The ET/SS Implant 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. The abutment is intended for use with a dental implant fixture to provide support for prosthetic restorations such as crowns, bridges, or overdenture.

Device Description

The ET/SS Implant System is a 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. Abutment is device made of titanium alloy intended for use as an aid in prosthetic restoration. It consists of Abutments and Abutment Screws. Its surfaces are partially Tin coated and uncoated.

AI/ML Overview

This 510(k) premarket notification for the ET/SS Implant System does not contain the level of detail typically found in a study describing acceptance criteria and device performance for AI/ML-based medical devices. The submission focuses on demonstrating substantial equivalence to predicate dental implants through a comparison of physical characteristics, intended use, and a summary of nonclinical testing (fatigue testing).

Therefore, I cannot directly extract the specific information requested in your prompt regarding acceptance criteria, study details, ground truth, sample sizes, or MRMC studies, as the document is for a traditional medical device (dental implant) and not an AI/ML device.

However, I can extract the information provided about the nonclinical testing for this device and present it in a similar structure:

1. Table of Acceptance Criteria and Reported Device Performance

Criteria Category	Acceptance Criteria	Reported Device Performance
Fatigue Testing	Compliance with ISO 14801 and "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.	Results were in compliance and similar to previously cleared predicate devices.

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

Not applicable as this is a nonclinical, component-level fatigue test, not a performance study on a test set of data.

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

Not applicable. Ground truth for fatigue testing is established by engineering standards and measurement.

4. Adjudication Method

Not applicable.

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

No, this type of study was not done. The device is a physical dental implant, not an AI system that assists human readers.

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

Not applicable. The "device" is a physical implant. The fatigue testing is a standalone test of the implant's physical properties.

7. The Type of Ground Truth Used

Engineering standards and measurements for fatigue life.

8. The Sample Size for the Training Set

Not applicable. There is no concept of a "training set" for physical fatigue testing of a dental implant in this context.

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

Not applicable.

Summary of Device Information from the Provided Document:

Device Name: ET/SS Implant System
Manufacturer: OSSTEM Implant Co., Ltd.
Device Type: Endosseous Dental Implant
Classification: Class II
Key Feature: Made of pure titanium metal, SA (Sandblasting and Acid etching) treated surface.
Intended Use: For use in partially or fully edentulous mandibles and maxillae, supporting single or multiple-unit restorations (cemented, screw-retained, or overdenture), and for final or temporary abutment support for fixed bridgework. Intended for delayed loading.
Nonclinical Testing: Fatigue testing performed according to ISO 14801 and relevant FDA guidance.
Clinical Testing: No clinical studies were submitted.
Basis for Equivalence: Substantial equivalence was claimed based on material, indication for use, and similar design and technological characteristics to predicate devices, supported by nonclinical testing results.

Summary

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Kiaosyz

510(k) Summary

AUG 1 0 2012

This summary of 510(k) safety and effectiveness information is being submitted in accordance with requirements of 21 CFR Part 807.92.

Date: March 16, 2012

Company and Correspondent making the submission:

Submitter's Name :
Address :
Contact :
Phone:
Correspondent's Name:
Address:
Contact:
Phone:
1. Device :

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

Classification Name :

OSSTEM Implant Co., Ltd. #507-8 Geoje3-Dong Yeonje-Gu Busan, 611-804, Republic of Korea Mr. Hee Kwon Son +82 51 850 2575

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

ET/SS Implant System Dental Implant Endosseous Dental Implant 21CFR872.3640 Class II DZE

3. Predicate Device:

The HU II / HS II Fixture System, Osstem Implant Co., Ltd, K080387 The ET III SA Fixture System, HIOSSEN Inc., K101096 The HS II Short Fixture System, Osstem Implant Co., Ltd, K083633 The Prosthetic System, Osstem Implant Co., Ltd., K110308 The Ziocera & Convertible System, Osstem Implant Co., Ltd., K081786 The HU.HS.HG Prosthetic System, Osstem Implant Co., Ltd., K081575

1. Description:
  The ET/SS Implant System is a 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.

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

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Image /page/1/Picture/0 description: The image shows the logo and contact information for OSSTEM Implant Co., Ltd. The address is #507-8 Geoje3-Dong Yeonje-Gu Busan, 611-804 Republic of Korea. The telephone number is +82 51 850-2500, and the fax number is +82 51 850-4341. The website address is www.osstem.com.

Abutment is device made of titanium alloy intended for use as an aid in prosthetic restoration. It consists of Abutments and Abutment Screws. Its surfaces are partially Tin coated and uncoated

The ET/SS Implant 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 ET/SS Implant System is substantially equivalent in design, function and intended use to the HU II / HS II Fixture System ( K080387) of Osstem Implant Co., Ltd., the ET III SA Fixture System (K101096) of HIOSSEN Inc. and the HS II Short Fixture System (K083633) of Osstem Implant Co., Ltd,

The Prosthetic System such as abutment and cylinder in the ET/SS Implant System is substantially equivalent in design, function and intended use to the Prosthetic System (K110308) of Osstem Implant Co., Ltd, The Ziocera & Convertible System(K081786) of Osstem Implant Co., Ltd and and The HU.HS.HG Prosthetic System(K081575) of Osstem Implant Co., Ltd.

	ET/SS ImplantSystem(SSII/III SAFixture)	Predicate devices
		HS II Fixture(K080387)	ETIII SA Fixture(K101096)	HS Short Fixture(K083633)
Design	Image: ET/SS Implant System	Image: HS II Fixture	Image: ETIII SA Fixture	Image: HS Short Fixture
Intendeduse	ET/SS Implant Systemis indicated for use inpartially or fullyedentulous mandiblesand maxillae, insupport of single ormultiple-unitrestorations including:cemented retained,screw retained, or	HS II Fixture Systemis intended for use inpartially or fullyedentulous mandiblesand maxillae, insupport of single ormultiple-unitrestorationsincluding; cementedretained,	ETIII SA FixtureSystem is indicated foruse in partially or fullyedentulous mandiblesand maxillae, insupport of single ormultiple-unitrestorationsincluding ; cementedretained, screw	HS II Short FixtureSystem is intended foruse in partially or fullyedentulous mandiblesand maxillae, insupport of single ormultiple-unitrestorations including;cemented retained,screw retained, or
overdenturerestorations, and finalor temporary abutmentsupport for fixedbridgework. It isintended for delayedloading. The abutmentis intended for use witha dental implant fixtureto provide support forprosthetic restorationssuch as crowns,bridges, oroverdenture.	screw retained, oroverdenturerestorations, andterminal orintermediateabutment support forfixed bridgework. Itis not for immediateload	retained, oroverdenturerestorations, andterminal orintermediate abutmentsupport for fixedbridgework. The ETIIISA Fixture System isfor singleand two stage surgicalprocedures. It is notfor immediate load.The Ultra wide FixtureSystem is intended tobe used in the molarregion.	overdenturerestorations, andterminal orintermediate abutmentsupport for fixedbridgework. It is notfor immediate load
Surgerytype	One and two stageSurgery	One and two stageSurgery	One and two stageSurgery	One and two stageSurgery
Structure	Fixture- Non Submerged- Self tapping- Internal Octagonalconnection- Straight Body	Fixture- Non Submerged- Self tapping- Internal Octagonalconnection- Straight Body	- Submerged Fixture- Self tapping- Internal Hexagonalconnection- Taper Body	Fixture- Non Submerged-Straight Body Type-Self tapping-Internal Octagonalconnection
Platform(D)	4.8~6.0	3.5~6.0	N/A	5.0~7.0
BodyDiameter(D)	4.1~~4.9/3.75~~5.0	3.5~5.0	3.5~5.0	4.95 ~ 6.85
Length(mm)	6~15.0	8.5~15.0	7.0~15.0	6.0
Materialof Fixture	Pure Titanium Grade 4(ASTM F67)	Pure Titanium Grade4 (ASTM F67)	Pure Titanium Grade 4(ASTM F67)	Pure Titanium Grade 4(ASTM F67)
Surface	SA	RBM	SA	RBM
Packaging	Polymeric Ampoule ina foil backed peel openblister pack	Polymeric Ampoulein a foil backed peelopen blister pack	Polymeric Ampoule ina foil backed peelopen blister pack	Polymeric Ampoule ina foil backed peelopen blister pack
Sterilization	Radiation Sterile	Radiation Sterile	Radiation Sterile	Radiation Sterile
Shelf life	5 years	3 years	5 years	5 years
SE	SSII/III SA Fixture has the same material, indication for use and similar design as the HSII Fixturein the HU II / HS II Fixture System (K080387) except surface treatment, but the surface treatmentof SS SA Fixture is the same with surface treatment of ETIII SA Fixture System (K101096)

- Substantial Equivalence Matrix

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

Letter(8.5 X 11in)

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Image /page/2/Picture/0 description: The image shows the logo for Osstem Implant. The logo is in black and white and features the word "OSSTEM" in a bold, sans-serif font. Below the word "OSSTEM" is the word "IMPLANT" in a smaller, sans-serif font. The logo is simple and modern, and it is likely used to represent the company's brand.

OSSTEM Implant Co., Ltd.

#507-8 Geoje3-Dong Yeonje-Gu Busan, 611-804 Republic of Korea Tel: +82 51 850-2500 Fax: +82 51 850-4341 www.osstem.com

Indication for use :

Letter(8.5 X 11in)

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Image /page/3/Picture/0 description: The image shows the logo for Osstem Implant. The word "OSSTEM" is written in bold, sans-serif font on the top line. Below it, the word "IMPLANT" is written in a smaller, sans-serif font. There is a small circle above and to the right of the "M" in "OSSTEM".

OSSTEM Implant Co., L #507-8 Geoje3-Dong Yeonje-Gu Busan, 611-804 Republic of Tel: +82 51 850-2500 Fax: +82 51 850-4341 www.osstem.com

a dental implant fixture to provide support for prosthetic restorations such as crowns, bridges, or overdenture.

1. Review :
  The ET/SS Implant System has same material and indication for use and similar design and technological characteristics as the predicate device.

The ET/SS Implant 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

The Fatigue testing 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."

1. Summary of clinical testing No clinical studies are submitted
1. 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 Osstem Implant Co., Ltd. concludes that the ET/SS Implant System is substantially equivalent to the predicate devices as described herein

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of an eagle with its wings spread.

Public Health Service

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

AUG 1 0 2012

OSSTEM Implant Company, Limited C/O HIOSSEN, Incorporated Mr. Patrick Lim . 85 Ben Fairless Drive Fairless Hills, Pennsylvania 19030

Re: K120847

Trade/Device Name: ET/SS Implant System Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: II Product Code: DZE, NHA Dated: June 29, 2012 Received: July 11, 2012

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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Page 2- Mr. Lim

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 go to

http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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/Resourcesfor You/Industry/default.htm.

Sincerely yours,

For

Anthony D. Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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DSSTEM Implant Co., L #507-8 Geoje3-Dong Yeonie-Gu Busan, 611-804 Republic of Korea Tel: +82 51 850-2500 Fax: +82 51 850-4341 www.osstem.com

510(k) Number K _

Device Name : ET/SS Implant System

Indication for use : The ET/SS Implant 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. The abutment is intended for use with a dental implant fixture to provide support for prosthetic restorations such as crowns, bridges, or overdenture.

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)

Susan Ruerner

Division Sign-Off) Division of Anesthesiology, General Hospital nfection Control, Dental Devices

510(k) Number: K120847

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

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.