ET II BIO-SA FIXTURE SYSTEM

K112532 · Hiossen, Inc. · DZE · Aug 6, 2012 · Dental

Device Facts

• Record ID: K112532
• Device Name: ET II BIO-SA FIXTURE SYSTEM
• Applicant: Hiossen, Inc.
• Product Code: DZE · Dental
• Decision Date: Aug 6, 2012
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3640
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The ETIII Bio-SA 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 ETIII Bio-SA Fixture System is for single and two stage surgical procedures. It is intended for delayed loading.

Device Story

ETIII Bio-SA Fixture System is an endosseous dental implant; surgically placed in upper or lower jaw arches to support prosthetic restorations. Device consists of a titanium fixture with internal hex connection and tapered body; features Bio-SA surface treatment (nano-thickness calcium phosphate coating via Al2O3 blasting and acid etching). Used by dental clinicians in clinical settings. Provides stable foundation for single/multiple-unit restorations; cemented, screw-retained, or overdenture; or fixed bridgework. Benefits patient by restoring chewing function. Device is supplied sterile.

Clinical Evidence

No clinical studies are submitted. Evidence is based on bench testing, including fatigue testing conducted per FDA guidance for root-form endosseous dental implants and biocompatibility testing per ISO 10993-5, 6, 10, and 11.

Technological Characteristics

Material: Pure Titanium Grade 4 (ASTM F67-06). Surface: Bio-SA (nano-thickness calcium phosphate on Al2O3 blasted/acid-etched surface). Design: Single thread, tapered body, internal hex connection. Sterilization: Radiation. Connectivity: N/A (mechanical device).

Indications for Use

Indicated for partially or fully edentulous patients (adults) requiring single or multiple-unit dental restorations, including cemented/screw-retained crowns, overdentures, or fixed bridgework support. Suitable for single or two-stage surgical procedures with 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

• ETIII SA Fixture System (K101096)
• NanoTite PREVAIL Implant (K072363)
• Dio Biotite-H Implant System (K073070)

Reference Devices

• GSIII Fixture System

Submission Summary (Full Text)

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# 112532

AUG

6 2012

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

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) safety and effectiveness information is being submitted in accordance with requirements of 21 CFR Part 807.92.

HiOSSEN Inc.

888 678 0001

Mr. Patrick Lim

85 Ben Fairless Dr. Fairless Hills PA 19030

Date : Aug 31th, 2011

1. Company and Correspondent making the submission:

1) Submitter's Name :

2) Address :

- 3) Telephone No.
4) Contact :

- 2. Device :
Trade or (Proprietary) Name : Common or usual name : Classification Name :

ETII Bio-SA Fixture System Dental Implant Endosseous Dental Implant 21CFR872.3640 Class II DZE

- 3. Predicate Device :
The ETII SA Fixture System, HiOSSEN Inc, K101096 The NanoTite PREVAIL Implant, Biomet 31 Inc. K072363 The Dio Biotite-H Implant System, DIO Department, DSI, Inc, K073070

## 4. Description :

I) The ETII Bio-SA Fixture System is dental implant made of titanium metal intended to be surgically placed in the bone of the upper or lower jaw arches. Fixture is made of pure titanium metal and supplied sterile. The surface treatment is Bio-SA.

- 2) ETII Bio-SA Fixture is composed of single threads with internal hex connection taper body of bone level for two stage surgery. It has Bio-SA surface treatment.
- 3) ETIII Bio-SA Fixture is coated with nano thickness calcium phosphate on the SA surface of Al2O3 blasting & acid etching

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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 all capitalized and black. The top of the "T" in the word has a curved extension over the "O".

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

- 4) The ETIII Bio-SA 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.
- 5) The ET D Bio-SA Fixture System is substantially equivalent in design, manufacturing process, function and intended use to the ETII SA Fixture System (K101096) of HiOSSEN Inc, NanoTite PREVAIL Implant (K072363) of Biomet 31 Inc and Dio Biotite-H Implant System (K073070) of DIO Department, DSI, Inc.

| | ETIII Bio-SA Fixture | Predicate devices | | |
|-----------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | ETIII SA Fixture<br>(K101096) | NanoTite PREVAIL<br>Implant (K072363) | Dio Biotite-H<br>Implant System<br>(K073070) | |
| Manufacturer | HIOSSEN Inc. | HIOSSEN Inc. | Biomet 3I Inc. | DIO Department, DSI,<br>Inc. |
| Intended<br>Use | The ETIII Bio-SA<br>Fixture System is<br>indicated for use in<br>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>Bio-SA Fixture System is<br>for single and two stage<br>surgical procedures. It is<br>intended<br>for<br>delayed<br>loading. | The ETIII SA Fixture<br>System is indicated for<br>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 ETIII<br>SA Fixture System is for<br>single and two stage<br>surgical procedures. It is<br>not for immediate load. | BIOMET 3i dental<br>implants are intended for<br>surgical placement in the<br>upper or lower jaw to<br>provide a means for<br>prosthetic attachment in<br>single tooth restorations<br>and in partially or fully<br>edentulous spans with<br>multiple single teeth<br>utilizing delayed or<br>immediate loading, or as<br>a terminal or<br>intermediary abutment<br>for fixed or removable<br>bridgework, and to retain<br>overdentures. BIOMET<br>3i NanoTite dental<br>implants are intended<br>for immediate function<br>on single tooth and/or<br>multiple tooth<br>applications when good<br>primary stability is<br>achieved, with<br>appropriate occlusal<br>loading, in order to<br>restore chewing function. | The DIO Biotite-H<br>Implant System is an<br>endosseous dental<br>implant that is indicated<br>to use for surgical<br>placement in the upper<br>and lower jaw arches, to<br>provide a root form<br>means for single or<br>multiple units' prosthetic<br>appliance attachment to<br>restore a patient's<br>chewing function. Also,<br>angled abutments on<br>small diameter implants<br>(3.8mm) of the DIO<br>Biotite-H Implant System<br>are intended for the<br>anterior region of the<br>mouth and not intended<br>for the posterior region of<br>the mouth due to possible<br>failure of the implant. |
| Structure | -Single Thread<br>-Taper body Type<br>-Self tapping<br>-Submerged fixture | -Single Thread<br>-Taper body Type<br>-Self tapping<br>-Submerged fixture | -Single Thread<br>-Straight body Type<br>-submerged fixture | Morse taper with thread |
| Connection | Internal hex connection | Internal hex connection | Internal connection | Internal connection |

#### - Substantial Equivalence Matrix

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Image /page/2/Picture/0 description: The image shows the word "Hiossen" in a bold, sans-serif font. The letters are black against a white background. The top of the "O" has a curved line over it.

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

www.hiossen.com

| Type | | | | |
|------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------|---------------------------------------|---------------------------------------|
| Diameter (D) | 3.5~5.0 | 3.5~5.0 | 3.25~5.0 | 3.8~5.3 |
| Length (mm) | 7.0~15.0 | 7.0~15.0 | 8.5-15.0 | 8.0~14.0 |
| Material of<br>Fixture | Pure Titanium Grade 4<br>(ASTMF67-06) | Pure Titanium Grade 4<br>(ASTMF67-06) | Pure Titanium Grade 4<br>(ASTMF67-06) | Pure Titanium Grade 4<br>(ASTMF67-06) |
| Surface | Bio-SA | RBM | NanoTite | HA |
| Sterilization | Radiation Sterile | Radiation Sterile | Radiation Sterile | Radiation Sterile |
| S & E | The ETIII Bio-SA Fixture System has same material, indication for use and design as the ETIII SA Fixture<br>System. But they have different surface treatment. The ETIII Bio-SA Fixture System has similar the surface<br>treatment as the NanoTite PREVAIL Implant and the manufacturing process as the Dio Biotite-H Implant<br>System | | | |

### 5. Indication for use :

The ETII Bio-SA 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 ETⅢ Bio-SA Fixture System is for single and two stage surgical procedures. It is intend for delayed loading.

- 6. Review :
The ETIII Bio-SA Fixture System has same material and indication for use and similar design and technological characteristics as the predicate device.

The ETIII Bio-SA 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
- 1) 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 and an angled abutment in support of the ETII Bio-SA Fixture. The ETIII Bio-SA Fixture System has same material and similar design as the GSIII Fixture System.

Therefore, the fatigue test result of GSIII Fixture System can be used as a proof of ETШ Bio-SA Fixture.

- 2) The biocompatibility test was conducted according to ISO 10993-5, ISO 10993-6, ISO 10993-10 and ISO 10993-11. The results are in compliance with it.
- 8. Summary of clinical testing No clinical studies are submitted

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Image /page/3/Picture/0 description: The image shows the word "HIOSSEN" in a bold, stylized font. The letters are black against a white background. The "O" in the word is a perfect circle, and there is a curved line above the "I".

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

9. Conclusion :

Based on the information provided in this premarket notification HiOSSEN concludes that the ETIII Bio-SA Fixture System is substantially equivalent to the predicate device as described herein.

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Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized caduceus, a symbol often associated with medicine and healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" are arranged in a circular pattern around the caduceus. The logo is black and white.

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

Mr. Patrick Lim Manager of Quality Assurance & Regulatory Affairs Hiossen Incorporated 85 Ben Fairless Drive Fairless Hills, Pennsylvania 19030

AUG 6 2012

Re: K112532

Trade/Device Name: ET III Bio-SA Fixture System Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: II Product Code: DZE Dated: July 17, 2012 Received: August 1, 2012

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 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/ResourcesforYou/Industry/default.htm.

Sincerely yours,

hu for

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

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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

Device Name : ETIII Bio-SA Fixture System

Indication for use : ETIII Bio-SA 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. ETⅢ Bio-SA Fixture System is for single and two stage surgical procedures. It is intended for delayed loading.

X Prescription Use (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)

Sheena Green for Dr. Susan Runner

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

6112532 510(k) Number: -