IS-III active System

K181138 · Neobiotech Co., Ltd. · DZE · Oct 3, 2018 · Dental

Device Facts

• Record ID: K181138
• Device Name: IS-III active System
• Applicant: Neobiotech Co., Ltd.
• Product Code: DZE · Dental
• Decision Date: Oct 3, 2018
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3640
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The IS-III active System is indicated for use in partially or fully edentulous mandibles and maxillae, in support of single or multiple-unit restorations including; cemented retained, screw retained, or overdenture restorations, and terminal or intermediate Abutment support for fixed bridgework. IS-III active System is dedicated for two stage surgical procedures and for immediate loading when there is good primary stability and an appropriate occlusal load. Also, implants with diameters larger than 5mm are indicated for molar regions.

Device Story

The IS-III active System consists of endosseous dental implants (fixtures) and various abutments used to replace missing teeth. Fixtures are surgically placed into the alveolar bone of the mandible or maxilla. The system uses an internal hex connection to attach prosthetic components. Fixtures are treated with SLA (Sandblasted with Large-grit and Acid-etching) to promote osseointegration. Abutments, including healing, solid, cemented, shapable, angled, ball, and UCLA types, are attached to the fixture to support crowns, bridges, or overdentures. The device is used in dental clinics by dentists or oral surgeons. The healthcare provider selects the appropriate abutment based on the clinical site and restoration type. The system provides a stable foundation for prosthetic teeth, restoring chewing function and aesthetics for the patient.

Clinical Evidence

Bench testing only. Evidence includes biocompatibility (ISO 10993 series), fatigue testing (ISO 14801:2016), bacterial endotoxin testing (ANSI/AAMI ST72, USP <161>, USP <85>), sterilization validation (ISO 17665, ISO 11137), and shelf-life testing (ASTM F1980). Results met all criteria, demonstrating substantial equivalence.

Technological Characteristics

Fixtures: Ti CP4 (ASTM F67), SLA surface. Abutments: Ti-6Al-4V ELI (ASTM F136), some with TiN-coating or anodizing. Protective caps/UCLA abutments: POM (ASTM F1855) or Gold Alloy. Connection: Internal hex. Sterilization: Gamma radiation for fixtures/healing abutments; others non-sterile. Dimensions: Various diameters/lengths with ±1% tolerance.

Indications for Use

Indicated for partially or fully edentulous adult patients requiring single or multiple-unit dental restorations (cemented, screw-retained, or overdenture) or fixed bridgework support. Implants >5mm diameter are indicated for molar regions. Suitable for two-stage surgical procedures and immediate loading given adequate primary stability and occlusal load.

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

• CMI Implant IS System (K113554)

Reference Devices

• CMI Implant IS II active (K120503)
• Dentum Implantium® / SuperLine® Prosthetics (K160828)
• IS-III HActive Fixture (K173938)
• Implantium Prosthetics (K070228)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters 'FDA' in a blue square, followed by the words 'U.S. FOOD & DRUG ADMINISTRATION' in blue text.

October 3, 2018

Neobiotech Co., Ltd. % April Lee Consultant Withus Group Inc 106 Superior Irvine, California 92620

Re: K181138

Trade/Device Name: IS-III active System Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: Class II Product Code: DZE, NHA Dated: August 30, 2018 Received: September 6, 2018

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. 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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; 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 mediation-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,

# Andrew I. Steen -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)

#### K181138

Device Name IS-III active System

#### Indications for Use (Describe)

The IS-III active System is indicated for use in partially or fully edentulous mandibles and maxillae, in support of single or multiple-unit restorations including: cemented retained, or overdenture restorations, and terminal or internediate Abutment support for fixed bridgework. IS-III active System is dedicated for two stage surgical procedures and for immediate loading when there is good primary stability and an appropriate occlusal load. Also, implants with diameters larger than 5mm are indicated for molar regions.

| 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

Neobiotech. Co., Ltd. Young-Ku, Heo #312-1, 36, Digital-ro 27 gil Guro-gu. Seoul 08381 South Korea Email: [e-mail] Tel. [phone] Fax. [phone]

#### Official Correspondent Withus Group Inc

April Lee 106 Superior, Irvine, CA 92620 USA Email: [e-mail] Phone: [phone] Fax: [phone]

#### Device Information

- Trade Name: IS-III active System
- Common Name: Endosseous Dental Implant
- Classification Name: Implant, Endosseous, Root-Form
- . Primary Product Code: DZE
- Secondary Product Code: NHA
- Panel: Dental
- Regulation Number: 21 CFR 872.3640
- Device Class: Class II
- Date Prepared: 10/03/2018

#### Predicate Devices:

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

Primary Predicate

- K113554, CMI Implant IS System manufactured by Neobiotech Co., Ltd. ●
Reference Devices

- . K120503, CMI Implant IS II active manufactured by Neobiotech Co., Ltd
- K160828, Dentum Implantium® / SuperLine® Prosthetics manufactured by Dentium Co., Ltd.
- K173938, IS-III HActive Fixture manufactured by Neobiotech Co., Ltd. ●
- K070228, Implantium Prosthetics by Dentium Co.,Ltd. ●

#### Indications for Use:

The IS-III active System is indicated for use in partially or fully edentulous mandibles and maxillae, in support of single or multiple-unit restorations including; cemented retained, screw retained, or overdenture restorations, and terminal or intermediate Abutment support for fixed bridgework. IS-III active System is dedicated for two stage surgical procedures and for immediate loading when there is good primary stability and an appropriate occlusal load. Also, implants with diameters larger than 5mm are indicated for molar regions.

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## Device Description

IS-III active System is composed of IS-III active fixtures and Abutments. IS-III active Fixture is a thread type implant made of TI CP4 according to ASTM F67 which will be placed in the alveolar bone to replace the function of the missing tooth. This device has connection between the upper prosthesis and the internal hex.

Fixture's surface is treated with SLA (Sandblasted with Large-grit and Acid-etching). It is only part to be implanted into bone, and to provide connection of prosthetic devices or other components of a dental implant set with human body (mandibular or maxillary bone).

| Fixture Type | Diameter (mm) | Length (mm) |
|-----------------------|-------------------|-----------------------------|
| Image: Dental Implant | Ø 3.5 | 8.5/10.0/11.5/13.0/15.0 |
| Image: Dental Implant | Ø 4.0/4.5/5.0 | 7.3/8.5/10.0/11.5/13.0/15.0 |
| Image: Dental Implant | Ø 3.5 | 8.5/10.0/11.5/13.0/15.0 |
| Image: Dental Implant | Ø 4.0/4.5/5.0/5.5 | 7.3/8.5/10.0/11.5/13.0/15.0 |
| Image: Dental Implant | Ø 6.0/7.0 | 7.3/8.5/10.0/11.5/13.0 |
| Image: Dental Implant | Ø 3.5 | 8.5/10.0/11.5/13.0/15.0 |
| Image: Dental Implant | Ø 4.0/4.5/5.0/5.5 | 7.3/8.5/10.0/11.5/13.0/15.0 |
| Image: Dental Implant | Ø 6.0 | 7.3/8.5/10.0/11.5/13.0 |
| Image: Dental Implant | Ø 7.0 | 7.3/8.5/10.0/11.5 |
| Image: Dental Implant | Ø 3.5 | 8.5/10.0/11.5/13.0/15.0 |
| Image: Dental Implant | Ø 4.0/4.5/5.0/5.5 | 7.3/8.5/10.0/11.5/13.0/15.0 |
| Image: Dental Implant | Ø 6.0/7.0 | 7.3/8.5/10.0/11.5/13.0 |

There are 4 types of fixtures in this system and the dimensions are as following:

Tolerance of dimension shall be within ± 1% range.

IS-III active System Abutments are composed of IS Cover Screw, IS Healing Abutment, IS Encoded Healing Abutment, IS Solid Abutment, Protective Cap, IS Cemented Abutment, IS Shapable Abutment, IS Angled Abutment, IS Gold UCLA Abutment, IS Temporary Abutment, IS Ball Abutment, IS Ball Abutment Component (Housing, Retainer, O-ring) and IS Abutment Screw.

The dimensions of abutments are as following:

| Name | | Diameter (mm) | Length of Cuff (mm) |
|---------------------|-------|-----------------------|-------------------------------|
| IS Cover Screw | | Ø 3.45 | 5.85/6.85/7.45 |
| | | Ø 3.6 | 6.4/7.4/8.0 |
| IS Healing Abutment | | Ø 4.8/5.5/6.0/6.8 | Cuff: 2.8/3.8/4.8/5.8/6.8/7.8 |
| | | Ø 4.0/4.5 | Cuff: 2.3/3.3/4.3/5.3/6.3 |
| | | Ø 8.0/9.0 | Cuff: 2.8/3.8/4.8 |
| IS Encoded Healing | Body | Ø 4.0/4.6 | Cuff: 3.3/4.3/5.3/6.3/7.3 |
| | | Ø 5.3/5.8/6.6/8.0/9.0 | Cuff: 2.3/3.3/4.3/5.3 |
| | Screw | Ø 2.3 | 8.4/9.4/10.4/11.4/12.4/13.4 |
| IS Solid Abutment | | Ø 4.5/5.2/5.7/6.5 | 4.0/4.5/5.5/7.0 |
| Protective cap | | Ø 5.0/5.7/6.2 | 5.5/6.3/7.3/8.8 |
| | | Ø 7.1 | 5.5/6.3/7.75/9.25 |

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| IS Cemented Abutment | Ø 4.5/5.2/5.7 | 4.0/4.5/5.5/7.0/8.0 | |
|--------------------------------|---------------|---------------------|-----|
| | *Ø6.5 | 4.0/4.5/5.5/7.0/8.0 | |
| | **Ø4.5 | 5.5/7.0 | |
| | **Ø5.2/5.7 | 4.0/4.5/5.5/7.0 | |
| IS Shapable Abutment | Ø 4.5/5.2/5.7 | 8.1/11.1 | |
| | Ø 6.5 | 8.1 | |
| IS Angled Abutment | Ø 4.5/5.2/5.7 | 7.0 | |
| IS Ball Abutment | Ø 3.5 | 11.1/12.1/13.1/14.1 | |
| IS Ball Abutment<br>_component | Housing | Ø 5.0 | 4.0 |
| | Retainer | Ø 5.0 | 2.0 |
| | O-ring | Ø 4.6 | - |
| | | Ø 4.7 | - |
| IS Gold UCLA Abutment | Ø 4.5 | 10.0 | |
| IS Temporary Abutment | Ø 4.5 | 6.0/8.0/11.5 | |
| Abutment Screw | Ø 2.3 | 8.8/8.3 | |

* Not all Ø6.5 diameter abutments are available in 8.0 length.

** Theses are a separate type of IS Cemented Abutment.

The features of each abutment are as following:

| Name | Uses | Surface<br>Treatment | Connection |
|--------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------|--------------------------------|
| IS Cover Screw | It is used for protecting inner hole<br>and connecting part with exposed<br>upper part of structure during the<br>healing period after inserting dental<br>implant fixture | Anodizing<br>(yellow),<br>Non-<br>Anodizing | Screw<br>Retained |
| IS Healing Abutment | Used to formation appropriate<br>gingival shape during the soft tissue<br>healing period combined with<br>implant | N/A | Screw Retained |
| IS Encoded Healing<br>Abutment | | N/A | Internal Hex |
| IS Solid Abutment | The Abutment is connected with<br>fixture and it supports prosthesis<br>which restores tooth function. | TiN-Coating | Screw<br>Retained |
| IS Cemented Abutment | | | Internal Hex, Non-Hex, |
| IS Shapable Abutment | | | SCRP |
| IS Angled Abutment | | | Internal Hex, Non-Hex |
| IS Ball Abutment | | N/A | Screw Retained |
| IS Gold UCLA<br>Abutment | | N/A | Internal Hex, Non-Hex,<br>SCRP |
| IS Temporary Abutment | | N/A | N/A |
| Protective Cap | Used to protect Solid Abutments in<br>the oral cavity. | N/A | - |
| IS Abutment Screw | It is used to fix Abutment at the top<br>of fixture | N/A | Screw<br>Retained |

Tolerance of dimension for Abutments shall be within ± 1% range.

The purpose of Anodizing for Cover Screw is to distinguish the sizes with the naked eyes for convenience. The surface of IS Solid, cemented, Shapable, Angled Abutments was treated with TiN-Coated.

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IS-III active Fixture, IS cover screw, and healing Abutments are provided sterilized. And other Abutments are provided non- sterilized.

IS-III active Fixture is enclosed with Cover Screw in a packing. Other Abutments are enclosed with Abutment Screw in a packing. The Solid Abutment is enclosed with Protective cap.

All of above products including enclosed product are packed separately for convenience.

## Materials:

- . The Fixtures are made of TI CP4 of ASTM F67.
- . The Abutments (IS Cover Screw, IS Healing Abutment, IS Encoded Abutment, IS Solid Abutment, IS Cemented Abutment, IS Shapable Abutment, IS Angled Abutment, IS Temporary Abutment, IS Abutment Screw) are fabricated from Ti-6A1-4V ELI of ASTM F136.
- The IS Gold UCLA Abutment is fabricated from Gold Alloy and Polyoxymethylene (POM) of ● ASTM F1855.
- . The Protective Cap is fabricated from Polyoxymethylene (POM) of ASTM F1855.
- . The IS Ball Abutment attachments are fabricated from Ti-6Al-4V ELI of ASTM F136(Housing, Retainer) and Silicon(O-ring).

#### Summaries of Technological Characteristics:

| | Subject Device | Primary Predicate | Reference Device |
|----------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Company | Neobiotech Co., Ltd | Neobiotech Co., Ltd. | Neobiotech Co., Ltd. |
| Device Name | IS-III active System | CMI Implant IS System | CMI Implant IS II active |
| 510(k) Number | K181138 | K113554 | K120503 |
| Device<br>Classification<br>Name | Implant, Endosseous,<br>Root-Form | Implant, Endosseous,<br>Root-Form | Implant, Endosseous, Root-<br>Form |
| Product Code | DZE | DZE | DZE |
| Regulation<br>Number | 872.3640 | 872.3640 | 872.3640 |
| Indications for<br>Use | The IS-III active System is<br>indicated for use in partially<br>or fully edentulous mandibles<br>and maxillae, in support of<br>single or multiple-unit<br>restorations including;<br>cemented retained, screw<br>retained, or overdenture<br>restorations, and terminal or<br>intermediate Abutment<br>support for fixed bridgework.<br>IS-III active System is<br>dedicated for two stage<br>surgical procedures and for<br>immediate loading when there<br>is good primary stability and<br>an appropriate occlusal load. | The CMI Implant IS System is<br>indicated for use in partially<br>or fully edentulous mandibles<br>and maxillae, in support of<br>single or multiple-unit<br>restorations including;<br>cemented retained, screw<br>retained, or overdenture<br>restorations, and terminal or<br>intermediate Abutment<br>support for fixed bridgework.<br>IS System is dedicated for two<br>stage surgical procedures and<br>for immediate loading when<br>there is good primary stability<br>and an appropriate occlusal<br>load. Also, implants with | The CMI Implant IS II active<br>is intended to be surgically<br>placed in the bone of the<br>upper or lower jaw arches to<br>provide support for prosthetic<br>devices, such as artificial<br>teeth, and to restore the<br>patient's chewing function. It<br>is intended for immediate<br>loading when good primary<br>stability is achieved and with<br>appropriate occlusal loading. |

#### 1) IS-III active Fixture

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| | Also, implants with diameters<br>larger than 5mm are indicated<br>for molar regions. | diameters larger than 5mm are<br>indicated for molar regions. | diameters larger than 5mm are<br>indicated for molar regions. |
|----------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Material | TI CP4 of ASTM F67 | TI CP4 of ASTM F67 | TI CP4 of ASTM F67 |
| Design | Image: dental implant | Image: dental implant | Image: dental implant |
| Anti-Rotational<br>Feature | Internal Hex | Internal Hex | Internal Hex |
| Diameters(Ø) | 3.5/4.0/4.5/5.0/5.5/6.0/7.0 | 3.5/4.0/4.5/5.0/5.5/6.0/7.0/8.0 | 3.5/4.0/4.5/5.0/5.5/6.0/7.0/8.0 |
| Lengths(mm) | 7.3/8.5/10.0/11.5/13.0/15.0 | 7.3/8.5/10.0/11.5/13.0/15.0 | 7.3/8.5/10.0/11.5/13.0/15.0 |
| Surface<br>Treatment | SLA | RBM | SLA |
| Sterilization | Gamma Sterilization | Gamma Sterilization | Gamma Sterilization |
| Principle of<br>Operation | This product is a root-type<br>fixture which is inserted in the<br>alveolar bone. It replaces the<br>functions of the missing teeth<br>as a dental implant fixture. | This product is a root-type<br>fixture which is inserted in the<br>alveolar bone. It replaces the<br>functions of the missing teeth<br>as a dental implant fixture | This product is a root-type<br>fixture which is inserted in the<br>alveolar bone. It replaces the<br>functions of the missing teeth<br>as a dental implant fixture. |
| Similarities | The IS-III active Fixture has same device characteristics with the Primary predicate devices, CMI<br>Implant IS System (K113554) such as diameters, Length, intended use, material, functions,<br>general shape (Design), structure and applied production method are similar. | | |
| Differences | The differences between the subject device and the primary predicate device is surface treatments<br>and product design. The surface treatment method of the predicate fixture is RBM (Resorbable<br>Blasting Media) and the surface treatment method of the subject device is SLA (Sandblasted with<br>Large-grit and Acid-etching). To support this discrepancy, K120503 was added as a reference<br>device which was treated with SLA method. | | |

# 2) IS Cover Screw

| | Subject Device | Primary Predicate | Reference Device |
|----------------------|---------------------------------------|----------------------------------------|-----------------------------------------|
| Company | Neobiotech Co., Ltd | Neobiotech Co., Ltd. | Neobiotech Co., Ltd. |
| Device Name | IS-III active System | CMI Implant IS System | IS-III HActive Fixture |
| 510(k)<br>Number | K181138 | K113554 | K173938 |
| Material | Ti-6Al-4V ELI of<br>ASTM F136 | Ti-6Al-4V ELI of<br>ASTM F136 | Ti-6Al-4V ELI of ASTM F136 |
| Design | Image: Design of IS-III active System | Image: Design of CMI Implant IS System | Image: Design of IS-III HActive Fixture |
| Diameters(Ø) | 3.45/3.6 | 3.19/3.35 | 3.45/3.6 |
| Lengths(mm) | 5.85/6.85/7.45/<br>6.4/7.4/8.0/ | 5.45/5.85 | 5.85/6.85/7.45/<br>6.4/7.4/8.0/ |
| Surface<br>Treatment | Anodizing/ Non-Anodizing, | N/A | Anodized/Non-Anodized |

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| Sterilization | Gamma Sterilization | Gamma Sterilization | Gamma Sterilization |
|---------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Principle of<br>Operation | It is used for protecting inner<br>hole and connecting part with<br>exposed upper part of<br>structure during the healing<br>period after inserting dental<br>implant fixture. When<br>inserting the Abutment,<br>Cover screw is removed. | It is used for protecting inner<br>hole and connecting part with<br>exposed upper part of<br>structure during the healing<br>period after inserting dental<br>implant fixture. When<br>inserting the Abutment,<br>Cover screw is removed. | It is used for protecting inner hole<br>and connecting part with exposed<br>upper part of structure during the<br>healing period after inserting<br>dental implant fixture. When<br>inserting the Abutment, Cover<br>screw is removed |
| Similarities | The subject device has same intended use, material, functions, principle of operation, shelf life and<br>similar design and dimensions. | | |
| Differences | There are slightly different designs and dimensions. Also, the subject device includes anodized<br>cover screw. To support the dimension, K173983 was referenced. This change doesn't affect<br>product's fundamental function, safety and effectiveness. | | |

# 3) IS Healing Abutment

| | Subject Device | Primary Predicate Device | Reference Device |
|---------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------|
| Company | Neobiotech Co., Ltd | Neobiotech Co., Ltd. | Dentium Co., Ltd. |
| Device Name | IS-III active System | CMI Implant IS System | Implantium Prosthetics |
| 510(k) Number | K181138 | K113554 | K070228 |
| Material | Ti-6Al-4V ELI of ASTM<br>F136 | Ti-6Al-4V ELI of ASTM F136 | Titanium Grade 4 of ASTM<br>F67 |
| Design | Image: Subject Device Design | Image: Primary Predicate Device Design | Image: Reference Device Design |
| Diameters (Ø) | 4.0/4.5/4.8/5.5/6.0/6.8/8.0/9.0 | 4.8/5.5/6.0/6.8 | 4.0/4.5/5.5/6.5/7.5/8.5/9.5 |
| Cuff(mm) | 2.3/2.8/3.3/3.8/4.3/4.8/5.3/5.8/<br>6.3/6.8/7.8/ | 2.0/3.0/4.0/5.0/6.0/7.0/8.0 | 2.0/3.5/5.0/7.0 |
| Surface<br>Treatment | N/A | N/A | N/A |
| Sterilization | Gamma Sterilization | Gamma Sterilization | Gamma Sterilization |
| Principle of<br>Operation | This product is healing<br>Abutment to formation<br>appropriate gingival shape<br>during the soft tissue healing<br>period combined with implant.<br>This product should be<br>removed when the<br>superstructure is set up. | This product is healing<br>Abutment to formation<br>appropriate gingival shape<br>during the soft tissue healing<br>period combined with implant.<br>This product should be removed<br>when the superstructure is set<br>up. | Implantium Prosthetic is<br>intended for use as an aid in<br>prosthetic rehabilitation. |
| Similarities | The subject device has same intended use, functions, material, surface treatment, principle of operation, shelf life and similar design and heights as the primary predicate. | | |
| Differences | There are slightly different diameters between the subject and primary predicate device. K070228 was added to support the large diameters of the subject healing abutments such as 8.0 and 9.0mm. | | |

{9}------------------------------------------------

| | | | | 4) IS Encoded Healing Abutment | |
|--|--|--|--|--------------------------------|--|
|--|--|--|--|--------------------------------|--|

| | Subject Device | Primary Predicate Device | Reference<br>Device | Reference<br>Device |
|---------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------|----------------------|
| Company | Neobiotech Co., Ltd | Neobiotech Co., Ltd. | Biomet 3i. | Dentium<br>Co., Ltd. |
| Device<br>Name | IS-III active System | CMI Implant IS System | Implantium Prosthetics | |
| 510(k)<br>Number | K181138 | K113554 | K070228 | |
| Material | Ti-6Al-4V ELI of ASTM F136 | Ti-6Al-4V ELI of ASTM<br>F136 | Titanium Grade 4 of ASTM<br>F67 | |
| Design | Image: Subject Device Design | Image: Primary Predicate Device Design | Image: Reference Device Design | |
| Diameters<br>(Ø) | Body:4.0/4.6/5.3/5.8/6.6/8.0/9.0 | 4.8/5.5/6.0/6.8 | 4.0/4.5/5.5/6.5/7.5/8.5/9.5 | |
| Lengths<br>(mm) | Body Cuff: 2.3/3.3/4.3/5.3/6.3/7.3 | 2.0/3.0/4.0/5.0/6.0/7.0/8.0 | 2.0/3.5/5.0/7.0 | |
| Surface<br>Treatment | N/A | N/A | N/A | |
| Sterilization | Gamma Sterilization | Gamma Sterilization | Gamma Sterilization | |
| Principle of<br>Operation | This product is healing Abutment<br>to formation appropriate gingival<br>shape during the soft tissue healing<br>period combined with implant.<br>This product should be removed<br>when the superstructure is set up.<br>It is two-piece type which is<br>consist with Healing Abutment<br>and Abutment screw.<br>The occlusal surface of the device<br>includes machined markings that<br>provide information about the<br>mating implant's position<br>and orientation. | This product is healing<br>Abutment to formation<br>appropriate gingival shape<br>during the soft tissue<br>healing period combined<br>with implant. This product<br>should be removed when the<br>superstructure is set up. | Implantium Prosthetic is<br>intended for use as an aid in<br>prosthetic rehabilitation. | |
| Similarities | The subject device has same intended use, material, function, surface treatment, principle of<br>operation and similar dimensions as the primary predicate. | | | |
| Differences | There are slightly different dimensions. To support diameters, K070228 was added and to support<br>heights, K070228 were added. | | | |

# 5) IS Solid Abutment

| | Subject Device | Primary Predicate Device |
|---------------|----------------------------|----------------------------|
| Company | Neobiotech Co., Ltd | Neobiotech Co., Ltd. |
| Device Name | IS-III active System | CMI Implant IS System |
| 510(k) Number | K181138 | K113554 |
| Material | Ti-6Al-4V ELI of ASTM F136 | Ti-6Al-4V ELI of ASTM F136 |

{10}------------------------------------------------

| Design | |
|------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------|
| Image: dental implant design | Image: dental implant design with length and cuff labels |
| Diameters (Ø) | 4.5/5.2/5.7/6.5 |
| Diameters (Ø) | 4.5/5.2/5.7/6.5 |
| Lengths(mm) | 4.0/4.5/5.5/7.0 |
| Lengths(mm) | 4.5/5.5/6.0/7.0/8.0 |
| Surface<br>Treatment | TiN-Coating |
| Surface<br>Treatment | TiN-Coating |
| Principle of<br>Operation | It is one body cement retained restoration, connected with fixture and cemented crown on the Abutment. |
| Principle of<br>Operation | It is one body cement retained restoration, connected with fixture and cemented crown on the Abutment. |
| Similarities | The subject device has same intended use, material, function, surface treatment, principle of operation and similar design and dimensions. |
| Differences | The dimensions are slightly different but it doesn't affect device's fundamental functions. |

## 6) Protective Cap

| | Subject Device | Predicate Device |
|---------------------------|-------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------|
| Company | Neobiotech Co., Ltd | Neobiotech Co., Ltd. |
| Device Name | IS-III active System | CMI Implant IS System |
| 510(k) Number | K181138 | K113554 |
| Material | Polyoxymethylene (POM) of ASTM F1855 | Polyoxymethylene (POM) of ASTM F1855 |
| Design | Image: Subject Device Design | Image: Predicate Device Design |
| Diameters (Ø) | 5.0/5.7/6.2/7.1 | 4.5/5.2/5.7/6.5 |
| Lengths(mm) | 5.5/6.3/7.3/8.8/7.75/9.25 | 4.5/5.5/6.0/7.0/8.0 |
| Surface<br>Treatment | N/A | N/A |
| Principle of<br>Operation | Used to protect Solid Abutments in the oral cavity | Used to protect Solid Abutments in the oral cavity |
| Similarities | The subject device has same intended use, material, function, principle of operation and similar design and dimensions. | |
| Differences | The dimensions are slightly different but it doesn't affect device's fundamental functions. | |

{11}------------------------------------------------

| 7) IS Cemented Abutment / IS Shapable Abutment/ IS Angled Abutment | |
|--------------------------------------------------------------------|--|
| | |

| | Subject Device | Primary Predicate Device | Reference Device |
|---------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------|
| Company | Neobiotech Co., Ltd | Neobiotech Co., Ltd. | Dentium Co., Ltd. |
| Device Name | IS-III active System | CMI Implant IS System | Dentum Implantium® /<br>SuperLine® Prosthetics |
| 510(k) Number | K181138 | K113554 | K160828 |
| Material | Ti-6Al-4V ELI of ASTM F136 | Ti-6Al-4V ELI of ASTM F136 | Pure Titanium Grade4 |
| IS Cemented Abutment | | | |
| Design | Image: IS Cemented Abutment Hex Design | Image: IS Cemented Abutment Non-Hex Design | Image: IS Cemented Abutment SCRP Design |
| | Hex | Non-Hex | SCRP |
| Diameters (Ø) | 4.5/5.2/5.7/6.5 | 4.5/5.2/5.7/6.5 | - |
| Lengths(mm) | 4.0/4.5/5.5/7.0/8.0 | 4.5/5.5/6.0/7.0/8.0 | - |
| IS Shapable Abutment | | | Dual Milling Abutment |
| Design | Image: IS Shapable Abutment Hex Design | Image: IS Shapable Abutment Non-Hex Design | Image: Dual Milling Abutment Design |
| | Hex | Non-Hex | Hex and Non-Hex |
| Hand Milling Only | Yes | | Yes |
| Diameters(Ø) | 4.5/5.2/5.7/6.5 | | 4.0~6.5 |
| Lengths(mm) | 8.1/11.1 | | 14.7…