Bone Chamber Implant

K223339 · Megagen Implant Co., Ltd. · DZE · Jul 18, 2023 · Dental

Device Facts

• Record ID: K223339
• Device Name: Bone Chamber Implant
• Applicant: Megagen Implant Co., Ltd.
• Product Code: DZE · Dental
• Decision Date: Jul 18, 2023
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3640
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Smaller Implant (Widest Thread Diameter: Ø4.0mm ~Ø5.0mm) The smaller Implant is intended to be surgically placed in the maxillary or mandibular arches for the purpose of providing prosthetic support for dental restorations (Crown, bridges, and overdentures) in partially or fully edentulous individuals. It is used to restore a patient's chewing function in the following situations and with the clinical protocols: - Delayed loading - Immediate loading when good primary stability is achieved and with appropriate occlusal loading. Larger Implant (Widest Thread Diameter: Ø5.6mm ~Ø7.0mm) The larger Implant is intended to be surgically placed in the maxillary or mandibular molar areas for the purpose of providing prosthetic support for dental restorations (Crown, bridges, and overdentures) in partially or fully edentulous individuals. These implants can be used where smaller implants have failed. It is used to restore a patient's chewing function in the following situations and with the clinical protocols: - Delayed loading.

Device Story

Bone Chamber Implant; endosseous root-form dental implant; CP Ti Grade 4 material; SLA surface treatment. Surgically placed in maxillary or mandibular arches by dental professionals. Features external chamber design; straight/tapered body; self-tapping cutting edge. Provides prosthetic support for crowns, bridges, and overdentures. Restores chewing function. Compatible with various MegaGen abutments. Bench testing confirms fatigue strength per ISO 14801. MR Conditional status established via scientific rationale.

Clinical Evidence

No clinical data. Bench testing only, including fatigue testing per ISO 14801, biocompatibility evaluation per ISO 10993-1, and MR compatibility assessment.

Technological Characteristics

Material: CP Ti Grade 4 (ASTM F67). Surface: SLA (Sand-blasted, Large grit, Acid-etched). Connection: Internal Octa. Sterilization: Gamma. Dimensions: Ø4.0-7.0mm diameters, 7.7-14.2mm lengths. Design: Tapered/straight body with external chamber and self-tapping cutting edge.

Indications for Use

Indicated for partially or fully edentulous patients requiring prosthetic support for dental restorations (crowns, bridges, overdentures) in maxillary or mandibular arches. Smaller implants (Ø4.0-5.0mm) indicated for delayed or immediate loading. Larger implants (Ø5.6-7.0mm) indicated for molar areas, including cases where smaller implants failed, for delayed loading.

Regulatory Classification

Identification

An endosseous dental implant is a prescription device made of a material such as titanium or titanium alloy that is intended to be surgically placed in the bone of the upper or lower jaw arches to provide support for prosthetic devices, such as artificial teeth, in order to restore a patient's chewing function.

Special Controls

*Classification.* (1) Class II (special controls). The device is classified as class II if it is a root-form endosseous dental implant. The root-form endosseous dental implant is characterized by four geometrically distinct types: Basket, screw, solid cylinder, and hollow cylinder. The guidance document entitled “Class II Special Controls Guidance Document: Root-Form Endosseous Dental Implants and Endosseous Dental Implant Abutments” will serve as the special control. (See § 872.1(e) for the availability of this guidance document.)(2) *Classification.* Class II (special controls). The device is classified as class II if it is a blade-form endosseous dental implant. The special controls for this device are:(i) The design characteristics of the device must ensure that the geometry and material composition are consistent with the intended use; (ii) Mechanical performance (fatigue) testing under simulated physiological conditions to demonstrate maximum load (endurance limit) when the device is subjected to compressive and shear loads; (iii) Corrosion testing under simulated physiological conditions to demonstrate corrosion potential of each metal or alloy, couple potential for an assembled dissimilar metal implant system, and corrosion rate for an assembled dissimilar metal implant system; (iv) The device must be demonstrated to be biocompatible; (v) Sterility testing must demonstrate the sterility of the device; (vi) Performance testing to evaluate the compatibility of the device in a magnetic resonance (MR) environment; (vii) Labeling must include a clear description of the technological features, how the device should be used in patients, detailed surgical protocol and restoration procedures, relevant precautions and warnings based on the clinical use of the device, and qualifications and training requirements for device users including technicians and clinicians; (viii) Patient labeling must contain a description of how the device works, how the device is placed, how the patient needs to care for the implant, possible adverse events and how to report any complications; and (ix) Documented clinical experience must demonstrate safe and effective use and capture any adverse events observed during clinical use.

Predicate Devices

• AnyRidge Octa 1 Implant System (K182448)
• Rescue Internal Implant System (K063216)

Reference Devices

• XPEED AnyRidge Internal System (K122231)
• Implacil Implant System (K202832)

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). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

7/18/2023

MegaGen Implant Co., Ltd. Eun Park Assistant Research Engineer 45, Secheon-ro, 7-gil Daegu, Dasa-eup, Dalesong-gun 42921 Korea. South

Re: K223339

Trade/Device Name: Bone Chamber Implant Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: Class II Product Code: DZE Dated: June 9, 2023 Received: June 16, 2023

Dear Eun Park:

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.

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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 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/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

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/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely.

Sherrill Lathrop Blitzer

for Andrew Steen Assistant Director DHT1B: Division of Dental and ENT Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known) K223339

Device Name Bone Chamber Implant

Indications for Use (Describe)

· Smaller Implant (Widest Thread Diameter: Ø4.0mm ~Ø5.0mm)

The smaller Implant is intended to be surgically placed in the maxillary or mandibular arches for the purpose of providing prosthetic support for dental restorations (Crown, bridges, and overdentures) in partially or fully edentulous individuals. It is used to restore a patient's chewing function in the following situations and with the clinical protocols:

- Delayed loading

- Immediate loading when good primary stability is achieved and with appropriate occlusal loading.

· Larger Implant (Widest Thread Diameter: Ø5.6mm ~Ø7.0mm)

The larger Implant is intended to be surgically placed in the maxillary or mandibular molar areas for the purpose of providing prosthetic support for dental restorations (Crown, bridges, and overdentures) in partially or fully edentulous individuals. These implants can be used where smaller implants have failed. It is used to restore a patient's chewing function in the following situations and with the clinical protocols:

- Delaved 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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# 510(k) Summary for K223339

Date: July 12, 2023

### Applicant / Submitter 1.

MegaGen Implant Co., Ltd. 45, Secheon-ro, 7-gil, Dasa-eup, Dalesong-gun, Daegu, Republic of Korea Tel: + 82-53-222-2828

# 2. Submission Correspondent

Eun Mi Park 45, Secheon-ro, 7-gil, Dasa-eup, Dalseong-gun, Daegu, Republic of Korea Tel: [phone] Fax: [phone] Email: [e-mail]

### 3. Device

| ■ Trade Name: | Bone Chamber Implant |
|--------------------------------|--------------------------------|
| ■ Common Name: | Implant, Endosseous, Root-Form |
| ■ Classification Name: | Endosseous Dental Implant |
| ■ Classification Product Code: | DZE |
| ■ Classification regulation: | Class II, 21 CFR 872.3640 |

#### 4. Predicate Device

■

■

# Section I : Smaller Implant

Primary Predicate Device: K182448- AnyRidge Octa 1 Implant System Reference Device: K122231- XPEED AnyRidge Internal System K202832-Implacil Implant System

# Section II : Larger Implant

Primary Predicate Device: K063216- Rescue Internal Implant System Reference Devices: K122231- XPEED AnyRidge Internal System K182448-AnyRidge Octa 1 Implant System K202832-Implacil Implant System

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### 5. Description

- Bone Chamber Implant is a dental implant made of CP Ti Grade 4 with the surface treated by SLA method. It is intended to be surgically placed in the maxillary or mandibular molar arches for smaller implants and in the maxillary or mandibular molar areas for larger implants. The fixture offers two connection types: 2.8 and 3.3 diameter. Also Bone Chamber Implant is characterized by having a chamber on the external surface.

| Device | Content | | |
|------------------------|-------------------------|----------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 1. Fixture<br>Products | Bone Chamber<br>Implant | Description | The Bone Chamber Implant is intended to be<br>surgically placed in the maxillary or mandibular<br>molar arches for smaller implants and in the<br>maxillary or mandibular molar areas for larger<br>implants. It purpose providing prosthetic support for<br>dental restorations (Crown, bridges, and<br>overdentures) in partially or fully edentulous<br>individuals. |
| | | Material | CP Ti Grade 4 of ASTM F67 |
| | | Wide Thread<br>Dimension<br>(Diameter &<br>Total Length) | Ø4.0 X 7.7, 9.2, 10.7, 12.2, 14.2 mm<br>Ø4.4 X 7.7, 9.2, 10.7, 12.2, 14.2 mm<br>Ø5.0 X 7.7, 9.2, 10.7, 12.2, 14.2 mm<br>Ø5.6 X 7.7, 9.2, 10.7, 12.2, 14.2 mm<br>Ø6.5 X 7.7, 9.2, 10.7, 12.2, 14.2 mm<br>Ø7.0 X 7.7, 9.2, 10.7, 12.2, 14.2 mm |

The Bone Chamber Implant is consisted of the following.

The Bone Chamber Implant is compatible with following MEGAGEN abutments cleared under:

| Device | Fixture - Abutment<br>Connection<br>Diameter (mm) | Prosthesis | 510(k) Number |
|-------------------------|---------------------------------------------------|----------------------------|---------------|
| Bone Chamber<br>Implant | 2.8, 3.3 | EZ Post Abutment | K182448 |
| | | Angled Abutment | |
| | | Milling Abutment | |
| | | Octa Abutment | |
| | | Multi-unit Abutment | |
| | | Multi-unit Angled Abutment | |
| | | CCM Abutment | |
| | | Octa Abutment | |
| | | Healing Abutment | |
| | | Temporary Abutment | |
| | | Fuse Abutment | |
| | | Abutment Screw | |
| | | Meg-Ball Abutment | |
| | | Meg-Loc Abutment | |
| | | Meg-Magnet Abutment | |

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### 6. Indication for use

- . Smaller Implant (Wide Thread Diameter: Ø 4.0 ~ Ø 5.0 mm) The smaller Implant is intended to be surgically placed in the maxillary or mandibular arches for the purpose of providing prosthetic support for dental restorations (Crown, bridges, and overdentures) in partially or fully edentulous individuals. It is used to restore a patient's chewing function in the following situations and with the clinical protocols: -Delayed loading. -Immediate loading when good primary stability is achieved and with appropriate occlusal loading.
- Larger Implant (Wide Thread Diameter: Ø 5.6 ~ Ø 7.0 mm) The larger Implant is intended to be surgically placed in the maxillary or mandibular molar areas for the purpose of providing prosthetic support for dental restorations (Crown, bridges, and overdentures) in partially or fully edentulous individuals. These implants can be used where smaller implants have failed. It is used to restore a patient's chewing function in the following situations and with the clinical protocols: -Delayed loading.

### 7. Basis for Substantial Equivalence

The Bone Chamber Implant is substantially equivalent to the predicate devices in terms of indication for use, technical characteristic and function. They are material and have similar design. Performance test of subject device demonstrated the minor differences in technological characteristics do not affect substantial equivalence.

The Indications for Use for the subject devices is divided into two types. One is for smaller implant (Wide Thread Diameter: Ø 4.0 ~ Ø 5.0 mm), and the other is for larger implants (Wide Thread Diameter: Ø 5.6 ~ Ø 7.0 mm). The Indication for Use of smaller implants is identical to the primary predicate, K182448. The Indications for Use for the larger implants is similar to the primary predicate device, K063216. The subject device, compared to the predicate, includes specific information on when the device should be loaded. This aspect does not affect substantial equivalence as the Indications for the subject device fall within the Indications of the predicate device

In order to demonstrate the difference in design does not raise any new issues, the performance test on the subject and predicate device have been performed in consideration of the worst case according to 'ISO 14801' and 'Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Implant Abutment'. The test result supports the substantial equivalence to the predicate devices.

Based on the comparison charts below and test results provided in this submission, we conclude that the subject device is substantially equivalent to the predicate devices.

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# Bone Chamber Implant

# Table 1. Comparison on AnyRidge Octa 1 Implant System (K182448)

| | Subject Device | Primary Predicate Device | Reference Device | |
|---------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) No. | K223339 | K182448 | K122231 | K202832 |
| Device Name | Bone Chamber Implant | AnyRidge Octa 1 Implant<br>System | XPEED AnyRidge Internal<br>Implant System | Implacil Implant System |
| Manufacturer | MegaGen Implant Co., Ltd. | MegaGen Implant Co., Ltd. | MegaGen Implant Co., Ltd. | Implacil De Bortoli Material<br>Odontologico Ltda |
| Indications for Use<br>Statement | The smaller Implant is intended<br>to be surgically placed in the<br>maxillary or mandibular arches<br>for the purpose of providing<br>prosthetic support for dental<br>restorations (Crown, bridges,<br>and overdentures) in partially<br>or fully edentulous individuals.<br>It is used to restore a patient's<br>chewing function in the<br>following situations and with<br>the clinical protocols:<br>-Delayed loading.<br>-Immediate loading when good<br>primary stability is achieved<br>and with appropriate occlusal<br>loading. | The AnyRidge Octa 1 Implant<br>System is intended to be<br>surgically placed in the<br>maxillary or mandibular arches<br>for the purpose of providing<br>prosthetic support for dental<br>restorations (Crown, bridges,<br>and overdentures) in partially<br>or fully edentulous individuals.<br>It is used to restore a patient's<br>chewing function in the<br>following situations and with<br>the clinical protocols:<br>-Delayed loading.<br>-Immediate loading when good<br>primary stability is achieved<br>and with appropriate occlusal<br>loading. Larger implants are<br>dedicated for the molar region. | The XPEED AnyRidge Internal<br>Implant System is intended to<br>be surgically placed in the<br>maxillary or mandibular molar<br>areas for the purpose providing<br>prosthetic support for dental<br>restorations (Crown, bridges,<br>and overdentures) in partially<br>or fully edentulous individuals.<br>It is used to restore patients<br>chewing function. Smaller<br>implants (less than 6.0 mm) are<br>dedicated for immediate<br>loading when good primary<br>stability is achieved and with<br>appropriate occlusal loading.<br>Larger implants are dedicated<br>for the molar region and are<br>indicated for delayed loading | Implacil Implant System is<br>intended for placement in the<br>maxillary or mandibular arch to<br>provide support for single-unit<br>and/or multi-unit restorations.<br>When a one-stage surgical<br>approach is applied, the<br>Implacil Implant System is<br>intended for<br>immediate loading when good<br>primary stability is achieved<br>and with appropriate occlusal<br>loading. |
| Design | | | | |
| Widest Thread<br>Diameter (Ø, mm) &<br>Total Length(mm) | · Normal thread<br>$Ø$ 4.0 X 7.7, 9.2, 10.7, 12.2, 14.2 mm<br>$Ø$ 4.4 X 7.7, 9.2, 10.7, 12.2, 14.2 mm<br>$Ø$ 5.0 X 7.7, 9.2, 10.7, 12.2, 14.2 mm | · Normal thread<br>$Ø$ 3.6 X 7.0, 7.7, 9.2, 10.7, 12.2, 14.2,<br>17.2 mm<br>$Ø$ 4.0 X 7.0, 7.7, 9.2, 10.7, 12.2, 14.2,<br>17.2 mm<br>$Ø$ 4.4 X 7.0, 7.7, 9.2, 10.7, 12.2, 14.2,<br>17.2 mm<br>$Ø$ 4.7 X 7.0, 7.7, 9.2, 10.7, 12.2, 14.2,<br>17.2 mm<br>$Ø$ 5.0 X 7.0, 7.7, 9.2, 10.7, 12.2, 14.2,<br>17.2 mm<br>· Deep thread<br>$Ø$ 4.0 X 7.0, 7.7, 9.2, 10.7, 12.2, 14.2,<br>17.2 mm<br>$Ø$ 4.4 X 7.0, 7.7, 9.2, 10.7, 12.2, 14.2,<br>17.2 mm<br>$Ø$ 4.8 X 7.0, 7.7, 9.2, 10.7, 12.2, 14.2,<br>17.2 mm<br>$Ø$ 5.0 X 7.0, 7.7, 9.2, 10.7, 12.2, 14.2,<br>17.2 mm<br>$Ø$ 5.5 X 7.0, 7.7, 9.2, 10.7, 12.2, 14.2,<br>17.2 mm | · Normal thread<br>$Ø$ 4.0 X 7.7, 9.2, 10.7, 12.2, 14.2,<br>17.2<br>$Ø$ 4.4 X 7.7, 9.2, 10.7, 12.2, 14.2,<br>17.2<br>$Ø$ 4.9 X 7.7, 9.2, 10.7, 12.2, 14.2,<br>17.2<br>$Ø$ 5.4 X 7.7, 9.2, 10.7, 12.2, 14.2,<br>17.2<br>$Ø$ 5.9 X 7.7, 9.2, 10.7, 12.2, 14.2,<br>17.2<br>· Deep thread<br>$Ø$ 6.4 X 7.9, 9.4, 10.9, 12.4, 14.4<br>$Ø$ 6.9 X 7.9, 9.4, 10.9, 12.4, 14.4<br>$Ø$ 7.4 X 7.9, 9.4, 10.9, 12.4, 14.4<br>$Ø$ 7.9 X 7.9, 9.4, 10.9, 12.4, 14.4<br>$Ø$ 8.4 X 7.9, 9.4, 10.9, 12.4, 14.4 | $Ø$ 3.5 X 8.0, 9.0, 10.0, 11.0, 12.0,<br>13.0, 14.0, 15.0 mm<br>$Ø$ 4.0 X.7.0, 8.0, 9.0, 10.0, 11.0,<br>12.0, 13.0, 14.0, 15.0 mm<br>$Ø$ 5.0 X 7.0, 8.0, 9.0, 10.0, 11.0, 12.0,<br>13.0, 14.0, 15.0 mm |
| Implant-to Abutment<br>Connection | Internal Octa | Internal Octa | Internal Hex | Internal Hex<br>External Hex |
| Material | CP Ti Grade 4 (ASTM F67) | CP Ti Grade 4 (ASTM F67) | CP Ti Grade 4 (ASTM F67) | CP Ti Grade 4 (ASTM F67) |
| Single Use | Yes | Yes | Yes | Yes |
| Surface Treatment | Sand-blasted, Large grit, Acid-<br>etched (SLA) | Sand-blasted, Large grit, Acid-<br>etched (SLA) | Sand-blasted, Large grit, Acid-<br>etched (SLA) | Sand-blasted, Large grit, Acid- etched (SLA) |
| Sterilization | Gamma sterilization | Gamma sterilization | Gamma sterilization | Gamma sterilization |
| Shelf Life | 5 years | 5 years | 5 years | 5 years |
| Feature | - Straight / Tapered body shape<br>- Submerged implant | - Straight / Tapered body shape<br>- Submerged implant<br>- cutting edge with self-tapping | - Submerged implant<br>- Tapered body<br>- cutting edge with self-tapping | - Tapered body<br>- cutting edge with self-tapping |
| Chamber | - Yes | No | No | - Yes |

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| | - Angle : 40~60° | | | | | | - Angle : 55° | | |
|------------------------------------|-----------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------|--------------------------|--|
| | | - Shape : Hemispherical shape | | | | | | - Shape : Radial channel | |
| Principle of Operation | | It is a tapered body fixture<br>which is inserted in the<br>alveolar bone. It replaces the<br>functions of the missing teeth<br>as a dental implant fixture. | | It is a tapered body fixture<br>which is inserted in the<br>alveolar bone. It replaces the<br>functions of the missing teeth<br>as a dental implant fixture. | | It is a tapered body fixture<br>which is inserted in the<br>alveolar bone. It replaces the<br>functions of the missing teeth<br>as a dental implant fixture. | | | |
| Substantial Equivalence Discussion | | | | | | | | | |
| Similarities | | | | The subject device has the similar characteristic for the followings compared to the predicate device. | | | | | |
| | | | | Indication for use, Design, Connection, Material, Single Use, Surface Treatment, Sterilization, Shelf Life and Principle of Operation. | | | | | |
| Differences | | | | | | | | | |
| | | | | The subject device has the different characteristic for the followings compared to the predicate device. | | | | | |
| | Design presence of chambers | | | | | | | | |
| | | | | The presence of chambers of subject device is different with predicate device, but the reference has it, but with different technical | | | | | |
| | | | | characteristics. These differences are explained not affecting on the substantial equivalence. | | | | | |
| | | Subject Device | | | Predicate | | | | |
| | Model name | Widest Thread<br>Diameter<br>(Ø,mm) | Total Length<br>(mm) | Model name | Widest Thread<br>Diameter<br>(Ø,mm) | Total Length<br>(mm) | 510k | | |
| | BC3308 | 4.0 | 7.7 | ARO3708 | 4.0 | 7.7 | K182448 | | |
| | BC3310 | 4.0 | 9.2 | ARO3710 | 4.0 | 9.2 | K182448 | | |
| | BC3311 | 4.0 | 10.7 | ARO3711 | 4.0 | 10.7 | K182448 | | |
| | BC3313 | 4.0 | 12.2 | ARO3713 | 4.0 | 12.2 | K182448 | | |
| | BC3315 | 4.0 | 14.2 | ARO3715 | 4.0 | 14.2 | K182448 | | |
| | BC3808 | 4.4 | 7.7 | ARO4108 | 4.4 | 7.7 | K182448 | | |
| | BC3810 | 4.4 | 9.2 | ARO4110 | 4.4 | 9.2 | K182448 | | |
| | BC3811 | 4.4 | 10.7 | ARO4111 | 4.4 | 10.7 | K182448 | | |
| | BC3813 | 4.4 | 12.2 | ARO4113 | 4.4 | 12.2 | K182448 | | |
| | BC3815 | 4.4 | 14.2 | ARO4115 | 4.4 | 14.2 | K182448 | | |
| | BC4308 | 5.0 | 7.7 | ARO4808 | 5.0 | 7.7 | K182448 | | |
| | BC4310 | 5.0 | 9.2 | ARO4810 | 5.0 | 9.2 | K182448 | | |
| | BC4311 | 5.0 | 10.7 | ARO4811 | 5.0 | 10.7 | K182448 | | |
| | BC4313 | 5.0 | 12.2 | ARO4813 | 5.0 | 12.2 | K182448 | | |
| | BC4315 | 5.0 | 14.2 | ARO4815 | 5.0 | 14.2 | K182448 | | |

Feature : Cutting edge

Cutting edge is for self-tapping, which does not affect the physical or performance.

### - Discussion

The proposed Bone Chamber Implant have common in the comparison chart except the design presence of chambers and cutting edge. These differences are explained not affecting on the substantial equivalence. The fatigue test was performed on worst asse to confirm the substantial equivalence acording to "ISO 14801" and "Class II Special Controls Guidance Document: Root-form Endosseous Dental Implant Abutment".

- On the basis of the discussion above, it is concluded that the subject device is substantially equivalent to the predicate device.

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| | Subject Device | Primary Predicate Device | Reference Device | | | | Surface<br>Treatment | | | | |
|------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------|-----|
| 510(k) No. | K223339 | K063216 | K122231 | K182448…