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 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.

AI/ML Overview

The provided text is a 510(k) summary for the "ET Hybrid Abutment" by HIOSSEN Inc. This document focuses on demonstrating substantial equivalence to predicate devices, rather than providing detailed acceptance criteria and a study proving that the device meets those criteria.

Therefore, most of the requested information regarding acceptance criteria, specific device performance, sample sizes, expert qualifications, adjudication methods, multi-reader multi-case studies, standalone performance, and ground truth establishment is not available in the provided text, as this type of information is typically part of performance studies, which are not included here.

However, based on the non-clinical testing summary, we can glean some information regarding the sterilization validation.

Here's what can be extracted and what is explicitly not available:

1. Table of acceptance criteria and the reported device performance:

Acceptance Criteria	Reported Device Performance
Biocompatibility	Relied upon predicate devices (K123627, K100245) for biocompatibility. Subject device manufactured using identical materials and manufacturing processes to previously cleared predicates.
Sterilization Validation (Steam sterilization)	All tests conducted in accordance with ISO 17665-1 and ISO/TS 17665-2 for gravity displacement on unwarped condition; no discrepancies.

2. Sample size used for the test set and the data provenance:

Not available. The document states "No additional biocompatibility testing was necessary for this device" as it relies on predicate devices. For sterilization validation, the specific sample size for the test set is not provided. Data provenance is also not specified beyond adherence to ISO standards.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not applicable/Not available. No specific ground truth establishment by experts for performance testing is detailed, as most of the evaluation relies on substantial equivalence to predicates and adherence to international standards for sterilization.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

Not applicable/Not available. No adjudication method is mentioned as there were no clinical studies or reported performance evaluations that would typically require such a method.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

Not applicable. This device is a dental abutment, not an AI-powered diagnostic device. Therefore, MRMC studies and AI-related effectiveness are not relevant.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:

Not applicable. This device is a dental abutment, not a software algorithm.

7. The type of ground truth used:

For biocompatibility: Implicitly, the "ground truth" relies on the established biocompatibility of the materials (Titanium Alloy Ti-6AL 4V and Zirconia) in the predicate devices and their manufacturing processes, which were deemed safe and effective.
For sterilization validation: The "ground truth" is adherence to the validated sterilization parameters and protocols defined by ISO 17665-1 and ISO/TS 17665-2.

8. The sample size for the training set:

Not applicable. As this is a medical device (dental abutment) and not an AI/machine learning system, there is no "training set."

9. How the ground truth for the training set was established:

Not applicable. No training set exists for this type of device.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, with a design that resembles an abstract bird or wing above them.

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 (800) 638-2041 or (301) 796-7100 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 (800) 638-2041 or (301) 796-7100 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 : 1-888-678-0001 / Fax : 1-267-759-7004 www.hiossen.com

4. Description:

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 MarginHeight ( 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 devicesET Hybrid Abutment	Primary predicate devicesStraumann VariobaseAbutments	Reference predicate devicesThe HS/HG Prosthetic System	Reference predicate devicesET Smartfit Abutment
510K	Proposed	K132219	K100245	K123627
Material	Titanium AlloyTi-6AL 4V	Titanium AlloyTi-6AL 4V	Titanium Alloy(most abutments in the submission)Zirconia(Ziocera angled abutment)	Titanium AlloyTi-6AL 4V
Manufacturer	HIOSSEN INC.	Institute Straumann AG	Osstem Implant Co., Ltd	HIOSSEN INC
Description	ET Hybrid Abutment is intended to beplaced onto Hiossen dental implants toprovide support for customizedprosthetic restorations such as crownsand bridges. The proposed devices arecomposed of ET Link Abutment andCoping. The ET Link Abutment is pre-manufactured abutment by Hiossen Inc.only and the coping would bemanufactured by Hiossen only withdesign input using CAD/CAM softwarefrom both by dental laboratories and byHiossen Inc. The final device of ETHybrid Abutment is under controlled byHiossen's Quality System and providedto the customer. ET Hybrid Abutmentis indicated for screw-retained singletooth or cement-retained single toothand bridge restorations. Titanium alloyis the raw material for the LinkAbutment and Zirconia material is forthe Coping. The ET Hybrid Abutmentgives the flexibility to designcustomized prosthetics. The coping isstraight only and the ET Link abutmentis not intended to provide an angleand/or divergence correction.	The Straumann VariobaseAbutments are pre-manufactured(stock) abutments, sometimesreferred to as "Ti-bases".Straumann Variobase Abutmentsare available to fit Straumanndental implant platforms NNC(Narrow Neck CrossFit), RN(Regular Neck), WN (WideNeck), NC (Narrow CrossFit),and RC (Regular CrossFit).A dental laboratory technicianwould design the correspondingcoping and/or crown (the secondcomponent of the Variobase two-piece abutment) and/or prostheticrestoration in the dentallaboratory using either a burnoutcoping or STL model for openCAD software.The coping and/or crown wouldbe manufactured via validatedStraumann milling.	The HS/HG Prosthetic System isdevice made of titanium, titaniumalloy, POM and PC and Zirconiaintended for use as an aid inprosthetic restoration. It consistsof Abutment, Protect Cap and/orAbutment Screw. Their surfacesare partially Tin coated anduncoated.The HS/HG Prosthetic System issimilar to other commerciallyavailable products based on theintended use, the technology used,the claims, the materialcomposition employed andperformance characteristics.Use the ZioCera Abutment forimplant restoration of singletooth or multiple teeth and foraesthetic restoration or whenexisting metal abutment cannotbe used.	The ET SMARTFit Abutment isdevice made of titanium alloyintended for use as an aid inprosthetic restoration. That iscustomized abutment consideringshape of the finial prosthesisbased on the patient's mouthmodel using CAD/CAM systemduring the manufacturing .The ET SMARTFit Abutment isused for cement-retained crownsand bridges using customizedabutment considering based onthe patient's mouth usingCAD/CAM system.Use only the basal screws providefor the Custom Abutment. Thesurgical procedure for customabutment is the same as thesurgical procedure for the cement-retained abutments.
Indication foruse	ET Hybrid Abutment is acustomized abutment intendedfor use with HIOSSEN ETdental implant in the edentulousor partially edentulous maxillaor mandible to provide supportfor prosthetic restorations suchas crowns and bridges. Alldigitally designed copings foruse with the ET HybridAbutment for CAD/CAM areintended to be sent to aHIOSSEN Inc. manufacturingfacility for manufacture.	The Straumann Variobase'Abutment is a titanium baseplaced onto Straumann dentalimplants to provide support forcustomized prostheticrestorations. StraumannVariobase Abutments areindicated for screw-retainedsingle tooth or cement-retainedsingle tooth and bridgerestorations.	HS/HG Prosthetic System isintended for use with a dentalimplant to provide support forprosthetic restorations such ascrowns, bridges, oroverdentures.	ET SmartFit Abutment isintended for use with a dentalimplant to provide support forprosthetic restorations such ascrowns, bridges, or overdentures.
Design	Two-piece Type	Two-piece Type	One-piece Type	One-piece Type
Diameter (mm)	Ti- Base: 4.0/4.5Two-piece : 4.2~15	Ti- Base : 2.8~3.3Two-piece : N/A	5.5/6.5	4~15
Height (mm)	Ti- Base : 3.2Two-piece: 4~16	Ti-Base : 3.5Two-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 : 1-888-678-0001 / Fax : 1-267-759-7004 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 : 1-888-678-0001 / Fax : 1-267-759-7004

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.

Indication for Use :

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.

Summary of clinical testing No clinical studies are submitted.
Conclusions

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

Regulation Number and Section

§ 872.3630 Endosseous dental implant abutment.

(a)
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.(b)
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.)