ET III SA ULTRA WIDE SYSTEM

K103537 · Hiossen, Inc. · DZE · Mar 10, 2011 · Dental

Device Facts

• Record ID: K103537
• Device Name: ET III SA ULTRA WIDE SYSTEM
• Applicant: Hiossen, Inc.
• Product Code: DZE · Dental
• Decision Date: Mar 10, 2011
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 872.3640
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

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

Device Story

ETIII SA Ultra wide System is a dental implant system consisting of a titanium fixture and healing abutment. Fixture is surgically placed into the bone of the upper or lower jaw (molar region) to support dental prosthetics. Device features an internal hex connection, tapered body, and sandblasted/acid-etched (SA) surface. Used by dental professionals in clinical settings for single or two-stage surgical procedures. Output is a stable base for restorations; aids in restoring masticatory function and aesthetics for edentulous patients. System is not for immediate load.

Clinical Evidence

Bench testing only. Fatigue testing was conducted according to FDA guidance for root-form endosseous dental implants. Biocompatibility testing was performed to ensure compliance with international and US regulations.

Technological Characteristics

Material: Pure Titanium Grade 4 (ASTM F67-06). Surface: Sandblasted and Acid-etched (SA). Design: Internal hex connection, tapered body. 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 patients (mandibles and maxillae) requiring single or multiple-unit restorations, including cemented, screw-retained, or overdenture restorations, and fixed bridgework support. Intended for molar region. Contraindicated for immediate 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

• HGIII Ultra wide Fixture System (K093889)
• ETIII SA Fixture System (K101096)
• HU/HS/HG Prosthetic System (K081575)

Submission Summary (Full Text)

{0}------------------------------------------------

K103537

Image /page/0/Picture/1 description: The image shows the word "Hiossen" in a stylized font. The letters are black and have a slightly distressed or textured appearance. The "H" is capitalized and bold, and there is a curved line above the "O".

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

MAR 10 2011

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

Date : Nov 11th, 2010

1. Company and Correspondent making the submission:

- Submitter's Name :

HiOSSEN Inc.

85 Ben Fairless Dr.

- Address :

Fairless Hills PA 19030 888 678 0001

Mr. Patrick Lim

- Telephone No.

- Contact :
- 2. Device :

Trade or (Proprietary) Name : Common or usual name : Classification Name :

ETII SA Ultra wide System Dental Implant Endosseous Dental Implant 21CFR872.3640 Class II DZE

- 3. Predicate Device :
The HGI Ultra wide Fixture System, Hiossen Inc, K093889 The ETI SA Fixture System, Hiossen Inc, K101096 The HU/HS/HG Prosthetic System, Osstem Implant Co., Ltd, K081575

## 4. Description :

- 1) The ETⅢ SA Ultra wide Fixture 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 ETM SA Ultra wide Fixture is composed of single threads with internal hex connection taper body of bone level. The surface is SA, Sandblasting and Acid etching, treated.
- 2) The ET Healing Abutment is used to make a natural soft tissue shape before setting up prosthetics and removing cover screw after osseointegration.

UD-L-001

{1}------------------------------------------------

Image /page/1/Picture/1 description: The image shows the word "HOSSEN" in a stylized font. The "H" and the top of the "O" are in bold black, while the rest of the letters are outlined. The word appears to be a logo or brand name.

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

Class II Special Controls Guidance Document Root-form Endosseous Dental Implants and Endosseous Dental Abutment" with the worst case scenario of the GS III Fixture(or HGII Fixture) and an angled abutment in support of the ETIII SA Ultra Wide Fixture. Therefore, the fatigue test result of GSIII Fixture System (or HGIII Fixture System) can be used as a proof of ETIII SA Ultra Wide Fixture since ETIII SA Ultra Wide Fixture has large diameter.

## 8. Conclusion :

Based on the information provided in this premarket notification HiOSSEN concludes that the ETII SA Ultra wide System is substantially equivalent to the predicate device as described herein.

{2}------------------------------------------------

Image /page/2/Picture/1 description: The image shows the logo for Hiossen Inc. The logo is in black and white and features the word "Hiossen" in a stylized font. The "H" is bold and solid, while the rest of the letters are outlined. There is a curved line above the "H" that adds a dynamic element to the logo. Below the word "Hiossen" is the text "Hiossen Inc."

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

- 3) The ETIII SA Ultra wide System is same to other commercially available products based on the intended use, the technology used, the claims, the material composition employed and performance characteristics.
- 4) The ETIII SA Ultra wide System is substantially equivalent in design, function and intended use to HGШ Ultra wide Fixture System (K093889). ETШ SA Fixture System (K101096) of Hiossen Inc. and Healing Abutment of HU/HS/HG Prosthetic System (K081575) of Osstem Implant Co., Ltd.

| | ETⅢ SA Ultra wide<br>Fixture | Predicate devices | |
|------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | | HGⅢ Ultra wide Fixture | ETⅢ SA Fixture |
| Manufacturer | Hiossen Inc | Hiossen Inc | Hiossen Inc |
| 510(k) Number | New | K093889 | K101096 |
| Design | Image: ETIII SA Ultra wide Fixture | Image: HGIII Ultra wide Fixture | Image: ETIII SA Fixture |
| Indication<br>for use &<br>Procedural<br>Precautions | The ETⅢ SA Ultra wide<br>System is indicated for use<br>in partially or fully<br>edentulous mandibles and<br>maxillae, in support of<br>single or multiple-unit<br>restorations including ;<br>cemented retained, screw<br>retained, or overdenture<br>restorations, and terminal<br>or intermediate abutment<br>support for fixed<br>bridgework. The ETⅢ<br>Ultra wide System is for<br>single and two stage<br>surgical procedures. It is<br>not for immediate load.<br>The HGⅢ Ultra wide<br>System is intended to be<br>used in the molar region. | The HGⅢ Ultra wide<br>Fixture System is indicated<br>for use in partially or fully<br>edentulous mandibles and<br>maxillae, in support of<br>single or multiple-unit<br>restorations including ;<br>cemented retained, screw<br>retained, or overdenture<br>restorations, and terminal<br>or intermediate abutment<br>support for fixed<br>bridgework. The HGⅢ<br>Ultra wide Fixture System<br>is for single and two stage<br>surgical procedures. It is<br>not for immediate load.<br>The HGⅢ Ultra wide<br>Fixture System is intended<br>to be used in the molar<br>region. | The ETⅢ SA Fixture<br>System is indicated for use<br>in partially or fully<br>edentulous mandibles and<br>maxillae, in support of<br>single or multiple-unit<br>restorations including ;<br>cemented retained, screw<br>retained, or overdenture<br>restorations, and terminal<br>or intermediate abutment<br>support for fixed<br>bridgework. The ETⅢ SA<br>Fixture System is for single<br>and two stage surgical<br>procedures. It is not for<br>immediate load. |

## - Substantial Equivalence Matrix

{3}------------------------------------------------

Image /page/3/Picture/1 description: The image shows the word "HOSSEN" in a stylized font. The letters are black, with the exception of the "O"s, which are outlined. A curved line extends from the top of the "H" over the first "O". The letters have a slightly textured appearance.

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

Diameter (D) Refer to the Table 1 *Length (mm) Material of Pure Titanium Grade 4 Pure Titanium Grade 4 Pure Titanium Grade 4 Fixture (ASTMF67-06) (ASTMF67-06) (ASTMF67-06) SA (Sandblasting and Acid SA (Sandblasting and Acid Surface RBM Treatment etching) (Resorbable Blast Media) etching) Polymeric Ampoule in a Polymeric Ampoule in a Polymeric Ampoule in a foil backed peel open Packaging foil backed peel open foil backed peel open blister pack blister pack blister pack Sterilization Radiation Sterile Radiation Sterile Radiation Sterile Shelf life 5 years 5 years 5 years

| ETIII SA Ultra wide Fixture | | Predicate devices | | | |
|-----------------------------|------------------------------|---------------------------------|------------------------------|-------------------------|-------------------------------------|
| (Ø) | (mm) | HGIII Ultra wide Fixture<br>(Ø) | (mm) | ETIII SA Fixture<br>(Ø) | (mm) |
| - | - | - | - | 3.75 | 8.7, 10.2, 11.7,<br>13.2, 15.2 |
| - | - | - | - | 4.25 | 7.2, 8.7, 10.2,<br>11.7, 13.2, 15.2 |
| - | - | - | - | 4.6, 4.65 | 7.2, 8.7, 10.2,<br>11.7, 13.2, 15.2 |
| - | - | - | - | 5.05, 5.08, 5.1 | 7.2, 8.7, 10.2,<br>11.7, 13.2, 15.2 |
| 5.9, 5.92, 6.0 | 7.2, 8.2, 9.7,<br>11.2, 12.7 | 5.9, 5.92, 6.0 | 7.2, 8.2, 9.7,<br>11.2, 12.7 | - | - |
| 6.8, 6.82 | 7.2, 8.2, 9.7,<br>11.2, 12.7 | 6.8, 6.82 | 7.2, 8.2, 9.7,<br>11.2, 12.7 | - | - |

Table 1. Diameter and length (ETII SA Ultra wide Fixture and Predicate devices)

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

- 6. Review :
The ETII SA Ultra wide System has same material, indication for use and technological characteristics as the predicate device.

The ETIII SA Ultra wide 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

{4}------------------------------------------------

Image /page/4/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of an eagle.

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

Mr. Patrick Lim Regulatory Affairs HiOSSEN Incorporated 85 Ben Fairless Drive Fairless Hills, Pennsylvania 19030

MAR 1 0 2011

Re: K103537

Trade/Device Name: ETIII SA Ultra wide System Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: II Product Code: DZE, NHA Dated: February 7, 2011 Received: February 8, 2011

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.

{5}------------------------------------------------

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 (OS) regulation (21 CFR Part 820): and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please 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/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/Resourcesfor You/Industry/default.htm.

Sincerely yours,

f Susan Ruones

Anthony D. 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

{6}------------------------------------------------

Image /page/6/Picture/0 description: The image shows the word "Hiossen" in a stylized font. The "H" and "I" are in bold black font, while the rest of the letters are outlined. There is a curved line above the "O" in "Hiossen."

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

510(k) Number K 103537

Device Name : ETII SA Ultra wide System

Indication for use : The ETII SA Ultra wide 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 ETII SA Ultra wide Fixture System is for single and two stage surgical procedures. It is not for immediate load. The ETII SA 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)

Office of Business Evaluation (SBE)

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

510(k) Number: K103537