MODIFICATION TO: HG III ULTRA WIDE SYSTEM

K093889 · Hiossen, Inc. · DZE · Apr 22, 2010 · Dental

Device Facts

• Record ID: K093889
• Device Name: MODIFICATION TO: HG III ULTRA WIDE SYSTEM
• Applicant: Hiossen, Inc.
• Product Code: DZE · Dental
• Decision Date: Apr 22, 2010
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 872.3640
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The HGIII Ultra wide Fixture 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. The HGIII Ultra wide Fixture System is for single and two stage surgical procedures. It is not for immediate load. The HGIII Ultra wide Fixture System is intended to be used in the molar region.

Device Story

HGIII Ultra wide Fixture System is a dental implant system; consists of titanium metal fixtures surgically placed into the bone of the upper or lower jaw arches. Designed for use in the molar region; supports single or multiple-unit restorations or fixed bridgework. Features a tapered body, single threads, and internal hex connection; surface treated with Resorbable Blast Media (RBM). Intended for single or two-stage surgical procedures; not for immediate load. Operated by dental professionals in a clinical setting. Provides a stable foundation for prosthetic restorations; benefits patients by restoring dental function and aesthetics.

Clinical Evidence

Bench testing only. Fatigue testing was conducted per FDA guidance for root-form endosseous dental implants, utilizing worst-case scenarios with angled abutments. No clinical data was provided.

Technological Characteristics

Material: Pure Titanium Grade 4 (ASTM F67-06). Design: Tapered body, single thread, internal hex connection. Surface: RBM (Resorbable Blast Media). Sterilization: Radiation. Packaging: Polymeric ampoule in foil-backed peel-open blister pack. Shelf life: 5 years.

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 in the molar region of the maxilla or mandible. Contraindicated for immediate 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

• HG II Ultra wide Fixture System (K073465)

Submission Summary (Full Text)

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K093889

Image /page/0/Picture/1 description: The image shows the word "HOSSEN" in a bold, sans-serif font. The "O" in "HOSSEN" is stylized with a curved line extending from the top left of the letter. The text is black against a white background.

APR 2 2 2010

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

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

Date : December 4, 2009

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 : | HGIII Ultra wide Fixture System |
|-------------------------------|---------------------------------|
| Common or usual name : | Dental Implant |
| Classification Name : | Endosseous Dental Implant |
| | 21CFR872.3640 |
| | Class II |
| | DZE |

- 3. Predicate Device :
The HG II Ultra wide Fixture System, HiOSSEN Inc, K073465

- 4. Description :
I) The HGIII Ultra wide Fixture System is dental implant made of titanium metal intended to be used in the molar region and surgically placed in the bone of the upper or lower jaw arches. Fixture is made of pure titanium metal and supplied sterile. The surface is RBM, Resorbable Blast Media, treated.

HGIII Ultra wide Fixture is composed of single threads with internal hex connection taper body of bone level for two stage surgery. It has RBM surface.

2) The HGIII Ultra wide Fixture 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.

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Image /page/1/Picture/0 description: The image shows the word "HIOSSEN" in a bold, sans-serif font. The letters are black against a white background. The "O" in "HIOSSEN" has a curved line extending from the top of the letter.

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

- 3) The HGIII Ultra wide Fixture System is substantially equivalent in design, function and intended use to the HG II Ultra wide Fixture System (K073465) of HiOSSEN Inc.
# - Substantial Equivalence Matrix

| | HGIII Ultra wide Fixture | Predicate devices<br>HG II Ultra wide<br>Fixture (K073465) | | |
|--------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------|-------------------------|
| Manufacturer | HIOSSEN Inc. | HIOSSEN Inc. | | |
| Intended Use | The HGIII Ultra wide Fixture<br>System is indicated for use in<br>partially or fully edentulous<br>mandibles and maxillae, in<br>support of single or multiple-unit<br>restorations including ; cemented<br>retained, screw retained, or<br>overdenture restorations, and<br>terminal or intermediate abutment<br>support for fixed bridgework. The<br>HGIII Ultra wide Fixture System<br>is for single and two stage<br>surgical procedures. It is not for<br>immediate load. The HGIII Ultra<br>wide Fixture System is intended<br>to be used in the molar region. | The HG II Ultra wide Fixture<br>System is indicated for use in<br>partially or fully edentulous<br>mandibles and maxillae, in<br>support of single or multiple-unit<br>restorations including ; cemented<br>retained, screw retained, or<br>overdenture restorations, and<br>terminal or intermediate abutment<br>support for fixed bridgework. The<br>HG II Ultra wide Fixture System<br>is for single and two stage<br>surgical procedures. It is not for<br>immediate load. The HG II Ultra<br>wide Fixture System is intended<br>to be used in the molar region. | | |
| | Structure | -Single Thread<br>-Taper body Type<br>-Self tapping | -Single Thread<br>-Straight body Type<br>-Self tapping | |
| | | Connection<br>Type | Internal hex connection | Internal hex connection |
| | | Diameter (D) | 6.0~7.0 | 6.0~7.0 |
| | Length (mm) | 7.0~13.0 | 7.0~13.0 | |
| | Material of<br>Fixture | Pure Titanium Grade 4<br>(ASTMF67-06) | Pure Titanium Grade 4<br>(ASTMF67-06) | |
| | Surface | RBM | RBM | |
| | Packaging | Polymeric Ampoule in a foil backed<br>peel open blister pack | Polymeric Ampoule in a foil backed<br>peel open blister pack | |
| | | Sterilization | Radiation Sterile | Radiation Sterile |
| | Shelf life | 5 years | 5 years | |
| | S & E | No changes in function and intended use | | |

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Image /page/2/Picture/0 description: The image shows the word "Hiossen" in a bold, stylized font. The letters are black against a white background. The "H" is capitalized and the "O" is large and round. There is a curved line above the "O" that connects to the "S".

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

- 5. Indication for use :
The HGIII Ultra wide Fixture 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. The HGIII Ultra wide Fixture System is for single and two stage surgical procedures. It is not for immediate load. The HGIII Ultra wide Fixture System is intended to be used in the molar region.

# 6. Review :

The HGIII Ultra wide Fixture System has same material and indication for use and similar design and technological characteristics as the predicate device.

The HGIII Ultra wide Fixture System has been subjected to safety, performance, and product validations prior to release. Safety tests including biocompatibility have been performed to ensure the devices comply with the applicable International and US regulations.

### 7. Summary of nonclinical testing

Fatigue testing was conducted according to the "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 of the GSIII Fixture(or HGIII Fixture) and an angled abutment in support of the HGIII Ultra Wide Fixture. Therefore, the fatigue test result of GSIII Fixture System (or HGM Fixture System) can be used as a proof of HGIII Ultra Wide Fixture since HGIII Ultra Wide Fixture has large diameter.

# 8. Conclusion :

Based on the information provided in this premarket notification HiOSSEN concludes that the HGIII Ultra wide Fixture System is safe and effective and substantially equivalent to the predicate device as described herein.

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

Mr. Patrick Lim Manager Hiossen, Incorporated 85 Ben Fairless Drive Fairless Hills, Pennsylvania 19030

Re: K093889

Trade/Device Name: HGIII Ultra Wide Fixture System Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: II Product Code: DZE Dated: April 1, 2010 Received: April 9, 2010

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.

APR 2 2 2010

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 go to

http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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/ReportalProblem/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/Resourcesfor You/Industry/default.htm.

Sincerely yours.

Wh fir

Anthony Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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

510(k) Number K Q 4 38 8 9

Device Name : HGIII Ultra wide Fixture System

Indication for use : The HGIII Ultra wide Fixture 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. The HGM Ultra wide Fixture System is for single and two stage surgical procedures. It is not for immediate load. The HGIII Ultra wide Fixture System is intended to be used in the molar region.

Prescription Use X (Per 21CFR801 Subpart D) OR

Over-The-Counter Use (Per 21CFR807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off) (Division Sign-On)
Division of Anesthesiology, General Hospital Jivision Control, Dental Devices

510(k) Number: K093369