ET Hybrid Abutment

K162390 · Hiossen, Inc. · NHA · Jan 30, 2017 · Dental

Device Facts

• Record ID: K162390
• Device Name: ET Hybrid Abutment
• Applicant: Hiossen, Inc.
• Product Code: NHA · Dental
• Decision Date: Jan 30, 2017
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3630
• Device Class: Class 2

Intended Use

ET Hybrid Abutment is a customized abutment intended for use with HIOSSEN ET dental implant in the edentulous or partially edentulous maxilla or mandible to provide support for prosthetic restorations such as crowns and bridges. All digitally designed copings for use with the ET Hybrid Abutment for CAD/CAM are intended to be sent to a HIOSSEN Inc. manufacturing facility for manufacture.

Device Story

ET Hybrid Abutment is a two-piece dental abutment system consisting of a pre-manufactured titanium alloy (Ti-6AL 4V) 'Link Abutment' and a customized zirconia coping. Used in dental clinics, the device is placed onto HIOSSEN ET dental implants to support screw-retained or cement-retained single tooth and bridge restorations. The coping is designed via CAD/CAM software by dental laboratories or HIOSSEN Inc. and manufactured exclusively at a HIOSSEN facility. The system provides flexibility for customized prosthetics; however, the coping is straight-only and the Link Abutment does not provide angle or divergence correction. The final assembly is controlled by HIOSSEN's quality system. By providing a customized interface between the implant and the final restoration, the device aids in restoring dental function and aesthetics for patients.

Clinical Evidence

No clinical data submitted. Substantial equivalence is supported by non-clinical bench testing, including steam sterilization validation per ISO 17665-1 and ISO/TS 17665-2, and reliance on biocompatibility data from predicate devices (K123627 and K100245).

Technological Characteristics

Two-piece abutment system: pre-manufactured Titanium alloy (Ti-6AL 4V) Link Abutment and customized Zirconia coping. Dimensions: Diameter 4.2-15mm, Post Height 4-16mm. Sterilization: Steam sterilization (ISO 17665-1, ISO/TS 17665-2). Connectivity: CAD/CAM design workflow. Intended for permanent contact (>30 days) with bone/tissue.

Indications for Use

Indicated for patients requiring prosthetic restorations (crowns/bridges) in the edentulous or partially edentulous maxilla or mandible, supported by HIOSSEN ET dental implants.

Regulatory Classification

Identification

An endosseous dental implant abutment is a premanufactured prosthetic component directly connected to the endosseous dental implant and is intended for use as an aid in prosthetic rehabilitation.

Special Controls

*Classification.* Class II (special controls). 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.)

Predicate Devices

• Straumann Variobase Abutments (K132219)

Reference Devices

• HS/HG Prosthetic System (K100245)
• ET Smartfit Abutment (K123627)

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

January 30, 2017

HIOSSEN Inc. Mr. David Kim RA Manager 85 Ben Fairless Dr. Fairless Hills, Pennsylvania 19030

Re: K162390

Trade/Device Name: ET Hybrid Abutment Regulation Number: 21 CFR 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: Class II Product Code: NHA Dated: December 30, 2016 Received: December 30, 2016

Dear Mr. David Kim:

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.

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 devicerelated 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.

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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" (21 CFR 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,

Michael J. Ryan -S

for Tina Kiang, Ph.D. Acting 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 and contact information for Hiossen Inc. The logo features the company name in a stylized font, with the "H" and part of the "I" in red. Below the logo is the company name, address (85 Ben Fairless Dr. Fairless Hills, PA 19030), phone number (1-888-678-0001), fax number (1-267-759-7004), and website (www.hiossen.com).

# Indications for Use Statement

510(k) Number K_162390

Device Name : ET Hybrid Abutment

Indication for use : ET Hybrid Abutment is a customized abutment intended for use with HIOSSEN ET dental implant in the edentulous or partially edentulous maxilla or mandible to provide support for prosthetic restorations such as crowns and bridges. All digitally designed copings for use with the ET Hybrid Abutment for CAD/CAM are intended to be sent to a HIOSSEN Inc. manufacturing facility for manufacture.

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)

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Image /page/3/Picture/1 description: The image shows the logo and contact information for Hiossen Inc. The logo is in red and gray, and the text includes the company name, address (85 Ben Fairless Dr. Fairless Hills, PA 19030), phone number (1-888-678-0001), fax number (1-267-759-7004), and website (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: Jan. 26, 2017

## 1. Company and Correspondent making the submission:

| - Submitter's Name : | HIOSSEN IINC. |
|----------------------|--------------------------------------------------|
| - Address : | 85 Ben Fairless Dr. Fairless Hills, PA 19030 USA |
| - Contact : | Mr. David Kim |
| - Telephone No. | 888 678 0001 |

## 2. Device:

| Trade or (proprietary) Name: | ET Hybrid Abutment |
|------------------------------|------------------------------------|
| Common or usual Name: | Dental Abutment |
| Classification Name: | Endosseous Dental Implant Abutment |
| Regulation Number: | 21 CFR 872.3630 |
| Device Classification: | Class II |
| Product Code: | NHA |

## 3. Predicate Device:

Primary : K132219 / Straumann Variobase Abutments / Institut Straumann AG Reference : K100245 / HS/HG Prosthetic System / Osstem Implant Co., Ltd. Reference : K123627 / ET Smartfit Abutment / HIOSSEN INC.

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Image /page/4/Picture/1 description: The image contains the logo for Hiossen Implant. The logo is composed of the word "Hiossen" in a stylized font. The "H" and part of the "i" are in red, while the rest of the word is in gray. The font is bold and modern, giving the logo a clean and professional look.

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

## 4. Description:

ET Hybrid Abutment is intended to be placed onto Hiossen dental implants to provide support for customized prosthetic restorations such as crowns and bridges. The proposed devices are composed of ET Link Abutment and Coping. The ET Link Abutment is premanufactured abutment by Hiossen Inc. only and the coping would be manufactured by Hiossen only with design input using CAD/CAM software from both by dental laboratories and by Hiossen Inc. The final device of ET Hybrid Abutment is under controlled by Hiossen's Quality System and provided to the customer. ET Hybrid Abutment is indicated for screw-retained single tooth or cement-retained single tooth and bridge restorations. Titanium alloy is the raw material for the Link Abutment and Zirconia material is for the Coping. The ET Hybrid Abutment gives the flexibility to design customized prosthetics. The coping is straight only and the ET Link abutment is not intended to provide an angle and/or divergence correction.

| Code | ETCMAMNZS / ETCMAMHZS | ETCMARNZS, ETCMARHZS |
|-----------------------------------|-----------------------|----------------------|
| Diameter (D) | 4.2~15 (mm) | 4.7~15 (mm) |
| Wall Thick. | 0.35~0.55(mm) | 0.40~0.65 (mm) |
| Post Height(H) | 4~16 (mm) | 4~16 (mm) |
| Post Wall Thick.(t) | 0.7~2.7 (mm) | 1.2~4.2 (mm) |
| Post Diameter (d) | 2.5~6.5 (mm) | 3.0~9.0 (mm) |
| Gingival Margin<br>Height ( G/H ) | 3.5~8.5 (mm) | 3.5~8.5 (mm) |

The design limitation for coping is defined as below.

The coping is straight only and the ET Link abutment is not intended to provide an angle and/or divergence correction.

The proposed devices are compatible with the implant systems below.

| No. | 510(K) | Proprietary name | Manufacture |
|-----|---------|------------------------------|--------------|
| 1 | K101096 | ET III SA Fixture System | HIOSSEN. Inc |
| 2 | K103537 | ETIII SA Ultra Wide System | HIOSSEN. Inc |
| 3 | K112532 | ET III Bio-SA Fixture System | HIOSSEN. Inc |
| 4 | K123471 | ETII SA FIXTURE SYSTEM | HIOSSEN. Inc |
| 5 | K140934 | HIOSSEN IMPLANT SYSTEM | HIOSSEN. Inc |
| 6 | K151626 | ET III NH System | HIOSSEN. Inc |

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Image /page/5/Picture/0 description: The image shows the logo and contact information for Hiossen Inc. The logo features the company name in a stylized font, with a red accent mark above the "H". The contact information includes the company's address at 85 Ben Fairless Dr. Fairless Hills, PA 19030, phone number 1-888-678-0001, fax number 1-267-759-7004, and website address www.hiossen.com.

## - Substantial Equivalence Matrix

| Part Name | Proposed devices<br>ET Hybrid Abutment | Primary predicate devices<br>Straumann Variobase<br>Abutments | Reference predicate devices<br>The HS/HG Prosthetic System | Reference predicate devices<br>ET Smartfit Abutment |
|-----------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510K | Proposed | K132219 | K100245 | K123627 |
| Material | Titanium Alloy<br>Ti-6AL 4V | Titanium Alloy<br>Ti-6AL 4V | Titanium Alloy<br>(most abutments in the submission)<br>Zirconia<br>(Ziocera angled abutment) | Titanium Alloy<br>Ti-6AL 4V |
| Manufacturer | HIOSSEN INC. | Institute Straumann AG | Osstem Implant Co., Ltd | HIOSSEN INC |
| Description | ET Hybrid Abutment is intended to be<br>placed onto Hiossen dental implants to<br>provide support for customized<br>prosthetic restorations such as crowns<br>and bridges. The proposed devices are<br>composed of ET Link Abutment and<br>Coping. The ET Link Abutment is pre-<br>manufactured abutment by Hiossen Inc.<br>only and the coping would be<br>manufactured by Hiossen only with<br>design input using CAD/CAM software<br>from both by dental laboratories and by<br>Hiossen Inc. The final device of ET<br>Hybrid Abutment is under controlled by<br>Hiossen's Quality System and provided<br>to the customer. ET Hybrid Abutment<br>is indicated for screw-retained single<br>tooth or cement-retained single tooth<br>and bridge restorations. Titanium alloy<br>is the raw material for the Link<br>Abutment and Zirconia material is for<br>the Coping. The ET Hybrid Abutment<br>gives the flexibility to design<br>customized prosthetics. The coping is<br>straight only and the ET Link abutment<br>is not intended to provide an angle<br>and/or divergence correction. | The Straumann Variobase<br>Abutments are pre-manufactured<br>(stock) abutments, sometimes<br>referred to as "Ti-bases".<br>Straumann Variobase Abutments<br>are available to fit Straumann<br>dental implant platforms NNC<br>(Narrow Neck CrossFit), RN<br>(Regular Neck), WN (Wide<br>Neck), NC (Narrow CrossFit),<br>and RC (Regular CrossFit).<br>A dental laboratory technician<br>would design the corresponding<br>coping and/or crown (the second<br>component of the Variobase two-<br>piece abutment) and/or prosthetic<br>restoration in the dental<br>laboratory using either a burnout<br>coping or STL model for open<br>CAD software.<br>The coping and/or crown would<br>be manufactured via validated<br>Straumann milling. | The HS/HG Prosthetic System is<br>device made of titanium, titanium<br>alloy, POM and PC and Zirconia<br>intended for use as an aid in<br>prosthetic restoration. It consists<br>of Abutment, Protect Cap and/or<br>Abutment Screw. Their surfaces<br>are partially Tin coated and<br>uncoated.<br>The HS/HG Prosthetic System is<br>similar to other commercially<br>available products based on the<br>intended use, the technology used,<br>the claims, the material<br>composition employed and<br>performance characteristics.<br>Use the ZioCera Abutment for<br>implant restoration of single<br>tooth or multiple teeth and for<br>aesthetic restoration or when<br>existing metal abutment cannot<br>be used. | The ET SMARTFit Abutment is<br>device made of titanium alloy<br>intended for use as an aid in<br>prosthetic restoration. That is<br>customized abutment considering<br>shape of the finial prosthesis<br>based on the patient's mouth<br>model using CAD/CAM system<br>during the manufacturing .<br>The ET SMARTFit Abutment is<br>used for cement-retained crowns<br>and bridges using customized<br>abutment considering based on<br>the patient's mouth using<br>CAD/CAM system.<br>Use only the basal screws provide<br>for the Custom Abutment. The<br>surgical procedure for custom<br>abutment is the same as the<br>surgical procedure for the cement-<br>retained abutments. |
| Indication for<br>use | ET Hybrid Abutment is a<br>customized abutment intended<br>for use with HIOSSEN ET<br>dental implant in the edentulous<br>or partially edentulous maxilla<br>or mandible to provide support<br>for prosthetic restorations such<br>as crowns and bridges. All<br>digitally designed copings for<br>use with the ET Hybrid<br>Abutment for CAD/CAM are<br>intended to be sent to a<br>HIOSSEN Inc. manufacturing<br>facility for manufacture. | The Straumann Variobase'<br>Abutment is a titanium base<br>placed onto Straumann dental<br>implants to provide support for<br>customized prosthetic<br>restorations. Straumann<br>Variobase Abutments are<br>indicated for screw-retained<br>single tooth or cement-retained<br>single tooth and bridge<br>restorations. | HS/HG Prosthetic System is<br>intended for use with a dental<br>implant to provide support for<br>prosthetic restorations such as<br>crowns, bridges, or<br>overdentures. | ET SmartFit Abutment is<br>intended for use with a dental<br>implant to provide support for<br>prosthetic restorations such as<br>crowns, bridges, or overdentures. |
| Design | Two-piece Type | Two-piece Type | One-piece Type | One-piece Type |
| Diameter (mm) | Ti- Base: 4.0/4.5<br>Two-piece : 4.2~15 | Ti- Base : 2.8~3.3<br>Two-piece : N/A | 5.5/6.5 | 4~15 |
| Height (mm) | Ti- Base : 3.2<br>Two-piece: 4~16 | Ti-Base : 3.5<br>Two-piece : N/A | 3.0, 4.0 (G/H) | 3~18 |

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Image /page/6/Picture/0 description: The image shows the logo for Hiossen Inc. The word "HIOSSEN" is written in a stylized font, with the "HI" in red and the rest of the word in gray. The words "Hiossen Inc." are written in black below the logo.

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

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Image /page/7/Picture/0 description: The image shows the Hiossen Inc. logo. The "HI" part of the logo is in red, while the "OSSEN" part is in gray. The text "Hiossen Inc." is written below the logo.

www.hiossen.com

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

#### SECTION 007

ET Hybrid Abutment has the similar intended use for, technological characteristics as predicate devices, K132219 Straumann Variobase Abutments (K132219) of Institut Straumann AG. Both devices are customized abutments. Especially Variosbase abutment and the subject devices are similar manufacturing processes. The Ti-base part is pre-milled and made ial and coping SE is designed by the dental laboratory and manufacturer using the CAD software and milled by manufacturer only. The only differences are connection structure and insignificant shapes. The connection and shape are only for the manufacturer's design and compatible to their own dental implant design. The ET Smart Fit abutment as the same manufacturing process and facility, similar dimensions but only difference is a material on the top (Zirconia vs Titanium ). The zirconia material is widely used in the Dental industry and the materials similarity is applicable to the Zirconia abutment (HS/HG Prosthetic System, K100245). This subject device is manufactured using identical materials and manufacturing processes to a previously cleared predicate.

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Image /page/8/Picture/0 description: The image shows the logo and contact information for Hiossen Inc. The logo features the company name in a stylized font, with the "H" in red and the rest of the name in gray. Below the logo is the company's address, which is 85 Ben Fairless Dr. Fairless Hills, PA 19030, as well as their phone number, 1-888-678-0001, fax number, 1-267-759-7004, and website, www.hiossen.com.

5. Indication for Use :

ET Hybrid Abutment is a customized abutment intended for use with HIOSSEN ET dental implant in the edentulous or partially edentulous maxilla or mandible to provide support for prosthetic restorations such as crowns and bridges. All digitally designed copings for use with the ET Hybrid Abutment for CAD/CAM are intended to be sent to a HIOSSEN Inc. manufacturing facility for manufacture.

## 6. Technological Characteristics

The proposed device has same technological characteristics as the predicate device of K132219) of Institut Straumann AG. ET Hybrid Abutment and predicate device are composed of ET Link Abutment and Coping. ET Link Abutment is pre-manufactured abutment made with Titanium alloy and Coping is customized with Zirconia. The only differences are connection structure and insignificant shapes.

## 7. Summary of nonclinical testing

Hiossen, Inc. predicate K123627 and K100245 was relied upon for biocompatibility. The subject device is manufactured using identical materials and manufacturing processes to a previously cleared predicates below. No additional biocompatibility testing was necessary for this device. The chemical composition, body contact and sterilization method are the predicate devices. (Category: Implant Device, Contact: BONE / TISSUE, Contact Duration: C-Permanent More than 30 days ) Additional non-clinical testing data submitted to demonstrate substantial equivalence includes steam sterlization according to ISO 17665-1, ISO/TS 17665-2 for gravity displacement on unwarp condition. All tests were conducted in accordance with relative standards without any discrepancies.

| TEST ITEM | STANDARD |
|--------------------------------|-----------------------------|
| Steam sterilization Validation | ISO 17665-1, ISO/TS 17665-2 |

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Image /page/9/Picture/0 description: The image shows the logo and contact information for Hiossen Inc. The logo features the company name in a stylized font, with the "H" in red and the rest of the name in gray. Below the logo is the company's address, which is 85 Ben Fairless Dr. Fairless Hills, PA 19030, as well as their phone number, 1-888-678-0001, fax number, 1-267-759-7004, and website, www.hiossen.com.

8. Summary of clinical testing No clinical studies are submitted.

9. Conclusions

The documentation submitted in this premarket notification demonstrates that the ET Hybrid Abutment is substantially equivalent to the predicate devices.