HIOSSEN IMPLANT SYSTEM

K140934 · Hiossen, Inc. · DZE · Nov 12, 2014 · Dental

Device Facts

• Record ID: K140934
• Device Name: HIOSSEN IMPLANT SYSTEM
• Applicant: Hiossen, Inc.
• Product Code: DZE · Dental
• Decision Date: Nov 12, 2014
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3640
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The HIOSSEN Implant 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 final or temporary abutment support for fixed bridgework. It is intended for delayed loading. ETIII SA Ultra Wide Fixture is intended to be used in the molar region.

Device Story

Dental implant system for surgical placement in jaw bone to support prosthetic restorations. System includes fixtures (ETIII SA, ETIII SA Ultra-Wide, ETII SA), cover screws, and healing abutments. Fixtures are surgically placed by dental professionals in clinical settings to provide a foundation for single/multiple-unit restorations or fixed bridgework. Device integrates with bone over time (osseointegration) before loading. Output is a stable mechanical anchor for dental prosthetics, enabling restoration of oral function and aesthetics for edentulous patients.

Clinical Evidence

No clinical studies are submitted. Substantial equivalence is supported by non-clinical bench testing, including engineering, dimensional, and static/dynamic compression-bending fatigue testing conducted under worst-case scenarios per FDA guidance.

Technological Characteristics

Endosseous dental implants constructed from Pure Titanium Grade 4 (ASTM F67). Features internal hex connection, submerged fixture design, and tapered or straight body shapes. Surface treatment is SA (sand-blasted and acid-etched). Sterilized via radiation. Shelf life 8 years.

Indications for Use

Indicated for partially or fully edentulous patients (mandibles and maxillae) requiring single or multiple-unit restorations (cemented, screw-retained, or overdenture) or fixed bridgework support. ETIII SA Ultra Wide Fixture is indicated for the molar region. Intended 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

• HT III SA FIXTURE SYSTEM (K101096)
• ETIII SA Ultra Wide System (K103537)
• ETII SA Fixture System (K123471)
• TS Implant System (K121585)
• HSII Short Fixture System (K083633)
• 3i OSSEOTITE® Certain® Dental Implants (K063341)

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

November 12,2014

Mr. Patrick Lim Manager HIOSSEN, Incorporated 85 Ben Fairless Drive Fairless Hills, PA 19030

Re: K140934

Trade/Device Name: HIOSSEN Implant System Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: II Product Code: DZE, NHA Dated: October 6, 2014 Received: October 10, 2014

Dear Mr. Lim:

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 - Mr. Lim

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 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR 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 Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Susan Runno DDS, MA

Erin I. Keith, M.S. Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

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Image /page/2/Picture/0 description: The image shows the logo for Hiossen. The logo is composed of the word "Hiossen" in a stylized font. The "H" and "I" are in red, while the rest of the letters are in gray. There is a red swoosh above the "O" in "Hiossen."

Hiossen Inc. 85 Ben Fairless Dr. Fairless Hills, PA 19030 Tel : [phone] / Fax : [phone] www.hiossen.com

# Indications for Use Statement

K140934 510(k) Number K

Device Name : HIOSSEN Implant System

Indication for use :

The HIOSSEN Implant 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 final or temporary abutment support for fixed bridgework. It is intended for delayed loading. ETIII SA Ultra Wide Fixture is intended to be used in the molar region.

Prescription Use X (Per 21CFR801 Subpart D) Over-The-Counter Use (Per 21CFR807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

OR

Concurrence of CDRH, Office of Device Evaluation (ODE)

Section 004

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Image /page/3/Picture/0 description: The image shows the Hiossen logo. The "HI" part of the logo is in red, and the "OSSEN" part is in gray. There is a red swoosh above the "HI" part of the logo. The logo is simple and modern.

Section 003

K140934

Hiossen Inc. 85 Ben Fairless Dr. Fairless Hills, PA 19030 Tel : [phone] / Fax : [phone] www.hiossen.com 510(k) Summary

This summary of 510(k) substantial equivalence information is being submitted in accordance with requirements of 21 CFR Part 807.92.

Date : November 15, 2013

1. Company and Correspondent making the submission:

| - Submitter's Name : | HiOSSEN Inc. |
|----------------------|------------------------------------------------|
| - Address : | 85 Ben Fairless Dr.<br>Fairless Hills PA 19030 |
| - Telephone No. | 888 678 0001 |
| - Contact : | Mr. Patrick Lim |

- 2. Device :

| Trade or (Proprietary) Name : | HIOSSEN Implant System |
|-------------------------------|--------------------------------------------------------------------|
| Common or usual name : | Dental Implant |
| Classification Name : | Endosseous Dental Implant<br>21CFR872.3640<br>Class II<br>DZE. NHA |

3. Predicate Device :

HT III SA FIXTURE SYSTEM, HIOSSEN Inc. K101096 ETII SA Fixture System. HiOSSEN Inc.. K123471 ETIII SA Ultra Wide System, HiOSSEN Inc., K103537 TS Implant System, OSSTEM CO., LTD., K121585 HSII Short Fixture System, OSSTEM CO., LTD., K083633 ET SS Implant System, OSSTEM CO., LTD., K120847 3i OSSEOTITE® Certain® Dental Implants, Implant Innovations, Inc., K063341

- 4. Description :
1) The HIOSSEN Implant System is similar to other commercially available products based on the intended use, the technology used, the claims, the material composition employed and performance characteristics.

2) The HIOSSEN Implant System include length 18mm implant Length 18mm implant has already predicated in K063341, 3i OSSEOTITE® Certain® Dental Implants( Length 7mm~20mm)

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Image /page/4/Picture/0 description: The image shows the logo for HIOSSEN. The letters "HI" are in red, and the rest of the word is in gray. There is a red swoosh above the "HI".

Hiossen Inc.

85 Ben Fairless Dr. Fairless Hills, PA 19030 Tel : [phone] / Fax : [phone] www.hiossen.com

3) ETIII SA Fixture

| Device<br>Description | Intended to be surgically placed in the bone of the upper or lower jaw arches. Fixture is<br>supplied sterile. | | |
|-----------------------|----------------------------------------------------------------------------------------------------------------|----------------------------------------|------------------------|
| Material | Pure Titanium (ASTM F 67) | | |
| Surface | SA surface treatment | | |
| Dimension | Diameter (mm) | Length (mm) | added/modified |
| | 3.77 | 8.7 | Diameter is modified |
| | 3.75 | 10.2, 11.7, 13.2, 15.2, 18.2 | Length 18.2mm is added |
| | 4.25 | 7.2, 8.7, 10.2, 11.7, 13.2, 15.2, 18.2 | Length 18.2mm is added |
| | 4.65 | 7.2 | None |
| | 4.63 | 8.7 | Diameter is modified |
| | 4.6 | 10.2, 11.7, 13.2, 15.2, 18.2 | Length 18.2mm is added |
| | 5.1 | 6.2, 7.2 | Length 6.2mm is added |
| | 5.08 | 8.7 | None |
| | 5.05 | 10.2, 11.7, 13.2, 15.2 | None |

### 4) ETIII SA Ultra-Wide Fixture

| Device<br>Description | Intended to be surgically placed in the bone of the upper or lower jaw arches. Fixture is supplied sterile. | | |
|-----------------------|-------------------------------------------------------------------------------------------------------------|--------------------------------|------------------------------------------------|
| Material | Pure Titanium (ASTM F 67) | | |
| Surface | SA surface treatment | | |
| Dimension | Diameter (mm) | Length (mm) | added/modified |
| | 5.95 | 6.2, 9.7 | Diameter is modified/<br>Length 6.2mm is added |
| | 5.92 | 11.2, 12.7 | Diameter is modified |
| | 6 | 7.2, 8.2 | None |
| | 6.8 | 6.2, 7.2, 8.2, 9.7, 11.2, 12.7 | Diameter is modified/<br>Length 6.2mm is added |

### 5) ETII SA Fixture

| Device | Intended to be surgically placed in the bone of the upper or lower jaw arches. Fixture is | | |
|-------------|-------------------------------------------------------------------------------------------|----------------------------------------|------------------------|
| Description | supplied sterile. | | |
| Material | Pure Titanium (ASTM F 67) | | |
| Surface | SA surface treatment | | |
| Dimension | Diameter (mm) | Length (mm) | added/modified |
| | 3.5 | 8.7, 10.2, 11.7, 13.2, 15.2, 18.2 | Length 18.2mm is added |
| | 4.2 | 7.2, 8.7, 10.2, 11.7, 13.2, 15.2, 18.2 | Length 18.2mm is added |
| | 4.45 | 7.2, 8.7, 10.2, 11.7, 13.2, 15.2 | None |
| | 5.0 | 6.2 | None |
| | 4.9 | 7.2, 8.7, 10.2, 11.7, 13.2, 15.2 | None |

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Image /page/5/Picture/0 description: The image shows the word "HIOSSEN" in a stylized font. The "HIO" portion of the word is in red, while the "SSEN" portion is in gray. There is a red swoosh above the "HIO" portion of the word, adding a dynamic element to the logo. The overall design is clean and modern.

### Hiossen Inc.

85 Ben Fairless Dr. Fairless Hills, PA 19030 Tel : [phone] / Fax : [phone] www.hiossen.com

6) Cover Screw

| Device<br>Description | Used to protect the exposed platform of the implant during healing period. |
|-------------------------------------------------------------|----------------------------------------------------------------------------|
| Material | Pure Titanium (ASTM F 67) |
| Surface | Anodizing |
| diameters | 3.03, 3.58, 3.25, 3.4, 3.75, 3.9 |
| lengths | 5.25, 5.9, 6.25, 6.85, 6.9, 7.5 |
| Change content<br>as compared to<br>the predicate<br>device | Products code, Art(#)s are changed & Design Change of screw bottom |

### 7) Healing Abutment

| Device<br>Description | Used to make a soft tissue in a funnel shape before setting up prosthetics<br>and removing cover screw after osseointegration. |
|-------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------|
| Material | Pure Titanium (ASTM F 67) |
| Surface | None |
| diameters | 4.3, 4.8, 5.3, 6.3, 7.3 |
| lengths | 7.5, 8.5, 9.5, 11.5, 12.5 |
| Change content<br>as compared to<br>the predicate<br>device | Addition of Ø4.5mm abutment.<br>Shape of middle part is changed |

### - Substantial Equivalence Matrix

| | The HIOSSEN Implant<br>System | Predicate devices | |
|--------------|-------------------------------|-----------------------------------------------------|------------------------|
| | | HTIII SA Fixture<br>/ ETIII SA Ultra Wide<br>System | ETII SA Fixture System |
| 510(K) No. | - | K101096 / K103537 | K123471 |
| Manufacturer | HIOSSEN Inc. | HIOSSEN Inc. | HIOSSEN Inc. |

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Image /page/6/Picture/0 description: The image shows the word "HIOSSEN" in a stylized font. The "HI" is in red, and the rest of the word is in gray. There is a red swoosh above the "HI".

## Section 003

### Hiossen Inc.

85 Ben Fairless Dr. Fairless Hills, PA 19030 Tel : [phone] / Fax : [phone] www.hiossen.com

| Design | | | |
|------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended<br>Use | The HIOSSEN Implant<br>System is indicated for use in<br>partially or fully edentulous<br>mandibles and maxillae, in<br>support of single or multiple-<br>unit restorations including:<br>cemented retained, screw<br>retained, or overdenture<br>restorations, and final or<br>temporary abutment support<br>for fixed bridgework. It is<br>intended for delayed loading.<br>ETIII SA Ultra-Wide Fixture<br>is intended to be used in the<br>molar region. | The HTIII Fixture 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 final or<br>temporary abutment support<br>for fixed bridgework. It is<br>intended for delayed loading.<br>Ultra wide Fixture System is<br>intended to be used in the<br>molar region. | The ETII Fixture 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 final or<br>temporary abutment support<br>for fixed bridgework. It is<br>intended for delayed loading. |
| Structure | - Internal Hex-connected<br>- Submerged Fixture<br>- Tapered body shape &<br>Straight body shape | - Internal Hex-connected<br>- Submerged Fixture<br>- Tapered body shape &<br>Straight body shape | - Internal Hex-connected<br>- Submerged Fixture<br>- Straight body shape |
| Diameter (D) | 3.5, 3.75, 3.77, 4.2, 4.25, 4.45,<br>4.6, 4.63, 4.65, 4.9, 5.0,<br>5.05, 5.08, 5.1, 5.92, 5.95, 6,<br>6.8 | 3.75, 4.25, 4.6, 5.05, 5.08,<br>5.1, 6, 5.92, 5.95, 6.8, 6.82 | 3.5, 4.2, 4.45, 4.9, 5.0 |
| Length (mm) | 6.2, 7.2, 8.7, 10.2, 11.7, 13.2,<br>15.2, 18.2 | 7.2, 8.7, 10.2, 11.7, 13.2, 15.2 | 6.2, 7.2, 8.7, 10.2, 11.7, 13.2,<br>15.2 |
| Material of<br>Fixture | Pure Titanium Grade 4<br>(ASTM F67) | Pure Titanium Grade 4<br>(ASTM F67) | Pure Titanium Grade 4<br>(ASTM F67) |
| Surface | SA | SA | SA |
| Sterilization | Radiation Sterile | Radiation Sterile | Radiation Sterile |
| Shelf life | 8 Years | 5 Years | 5 Years |

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Image /page/7/Picture/0 description: The image contains the logo for HIOSSEN. The logo is composed of the letters "HIOSSEN" in a stylized font. The "HI" portion of the logo is in red, while the "OSSEN" portion is in gray. The "H" and "I" are connected by a red swoosh.

#### Hiossen Inc.

85 Ben Fairless Dr. Fairless Hills, PA 19030 Tel : [phone] / Fax : [phone] www.hiossen.com

| SE | The HIOSSEN Implant System is revised product that Dimension and code(art#) are changed<br>and added from predicate product, ETII SA Fixture, HTIII SA Fixture and ETIII SA Ultra Wide<br>Fixture therefore there is no difference about material, indication for use and design from<br>predicate as above<br>And the subject devices and the predicate devices encompass the same range of physical<br>dimensions except length 18mm and characteristics, including implant diameter and surface<br>treatment therefore The HIOSSEN Implant System is substantially equivalent to the predicate<br>devices |
|----|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
|----|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|

### 5. Indication for use :

The HIOSSEN Implant 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 final or temporary abutment support for fixed bridgework. It is intended for delayed loading. ETIII SA Ultra-Wide Fixture is intended to be used in the molar region.

### 6. Review :

The HIOSSEN Implant System has same material, indication for use, similar design and technological characteristics as the predicate device.

### 7. Summary of nonclinical testing

Non-clinical testing data submitted, referenced, or relied upon to demonstrate substantial equivalence includes engineering analysis, dimensional analysis, static and dynamic compression-bending testing according to "Guidance for industry and FDA staff Class II Special Controls Guidance Document Root-form Endosseous Dental Implants and Endosseous Dental Abutment" with the worst case scenario. Fatigue testing in air demonstrated the subject device to the tested predicate because shape and minimum diameter of subject devices are the same with predicate.

### 8. Summary of clinical testing

No clinical studies are submitted

### 9. Conclusions

In accordance with the Federal Food, Drug and Cosmetic Act, 21 CFR Part 807, and based on the information provided in this premarket notification HiOSSEN Inc. concludes that the The HIOSSEN Implant System is substantially equivalent to the predicate devices as described herein