Hiossen Prosthetic system is intended for use with a dental implant to provide support for prosthetic restorations such as crowns, bridges, or over-dentures.

Device Description

The Hiossen Prosthetic system is intended for use as an aid in prosthetic restoration. It consists of Abutments, overdenture components and Abutment Screws. The Hiossen Prosthetic 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.

AI/ML Overview

I am sorry, but the provided text does not contain the detailed information necessary to answer your request about acceptance criteria and a study proving device performance. The document is a 510(k) summary for a dental prosthetic system, and it primarily focuses on demonstrating substantial equivalence to predicate devices, rather than presenting a performance study against specific acceptance criteria.

Here's what is missing from the document based on your request:

A table of acceptance criteria and reported device performance: The document mentions safety, performance, and product validations but does not provide a table with specific criteria and results.
Sample size and data provenance for a test set: This information is not present.
Number and qualifications of experts for ground truth: This is not discussed.
Adjudication method: Not mentioned.
Multi-reader multi-case (MRMC) comparative effectiveness study: The document explicitly states "No clinical studies are submitted."
Standalone algorithm performance study: This is not a software device, and no such study is described.
Type of ground truth used: Not applicable given the nature of the device and the lack of clinical studies.
Sample size and ground truth establishment for the training set: Not applicable and not mentioned, as this is a hardware device approval, not an AI/software device.

The document states: "Proposed devices in this submission are substantially equivalent to the predicate devices Therefore we didn't consider conducting additional test but biocompatibility test and retention test of O-Ring are conducted because material of O-Ring is changed." This indicates that the primary method of demonstrating safety and effectiveness was through comparison to existing cleared devices, with limited specific testing mentioned for material changes.

Summary

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Image /page/0/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" arranged around the perimeter. Inside the circle is an abstract symbol resembling a stylized human figure, with three overlapping profiles facing to the right. The profiles are rendered in a dark color, contrasting with the white background of the seal.

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

Auqust 20, 2014

OSSTEM IMPLANT Company, Ltd. C/O Mr. Patrick Lim Manager 85 Ben Fairless Dr Fairless Hills, PA 19030

Re: K140507

Trade/Device Name: Hiossen Prosthetic System Regulation Number: 21 CFR 872.3630 Regulation Name: Endosseous dental implant abutment Regulatory Class: Class II Product Code: NHA Dated: July 17, 2014 Received: July 23, 2014

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 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/Resourcesfor You/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,

Mary S. Runner -S

Erin I. Keith, M.S. Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

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Image /page/2/Picture/1 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.

Indications for Use Statement

Indications for Use

510(k) Number K _140507

Device Name : Hiossen Prosthetic system

Indication for use : Hiossen Prosthetic system is intended for use with a dental implant to provide support for prosthetic restorations such as crowns, bridges, or over-dentures.

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)

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

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Section 010

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

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: December 13, 2013

Company and Correspondent making the submission:

Submitter's Name :
Address :
Contact :
Phone:
Correspondent's Name:
Address:
Contact:
Phone:

. 2. 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

Hiossen Prosthetic system Dental Abutment Endosseous dental implant abutment 21CFR872.3630 Class II NHA

3. Predicate Device:

HU.HS.HG Prosthetic System, OSSTEM Implant Co., Ltd., K081575 TS implant system, OSSTEM Implant Co., Ltd., K121585 NP-cast abutment system, OSSTEM Implant Co., Ltd., K121843 Prosthetic system, OSSTEM Implant Co., Ltd., K110308 US.SS.GS System, OSSTEM Implant Co., Ltd., K073247 TS Fixture system, OSSTEM Implant Co., Ltd., K121995

4. Description :

The Hiossen Prosthetic system is intended for use as an aid in prosthetic restoration. It consists of Abutments, overdenture components and Abutment Screws

The Hiossen Prosthetic system is similar to other commercially available products based on

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

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OSSTEM Implant Co., Ltd.

STEM® #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

the intended use, the technology used, the claims, the material composition employed and performance characteristics.

The Hiossen Prosthetic system is substantially equivalent in design, function and intended use to the HU.HS.HG Prosthetic System (K081575), TS implant system (K121585), NP-cast abutment system (K121843), US.SS.GS System, (K073247) and Prosthetic system (K110308)

These proposed abutments are compatible with the HIOSSEN Implant fixture only. HTIII SA Fixture (K101096)

Item	Content
ET Custom HealingAbutment	DescriptionUsed after successful osseointegration and removing cover screw to make a soft tissue shape before loading prosthetics.
	MaterialPEEK
	Diameter7.05mm/ 5.0mm (Oval in shape)
	Height7mm, 9mm, 11mm, 7.5mm, 9.5mm, 11.5mm
NP-Cast Abutment	DescriptionNP-Cast Abutment is used for cases with path and aesthetic and spatial constraintsAfter customization, be sure to use only dental non-precious metal alloy for casting to make the prosthesis
	MaterialCo-Cr-Mo Alloy + POM
	Diameter4.0mm, 4.5mm
	Height10.5mm, 15.5mm, 13.71mm, 15.71mm, 13mm, 15mm
O-Ring	DescriptionUse for making stud-type overdenture
	MaterialPolymer
	Diameter4.6mm
O-Ring Retainer Cap set	O-Ring Retainer Cap set consist of Retainer and O-ringRetainer Cap is cleared K81575
O-Ring Retainer set	O-Ring Retainer set consist of Retainer and O-ringRetainer is cleared K81575
Esthetic Low GoldCylinder	DescriptionUse for making screw-retained prosthesisAfter customization, be sure to use only dental gold alloy for casting to make the prosthesis
	MaterialGold Alloy + POM
	Diameter4.8mm
	Height12mm

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

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OSSTEM Implant Co., Ltd.

OSSTEM®

#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

- Substantial Equivalence Matrix

< ET Custom Healing abutment>

	ET Custom Healingabutment	Predicate devices
Part Name		Healing Abutment	Quick TemporaryAbutment
510K	Proposed	K081575	K121585
Material	PEEK	Titanium	PEEK
Manufacturer	OSSTEM Implant Co.,Ltd.	OSSTEM Implant Co.,Ltd.	OSSTEM Implant Co.,Ltd.
Description(Intended foruse)	Used to make a softtissue shape beforesetting up prosthetics andremoving cover screwafter osseointegration.	Used to make a softtissue shape beforesetting up prosthetics andremoving cover screwafter osseointegration	It is used temporary untilfinal prosthesis is madeto maintain estheticApperance
Indication foruse	Hiossen Prostheticsystem is intended foruse with a dental implantto provide support forprosthetic restorationssuch as crowns, bridges,or overdentures.	HU/HS/HG ProstheticSystem is intended foruse as an aid inprostheticrestoration.	The abutment is intendedfor use with a dentalimplant fixture toprovide support forprosthetic restorationssuch as crowns, bridges,or overdenture.
Design	Image: ET Custom Healing abutment design	Image: Healing Abutment design	Image: Quick Temporary Abutment design
SE	ET Custom Healing abutment has tha same "Inatended for use" with predicatedevice, Healing Abutment (K081575) but material is differenceMaterier of ET Custom Healing abutment is the same with predicate device,Quick Temporary Abutment (K121585)

< Substantial equivalence of ET Custom Healing Abutment Package>

Package for ET Custom Healing Abutment to keep sterile is Blister & Tyvek package Package of ET Custom Healing Abutment, has the same material and contact area as package for TS Fixture System that has already been cleared by 510(K), K121995 with shelf life of 8years. Therefore, shelf life of 8years for TS Custom Healing Abutment was submitted

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

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STEM Implant Co.,

OSTEON
IMPLANT #50

07-8 Geoje3-Dong Yeonje-Gu Busan, 611-804 Republic of Korea Tel: +82 51 850-2500 Fax: +82 51 850-4341 www.osstem.com

Part Name	O-Ring Retainer Cap SetO-Ring Retainer SetO-ring	Predicate devicesO-Ring Retainer Cap SetO-Ring Retainer SetO-ring
510K	Proposed	K081575
Material	Retainer: TitaniumO-Ring : Acrylonitrile & ButadienePolymer	Retainer: TitaniumO-Ring : Silicone
Manufacturer	OSSTEM Implant Co., Ltd.	OSSTEM Implant Co., Ltd.
Intended use	Use for marking stud-type overdenture	Use for marking stud-type overdenture
Design	Image: O-Ring Retainer Cap Set Design	Image: O-Ring Retainer Cap Set Design
SE	O-Ring Retainer Cap, O-Ring Retainer and O-Ring have a cleared with 510(K),K81575 but material of O-ring is changed

5. Indication for use :

Hiossen prosthetic system is intended for use with a dental implant fixture to provide support for prosthetic restorations such as crowns, bridges, or over-dentures.

1. Review :
  Hiossen prosthetic system has same indication for use and technological characteristics as the predicate device.

Hiossen prosthetic system has been subjected to safety, performance, and product validations prior to release. Safety tests including biocompatibility have been considered to ensure the devices comply with the applicable International and US regulations.

1. Summary of nonclinical testing
  Proposed devices in this submission are substantially equivalent to the predicate devices Therefore we didn't consider conducting additional test but biocompatibility test and retention test of O-Ring are conducted because material of O-Ring is changed
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 Hiossen prosthetic system is substantially equivalent to the predicate devices as described herein.

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

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.)