or<br>full dentures, which are<br>connected to the implants |
| | | | | |
| | | Because of their reduced<br>mechanical stability, small<br>diameter and short implants are<br>only used in cases with a low<br>mechanical load. We<br>recommend only used in the<br>mandibular anterior region and<br>maxillary lateral incisor. | | through the corresponding<br>components (abutments). In<br>cases of fully edentulous<br>patients, 4 or more implants<br>must be used in immediately<br>loaded cases. |
| 4 | Material | Titanium | Titanium | Titanium |
| 5 | Body<br>Diameter | SB-III and ST series:<br>3.5mm, 4.0mm, 4.5mm, 5.0mm<br>AT series:<br>3.3mm, 4.1mm, 4.8mm | 3.4mm, 3.5mm, 3.8mm, 4.0mm,<br>4.3mm, 4.5mm, 4.8mm, 5.0mm | 3.3mm, 4.1mm, 4.8mm |
| 6 | Length | SB-III and ST series:<br>7mm, 8.5mm, 10mm, 11.5mm,<br>13mm, 15mm<br>AT series:<br>8mm, 9mm, 10mm, 11mm,<br>12mm, 13mm, 14mm,<br>15mm | 7mm, 8mm, 8.5mm, 10mm,<br>11.5mm, 12mm, 13mm, 14mm,<br>15mm | 6mm, 8mm, 10mm, 12mm,<br>14mm, 16mm |
| 7 | Design of<br>fixture body | SB-III and ST series: tapered<br>design.<br>AT series: Straight design. | Tapered design | Straight design |
| 8 | Platform<br>Switching | SB-III series: YES<br>ST & AT series: NO | YES | NO |
| 9 | Internal<br>connection | SB-III series: Internal hex<br>connection and 11°morse taper<br>structure.<br>ST & AT series: Internal octa<br>connection and 8°morse taper<br>structure. | Internal hex connection and<br>11°morse taper structure. | Internal octa connection and<br>8°morse taper structure. |
| 10 | Thread<br>design | SB-III and ST series:<br>combined with micro thread<br>(0.45mm pitch distance,<br>fourfold thread) and macro<br>thread (0.9mm pitch distance,<br>double thread) structure.<br>AT series: same pitch distance<br>on whole fixture body. | Combined with micro thread<br>(0.45mm pitch distance,<br>fourfold thread) and macro<br>thread (0.9mm pitch distance,<br>double thread) structure. | Same pitch distance on whole<br>fixture body. |
| 11 | Apex design | SB-III and ST series: three<br>blade self tapping design and<br>blunt end structure.<br>AT series: no blade design and<br>round end structure. | Three blade self tapping design<br>and blunt end structure. | No blade design and round end<br>structure. |
| 12 | Surface<br>Treatment | S.L.A. (Sand-blasted, Large<br>grit, Acid-etched surface) | S.L.A. (Sand-blasted, Large grit,<br>Acid-etched surface) | S.L.A. (Sand-blasted, Large grit,<br>Acid-etched surface) / SLActive |
| | | Image: Sand blasted large grit acid etched surface | Image: Sand blasted large grit acid etched surface | Image: Sand blasted large grit acid etched surface |
| 13 Sterilization | γ-ray (Radiation) | γ-ray (Radiation) | γ-ray (Radiation) | |
| 14 Material of<br> Abutments | Titanium alloy and stainless steel | Titanium alloy and stainless steel | Titanium and titanium alloy | |

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Image /page/8/Picture/0 description: The image shows the logo for Alliance Global Technology Co., Ltd. The logo features a green globe in the background, with the word "ALLIANCE" in large, bold, green letters in the foreground. Below the word "ALLIANCE" is the text "GLOBAL TECHNOLOGY CO., LTD." in smaller, less bold letters.

When compared to the predicate devices. Anker Dental Implant System (K131165) and Straumann Dental Implant System (K123784), Anker Dental Implant System SB-III, ST and AT series are equivalent in surface treatment, intended use, method of operation, material and design.

### 11. Non-clinical Testing:

Overview all non-clinical testing:

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

Non-clinical test was used to support the decision of substantial equivalence. 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 - SB-III, ST and AT series are substantially equivalent to the predicate devices.

### 12. Clinical Testing:

No clinical studies are submitted.

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Image /page/9/Picture/0 description: The image shows the logo for Alliance Global Technology Co., LTD. The logo features a green globe above the word "ALLIANCE" in large, green letters. Below the word "ALLIANCE" is the text "GLOBAL TECHNOLOGY CO., LTD." in smaller letters.

### 13. Conclusion:

The evaluation of the Anker Dental Implant System – SB-III, ST and AT series do not raise any additional concerns regarding substantial equivalence and Anker Dental Implant System – SB-III, ST and AT series may therefore be considered substantially equivalent to their predicate device.