The ETII SA Fixture system is indicated for use in partially or fully edentulous mandibles and maxillae, in support of single or multiple-unit restorations including; cemented retained, screw retained, or overdenture restorations, and final or temporary abutment support for fixed bridgework. It is intended for delayed loading.

Device Description

The ETII SA Fixture System is dental implant made of titanium metal intended to be surgically placed in the bone of the upper or lower jaw arches. Fixture is made of pure titanium metal and supplied sterile. The surface is SA, Sandblasting and Acid etching, treated. ETII SA Fixture is composed of single threads with internal hex connection straight body of bone level for two stage surgery. It has SA surface. The ETII SA Fixture System is for single and two stage surgical procedures. ETII SA Fixture System is compatibly used with abutment in the ET/SS Implant System (K120847). The ETII SA Fixture System is similar to other commercially available products based on the intended use, the technology used, the claims, the material composition employed and performance characteristics. The ETII SA Fixture is available in various lengths and diameters according to the anatomical situation.

AI/ML Overview

This document describes a 510(k) premarket notification for the Hiossen ETII SA Fixture System, a dental implant. The purpose of the submission is to demonstrate substantial equivalence to previously cleared predicate devices.

1. Table of Acceptance Criteria and Reported Device Performance

The submission does not explicitly state quantitative "acceptance criteria" in the format typically seen for algorithm performance (e.g., sensitivity, specificity thresholds). Instead, the performance is demonstrated through a declaration of substantial equivalence based on material, indication for use, and similar design/technological characteristics to predicate devices. The primary "acceptance" is the FDA's determination of substantial equivalence.

Aspect of Equivalence	Acceptance Criteria (Implied)	Reported Device Performance
Material	Must be the same as predicate device (Pure Titanium Grade 4).	The ETII SA Fixture System uses Pure Titanium Grade 4 (ASTMF67-06), which is the same as the predicate devices (ET III SA Fixture System, HGII Fixture system, HG II Short Fixture System).
Indication for Use	Must be the same as predicate devices.	The ETII SA Fixture System's indication for use is identical to the predicate devices: "for use in partially or fully edentulous mandibles and maxillae, in support of single or multiple-unit restorations including; cemented retained, screw retained, or overdenture restorations, and final or temporary abutment support for fixed bridgework. It is intended for delayed loading."
Design & Technological Characteristics	Must be similar to predicate devices, with no significant differences altering safety or effectiveness.	The ETII SA Fixture System has a straight body type, self-tapping, submerged fixture, and internal hex connection, similar to the HGII Fixture system. The surface is SA treated, similar to the ET III SA Fixture System. The document states there are "no big differences between design of ETII SA Fixture System and predicate device, especially ETII SA Fixture System is almost the same with HGII Fixture system except thread shape of the top."
Fatigue Testing	Must demonstrate comparable or superior resistance to fatigue as predicate device, considering worst-case scenarios.	Fatigue testing was conducted according to FDA guidance using a worst-case scenario (HGII Fixture with an angled abutment). The report states that the "fatigue test result of HGII Fixture can be used as a proof of ETII SA Fixture System" because the ETII SA Fixture System has the same material and similar design as the HGII Fixture.
Biocompatibility	Must comply with applicable international and US regulations.	Biocompatibility tests have been performed to ensure compliance with applicable regulations.

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

This submission is for a medical device (dental implant) and does not involve an AI algorithm with a 'test set' in the traditional sense of evaluating diagnostic or predictive performance on a dataset. The "test" in this context refers to non-clinical bench testing (fatigue testing, biocompatibility).

Sample Size for Non-Clinical Testing: The specific number of devices tested for fatigue or biocompatibility is not provided in this summary. It only indicates that "fatigue testing was considered" and "biocompatibility have been performed."
Data Provenance: The data provenance for the non-clinical tests (fatigue, biocompatibility) would be from the manufacturer's internal testing. The submission does not specify the country of origin of this testing, but Hiossen Inc. is located in Fairless Hills, PA, USA. The testing is prospective in the sense that it was performed specifically for this submission to demonstrate substantial equivalence.

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

Not applicable. This is not an AI diagnostic device that requires expert-established ground truth on a test set of medical images or patient data. The "ground truth" for a dental implant's performance is established through material standards, engineering specifications, and biological compatibility, verified by laboratory testing as opposed to expert consensus on clinical cases.

4. Adjudication Method for the Test Set

Not applicable, as there is no 'test set' requiring expert adjudication for ground truth establishment.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance

Not applicable. This device is a physical dental implant, not an AI-assisted diagnostic or therapeutic tool. Therefore, MRMC studies and the concept of human reader improvement with AI assistance are irrelevant to this submission.

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

Not applicable. This is a physical medical device, not an algorithm.

7. The Type of Ground Truth Used

For this type of device, the "ground truth" is defined by:

Material Specifications: Adherence to standards like ASTM F67-06 for Pure Titanium Grade 4.
Engineering Standards: Meeting performance criteria for mechanical properties, particularly fatigue resistance, often guided by industry standards and FDA guidance documents (e.g., "Guidance for industry and FDA staff Class II Special Controls Guidance Document Root-form Endosseous Dental Implants and Endosseous Dental Abutment").
Biocompatibility Standards: Compliance with ISO or FDA standards for biological evaluation of medical devices.

8. The Sample Size for the Training Set

Not applicable. This is a physical medical device, not an AI algorithm that requires a training set.

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

Not applicable. There is no training set for a physical dental implant.

Summary

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12247

5 2013 JUL

Image /page/0/Picture/2 description: The image shows the word "Hiossen" in a stylized font. The letters are black and have a textured appearance. The "H" is capitalized and slightly larger than the other letters. The "i" has a curved line extending from the top, adding a unique design element to the word.

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 : October 10, 2012

Company and Correspondent making the submission:

Submitter's Name :

HiOSSEN Inc.

888 678 0001

Mr. Patrick Lim

Address :

85 Ben Fairless Dr. Fairless Hills PA 19030

Telephone No.
Contact :

Device :

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

ETII SA Fixture System Dental Implant Endosseous Dental Implant 21CFR872.3640 Class II DZE

Predicate Device :

The ET III SA FIXTURE SYSTEM, HIOSSEN Inc, K101096 The HGII Fixture system, HIOSSEN Inc, K090237 The HG II Short Fixture System, OSSTEM CO., LTD, K091678

Description :

I) The ETII SA Fixture System is dental implant made of titanium metal intended to be surgically placed in the bone of the upper or lower jaw arches. Fixture is made of pure titanium metal and supplied sterile. The surface is SA, Sandblasting and Acid etching, treated.

ETII SA Fixture is composed of single threads with internal hex connection straight body of bone level for two stage surgery. It has SA surface. The ETII SA Fixture System is for single and two stage surgical procedures.

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Image /page/1/Picture/1 description: The image shows the word "OSSEN" in a stylized font. The letters are bold and slightly slanted to the right. The letter "T" has an extended curved top, giving it a unique appearance.

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

1. ETII SA Fixture System is compatibly used with abutment in the ET/SS Implant System (K120847)
1. The ETII SA Fixture System is similar to other commercially available products based on the intended use, the technology used, the claims, the material composition employed and performance characteristics.
1. The ETII SA Fixture is available in various lengths and diameters according to the anatomical situation.

diameter	lengths
3.5mm	8.7mm, 10.2mm, 11.7mm, 13.2mm, 15.2mm
4.2mm	7.2mm, 8.7mm, 10.2mm, 11.7mm, 13.2mm, 15.2mm
4.45mm	7.2mm, 8.7mm, 10.2mm, 11.7mm, 13.2mm, 15.2mm
5.0mm	6.2mm
4.9mm	7.2mm, 8.7mm, 10.2mm, 11.7mm, 13.2mm, 15.2mm

- Substantial Equivalence Matrix

	ETII SA FixtureSystem	Predicate devices
		ET III SA Fixturesystem	HGII Fixturesystem	HG II ShortFixture System
510(K) No.	-	K101096	K090237	K091678
Manufacturer	HIOSSEN Inc.	HIOSSEN Inc.	HIOSSEN Inc.	OSSTEMIMPLANT CO.,LTD.
Design	Image: ETII SA Fixture System Design	Image: ET III SA Fixture system Design	Image: HGII Fixture system Design	Image: HG II Short Fixture System Design
IntendedUse	The ETII SAFixture system isindicated for use inpartially or fullyedentulousmandibles andmaxillae, in support	ET III SA FixtureSystem is indicatedfor use in partiallyor fullyedentulousmandibles andmaxillae, in support	The HG II FixtureSystem is indicatedfor use in partiallyor fully edentulousmandibles andmaxillae, in supportof single or	The HG II ShortFixtureSystem is intendedfor use inpartially or fullyedentulousmandibles and
	of single ormultiple-unitrestorationsincluding; cementedretained, screwretained, oroverdenturerestorations, andfinal or temporaryabutment supportfor fixedbridgework. It isintended for delayedloading. Ultra wideFixture System isintended to be usedin the molar region.	of single ormultiple-unitrestorationsincluding:cemented retained,screw retained, oroverdenturerestorations, andterminal orintermediateabutmentsupport for fixedbridgework. TheETIII SA FixtureSystem is for singleand two stagesurgicalprocedures. It is notfor immediate load.The Ultra wideFixture System isintended to be usedin the molar region.	multiple-unitrestorationsincluding;cemented retained,screw retained, oroverdenturerestorations,and terminal orintermediateabutment supportfor fixedbridgework.The HG II FixtureSystem is for singleand two stagesurgical procedures.It is not forimmediate load.	maxillae, insupport of single ormultiple-unitrestorationsincluding; cementedretained, screwretained, oroverdenturerestorations, andterminal orintermediateabutment supportfor fixedbridgework. It is notfor immediate load.
Structure	- Straight bodyType-Self tapping-Submerged fixture- ETII SA FixtureSystem is for singleand two stagesurgical procedures.	-Taper body Type-Self tapping-Submerged fixture- ETIII SA FixtureSystem is for singleand two stagesurgical procedures.	- Straight bodyType-Self tapping-Submerged fixture	- Straight bodyType-Self tapping-Submerged fixture
ConnectionType	Internal hexconnection	Internal hexconnection	Internal hexconnection	Internal hexconnection
Diameter (D)	3.5, 4.2, 4.45, 4.9,5.0	3.75~5.05	3.5~4.85	4.85~6.85
Length (mm)	6.2, 7.2, 8.7, 10.2,11.7, 13.2, 15.2	7.2~15.2	7.2~15.2	6.2
Material ofFixture	Pure TitaniumGrade 4(ASTMF67-06)	Pure TitaniumGrade 4(ASTMF67-06)	Pure TitaniumGrade 4(ASTMF67-06)	Pure TitaniumGrade 4(ASTMF67-06)
Surface	SA	SA	RBM	RBM
Sterilization	Radiation Sterile	Radiation Sterile	Radiation Sterile	Radiation Sterile
Shelf life	5 years	5 years	5 years	5 years
SE	The ETII SA Fixture System has same material, indication for use and surface treatmentas predicate device such as above and there are no big differences between design of ETIISA Fixture System and predicate device, especially ETII SA Fixture System is almost thesame with HGII Fixture system except thread shape of the top

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长123471

Image /page/2/Picture/1 description: The image shows the word "HIOSSEN" in a bold, sans-serif font. The letters are black and slightly distressed, giving them a textured appearance. The word appears to be a logo or brand name.

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/3/Picture/1 description: The image shows the word "Hiossen" in a stylized, bold font. The letters are black and slightly distorted, giving them a textured appearance. The "H" and "i" are connected, and there is a curved line above the "i" that extends over the "O".

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

1. Indication for use :
  ETII SA Fixture system is indicated for use in partially or fully edentulous mandibles and maxillae, in support of single or multiple-unit restorations including; cemented retained, screw retained, or overdenture restorations, and final or temporary abutment support for fixed bridgework. It is intended for delayed loading.

6. Review :

The ETII SA Fixture System has same material and indication for use and similar design and technological characteristics as the predicate device.

The ETII SA Fixture System 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.

7. Summary of nonclinical testing

Fatigue testing was considered according to the "Guidance for industry and FDA staff Class II Special Controls Guidance Document Root-form Endosseous Dental Implants and Endosseous Dental Abutment" with the worst case scenario of the HGII Fixture and an angled abutment in support of the ETII SA Fixture.

ETII SA Fixture System has same material and similar design as the HGII Fixture. Therefore, the fatigue test result of HGII Fixture can be used as a proof of ETII SA Fixture System

1. Summary of clinical testing No clinical studies are submitted

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 ETII SA Fixture System is substantially equivalent to the predicate devices as described herein

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

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

July 5, 2013

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

Re: K123471

Trade/Device Name: ETII SA Fixture System Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: II Product Code: DZE Dated: May 10, 2013 Received: May 15, 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 device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of 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,

Lester W. Schultheis Jr 2013.07 05 12

Acting for 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 Falrless Dr. Fairless Hills, PA 19030 Tel : 1-888-678-0001 / Fax : 1-267-759-7004 www.hiossen.com

510(k) Number K | 123471

Device Name : ETII SA Fixture System

Indication for use :

Prescription Use	X
(Per 21CFR801 Subpart D)

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)

Sheena A. Green 2013.07.02 13:23:25 04

for M.Susan Runner, DDS, MA

(Division Sign-Off) Division of Anesthestology, General Hospital Infection Control, Dental Devices

510(k) Number:

UD-L-001

Regulation Number and Section

§ 872.3640 Endosseous dental implant.

(a)
Identification. An endosseous dental implant is a prescription device made of a material such as titanium or titanium alloy that is intended to be surgically placed in the bone of the upper or lower jaw arches to provide support for prosthetic devices, such as artificial teeth, in order to restore a patient's chewing function.(b)
Classification. (1) Class II (special controls). The device is classified as class II if it is a root-form endosseous dental implant. The root-form endosseous dental implant is characterized by four geometrically distinct types: Basket, screw, solid cylinder, and hollow cylinder. The guidance document entitled “Class II Special Controls Guidance Document: Root-Form Endosseous Dental Implants and Endosseous Dental Implant Abutments” will serve as the special control. (See § 872.1(e) for the availability of this guidance document.)(2)
Classification. Class II (special controls). The device is classified as class II if it is a blade-form endosseous dental implant. The special controls for this device are:(i) The design characteristics of the device must ensure that the geometry and material composition are consistent with the intended use;
(ii) Mechanical performance (fatigue) testing under simulated physiological conditions to demonstrate maximum load (endurance limit) when the device is subjected to compressive and shear loads;
(iii) Corrosion testing under simulated physiological conditions to demonstrate corrosion potential of each metal or alloy, couple potential for an assembled dissimilar metal implant system, and corrosion rate for an assembled dissimilar metal implant system;
(iv) The device must be demonstrated to be biocompatible;
(v) Sterility testing must demonstrate the sterility of the device;
(vi) Performance testing to evaluate the compatibility of the device in a magnetic resonance (MR) environment;
(vii) Labeling must include a clear description of the technological features, how the device should be used in patients, detailed surgical protocol and restoration procedures, relevant precautions and warnings based on the clinical use of the device, and qualifications and training requirements for device users including technicians and clinicians;
(viii) Patient labeling must contain a description of how the device works, how the device is placed, how the patient needs to care for the implant, possible adverse events and how to report any complications; and
(ix) Documented clinical experience must demonstrate safe and effective use and capture any adverse events observed during clinical use.