IS-III HActive Fixture

K173938 · Neobiotech Co., Ltd. · DZE · May 24, 2018 · Dental

Device Facts

• Record ID: K173938
• Device Name: IS-III HActive Fixture
• Applicant: Neobiotech Co., Ltd.
• Product Code: DZE · Dental
• Decision Date: May 24, 2018
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3640
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The IS-III HActive Fixture 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, and to restore the patient's chewing function. It is intended for immediate loading when good primary stability is achieved and with appropriate occlusal loading.

Device Story

IS-III HActive Fixture is an endosseous dental implant system consisting of a titanium alloy fixture and cover screw. The fixture is surgically placed into the alveolar bone of the jaw to replace missing teeth. It features an internal hex connection for prosthetic abutments. The surface is treated with Resorbable Blasting Media (RBM) using hydroxyapatite (HA) powder, followed by plasma-spray HA coating to enhance osseointegration. The cover screw protects the internal connection during the healing period. Used in clinical dental settings by trained dental professionals. The device provides a stable foundation for prosthetic restorations, enabling functional chewing for the patient.

Clinical Evidence

Bench testing only. Evidence includes biocompatibility (ISO 10993 series), fatigue testing (ISO 14801), sterilization validation (ISO 11137), shelf-life testing (ASTM F1980), and bacterial endotoxin testing. Adhesion testing was performed to evaluate HA coating stability. Results met all applicable standards, demonstrating substantial equivalence.

Technological Characteristics

Materials: Ti-6Al-4V ELI (ASTM F136). Design: Root-form endosseous dental implant with internal hex connection. Surface: HA coating via RBM and plasma-spray. Cover screw: Anodized or non-anodized titanium alloy. Sterilization: Gamma radiation. Dimensions: Diameters 3.5-7.0mm, Lengths 7.3-15.0mm.

Indications for Use

Indicated for patients requiring dental implants in the upper or lower jaw arches to support prosthetic devices (artificial teeth) and restore chewing function. Suitable for immediate loading when primary stability and appropriate occlusal loading are achieved.

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 II active (K120503)
• CMI Implant IS System (K113554)
• Legacy System Dental Implant With HA Coating (K073033)
• Dentis HAPTITE Implant System (K111364)

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.

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

June 1, 2018

Re: K173938

Trade/Device Name: IS-III HActive Fixture Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous dental implant Regulatory Class: Class II Product Code: DZE, NHA Dated: April 24, 2018 Received: May 23, 2018

Dear April Lee:

This letter corrects our substantially equivalent letter of May, 24, 2018.

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 to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part

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801); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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.

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,

# Mary S. Runner -S

For Tina Kiang, Ph.D. Acting Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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#### DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

# Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below.

510(k) Number (if known) K173938

Device Name IS-III HActive Fixture

Indications for Use (Describe)

The IS-III HActive Fixture 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, and to restore the patient's chewing function. It 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) | <span> <div style="display:inline-block;"> <span style="text-decoration: overline;">☒</span> Prescription Use (Part 21 CFR 801 Subpart D) </div> <div style="display:inline-block;"> <span>☐</span> Over-The-Counter Use (21 CFR 801 Subpart C) </div> </span> |
|-------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
|-------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|

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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: samw728@@neobiotech.co.kr 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 HActive Fixture ●
- 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
- Class II ● Device Class:
- . Date Prepared: 05/23/2018

# General Description

IS-III HActive Fixture is composed of fixtures and cover screw. Fixtures are thread type implants made of titanium alloy which will be placed in the alveolar bone to replace the function of the missing It is made of Titanium Alloy based on ASTM F136. Surface treatment is HA Coating. This tooth. device has connection between the upper prosthesis and the internal hex.

Surface is treated with RBM (Resorbable Blasting Media) using Hydroxyapatite powder. Residues are removed through a washing procedure after Plasma-spray with Hydroxyapatite and formation of the HA coating.

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).

The diameters are 3.5/4.0/4.5/5.0/6.0/7.0mm and the lengths are 7.3/ 8.5/10.0/ 11.5/13.0/15.0mm. (Do not offer 3.5 x 7.3mm implant, 6.0 x 15mm implant, or 7.0 x 15mm implant)

|--|

| K number | List of Abutments |
|----------|------------------------------------------------------------------------------------------------------------------------------------------------|
| K113554 | Healing Abutment, Abutment(Cemented(Hex/non-Hex), Angled, SCRP), Solid<br>Abutment, UCLA Gold Abutment, Ball Abutment, and Temporary Abutment) |

Cover Screw intended to protect the inside of the implant during osseointegration. It is made of titanium alloy according to ASTM F136. The surface treatment of the cover Screw is anodizing or non-anodizing. The purpose of anodizing is to distinguish the sizes with the naked eyes for convenience. The diameter of cover screw is 3.45/3.6mm

IS-III HActive Fixture is enclosed with Cover Screw in a packing. IS-III HActive Fixture and Cover Screw can be packed separately for convenience.

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#### Indication for Use:

The IS-III HActive Fixture 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, and to restore the patient's chewing function. It is intended for immediate loading when good primary stability is achieved and with appropriate occlusal loading.

#### Materials:

The fixtures and cover screws are fabricated from Ti-6A1-4V ELI of ASTM F136.

#### Predicate Devices:

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

- o K120503, CMI Implant IS II active manufactured by Neobiotech Co., Ltd.
- K113554, CMI Implant IS System manufactured by Neobiotech Co., Ltd. ●
- K073033, Legacy System Dental Implant With HA Coating manufactured by Implant Direct LLC ●
- K111364, Dentis HAPTITE Implant System, manufactured by Dentis Co.,Ltd. .

#### Comparison to Predicate Devices:

| 1) Fixture |
|------------|
| |

| | Subject Device | Primary Predicate<br>Device | Reference Device | Reference Device |
|----------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Company | Neobiotech Co., Ltd | Neobiotech Co., Ltd. | Implant Direct LLC | Dentis Co.,Ltd. |
| Device Name | IS-III HActive Fixture | CMI Implant IS II<br>active | Legacy System<br>Dental Implant Whit<br>HA Coating | Dentis HAPTITE<br>Implant System |
| 510(k) Number | N/A | K120503 | K073033 | K111364 |
| Device<br>Classification<br>Name | Implant, Endosseous,<br>Root-Form | Implant, Endosseous,<br>Root-Form | Implant, Endosseous,<br>Root-Form | Implant, Endosseous,<br>Root-Form |
| Product Code | DZE | DZE | DZE | DZE |
| Regulation<br>Number | 872.3640 | 872.3640 | 872.3640 | 872.3640 |
| Intended Use | The IS-III HActive<br>Fixture is intended to<br>be surgically placed in<br>the bone of the upper<br>or lower jaw arches to<br>provide support for<br>prosthetic devices,<br>such as artificial teeth,<br>and to restore the<br>patient's chewing<br>function. It is intended<br>for immediate loading<br>when good primary | The CMI Implant IS II<br>active is intended to be<br>surgically placed in the<br>bone of the upper or<br>lower jaw arches to<br>provide support for<br>prosthetic devices,<br>such as artificial teeth,<br>and to restore the<br>patient's chewing<br>function. It is intended<br>for immediate loading<br>when good primary | The intended use of<br>the Legacy System<br>Implants with HA<br>Coating is identical<br>to the intended use of<br>the predicate<br>abutments. These<br>implants are two-<br>piece implants for<br>single-stage or two-<br>stage surgical<br>procedures. The<br>Legacy implants | The Dentis Implant<br>System is indicated<br>for use in partially or<br>fully edlentulous<br>mandibles and<br>maxillae, in support<br>of single or multiple-<br>unit restorations<br>including; cemented<br>retained, screw<br>retained, or<br>overdenture<br>restorations, and |
| | stability is achieved<br>and with appropriate<br>occlusal loading. | stability is achieved<br>and with appropriate<br>occlusal loading. | are intended for use<br>in the mandible and<br>maxilla, in support of<br>single or multipleunit<br>cement or screw<br>receiving fixed<br>restorations and for<br>retention and support<br>of overdentures. The<br>implants are intended<br>for immediate<br>placement and<br>function<br>for support of single<br>tooth and/or multiple<br>tooth restorations,<br>recognizing bone<br>stability and<br>appropriate occlusal<br>load requirements | terminal or<br>intermediate<br>abutment support for<br>fixed<br>bridgework. This<br>system is dedicated<br>for one and two stage<br>surgical procedures<br>and not dedicated for<br>immediate loading.<br>This system is<br>intended for delayed<br>loading. |
| Material | Ti-6Al-4V ELI of<br>ASTM F136 | Pure Titanium of<br>ASTM F 67 | Ti-6Al-4V ELI of<br>ASTM F136 | Pure Titanium of<br>ASTM F 67 |
| Design | Image: dental implant | Image: dental implant | Image: dental implant | Image: dental implant |
| Anti-Rotational<br>Feature | Internal Hex | Internal Hex | Internal Hex | Internal Hex |
| Diameters<br>(mm) | 3.5/4.0/4.5/5.0/5.5/6.0/<br>7.0 | 3.5/4.0/4.5/5.0/5.5/6.0/<br>7.0/8.0 | 3.2/3.7/4.2/4.7/<br>5.2/5.7/7.0 | 3.7/4.1/4.3/4.8/5.5/6.<br>0/6.5/7.0 |
| Surface | HA Coating | S.L.A | HA Coating | HA Coating |
| Lengths<br>(mm) | 7.3/8.5/10.0/<br>11.5/13.0/15.0 | 7.3/8.5/10.0/<br>11.5/13.0/15.0 | 6/8/10/11.5/13<br>/16 | 7/8/9/10/12/14<br>/16 |
| Sterilization | Gamma Sterilization | Gamma Sterilization | Gamma Sterilization | Gamma Sterilization |
| Principle of<br>Operation | This product is a root-<br>type fixture which is<br>inserted in the alveolar<br>bone. It replaces the<br>functions of the<br>missing teeth as a<br>dental implant fixture. | This product is a root-<br>type fixture which is<br>inserted in the alveolar<br>bone. It replaces the<br>functions of the<br>missing teeth as a<br>dental implant fixture. | This product is a<br>root-type fixture<br>which is inserted in<br>the alveolar bone. It<br>replaces the<br>functions of the<br>missing teeth as a<br>dental implant<br>fixture. | This product is a<br>root-type fixture<br>which is inserted in<br>the alveolar bone. It<br>replaces the<br>functions of the<br>missing teeth as a<br>dental implant<br>fixture. |
| Shelf Life | 3 Years | 5 Years | - | - |

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- 2) Cover Screw

| 2) Cover Screw | | |
|-------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Subject Device | Predicate Device |
| Company | Neobiotech Co., Ltd | Neobiotech Co., Ltd. |
| Device Name | IS-III HActive Fixture | CMI Implant IS System |
| 510(k) Number | N/A | K113554 |
| Device Classification<br>Name | Abutment, Endosseous,<br>Root-Form | Abutment, Endosseous,<br>Root-Form |
| Product Code | NHA | NHA |
| Intended Use | The IS-III HActive Fixture is<br>intended to be surgically placed<br>in the bone of the upper or<br>lower jaw arches to provide<br>support for prosthetic devices,<br>such as artificial teeth, and to<br>restore the patient's chewing<br>function. It is intended for<br>immediate loading when good<br>primary stability is achieved<br>and with appropriate occlusal<br>loading. | The CMI Implant IS System is indicated for use in<br>partially or fully edentulous mandibles and maxillae, in<br>support of single or multiple-unit restorations including;<br>cemented retained, screw<br>retained, or overdenture restorations, and terminal or<br>intermediate abutment support for fixed bridgework. IS<br>System is dedicated for two stage surgical procedures<br>and for immediate loading when<br>there is good primary stability and an appropriate<br>occlusal load. Also, implants with diameters larger than<br>5 mm are indicated for molar regions. |
| Material | Ti-6Al-4V ELI of ASTM F136 | Ti-6Al-4V ELI of ASTM F136 |
| Design | Image: Two dental implants, one gold and one silver | Image: Dental implant |
| Diameters (mm) | 3.45/3.6 | 3.19/3.35 |
| Surface | Anodized/Non-Anodized | Non-anodized |
| Lengths (mm) | 6.4/7.4/8.0/<br>5.85/6.85/7.45mm | 5.45/5.85mm |
| Sterilization | Gamma Sterilization | Gamma Sterilization |
| Principle of Operation | Cover screw as a set of medical<br>devices is used for protecting<br>inner hole and connecting part<br>with exposed upper part of<br>structure during the healing<br>period after inserting dental<br>implant fixture. When inserting<br>the abutment, Cover screw is<br>removed. | Cover screw as a set of medical device is used for<br>protecting inner hole and connecting part with exposed<br>upper part of structure during the healing period after<br>inserting dental implant fixture. When inserting the<br>abutment, Cover screw is removed. |
| Shelf Life | 3 Years | 5 Year |

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#### Substantial Equivalence Discussion

#### Similarities:

The IS-III HActive Fixture has same device characteristics with the Primary predicate devices, CMI Implant IS System and CMI Implant IS-II active such as diameters, Length, intended use, general shape (Design), structure and applied production method are similar.

The subject device has been supposed to performance and product validations prior to release. Testing including biocompatibility tests and fatigue test has been performed to ensure the devices comply with the applicable International and US FDA Guidance.

#### Differences:

The differences between the subject device and the primary predicate device are surface treatment. The surface treatment method of the predicate fixture is SLA (sandblasted and acid-etched). The surface treatment method of the subject device is RBM (Resorbable Blasting Media) using hydroxyapatite powder and Plasma-spray with Hydroxyapatite for formation of the HA coating. The surface treatment of the subject cover screw is anodized.

#### Non-clinical testing data:

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

- Biocompatibility testing according to ISO 10993-1:2009, ISO 10993-3:2014, ISO 10993-. 5:2009, ISO 10993-6:2007, ISO 10993-10:2010 and ISO 10993-11:2006 on fixtures
- Bench testing such as visual test, dimension test, compressive loads, fatigue, adaptation ● accuracy, and torque tests on fixture and cover screw
- Fatigue Testing according to ISO 14801:2016 under the worst-case scenario ●
- Sterilization Testing according to ISO 11137-1:2006, ISO 11137-2:2013, and ISO 11137-● 3:2006
- Shelf Life Testing according to ASTM F1980
- Bacterial Endotoxin Test Report according to ANSI/AAMI ST72:2011, USP <161>, and ● USP <85>
- Adhesion Testing

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

Biocompatibility Test was conducted for the subject devices and it demonstrates that the subject device is biocompatible and substantial equivalence with the predicate device, K120503. Fatigue evaluation was performed with the angled abutment of the predicate device under the worst-case scenario in accordance with ISO 14801 and "Guidance for Industry and Staff - Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Implant Abutments".

The comparative SEM surface evaluation of the subject and reference device after insertion into a cow bone to demonstrate HA coating adhesion.

The non-clinical testing results demonstrate that the subject device is substantially equivalent to the predicate device.

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# Conclusion

IS-III HActive Fixture constitutes a substantially equivalent medical device, meeting all the declared requirements of its intended use. This system has the same intended use and fundamental scientific technology as its predicate devices. Therefore, IS-III HActive Fixture and its predicates are substantially equivalent.