ET SmartFit Abutment is intended for use with a dental implant to provide support for prosthetic restorations such as crowns, bridges, or overdentures.

Device Description

The ET SmartFit Abutment is device made of titanium alloy intended for use as an aid in prosthetic restoration. That is customized abutment considering shape of the finial prosthesis based on the patient's mouth model using CAD/CAM system during the manufacturing. All manufacturing processes of ET SmartFit abutment such as CAD/CAM manufacturing and milling are conducted in the Hiossen factory. The ET SmartFit Abutment is used for cement-retained crowns and bridges using customized abutment considering based on the patient's mouth using CAD/CAM system. Use only the basal screws provided for the Customized Abutment. The surgical procedure for Customized abutment is the same as the surgical procedure for the cement-retained abutments.

AI/ML Overview

Acceptance Criteria and Device Performance Study for ET SmartFit Abutment

The ET SmartFit Abutment is a dental device made of titanium alloy intended for use as an aid in prosthetic restoration, specifically for cement-retained crowns, bridges, or overdentures with dental implants.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Implied from Predicate Equivalence & Testing)	Reported Device Performance (ET SmartFit Abutment)
Material Composition	Titanium Alloy (Ti-6Al-4V) - Matches predicate device (K110308).
Intended Use	"Intended for use with a dental implant to provide support for prosthetic restorations such as crowns, bridges, or overdentures." - Matches predicate device.
Design Characteristics	Customized abutment considering shape of the final prosthesis based on the patient's mouth model using CAD/CAM system. - Substantially equivalent to predicate.
Performance - Fatigue Resistance (Worst Case Scenario)	Compliant with ISO 14801 Dentistry - Fatigue test for endosseous dental implants. Results similar to previously cleared predicate devices.
Biocompatibility	Performed and ensures compliance with applicable international and US regulations.
Dimensions (Range of Diameters)	Ø4 mm ~ Ø15mm (Stated as characteristic, not explicit criterion in summary, but assumed to meet functional needs).
Dimensions (Possible Range of Angulations)	0° ~ 30° (Stated as characteristic and confirmed not to be under 30° when angulated, indicating compliance with design limitations).
Implant-Abutment Connection Types	Hex (2.1mm, 2.5mm), Non Hex (Stated as characteristic).
Manufacturing Process	Same as predicate, utilizing CAD/CAM and milling in-house.

2. Sample Size Used for the Test Set and Data Provenance

The summary does not mention a specific "test set" for the ET SmartFit Abutment's performance. The primary approach for demonstrating safety and effectiveness was via substantial equivalence to a predicate device (K110308).

For Fatigue Testing: While not explicitly stated as a "test set" with a specific sample size, the fatigue testing was conducted according to ISO 14801 using a "worst-case scenario." This implies that a sufficient number of samples were tested to meet the requirements of the standard, but the exact number is not provided.
Data Provenance: The document does not specify the country of origin for the data if the testing took place outside of the US. The studies were likely prospective in nature as they describe mechanical tests performed on the device.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

Given that this is a 510(k) submission primarily relying on substantial equivalence and non-clinical bench testing, there is no mention of experts establishing a ground truth for a clinical test set. The "ground truth" for the non-clinical tests would be the established international standards (e.g., ISO 14801) and the performance of the predicate device.

4. Adjudication Method for the Test Set

Not applicable. As noted above, there was no clinical test set for which an adjudication method would be required. The evaluation was based on compliance with international standards and comparison to a predicate device's characteristics.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not performed, nor would it be relevant for this type of device (dental abutment) and submission. MRMC studies are typically used for diagnostic or imaging devices to assess human reader performance with and without AI assistance.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Not applicable. The ET SmartFit Abutment is a physical medical device, not an algorithm or AI system. Therefore, a standalone algorithm performance study was not conducted.

7. The Type of Ground Truth Used

For Non-Clinical Testing (Fatigue, Biocompatibility): The "ground truth" was established by recognized industry standards (e.g., ISO 14801) and regulatory compliance requirements for biocompatibility. The performance was also benchmarked against the predicate device.
For Substantial Equivalence: The ground truth for comparative purposes was the characteristics and performance of the legally marketed predicate device (K110308).

8. The Sample Size for the Training Set

Not applicable. The ET SmartFit Abutment is a physical medical device, not an AI or machine learning model. Therefore, there is no "training set."

9. How the Ground Truth for the Training Set Was Established

Not applicable. As there is no training set, there is no ground truth for a training set to be established.

Summary of the Study Proving Device Meets Acceptance Criteria:

The Hiossen Inc. ET SmartFit Abutment demonstrated its safety and effectiveness through a 510(k) Pre-market Notification pathway by establishing substantial equivalence to a legally marketed predicate device, The Prosthetic System (K110308) from Osstem Implant Co., Ltd.

The key study performed was non-clinical bench testing, specifically fatigue testing, conducted according to ISO 14801. This testing focused on the "worst-case scenario" to ensure the device's mechanical integrity under simulated oral conditions. The results of this fatigue testing were reported to be in compliance with the standard and similar to previously cleared predicate devices.

Additionally, biocompatibility testing was performed to confirm that the device materials (Titanium Alloy - Ti-6Al-4V) comply with applicable international and US regulations.

The manufacturer explicitly states that no clinical studies were submitted because the ET SmartFit Abutment shares the same materials, manufacturing process, chemical composition, indication for use, and body contact characteristics as the predicate device (K110308). This strong similarity, supported by the non-clinical testing, formed the basis for the FDA's determination of substantial equivalence.

Summary

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K123627

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JUN 2 8 2013

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: February 28, 2012

Company and Correspondent making the submission:

Submitter's Name :
Address :
Telephone No. :
Contact :

Device :

Trade or (Proprietary) Name : Common or usual name :

Classification Name :

HIOSSEN Inc. 85 Ben Fairless Dr. Fairless Hills PA 19030 888 678 0001 Mr. Patrick Lim

ET SmartFit Abutment Dental Device Abutment, implant, dental, endosseous 21CFR872.3630 Class II NHA

3. Predicate Device :

K110308, The Prosthetic System, Osstem Implant Co., Ltd.

Description :

I ) The ET SmartFit Abutment is device made of titanium alloy intended for use as an aid in prosthetic restoration. That is customized abutment considering shape of the finial prosthesis based on the patient's mouth model using CAD/CAM system during the manufacturing . All manufacturing processes of ET SmartFit abutment such as CAD/CAM manufacturing and milling are conducted in the Hiossen factory

range of diameters	Ø4 mm ~ Ø15mm
possible range of angulations	0° ~ 30°
type of implant-abutment	Hex (2.1mm, 2.5mm)
connection ports	Non Hex

QS-QI-505-3(Rev.0)

Letter(8.5 X 11in)

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

The ET SmartFit Abutment is used for cement-retained crowns and bridges using customized abutment considering based on the patient's mouth using CAD/CAM system. Use only the basal screws provided for the Customized Abutment. The surgical procedure for Customized abutment is the same as the surgical procedure for the cement-retained abutments.

1. The ET SmartFit Abutment is the same with other commercially available products based on the intended use, the technology used, the claims, the material composition employed and performance characteristics.

The ET SmartFit Abutment is substantially equivalent in design, function and intended use to the Prosthetic System (K110308) of Osstem Implant Co., Ltd.
The ET SmartFit Abutment is used with ETIII SA Fixture (K101096)

	ET SmartFit Abutment	Prosthetic System (Custom Abutment)
Manufacturer	HIOSSEN Inc.	Osstem Implant Co., Ltd
510(k)Number	New	K110308
Design	Image: ET SmartFit Abutment design	Image: Prosthetic System design
Intended use	ET SmartFit Abutment isintended for use with adental implant to providesupport for prostheticrestorations such ascrowns, bridges, oroverdentures.	Prosthetic System isintended for use with adental implant to providesupport for prostheticrestorations such ascrowns, bridges, oroverdentures.
Material	Titanium Alloy(Ti-6Al-4V)	Titanium Alloy(Ti-6AI-4V)

- Substantial Equivalence Matrix

Indication for use :

ET SmartFit Abutment is intended for use with a dental implant to provide support for prosthetic restorations such as crowns, bridges, or overdentures.

QS-QI-505-3(Rev.0)

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Image /page/2/Picture/1 description: The image shows the word "HOSSEN" in a stylized font. The letters are outlined in black and filled with a textured pattern. The "H" has an extended flourish at the top.

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

6. Review :

ET SmartFit Abutment has the same material, indication for use, design and technological characteristics as the predicate device.

ET SmartFit Abutment has been subjected to safety, performance, and product validations prior to release. Safety tests including biocompatibility have been performed to ensure the devices comply with the applicable international and US regulations.

Summary of nonclinical testing

The Fatigue testing for ET SmartFit Abutment was conducted according to the "Guidance for industry and FDA staff Class II Special Controls Guidance Document Root-form Endosseous Dental Implants and Endosseous Dental Abutment" and ISO 14801 Dentistry -Fatigue test for endosseous dental implants with the worst case scenario. The results are in compliance with it and were similar to previously cleared predicate devices."

8. Summary of clinical testing

No clinical studies are submitted because the ET SmartFit Abutment has the same materials, manufacturing process, chemical composition, indication for use and body contact as Prosthetic System (K110308).

Additionally, we certify that ET SmartFit Abutment is not processed that length of post is under 4mm and angulations is under 30°

9. Conclusions

In accordance with the Federal Food, Drug and Cosmetic Act, 21 CFR Part 807, and based on the information provided in this premarket notification HIOSSEN Inc. concludes that the ET SmartFit Abutment is substantially equivalent to the predicate devices as described herein

QS-Q1-505-3(Rev.0)

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DEPARTMENT OF HEALTH & HUMAN SERVICES

June 28, 2013

Public Health Service

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

Mr. Patrick Lim Manager HIOSSEN. Incorporated 85 Ben Fairless Drive FAIRLESS HILLS PA 19030

Re: K123627

Trade/Device Name: ET SMARTFit Abutment Regulation Number: 21 CFR 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: II Product Code: NHA Dated: May 29, 2013 Received: June 5, 2013

Dear Mr. Lim:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree 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" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Kwame O. Ulmer -S

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

K 123627 510(k) Number K _

Device Name : ET SMARTfit Abutment

Indication for use : ET SMARTfit Abutment is intended for use with a dental implant to provide support for prosthetic restorations such as crowns, bridges, or overdentures.

Prescription Use X (Per 21CFR801 Subpart D)

Over-The-Counter Use OR (Per 21CFR807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDBD)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Sheena A. Green -5
2013.06.28 09:27:33 -04100

for Susan Runner, DDS, MA

(Division Sign-Off) (Division Sign-Off)
Division of Anesthesiology, General Hospital
Division of Anesthesi Devices Division of Antaliastonogram

123627

510(k) Number:

QS-QI-505-2(Rev.0)

Letter(8.5 X 11in)

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.)