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 and bonded into the ET Link Abutment by Hiossen only with design input using CAD 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.

AI/ML Overview

This document is a 510(k) summary for the ET Hybrid Abutment by HIOSSEN Inc., intended for use with HIOSSEN ET dental implants to support prosthetic restorations. The submission relies on the substantial equivalence to a primary predicate device, ET Hybrid Abutment (K162390), and two reference predicates: Straumann Variobase Abutments (K132219) and ET SmartFit Abutment (K123627). No clinical studies were submitted. Therefore, the information provided below will be based on the non-clinical testing and comparison to predicate devices, rather than a clinical study establishing the device's meeting of acceptance criteria from human data.

1. A table of acceptance criteria and the reported device performance

The document does not explicitly state "acceptance criteria" in a quantitative format for the entire device. Instead, it relies on demonstrating substantial equivalence to predicate devices through material similarity, manufacturing processes, intended use, and non-clinical testing (biocompatibility and fatigue). The performance is demonstrated by conformance to relevant ISO standards for dental implants.

Acceptance Criteria (Implied / Indirect)	Reported Device Performance (Demonstrated vs. Predicate)
Biocompatibility: Meet requirements for implantable devices.	Demonstrated by relying on the predicate K162390. The subject device is manufactured using identical materials (Titanium Alloy Ti-6AL 4V, Zirconia Oxide) and manufacturing processes. Chemical composition, body contact (BONE / TISSUE, permanent > 30 days), and sterilization methods are the same as predicate devices. No additional biocompatibility testing was deemed necessary.
Fatigue Strength: Withstand static and dynamic forces in oral environment.	Successfully demonstrated through additional non-clinical testing: static and dynamic fatigue tests according to ISO 14801 in saline at 2Hz on the final finished sterilized abutment. The details of the performance (e.g., specific load cycles endured) are not provided in this summary but are implicit in the conclusion of substantial equivalence.
Sterilization Efficacy: Ensure sterility after processing.	Demonstrated by relying on the predicate device's sterilization validation. The subject device uses the same materials (Titanium & Zirconia, Cement) and the predicate's validation for steam sterilization was conducted according to ISO 17665-1, ISO/TS 17665-2 for gravity displacement on wrapped conditions. The worst-case sample (longest height, largest diameter) was used.
Dimensional Specifications: Adhere to design limitations.	The device specifications (Angulation, Gingival Diameter, Total Height, Contact Diameter, Wall Thickness, Gingival Height, Post Diameter, Post Height) are explicitly listed (e.g., Angulation 0~~30°, Gingival Diameter 4.2~~15 mm), indicating controlled design parameters. These are compared to the predicate, with the only difference noted as the coping part angle.
Material Composition: Use specified materials.	Uses Titanium Alloy Ti-6AL 4V and Zirconia Oxide, identical to the primary predicate device.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Sample Size for Test Set: Specific sample sizes for the fatigue tests (ISO 14801) are not explicitly stated in this 510(k) summary. ISO standards typically specify minimum sample sizes for such tests.
Data Provenance: The origin of the testing data is not explicitly stated in terms of country, but it would have been conducted by or for HIOSSEN Inc., which is based in Fairless Hills, Pennsylvania, USA. The testing is prospective as it was conducted to support the
510(k) submission.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable. This is a medical device (dental abutment) undergoing non-clinical mechanical and biological testing for substantial equivalence, not an AI or diagnostic device requiring expert consensus for a ground truth in image interpretation or patient diagnosis.

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

Not applicable. As this is not a diagnostic device or a study involving human interpretation of data, there is no adjudication method used. The testing relies on objective, standardized physical and material property measurements.

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 is not an AI-assisted diagnostic device, and therefore, no MRMC study or AI-related effectiveness study was conducted.

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

Not applicable. This is a physical medical device (dental abutment), not an algorithm or software.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

The "ground truth" in this context refers to the established standards and specifications for material properties, mechanical performance, and biocompatibility of dental implant abutments. These are based on:

International Standards: Primarily ISO 14801 for fatigue testing, and ISO 17665-1, ISO/TS 17665-2 for sterilization validation.
Predicate Device Data: The performance and safety profile of the legally marketed predicate devices (K162390, K132219, K123627) serve as the benchmark for demonstrating substantial equivalence.
Material Specifications: Established specifications for Titanium Alloy Ti-6AL 4V and Zirconia Oxide.

8. The sample size for the training set

Not applicable. There is no training set as this is not a machine learning or AI device.

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

Not applicable. No training set was used.

Summary

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health and Human Services logo on the left and the FDA logo on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. Food & Drug Administration" in blue.

January 11, 2018

HIOSSEN Inc. David Kim Regulatory Affair Manager 85 Ben Fairless Dr. Fairless Hills, Pennsylvania 19030

Re: K170421

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 12, 2017 Received: December 12, 2017

Dear 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.

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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 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.

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.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely.

Mary S. Runner -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 letters "HI" 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, along with their phone number, 1-888-678-0001, fax number, 1-267-759-7004, and website, www.hiossen.com.

Indications for Use Statement

K170421 510(k) Number

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/2 description: The image shows the logo for Hiossen. The word "Hiossen" is written in a stylized font. The "H" and "I" are in red, and the rest of the word is in gray. There is a red swoosh above the "H" and "I".

Hiossen Inc. 85 Ben Fairless Dr. Fairless Hills, PA 19030 Tel:1-888-678-0001 / Fax: 1-267-759-7004 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. 11, 2018

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:

1. Primary : ET Hybrid Abutment K162390 / Hiossen, Inc.
1. Reference: Straumann Variobase Abutments (K132219, Institut Straumann AG)
1. Reference: ET SmartFit Abutment (K123627, Hiossen Inc.)

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Image /page/4/Picture/1 description: The image shows the logo for HIOSSEN. The logo is in two colors, red and gray. The letters "HI" are in red, and the rest of the word "OSSEN" is in gray. There is a red swoosh above the "O" in "OSSEN".

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	ETCMARNZS
(A) Angulation	0~30(°)	0~30(°)
(B) Gingival Diameter	4.2~15 (mm)	4.7~15 (mm)
(C)Total Height	4.5~16(mm)	4.5~16(mm)
(D)Contact Diameter	Ø4.2	Ø4.7
(E)Wall Thickness	Minimum 0.35 (mm)	Minimum 0.44 (mm)
(F)Gingival Height	0.5~8.0 (mm)	0.5~8.0 (mm)
(G)Post Diameter	2.0~6.5 (mm)	3.0~9.0(mm)
(H)Post Height	4~16(mm)	4~16(mm)

The design limitation for coping is defined as below.

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Image /page/5/Picture/1 description: The image shows the word "HIOSSEN" in a stylized font. The "HI" portion of the word is in red, and there is a red curved line above the "I". The rest of the word, "OSSEN", is in gray. The font is bold and sans-serif.

Hiossen Inc. 85 Ben Fairless Dr. Fairless Hills, PA 19030 Tel : 1-888-678-0001 / Fax : 1-267-759-7004 www.hiossen.com

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 BA 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/6/Picture/0 description: The image contains the word "HIOSSEN" in a stylized font. The "HI" is in red, and the "OSSEN" is in gray. There is a red swoosh above the "H" that connects to the "I".

Hiossen Inc. 85 Ben Fairless Dr. Fairless Hills, PA 19030 Tel:1-888-678-0001 / Fax: 1-267-759-7004 www.hiossen.com

Substantial Equivalence Matrix

Part Name	Proposed devices	Primary predicate devices	Reference Predicates
Part Name	ET Hybrid Abutment	ET Hybrid Abutment	Straumann VariobaseAbutments	ET Smartfit Abutment
510K	Proposed	K162390	K132219	K123627
Material	Titanium Alloy Ti-6AL 4VZirconia Oxide	Titanium Alloy Ti-6AL 4VZirconia Oxide	Titanium Alloy Ti-6AL 4VZirconia Oxide	Titanium AlloyTi-6AL 4V
Manufacturer	HIOSSEN INC.	HIOSSEN INC.	Institut Straumann AG	HIOSSEN INC.
Description	ET Hybrid Abutment is intended to beplaced onto Hiossen dental implantsto provide support for customizedprosthetic restorations such as crownsand bridges. The proposed devices arecomposed of ET Link Abutment andCoping. The ET Link Abutment ispre-manufactured abutment byHiossen Inc. only and the copingwould be manufactured and bondedinto the ET Link Abutment byHiossen only with design input usingCAD software from both by dentallaboratories and by Hiossen Inc. Thefinal device of ET Hybrid Abutmentis under controlled by Hiossen'sQuality System and provided to thecustomer.	ET Hybrid Abutment is intended to beplaced onto Hiossen dental implantsto provide support for customizedprosthetic restorations such as crownsand bridges. The proposed devices arecomposed of ET Link Abutment andCoping. The ET Link Abutment ispre-manufactured abutment byHiossen Inc. only and the copingwould be manufactured by Hiossenonly with design input using CAD/CAM software from both by dentallaboratories and by Hiossen Inc. Thefinal device of ET Hybrid Abutmentis under controlled by Hiossen'sQuality System and provided to thecustomer.	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 (Wide Neck),NC (Narrow CrossFit), and RC(Regular CrossFit). A dentallaboratory technician would designthe corresponding coping and/orcrown (the second component ofthe Variobase two-pieceabutment) and/or prostheticrestoration in the dental laboratory	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.
Description(Continue)	ET Hybrid Abutment is indicated forscrew-retained single tooth or cement-retained single tooth and bridgerestorations. The ET Hybrid Abutmentgives the flexibility to designcustomized prosthetics.	ET Hybrid Abutment is indicated forscrew-retained single tooth or cement-retained single tooth and bridgerestorations. 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.	using either a burnout coping orSTL model for open CAD software.The coping and/or crown would bemanufactured via validated.	Use only the basal screws providefor the Custom Abutment. Thesurgical procedure for customabutment is the same as the surgicalprocedure for the cement- retainedabutments.
Indicationfor use	ET Hybrid Abutment is a customizedabutment intended for use withHIOSSEN ET dental implant in theedentulous or partially edentulousmaxilla or mandible to provide supportfor prosthetic restorations such ascrowns and bridges. All digitallydesigned copings for use with the ETHybrid Abutment for CAD areintended to be sent to a HIOSSEN Inc.manufacturing facility for manufacture.	ET Hybrid Abutment is a customizedabutment intended for use withHIOSSEN ET dental implant in theedentulous or partially edentulousmaxilla or mandible to provide supportfor prosthetic restorations such ascrowns and bridges. All digitallydesigned copings for use with the ETHybrid Abutment for CAD areintended to be sent to a HIOSSEN Inc.manufacturing facility for manufacture.	The Straumanho Variobase' Abutmentis a titanium base placed ontoStraumann dental implants to providesupport for customized prostheticrestorations. Straumann VariobaseAbutments are indicated for screw-retained single tooth or cement-retained single tooth and bridgerestorations.	ET SmartFit Abutment is intended foruse with a dental implant to providesupport for prosthetic restorationssuch as crowns, bridges, oroverdentures.
Design	Image: Two-piece Type [Abutment + Screw]	Image: Two-piece Type [Abutment + Screw]	Image: Two-piece Type [Abutment + Screw]	Image: Two-piece Type [Abutment + Screw]
Diameter (mm)	Ti- Base: 4.0/4.5Two-piece: 4.2~15	Ti- Base: 4.0/4.5Two-piece : 4.2~15	Ti- Base : 2.8~3.3Two piece : N/A	4~15
Height (mm)	Ti- Base : 3.2Two-piece : 4.5~16	Ti- Base : 3.2Two-piece : 4.5~16	Ti-Base : 3.5Two piece : N/A	3~18
Angle (°)	0 ~ 30	0	0 ~ 30	0 ~ 30

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Image /page/7/Picture/0 description: The image shows 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 "H".

Hiossen Inc.

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/8/Picture/0 description: The image shows the Hiossen logo. 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.

Ben Fairless Dr. Fairless Hills. PA 19030 1-888-678-0001 / Fax :- 1-267-759-7004

www.hiossen.com

The propose device has the similar intended use for, technological characteristics as predicate devices, ET Hybrid Abutment(K162390) and ET SmartFit Abutnent(K123627) by Hossen.Inc. , Straumann Variobase Abutment(K132219) of Institut Straumann AG. Those devices are the customized abuttrent devices. Especially, the ET Hybrid Abutnent system K162390. Primary predicate) and Variobase Abutments system K132219, Reference predicate) are similar process. The Ti-base(or in pre-milled and made of titaniumnaterial and coping part is designed by the clent al laboratory and nanufacturer using the CAD software and milled and bonded into ET Link Abutment by manufacture only. The only differences with S.E the reference predicate (Variobase Abutnent,K13219) are connection shapes. The shape are only for the manufacturer's properties such as design and compatible to their own dental implant design. The primary precicate (ET Hybrid Abutment, K162390) is almost same structure and dimension but it's straight only which is no angulation compensation and gingival height range. The second reference predicate (ET SmartFit, K123627) has same manufacturing process and facility, similar dimensions but only difference is a material on the top ( Zironia vs Titanium). This proposed device is manufactured using identical material and manufacturing process to a previously cleared predicates.

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Image /page/9/Picture/1 description: The image shows the logo for Hiossen Implant. The logo is composed of the word "Hiossen" in a stylized font. The "H" and the top part of the "i" are in red, while the rest of the word is in gray. The logo is simple and modern, and the use of color helps to make it stand out.

Hiossen Inc. 85 Ben Fairless Dr. Fairless Hills, PA 19030 Tel : 1-888-678-0001 / Fax : 1-267-759-7004 www.hiossen.com

5. Indication for use :

6. Technological Characteristics

The proposed device has similar technological characteristics as the predicate device of the ET Hybrid Abutments (K162390) of Hiossen, Inc.. ET Hybrid Abutment and predicate device are composed of ET Link Abutment and Coping. ET Link Abutment is premanufactured abutment made with Titanium allov and Coping is customized with Zirconia. The only difference is the angle of coping part.

7. Summary of nonclinical testing

The following nonclinical testing data were provided or relied upon in support of the substantial equivalence determination.

1) Biocompatibility

Hiossen. Inc predicate K162390 was relied upon for biocompatibility. The subject device is manufactured using identical materials and manufacturing processes to a previously cleared predicates identified above. No additional biocompatibility testing was necessary for this device. The chemical composition, body contact and sterilization method are the same as the predicate devices. (Category: Implant Device. Contact: BONE / TISSUE. Contact Duration: C-Permanent More than 30 days )

2) Fatigue testing

Additional non-clinical testing data submitted to demonstrate substantial equivalence includes static and dynamic fatigue test according to ISO 14801 in saline at 2Hz on the final finished sterilized abutment.

3) Sterilization Validation

For the subject device, it is same in material(Titanium & Zirconia, Cement). This test had been conducted using worst case sample which is the longest height and the largest diameter. But only difference in between the proposed device and primary predicate device is angulation. Therefore, no additional testing is required. The steam sterilization validation for the predicate device was conducted according to ISO 17665-1, ISO/TS 17665-2 for gravity displacement on wrapped condition.

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.

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.)