Anchor plate

K173623 · Biomaterials Korea, Inc. · OAT · Aug 30, 2018 · Dental

Device Facts

• Record ID: K173623
• Device Name: Anchor plate
• Applicant: Biomaterials Korea, Inc.
• Product Code: OAT · Dental
• Decision Date: Aug 30, 2018
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3640
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The subject devices are intended to be place in the mouth for use as an anchor in orthodontic procedures.

Device Story

Anchor plate system provides intraoral absolute anchorage for orthodontic tooth movement (e.g., molar intrusion/distalization). Device consists of pure titanium/titanium alloy plates (T, I, Y, W-types) with head, arm, and body portions; fixed to bone via screws. Placed outside dentition to avoid interference with tooth movement. Used by dental professionals in clinical settings. Surgeon selects plate shape/dimension based on patient bone contour and implantation site. Output is a stable skeletal anchor point for attachment of orthodontic appliances (wires, elastics, springs). Benefits include enhanced control of tooth movement and stability where dental fixation is insufficient.

Clinical Evidence

Bench testing only. Performance verified via mechanical testing including bending strength (ISO 9585) and tensile force tests. Biocompatibility evaluated per ISO 10993-1, including genotoxicity, cytotoxicity, implantation, sensitization, oral mucous irritation, and systemic toxicity.

Technological Characteristics

Materials: Pure titanium and titanium alloy (ASTM F67, ASTM F136-02a). Design: Four plate types (T, I, Y, W) with head, arm, and body. Energy: None (mechanical). Connectivity: None. Sterilization: Non-sterile, requires autoclave (121°C, 30 min). Single-use only.

Indications for Use

Indicated for use as an intraoral anchor in orthodontic procedures to provide skeletal fixation for tooth movement, such as intrusion or distalization of molars.

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

• BOLLARD MINIPLATE SKELETAL ANCHORAGE SYSTEM, TITA-LINK (K091051)

Reference Devices

• KLS MARTIN ORTHO ANCHORAGE SYSTEM (K040891)
• SYNTHES ORTHODONTIC BONE ANCHOR SYSTEM (K063473)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services seal on the left and the FDA acronym with the full name of the agency on the right. The seal features an abstract design, while the FDA part includes the acronym in a blue square and the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.

BioMaterials Korea, Inc Jiyea Kim Staff #413, #329, #331 150, Jojeong-daero, Hanam-si Gyeonggi-do, KR 12930

Re: K173623

Trade/Device Name: Anchor plate Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: Class II Product Code: OAT Dated: November 9, 2017 Received: November 24, 2017

Dear Jiyea Kim:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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

August 30, 2018

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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 of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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 comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely.

### Mary S. Runner -S

For Tina Kiang, Ph.D. Acting 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) K173623

Device Name Anchor plate

Indications for Use (Describe)

The subject devices are intended to be place in the mouth for use as an anchor in orthodontic procedures.

| Type of Use (Select one or both, as applicable) | |
|-------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------|
| <div> <span> <span style="text-decoration: overline;">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) </span> </div> | <div> <span> ☐ Over-The-Counter Use (21 CFR 801 Subpart C) </span> </div> |

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#### Date: August 30, 2018

#### 1. Submitter:

| Manufacturer Name: | BioMaterials Korea, Inc<br>#413, #329, #331 150, Jojeong-daero, Hanam-si,<br>Gyeonggi-do, Rep of Korea<br>Phone: [phone]<br>Fax: [phone]<br>Contact name: Jiyea Kim<br>Email: [e-mail]<br>Web page: www.BioMK.com |
|---------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Correspondent Name: | Regulatory Insight, Inc<br>33 Golden Eagle Lane, Littleton, CO, 80127<br>Phone: [phone]<br>Fax: [phone]<br>Contact name: Kevin Walls<br>Email: [e-mail] |

#### 2. Device Name and Classification

| Trade/Proprietary Name: | Anchor Plate |
|-------------------------|---------------------------|
| Common Name: | Endosseous Dental Implant |
| Regulatory Class: | Class II, 872.3640 |
| Product Code: | OAT |

#### 3. Predicated Device

- . Primary Predicate Device BOLLARD MINIPLATE SKELETAL ANCHORAGE SYSTEM, TITA-LINK, K091051
- . Reference Predicate Devices KLS MARTIN ORTHO ANCHORAGE SYSTEM, KLS-MARTIN L.P., K040891 SYNTHES ORTHODONTIC BONE ANCHOR SYSTEM, SYNTHES(USA), K063473

### 4. Device Description

The anchor plates for attachment to the orthodontic device offer four types (T-Type, Y-Type and W-Type). This plate has three portions; head, arm and body, and there are two types of head portion.

Anchor plate is developed to provide intraoral absolute anchorage for the intrusion or molars. Anchor Plate does not disturb any kind of tooth movement because they are placed outside the dentition. The anchor plate consists of pure titanium alloy, which is suitable for osseointegration and also tissue integration.

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| Anchor plate | | Screw | | |
|----------------------------|--------|----------------------|-------------|----------------------------------------|
| Design | Type | Design | Trade names | Model name |
| Image: T-Type Anchor Plate | T-Type | Image: Bone Screw | Bone Screw | OSS-T2004S<br>OSS-T2005S<br>OSS-T2006S |
| Image: I-Type Anchor Plate | I-Type | Image: Bone Screw | Bone Screw | OSS-T2004S<br>OSS-T2005S<br>OSS-T2006S |
| Image: I-Type Anchor Plate | | | | |
| Image: Y-Type Anchor Plate | Y-Type | Image: Bone Screw | Bone Screw | OSS-T2004S<br>OSS-T2005S<br>OSS-T2006S |
| Image: W-Type Anchor Plate | W-Type | Image: CT Type Screw | CT Type | OAS-T1506T |
| | | Image: C-Type Screw | C-Type | OAS-T1507 |

Compatibility information is summarized in the table below.

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| Image: W-Type | CT Type | OAS-T1506T |
|---------------|---------|------------|
| | C-Type | OAS-T1507 |

# 5. Intended Use

The subject devices are intended to be place in the mouth for use as an anchor in orthodontic procedures.

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| - | Proposed Device | Primary Predicate Device<br>(K091051) | Reference<br>Device I<br>(K040891) | Predicate<br>Reference<br>Device II<br>(K063473) | Predicate Discuss/Justify<br>differences |
|---------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Trade name | Anchor Plate | BOLLARD MINIPLATE<br>SKELETAL<br>ANCHORAGE SYSTEM | KLS MARTIN ORTHO<br>ANCHORAGE SYSTEM | SYNTHES<br>ORTHODONTIC BONE<br>ANCHOR SYSTEM | |
| Common name | Endosseous dental<br>implant | Endosseous dental<br>implant | Bone plate | Endosseous dental<br>implant | Same |
| Classification name | Endosseous implant | Endosseous implant | Endosseous implant | Endosseous implant | Same |
| Class | II | II | III | II | Same |
| Product Code | OAT | DZE | DZE | OAT | There are different product<br>codes, DZE and OAT<br>between proposed device<br>and predicate devices.<br>However, all devices consist<br>of orthodontic anchorage<br>system under same intended<br>use.<br>For product code as DZE,<br>Bollard Miniplate Skeletal<br>Anchorage System<br>(K091051) and Ortho<br>Anchorage System<br>(K040891) are used as an<br>anchor for orthodontic<br>procedures by providing<br>skeletal fixation which are<br>same with T-Type, I-Type<br>and Y-Type of proposed<br>device.<br>For product code as OAT, |
| | | | | | The<br>Orthodontic<br>Bone<br>Anchor System (K063473)<br>are used as an anchor for<br>orthodontic procedure by<br>providing bone fixation<br>which is same with W-Type<br>of proposed device. |
| Device description | The anchor plates for the<br>attachment to the<br>orthodontic device offer<br>four types (T-Type, I-<br>Type, Y-Type and W-<br>Type). This plate has three<br>portions; head, arm and<br>body, and there are two<br>types of head portion.<br><br>Anchor plate is developed<br>to provide intraoral<br>absolute anchorage for the<br>intrusion or distalization<br>of molars. Anchor Plate<br>does not disturb any kind<br>of tooth movement<br>because they are placed<br>outside the dentition. The<br>anchor plate consists of<br>pure titanium and titanium<br>alloy, which is suitable for<br>osseointegration and also<br>tissue integration. | The Bollard Miniplate<br>Skeletal Anchorage<br>System was invented by<br>Dr. Hugo DeClerck.<br><br>The Bollard Miniplate<br>Skeletal Anchorage<br>System provides a fixed<br>anchorage point for the<br>attachment of orthodontic<br>appliances to facilitate<br>orthodontic movement of<br>teeth. Small stationary<br>points connected to bone<br>inside the Mouth allow<br>connection of wire,<br>elastic, or other hardware.<br><br>The Bollard Miniplate<br>Skeletal Anchorage<br>System includes<br>Commercially Pure<br>Titanium miniplates fixed<br>by miniscrews to the<br>cortical bone. After<br>insertion by the surgeon<br>the miniplates are<br>completely covered by<br>soft tissue. The miniplates<br>and miniscrews are sold<br>sterile and are sterilized<br>using Gamma Radiation<br>per ISO 111137-1. | The KLS-Martin Ortho<br>Anchorage System<br>includes several different<br>designs of titanium plates. | The Synthes (USA) Same<br>Orthodontic Bone Anchor<br>System is a plate and<br>screw system designed to<br>be implanted intraorally<br>and used as an anchor for<br>orthodontic procedures.<br>The plate anchor portion<br>of the system consists of<br>T-shaped plate anchors<br>which are attached to the<br>bone via 1.55 mm cortex<br>screws and 1.85 mm<br>emergency screws. The<br>plate anchors are offered<br>in various designs for<br>attachment to the<br>orthodontic device. The<br>screw anchor portion of<br>the system consists of<br>1.55 mm self-drilling and<br>self-tapping screw<br>anchors which incorporate<br>a non-threaded gingival<br>collar beneath the screw<br>head which protects the<br>soft tissue. | |
| | | | | | |
| | | The bone anchor consists<br>of a miniplate (M) with 2<br>or 3 holes, a round<br>connecting bar (C), and a<br>fixation unit (F) with a<br>blocking screw (5). The<br>miniplate is fixed to the<br>bone by self-tapping or<br>selfdrilling screws. The<br>fixation unit contains 2<br>slots with a diameter of<br>0.045" (1.1mm). A<br>square connecting wire<br>with a maximum size of<br>0.032x0.032" can be<br>inserted and tightly fixed<br>by the blocking<br>screw.<br>The Bollard miniplates<br>are also offered with a<br>hook. The Bollard with<br>hook is smaller than the<br>original model and<br>contains a tube with<br>section 0.020"x0.020".<br>The hook can affix<br>directly to elastics or coil<br>springs<br>The subject devices are<br>used with standard<br>instrumentation for<br>orthodontic surgery<br>including pliers,<br>punches, screwdrivers,<br>burrs, and grasping or<br>holding instruments. | | | |
| | | | | | |
| Indications for use | The subject devices are<br>intended to be place in the | The subject devices are<br>intended to be placed in | Orthodontic tooth-<br>moving procedures where | The Orthodontic Bone<br>Anchor (OBA) System is | Same |
| | mouth for use as an<br>anchor in orthodontic<br>procedures. | the mouth for use as an<br>anchor in orthodontic<br>procedures. | maximum stability is<br>required<br>• Patients in their<br>permanent dentition<br>• Patients where dental<br>fixation is not possible<br>(tooth or alveolar loss,<br>trauma) | indicated for intrusion and<br>extrusion of teeth, distal<br>and mesial movement of<br>teeth, treatment of<br>anterior cross bite and<br>open bite, space closure,<br>3-D control of teeth. | |
| Raw material | ASTM F67<br>ASTM F136-02a | Pure titanium | F67 grade 2 titanium | ASTM-F67 grade 4<br>ASTM-R136-02a | Same |
| Design | T-Type<br>Image: T-Type | The Bollard<br>Image: The Bollard | C-tube plates<br>Image: C-tube plates | Mesh plate anchor<br>Image: Mesh plate anchor | Different.<br>In clinical application<br>literature, different shapes<br>of the plates are described in<br>the literature as following; |
| | Image: I-Type | The Bollard with hook<br>Image: The Bollard with hook | Image: Hook plates | Image: Mesh plate anchor | L-shaped, T-shaped, Y-<br>shaped, I-shaped rectangular<br>or triangular comprising 2,<br>or 5 holes for screw<br>fixation.(Reference 1-5)<br>Also, some articles studied<br>the influence of the shape of<br>the bone plate, but it didn't<br>seem to be a significant<br>factor for<br>success.(Reference 1) |
| | Image: I-Type | | | | Finally, the variations in<br>shape mean that the surgeon<br>can select the most<br>appropriate anchor plate<br>according to the bone<br>contour of the implantation<br>site. Therefore, its minor |

# 6. Comparison of technological characteristics with the predicate device

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Image /page/10/Picture/0 description: This image shows different types of surgical plates. The plates are labeled as Y-Type, W-Type, BH-UR-19 Y, C-palatal Plate, Bondable surface plates, Bracket Plate anchor, and Domed plate anchor. The bracket plate anchor has 4-hole and 5-hole variations.

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| Intended Use | The subject devices are<br>intended to be place in the<br>mouth for use as an<br>anchor in orthodontic<br>procedures. | | In cases of dental<br>regulations a C-tube<br>(Chung's<br>microplate with tube) can<br>be fixed in the lateral part<br>of the maxilla or<br>mandible. The eyelet will<br>remain<br>in the buccal sulcus and<br>serves to hold the dental<br>arch wire.<br><br>The KLS-Martin Ortho<br>Anchorage System is<br>intended to be surgically<br>placed in the mouth for<br>use as an anchor for<br>orthodontic procedures. | The Orthodontic Bone<br>Anchor(OBA) System is<br>intended to be implanted<br>intraorally and used as an<br>anchor for orthodontic<br>procedures. | Similar |
|-----------------------|-------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Dimensions(unit:mm) | Thickness : 0.8/ 1<br>Length : 13.35 - 40.35 | Not Listed | Thickness : 0.6/1.0/1.5 | Not Listed | Similar.<br>As literature (Reference 6)<br>C-tube plate, 0.66 of<br>dimension and 14.0 of<br>length, were used. and<br>Synthes OBA domed design |
| | | | | | 4 holes, 0.76 of thickness<br>and 13.5 of length, were<br>used. |
| | | | | | Generally, Anchor plate was<br>selected according to the<br>distance between the<br>implantation site and the<br>dentition by professional. |
| Surface Treatment | Machined | Machined | Machined | Not Listed | Same |
| Sterilization | Provided as non-sterile,<br>needs autoclave prior to<br>use.<br>· Temperature : 121 °C<br>· Exposure time : 30 min<br>· Dry time : 15 min | Gamma Radiation<br>ISO 11137-1 | Not Listed | Provided as non-sterile,<br>needs autoclave prior to<br>use.<br>Thermal disinfect at 93°C<br>for minimum of 2 minutes<br>and 30 seconds. | Same |
| Usage | Single use Only | Single use Only | Not Listed | Single use Only | Same |
| Biocompatibility | Device is biocompatible<br>when used as directed by<br>dental professionals per<br>ISO 10993-1. | Device is biocompatible<br>when used as directed by<br>dental professionals per<br>ISO 10993-1. | Device is biocompatible<br>when used as directed by<br>dental professionals per<br>ISO 10993-1. | Device is biocompatible<br>when used as directed by<br>dental professionals per<br>ISO 10993-1. | Same |
| mechanical properties | Bending strength (Avg.,<br>N·mm): 102.428<br>Tensile force (Avg., N):<br>301.814 | Bending strength (Avg.,<br>N·mm): 97.125<br>Tensile force (Avg., N):<br>176.782 | Not Listed | Not Listed | Different.<br>Mechanical and physical<br>properties of subject device<br>are compared with primary<br>predicate device where<br>details method, apparatus<br>and results can be found in |

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| | the test report (Bench test<br>report (subject device VS |
|--|----------------------------------------------------------|
| | predicate device). Since |
| | there is no unknown |
| | standard for performance, |
| | the results showed that the |
| | properties considered were |
| | similar when used for |
| | intended use. |

The subject device is similar to predicate device in terms of indication for use, design, raw material etc.

The subject device consists of orthodontic anchorage system, as is the mechanical properties and performance of subject device are not significantly from the predicate device, as indicated by non-clinical performance testing.

The shape, dimension and mechanical properties are different between the primary predicate device. But the variations in shape or dimension mean that the surgeon can select the most according to the bone contour or distance of the implantation site by professional. Also, in terms of mechanical properties, these differences are not significantly difference on its intended use or performance. Therefore, its minor deviation is acceptable for clinical application.

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### 7. Performance Data(Non-Clinical)

The test such as appearance, dimension and bending strength is to verify the performance of the device as it designed. Bending strength was performed according to ISO 9585. All of test results obtained from these tests indicated that Anchor Plate is substantially equivalent to the predicate device in terms of mechanical properties and performance.

The biocompatibility evaluation for the Anchor Plate was conducted in accordance with the FDA Blue Book Memorandum #G95-1 "Use of International Standard ISO 10993, 'Biological Evaluation of Medical Devices Part 1:Evaluation and Testing" May 1, 1995, and International Standard ISO 10993-1 "Biological Evaluation of Medical Devices - Part 1 : Evaluation and Testing Within a Risk Management Process" as recognized by FDA. The device of testing included the following tests:

- . Genotoxicity, ISO 10993-3(2014)
- Cytotoxicity, ISO 10993-5(2009)
- Implantation, ISO 10993-6(2007)
- Sensitization(GPMT), ISO 10993-10(2010)
- Oral mucous irritation / Intracutaneous reactivity, ISO 10993-10(2010)
- . Systemic toxicity(Acute), ISO 10993-11(2006)

Anchor Plate and the primary predicate device were tested for the non-clinical performance including Pullout force with 3-point bending test according to JS T 0312:2008, Testing methods for bending properties of metallic osteosynthesis devices and tensile force test. For tensile force test, there is no international standard or required guidance, therefore it is performed according to own test method. The results showed that the subject and predicate devices are fundamency. Based on the comparative data, subject devices are essentially the same as currently marketed devices for the same indication, with similar physical properties or design, which supports our claim for substantial equivalence. Anchor plate shows no differences in technological characteristics compared to the predicate devices.

#### 8. Substantial Equivalence Discussion

The subject device is similar to predicate device in terms of indication for use, design, raw material etc.

The subject device consists of orthodontic anchorage system, as is the predicate device. The mechanical properties and performance of subject device are not significantly different from the predicate device, as indicated by non-clinical performance testing.

The length and thickness are different between subject device and predicate device.

#### 9. Conclusions

The indications and technological characteristics of anchor plate are very similar to predicate device. Therefore, anchor plate is substantially equivalent to the identified predicate device.