Internal Octa Implant System

K170031 · Ebi, Inc. · DZE · Aug 31, 2017 · Dental

Device Facts

• Record ID: K170031
• Device Name: Internal Octa Implant System
• Applicant: Ebi, Inc.
• Product Code: DZE · Dental
• Decision Date: Aug 31, 2017
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3640
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Internal Octa Implant System is intended for placement in the maxillary and/or mandibular arches to support crowns, bridges, or overdentures in edentulous or partially edentulous patients. The Internal Octa Implant System is intended for immediate loading when good primary stability is achieved and with appropriate occlusal loading.

Device Story

Endosseous dental implant system; includes BLT III, Precision III, and LISA fixtures. Fabricated from Grade 4 CP Titanium; surface treated with SLA (Sandblast, Large grit Acid etched). Designed for surgical placement in maxillary/mandibular arches by dental professionals. Supports crowns, bridges, or overdentures; enables immediate or early loading protocols. Fixtures provided sterile. Clinical benefit: restores masticatory function in patients with tooth loss.

Clinical Evidence

Bench testing only. Biocompatibility (ISO 10993-1:2009), surface characterization (roughness, SEM, EDS), and endotoxin testing (ANSI/AAMI ST 72:2011, USP <85>, <161>) performed. Sterilization and shelf-life validation leveraged from predicate K073116.

Technological Characteristics

Material: CP Titanium Grade 4 (ASTM F67). Surface: SLA (Sandblast, Large grit Acid etched). Connection: Internal Octa. Form factor: Root-form endosseous fixtures (BLT III, Precision III, LISA). Sterilization: Radiation (Gamma).

Indications for Use

Indicated for edentulous or partially edentulous patients requiring maxillary or mandibular arch restoration via crowns, bridges, or overdentures. Supports immediate loading if primary stability and occlusal conditions are met.

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

• EBI Internal Implant (K073116)

Reference Devices

• ETIII SA Fixture (K101096)
• SM® IMPLANT SYSTEMS (K061797)

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

August 31, 2017

EBI Inc. % April Lee Consultant Withus Group Inc. 2531 Pepperdale Drive Rowland Heights, California 91748

Re: K170031

Trade/Device Name: Internal Octa Implant System Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: Class II Product Code: DZE Dated: July 27, 2017 Received: August 3, 2017

Dear April Lee:

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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Page 2 - April Lee

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 (OS) 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,

# Andrew I. Steen -S

- for Lori A. Wiggins, MPT, CLT 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) K170031

Device Name Internal Octa Implant System

#### Indications for Use (Describe)

The Internal Octa Implant System is intended for placement in the maxillary and/or mandibular arches to support crowns, bridges, or overdentures in edentulous or partially edentulous patients. The Internal Octa Implant System is intended for immediate loading when good primary stability is achieved and with appropriate occlusal 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

#### Submitter

EBI Inc. Mi Sook Kim 124, Uisong-gil, Amnyang-myeon, Gyeongsan-si Gyeongsangbuk-do38493 Republic of Korea Email: [e-mail] Tel. [phone] Fax. [phone]

#### Official Correspondent

Withus Group Inc. April Lee 2531 Pepperdale Drive, Rowland Heights, CA 91748 USA Email: [e-mail] Phone: [phone] Fax: [phone]

#### Device Information

- Trade Name: Internal Octa Implant System .
- Common Name: Dental Implant System
- Classification Name: implant, endosseous, root-form
- Product Code: DZE ●
- Panel: Dental
- Regulation Number: 872.3640 ●
- Device Class: Class II
- Date prepared: 08/31/2017

#### General Description

An endosseous dental implant is a device made of Pure Titanium Grade 4. Internal Octa Implant System has been designed to accommodate the following dental implant restoration protocols; Immediate or Early loading, immediate placement or one or two stage placements. Internal Octa Implant Systems help patients who have partial or whole teeth loss mastication to chew as dental implant. The Internal Octa Implant System has an internal connection. The surface of the system has been treated with SLA (Sandblast, Large grit Acid etched).

There are 3different kinds of fixtures, BLT III, Precision III and LISA Implants. The only differences between these implants are designs and dimensions. The appearance of implants is different depending on the presence of cutting edge and taper. The Fixtures are supplied sterile.

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| | BLT III Implant | Precision III Implant | LISA Implant |
|-------------------|--------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Implant Type | Bone Level | Tissue Level | Bone Level |
| Platform Diameter | 4.1, 4.8mm | 4.8, 6.5mm | 4.1, 4.8mm |
| Body Diameter | 4.1, 4.8mm | 3.3, 4.1, 4.8mm | 4.1, 4.8mm |
| Length | 7.2, 7.7, 8.2, 8.7, 9.2,<br>9.7, 10.2, 10.7, 11.2,<br>11.7, 12.2, 12.7, 13.2,<br>13.7, 14.2 mm | 8.3, 9.3, 10.3, 11.3,<br>12.3, 13.3, 14.3, 15.3<br>mm | 11.2, 12.2 mm |
| Pitch | 0.8mm | 1.25mm | 0.8mm |
| Unique features | It is made of Pure<br>Titanium Grade 4. The<br>surface treated with SLA<br>(Sandblast, Large grit<br>Acid etched). | It is made of Pure<br>Titanium Grade 4.<br>The surface treated<br>with SLA (Sandblast,<br>Large grit Acid<br>etched). | It is made of Pure Titanium Grade<br>4. The surface treated with SLA<br>(Sandblast, Large grit Acid<br>etched). It has a concave<br>appearance to be placed in the<br>narrow ridge area. |

The ranges of the fixtures' dimensions are below:

#### Indication for Use

The Internal Octa Implant System is intended for placement in the maxillary and/or mandibular arches to support crowns, bridges, or overdentures in edentulous or partially edentulous patients. The Internal Octa Implant System is intended for immediate loading when good primary stability is achieved and with appropriate occlusal loading.

#### Materials:

The devices are fabricated from CP Titanium (Grade 4) that conforms to ASTM F67 for Dental Implant.

#### Performance Data (Bench Testing):

The subject device was tested to evaluate its substantial equivalence according to the following standards:

- Biocompatibility Testing such as cytotoxicity, sensitization, irritation and acute systemic toxicity ● was performed in accordance with ISO 10993-1:2009
- Surface roughness demonstration, surface SEM, and surface EDS
- LAL Endotoxin testing in accordance with ANSI/AAMI ST 72:2011, USP <85> and <161>

Below test was performed for primary predicate devices and leveraged for the subject device:

- Sterilization Test according to ISO 11137-1,-2,-3 referenced in K073116 .
- Shelf life Validation Test according to ISO 11607-1, -2, and ASTM F1980-07 referenced in . K073116

The results of the above tests have met the criteria of the standards, and demonstrated the substantial equivalence with the predicate device.

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# Predicate Devices:

The subject device is substantially equivalent to the following predicate devices:

- 1) BLT III Implants

| | Subject Device | Primary Predicate | Reference Predicate |
|--------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Company | EBI Inc. | EBI Inc. | OSSTEM Implant<br>Co.,Ltd. |
| Device Name | Internal Octa Implant<br>System | EBI Internal Implant | ETIII SA Fixture |
| 510(k) Number | NA | K073116 | K101096 |
| Device Classification<br>Name | Implant, Endosseous, Root-<br>form | Implant, Endosseous,<br>Root-form | Implant, Endosseous,<br>Root-form |
| Classification Product<br>Code | DZE | DZE, NHA | DZE |
| Regulation Number | 21 CFR872.3640 | 21 CFR872.3640 | 21 CFR872.3640 |
| Intended Use | The Internal Octa Implant<br>System is intended for<br>placement in the maxillary<br>and/or mandibular arches<br>to support crowns, bridges,<br>or overdentures in<br>edentulous or partially<br>edentulous patients. The<br>Internal Octa Implant<br>System is intended for<br>immediate loading when<br>good primary stability is<br>achieved and with<br>appropriate occlusal<br>loading. | EBI Implant System is<br>intended for immediate,<br>delayed, or conventional<br>placement in the<br>maxillary and/or<br>mandibular arches to<br>support crowns, bridges,<br>or overdentures in<br>edentulous or partially<br>edentulous patients. | ET III Fixture System is<br>indicated for use in<br>partially or fully<br>edentulous mandibles and<br>maxillae, in support or<br>single or multiple-unit<br>restorations including;<br>cemented retained, screw<br>retained, or overdenture<br>restorations, and terminal<br>or intermediate abutment<br>support for fixed<br>bridgework. |
| Material | Titanium Gr.4 | Titanium Gr.4 | Titanium Gr.4 |
| Design | Image: Implant Design 1 | Image: Implant Design 2 | Image: Implant Design 3 |
| Body Diameters | 4.1, 4.8mm | 3.3 - 4.8 mm | 3.5 – 5.0 mm |
| Platform Diameters | 4.1, 4.8mm | 4.8, 6.5mm | 3.5 - 5.0 mm |
| Total Lengths | 7.2-14.2 mm | 6-15.3 mm | 7-15 mm |
| Connection Type | Internal Octa | Internal Octa | Internal Octa |
| Surface Treatment | SLA | RBM | SLA |
| Gamma Sterilization | Radiation Sterile | Radiation Sterile | Radiation Sterile |
| Shelf Life | 5 years | 5 years | 5 years |
| Implant Type | Bone Level | Bone Level | Bone Level |

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## 2) Precision III Implant

| | Subject Device | Primary Predicate |
|-----------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Company | EBI Inc. | EBI Inc. |
| Device Name | Internal Octa Implant System | EBI Internal Implant |
| 510(k) Number | NA | K073116 |
| Device Classification Name | Implant, Endosseous, Root-form | Implant, Endosseous, Root-form |
| Classification Product Code | DZE | DZE, NHA |
| Regulation Number | 21 CFR872.3640 | 21 CFR872.3640 |
| Intended Use | The Internal Octa Implant System is<br>intended for placement in the<br>maxillary and/or mandibular arches<br>to support crowns, bridges, or<br>overdentures in edentulous or<br>partially edentulous patients. The<br>Internal Octa Implant System is<br>intended for immediate loading<br>when good primary stability is<br>achieved and with appropriate<br>occlusal loading. | EBI Implant System is intended for<br>immediate, delayed, or<br>conventional placement in the<br>maxillary and/or mandibular arches<br>to support crowns, bridges, or<br>overdentures in edentulous or<br>partially edentulous patients. |
| Material | Titanium Gr.4 | Titanium Gr.4 |
| Design | Image: Implant | Image: Implant |
| Body Diameters | Regular: 3.3, 4.1, 4.8 mm<br>Wide: 4.8 mm | Regular: 3.3, 4.1, 4.8 mm<br>Wide: 4.8 mm |
| Platform Diameters | 4.8, 6.5 mm | 4.8, 6.5 mm |
| Total Lengths | 8.3-15.3 mm | 6-15.3 mm |
| Connection Type | Internal Octa | Internal Octa |
| Surface Treatment | SLA | RBM |
| Gamma Sterilization | Radiation Sterile | Radiation Sterile |
| Shelf Life | 5 years | 5 years |

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## 3) LISA Implant

| | Subject Device | Primary Predicate | Reference Predicate |
|----------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Company | EBI Inc. | EBI Inc. | DIO Department, DSI, Inc |
| Device Name | Internal Octa Implant<br>System | EBI Internal Implant | SM® IMPLANT SYSTEMS |
| 510(k) Number | NA | K073116 | K061797 |
| Device<br>Classification<br>Name | Implant, Endosseous,<br>Root-form | Implant, Endosseous,<br>Root-form | Implant, Endosseous, Root-form |
| Classification<br>Product Code | DZE | DZE, NHA | DZE, NHA |
| Regulation<br>Number | 21 CFR872.3640 | 21 CFR872.3640 | 21 CFR872.3640 |
| Intended Use | The Internal Octa<br>Implant System is<br>intended for<br>placement in the<br>maxillary and/or<br>mandibular arches to<br>support crowns,<br>bridges, or<br>overdentures in<br>edentulous or<br>partially edentulous<br>patients. The Internal<br>Octa Implant System<br>is intended for<br>immediate loading<br>when good primary<br>stability is achieved<br>and with appropriate<br>occlusal loading. | EBI Implant System is<br>intended for immediate,<br>delayed, or conventional<br>placement in the maxillary<br>and/or mandibular arches<br>to support crowns,<br>bridges, or overdentures in<br>edentulous or partially<br>edentulous patients. | The SM® Implant System is<br>anendosseous dental implant is<br>indicated for surgical placement in<br>theupper and lower jaw arches, to<br>provide a root form means for single or<br>multiple units' prostheticappliance<br>attachment to restorea patient's chewing<br>function. Implants can be placed<br>withconventional two stage surgical<br>process with an option fortransmucosal<br>healing or they can beplaced in a single<br>stage surgical process for immediate<br>loading. Immediate loading isrestricted<br>tothe anterior mandible, based on four<br>splinted interforminal placed implants,<br>and notindicated forsingle, unsplinted<br>implants. Patients must besubject for<br>dental treatment<br>withendosseousimplants. |
| Material | Titanium Gr.4 | Titanium Gr.4 | Titanium Gr.4 |
| Design | Image: Implant design | Image: Implant design | Image: Implant design |
| Body Diameters | 4.1, 4.8mm | Regular: 3.3, 4.1, 4.8 mm<br>Wide: 4.8 mm | 3.8, 4.5, 5.3 mm |
| Platform<br>Diameters | 4.1, 4.8mm | 4.8, 6.5 mm | 3.8, 4.5, 5.3 mm |
| Total Lengths | 11.2, 12.2 mm | 6-15.3 mm | 8-14 mm |

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| Connection<br>Type | Internal Octa | Internal Octa | Internal Octa |
|------------------------|-------------------|-------------------|-------------------|
| Surface<br>Treatment | SLA | RBM | RBM |
| Gamma<br>Sterilization | Radiation Sterile | Radiation Sterile | Radiation Sterile |
| Shelf Life | 5 years | 5 years | 5 years |
| Implant Type | Bone Level | Tissue Level | Bone Level |

#### Substantial Equivalence Discussion

The Internal Octa Implant System has a substantially equivalent intended use as the identified predicates. The subject device is similar in fundamental scientific technology to the predicate device in that they all have been designed, manufactured and tested in compliance with FDA's Class II special controls guidance document root-form endosseous dental implants and endosseous dental implant abutment, and they are all constructed of titanium.

The subject and primary predicate devices are similar in indications, design, technology, functions, dimensions, and material.

The differences between the subject device and the primary predicate are:

- 1) Surface Treatment Method
The surface treatment method of the subject device is SLA (Sandblast, Large grit Acid etched) and the surface treatment method of the primary predicate device is RBM (Resorbable Blasted Media). To support this discrepancy, the predicate, K101096 is selected as reference and biocompatibility testing, surface roughness demonstration, surface SEM, and surface EDS were performed on the subject device.

- 2) Slight differences in fixture designs, especially LISA Implant LISA Implant has a concave appearance to be placed in the narrow ridge area, which is difference of the shape between the subject and primary predicate, K073116. To support this discrepancy, the predicate, K061797 is selected as reference.
Any differences in technology characteristics are accompanied by information that demonstrated the device is substantially equivalent as the predicates and do not raise different questions of safety and effectiveness than the predicate.

#### Conclusion

The Internal Octa Implant System, subject device of this submission, constitutes a substantially equivalent medical device, meeting all the declared requirements of its intended use. The risks of using the device as recommended pose no greater risks than any other implant systems. This system has the same intended use and fundamental scientific technology as its predicate devices. Therefore, Internal Octa Implant System and its predicates are substantially equivalent.