ET III Bio-SA Fixture System

K151626 · Hiossen, Inc. · DZE · Jul 21, 2016 · Dental

Device Facts

• Record ID: K151626
• Device Name: ET III Bio-SA Fixture System
• Applicant: Hiossen, Inc.
• Product Code: DZE · Dental
• Decision Date: Jul 21, 2016
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3640
• Device Class: Class 2
• Attributes: Therapeutic, Real-World Evidence

Real-World Evidence

Submission	Device	Sponsor	RWD Sources	RWE Use Summary	Key Tags
K151626 · Jul 21, 2016	ET III Bio-SA Fixture System	Hiossen, Inc.	Clinical patient records/chart review	Clinical data from 45 subjects with 66 implants were reviewed to evaluate primary stability, bone resorption, peri-implantitis, complications, and implant survival rates.	Retrospective clinical review; Implant survival; Clinical performance

Clinical Evidence

Study Design	Population	Comparator	Key Endpoints
Retrospective clinical review; Follow-up/Duration: 13.7 to 18.2 months (average 16.3 months)	45 subjects ages 18 or older; Sample Size: 45 subjects (66 implants)	Not applicable for this study	Primary stability, sensory abnormality, bone resorption, peri-implantitis, complications, fracture, and implant body failure

Indications 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. 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; used by dental clinicians in surgical procedures for tooth replacement. Device consists of a tapered, pure titanium (Grade 4) fixture with single threads and internal hex connection. Surface is sandblasted, acid-etched, and coated with calcium phosphate and hydrophilic materials (glucose/NaCl) to enhance wettability. Implant is placed into the mandible or maxilla during single or two-stage surgery; intended for delayed loading. Clinician uses device to provide stable foundation for prosthetic restorations; benefits patient by restoring chewing function and oral aesthetics. No software or electronic components involved.

Clinical Evidence

Clinical study of 45 subjects (age 18+) with 66 implants. Evaluated primary stability, bone resorption, peri-implantitis, and complications. Follow-up averaged 16.3 months (range 13.7–18.2). Results showed 100% survival rate with no adverse events reported after 1-year follow-up. Biocompatibility testing performed per ISO 10993 standards.

Technological Characteristics

Material: Pure Titanium Grade 4 (ASTM F67-06). Design: Single threads, internal hex connection, tapered body. Surface: Sandblasted, acid-etched, calcium phosphate coated, and hydrophilic (glucose/NaCl) treated. Sterilization: Radiation. Dimensions: Diameters 3.3–5.0mm; Lengths 6.0–18mm.

Indications for Use

Indicated for partially or fully edentulous adult patients (18+) requiring single or multiple-unit dental restorations, including cemented, screw-retained, or overdenture restorations, and fixed bridgework support in mandibles or maxillae.

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 Bio-SA Fixture System (K112532)

Reference Devices

• HIOSSEN Implant System (K140934)
• SLActive (Straumann USA) (K053088)

Submission Summary (Full Text)

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular emblem with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other.

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

July 21, 2016

Hiossen Inc. Mr. David Kim RA/OA Manager 85 Ben Fairless Dr. Fairless Hills, Pennsylvania 19030

Re: K151626

Trade/Device Name: ETIII Bio-SA Fixture System Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: II Product Code: DZE Dated: June 20, 2016 Received: June 20, 2016

Dear Mr. Kim:

This letter corrects our substantially equivalent letter of July 21, 2016. 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. David Kim

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 Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/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 Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely,

Tina Kiang -

for 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

Enclosure

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Image /page/2/Picture/1 description: The image shows the logo for Hiossen. 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.

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

# Indications for Use Statement

510(k) Number K _151626

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

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)

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Image /page/3/Picture/0 description: The image shows the Hiossen logo. The "HI" is in red, and the "OSSEN" is in gray. The "I" in "HI" has a red curved line over it. The logo is simple and modern.

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

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

Date : July 20, 2016

1. Company and Correspondent making the submission:

| 1) Submitter's Name : | HIOSSEN Inc. | |
|-------------------------------------------------|------------------------------------------------|--------------|
| 2) Address : | 85 Ben Fairless Dr.<br>Fairless Hills PA 19030 | |
| <td>3) Telephone No.</td> <td>888 678 0001</td> | 3) Telephone No. | 888 678 0001 |
| 4) Contact : | Mr. David Kim | |

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

Classification Name :

Dental Implant Endosseous Dental Implant 21CFR872.3640 Class II DZE

ETIII Bio-SA Fixture System

- 3. Predicate Device :
1)Primary Predicate : ETIII Bio-SA Fixture System / HIOSSEN INC. / K112532 2)Reference Predicate : HIOSSEN Implant System / HIOSSEN INC. / K140934 3)Reference Predicate : SLActive / Straumann USA / K053088

# 4. Description :

1) Indication for use > same as the primary predicate device, K112532 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 intended for delayed loading.

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Image /page/4/Picture/0 description: The image shows the Hiossen logo. The logo is composed of the word "Hiossen" in a stylized font. The "H" and the swoosh above the "i" are in red, while the rest of the word is in gray. The font is bold and sans-serif.

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

- 2) Technology
- (1) Design Features

ETIII Bio-SA Fixture has features of single threads, internal hex connection, taper body, and Bio-SA surface treatment.

- (2) Raw material used
ETIII Bio-SA Fixture System is permanent dental implant made with Pure titanium Grade 4 (ASTMF67-06)

- (3) Surface treatment
The proposed device is sandblasted, acid etched, coated with calcium phosphate by immersing and then finally coated with hydrophilic materials (glucose and NaCl with saline concentrations). Coating with hydrophilic material is added to the predicate device(ETIII Bio-SA Fixture, K112532) to improve a cosmetic characteristic(darker than predicate device, K112532).

- 5. Device comparison table
The proposed device, ETIII Bio-SA Fixture System is similar to other commercially and legally available medical devices (ETIII Bio-SA Fixture System, K112532 and HIOSSEN IMPLANT SYSTEM, K140934, Straumann SLActive Implants, k053088) based on the intended use, the technology used, the claims, the material used and performance characteristics.

| | Proposed device | Primary<br>Predicate devices | Reference(1)<br>Predicate devices | Reference(1)<br>Predicate devices |
|-------------------|-----------------------------|--------------------------------------|-------------------------------------------|-----------------------------------|
| | ETIII Bio-SA<br>Fixture | ETIII Bio-SA<br>Fixture<br>(K112532) | HIOSSEN<br>IMPLANT<br>SYSTEM<br>(K140934) | SLActive<br>Implants<br>(K053088) |
| Manufac-<br>turer | HIOSSEN INC. | HIOSSEN INC. | HIOSSEN INC. | Straumann USA,LLC |
| Design | Image: ETIII Bio-SA Fixture | Image: ETIII Bio-SA Fixture | Image: HIOSSEN IMPLANT SYSTEM | Image: SLAactive Implants |

# - Substantial Equivalence Matrix

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Image /page/5/Picture/0 description: The image shows the Hiossen logo. The "HI" is in red, and the "OSSEN" is in gray. The logo is simple and modern.

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

The ETIII Bio-SA The ETIII Bio-SA The ETIII SA Fix-SLActive implants Fixture System is Fixture System is ture System is indiare for single-stage indicated for use in indicated for use in cated for use in or two-stage surgical partially or fully partially or fully partially or fully procedures. SLActive implants edentulous edentulous edentulous mandibles and mandibles and mandibles and are intended for maxillae, in support maxillae, in support maxillae, in support immediate of single or multiple of single or multiple of single or multiple placement and -unit restorations -unit restorations unit restorations function on single including ;cemented including ;cemented including ;cemented tooth and/or multiple retained, screw retained, screw retained, screw tooth applications retained, or overretained, or overretained, or overwhen good primary Intended denture restorations, denture restorations, denture restorations. stability is achieved and terminal or and terminal or and terminal or and with appropriate Use intermediate abutintermediate abutintermediate abutocclusal loading, to ment support for ment support for ment support for restore chewing fixed bridgework. fixed bridgework. fixed bridgework. function. Multiple The ETIII Bio-SA The ETIII Bio-SA The ETIII Bio-SA tooth applications Fixture System is Fixture System is Fixture System is mav be rigidly for single and two for single and two for single and two splinted. In the case stage surgical prostage surgical prostage surgical proof edentulous cedures. It is not for cedures. It is not for cedures. It is not for patients, 4 or more immediate load. immediate load. immediate load. implants must be used in immediately loaded cases. -Single Thread -Single Thread -Single Thread -BONE CONTROL -Taper body Type -Taper body Type -Taper body Type Structure DESIGNTM -Self tapping -Self tapping -Self tapping -Apically Tapered -Submerged fixture -Submerged fixture -Submerged fixture Connection Internal hex Internal hex Internal hex CROSSFIT® connection CONNECTION Type connection connection 3.77, 3.75, 4.25, 4.6 3.77, 3.75, 4.25, 4.6 Diameter Ø 3.3, Ø 4.1 and Ø 4.65. 4.63. 5.05. 4.65. 4.63. 5.05. 3.5~5.0 (D) 4.8 mm 5.08, 5.10 5.08, 5.10 7.2 . 8.7 . 10.2 . 7.2 . 8.7 . 10.2 . Length 8, 10, 12, 14 and 6.0~18 11.7 , 13.2 11.7 , 13.2 (mm) 16 mm 15.2 15.2 Pure Titanium Pure Titanium Pure Titanium Pure Titanium Material of Grade 4 Grade 4 Grade 4 Grade 4 Fixture (ASTMF67-06) (ASTMF67-06) (ASTMF67-06) (ASTMF67-06) Bio-SA Bio-SA Surface (SA + D-glucose (SA + coating with SA (Acid etched) SLActive +Nacl) calcium hosphate)

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Image /page/6/Picture/0 description: The image shows the Hiossen logo. The logo is in two colors, red and gray. The "HI" part of the logo is in red, and the "OSSEN" part is in gray. The "H" in "HI" is larger than the other letters in the logo. The logo is simple and modern.

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

| Sterilization | Radiation Sterile | Radiation Sterile | Radiation Sterile | Radiation Sterile |
|---------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------|-------------------|-------------------|
| Difference | There are no differences in intended use, materials, fundamental scientific<br>technology, etc. between proposed device and primary predicate device, ETIII BA<br>Fixture, K112532. Only difference between them is additional hydrophilic<br>materials applied on the surface is intended to aid in the wettability. | | | |
| S.E. | The intended use, material used, design, and fundamental scientific technology,<br>etc. of the propose device and the predicate device are similar. The proposed<br>device is substantially equivalent to the predicate devices. | | | |

# 7. Summary of tests

Wettability and blood affinity of Bio-SA surface with hydrophilic material compared to existing BA surface, the primary predicate device (K112532) and the reference predicate device(K123784) has been observed. The materials(Glucose and NaCl) of the primary predicate device(K112532) and the material(NaCl) of the reference predicate device(K123784) used for wetting ability that simulate the implantation of product.

Surface analysis and characteristic testing of the hydrophilic material was conducted by EDS, FE-SEM and ICP-AES was conducted,

The biocompatibility tests have been conducted in accordance with ISO 10993-1 and FDA G95-1 Guidelines. The subject device is classified Implant Devices and Tissue/Bone (Contact Duration: c - Permanent [ >30 days].

| Test Items | Standard |
|---------------------------------|-----------------|
| Cytotoxicity | ISO 10993-5 |
| Sensitization | ISO 10993-10 |
| Irritation | ISO 10993-10 |
| Systemic Toxicity (Acute ) | ISO 10993-11 |
| Sub-acute(sub-chronic Toxicity) | ISO 10993-6/11 |
| Chromosome aberration | ISO 10993-3 /12 |
| Implantation | ISO 10993-6 |
| Pyrogen | ISO 10993-11 |

All biocompatibility tests have also been conducted according to the related standards and no discrepancies have been observed.

# 8.Animal test

- a. Information on test animals
- i. Species (strain) /gender: Beagle from Korea, male

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Image /page/7/Picture/0 description: The image shows the logo for Hiossen Implant. The logo is composed of the word "Hiossen" in a stylized font. The "Hi" is in red, and the "ossen" is in gray. The "H" and "I" are connected, and there is a red swoosh above the "I".

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

- ii. Weight : 10kg
- Source: ORIENTBIO Inc. in Korea iii.
- Number of test animals : 12 iv.
- v. Acclimation and quarantine
- -. Acclimation for 2weeks

-. Quarantine ; Animal Research Institute, School of Dentistry, Seoul National University, Seoul, Korea (anti body test, heartworm test, ant helministration, DHPPL inject, Rabies inject. Ivermectin inject, etc.)

b. Results: Comparative testing of the BA and SA Implant bodies was conducted for"

- i. Removal torque after two weeks and eight weeks were measured.
- Length of bone loss from marginal bone level was measured by optical images at 2,4, ii. and 8 weeks
- iii. Bone-to-implant contact was measured at 2,4, and 8 weeks

9.Shelf-life validation (ASTM F1980) and sterilization conducted to ISO 11137-2

- 10. Summary of clinical testing
Investigated patient ages, genders, insertion areas, specific treatment (indications), bone distributions, diameter and length of fixtures used, treatment (bone level or non-bone level procedures), initial fixation of implant during insertion, final prosthesis date, failure and complications.

Clinical data was provided for 45 subjects ages 18 or older with a total of 66 implants placed. The study evaluated primary stability, sensory abnormality, bone resorption, periimplantitis、complications、delayed treatment, fracture, and implant body failure. The final follow-up was 13.7 to 18.2 months with an average of 16.3 months revealed 100% success rate for survival and no adverse events after the 1 year follow-up.

- 11. Conclusion:
Based on the information provided in this premarket notification HIOSSEN concludes that the ETIII BA Fixture System is substantially equivalent to the predicate devices as described herein.

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