The Link Abutment for CEREC is titanium alloy abutments placed onto HIOSSEN dental implants to provide support for customized prosthetic restorations. Link Abutment for CEREC is indicated for screw-retained single tooth or cement-retained single tooth and bridge restorations.
• Link abutment for CEREC
All digitally designed copings and/or crowns for use with the Link abutment for CEREC is to be scanned using Sirona CEREC AC or CEREC AF or CEREC AI, designed using Sirona inLab software (Version 3.65) or Sirona CEREC Software (Version 4.2) and manufactured using a Sirona CEREC or inLab MC X or MC XL milling unit. CAD/CAM manufacturing/milling occurs at dental laboratories per the design limitations of the Sirona CEREC.

Device Description

The Link Abutment for CEREC provide the interface for mesostructure designed and milled using the Sirona CEREC system with HIOSSEN Implant System (K140934) The Link Abutment for CEREC is pre-manufactured (stock) abutment made from a titanium alloy (ASTM F 136). The Link Abutment for Cerec is a Ti-base abutment design consisting of the Link Abutment and Sirona ceramic mesostructure. The coronal portion is designed to interface with the pre-machined mounting hole in the milling blanks compatible with the Sirona CEREC MC X and MC XL prosthetic milling systems.

AI/ML Overview

This document is a 510(k) premarket notification for a dental device, the "Link Abutment for CEREC." It primarily focuses on demonstrating substantial equivalence to previously cleared predicate devices, rather than presenting a study for acceptance criteria of an AI/ML device. Therefore, much of the requested information regarding AI/ML device performance and ground truth establishment is not available in this document.

However, based on the information provided, here's what can be extracted and inferred:

1. Table of Acceptance Criteria and Reported Device Performance

This document does not present "acceptance criteria" in the typical sense of metrics for an AI/ML device. Instead, it demonstrates substantial equivalence through comparisons of design, materials, indications for use, and non-clinical testing. The "reported device performance" is primarily in the context of mechanical properties and safety.

Aspect	Acceptance Criteria (Inferred from Predicate Equivalence)	Reported Device Performance (Summary of Non-clinical Testing)
Material	Titanium Alloy comparable to predicates	Titanium Alloy (Ti-6Al-4V)
Gingival Heights	Comparable to predicate abutment designs	0.5mm
Connection Type	Compatible with HIOSSEN dental implants	11° Morse taper internal connection, Mini/Regular (Hex/non-Hex)
Diameter	Ranges comparable to predicate abutments	Ø 4.5mm
Post Height	Ranges comparable to predicate abutments	4.7mm
Indications for Use	Similar to predicate devices	Screw-retained single tooth or cement-retained single tooth and bridge restorations. Uses Sirona CEREC AC/AF/AI, inLab software (v3.65)/CEREC Software (v4.2), and Sirona CEREC/inLab MC X/MC XL milling unit.
Fatigue Resistance	Demonstrated by substantial equivalence to K120847	Fatigue testing conducted according to "Guidance for industry and FDA staff Class II Special Controls Guidance Document Root-form Endosseous Dental Implants and Endosseous Dental Abutment" with worst-case scenario.
Sterilization	Validated per recognized standards	Sterilization conducted according to ISO 17665-1:2006.
Biocompatibility	Demonstrated by substantial equivalence to K120847	Demonstrated by reference to K120847.
Superstructure Design Limitation	Within specified ranges for Diameter, Height, Wall thickness, Angle, comparable to Sirona CEREC design limitations.	Diameter: 4.2~~15 mm, Height: 6~~15 mm, Min. 0.275mm wall thickness, 0~20° angle.

2. Sample size used for the test set and the data provenance

This document describes non-clinical performance testing (fatigue, sterilization) of a physical dental device, not an AI/ML algorithm. Therefore, there isn't a "test set" of data in the AI/ML sense. The "sample size" would refer to the number of physical abutment samples tested. This specific number is not provided in the document, but it states "fatigue testing was considered... with the worst case scenario."
Data provenance: Not applicable in the AI/ML context. The document refers to testing of the physical medical device and reference to predicate devices. The manufacturer is OSSTEM Implant Co., Ltd. from Busan, Republic of Korea.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable as this is not an AI/ML device study. Ground truth, in this context, would relate to the established engineering standards and specifications for dental abutments.

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

Not applicable as this is not an AI/ML device study. Adjudication methods are relevant for resolving discrepancies in expert labeling or diagnoses for AI/ML ground truth.

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

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done because this is a physical dental abutment, not an AI/ML diagnostic or assistive device.

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

No, a standalone algorithm performance study was not done because this is a physical dental abutment, not an AI/ML algorithm.

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

The "ground truth" for this device's safety and effectiveness relies on established engineering principles, material science standards (e.g., ASTM F 136 for titanium alloy, ISO 17665-1:2006 for sterilization), and comparison to predicate devices that have already demonstrated safety and effectiveness through their prior clearances (K120847, K151324). It's essentially a demonstration of conformance to pre-defined physical and mechanical properties and established clinical use for dental abutments.

8. The sample size for the training set

Not applicable as this is not an AI/ML device and therefore does not have a training set.

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

Not applicable as this is not an AI/ML device and therefore does not have a training set.

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 features the department's name in a circular arrangement around a symbol. The symbol consists of a stylized caduceus, which is a staff with two snakes entwined around it, often associated with medicine and healthcare. The logo is presented in black and white.

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

October 28, 2016

OSSTEM Implant Co., Ltd % David Kim Manager HiOSSEN Inc. 85 Ben Fairless Dr. Fairless Hills, Pennsylvania 19030

Re: K160519

Trade/Device Name: Link Abutment for CEREC Regulation Number: 21 CFR 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: Class II Product Code: NHA Dated: September 28, 2016 Received: September 28, 2016

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.

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

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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 Industry and Consumer Education 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. 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.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education 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.

Michael J. Ryan -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 OSSTEM Implant Co., Ltd. The logo includes the company name in a large, bold font, with the word "OSSTEM" in orange and "Implant Co., Ltd." in black. Below the logo is the company's address: 66-16, Bansong-ro 513beon-gil, Haeundae-gu, Busan, Republic of Korea. The image also includes the company's telephone number (+82 51 850-2500), fax number (+82 51 850-4341), and website address (www.osstem.com).

Indications for Use Statement

510(k) Number: K160519

Device Name : Link Abutment for CEREC

Indication for use :

• Link abutment for CEREC

All digitally designed copings and/or crowns for use with the Link abutment for CEREC is to be scanned using Sirona CEREC AC or CEREC AF or CEREC AI, designed using Sirona inLab software (Version 3.65) or Sirona CEREC Software (Version 4.2) and manufactured using a Sirona CEREC or inLab MC X or MC XL milling unit. CAD/CAM manufacturing/milling occurs at dental laboratories per the design limitations of the Sirona CEREC.

Prescription Use X OR (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)

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DSSTEM Implant Co., Ltd.

K160519

66-16, Bansong-ro 513beon-gil, Haeundae-gu, Busan, Republic of Korea Tel: +82 51 850-2500 Fax: +82 51 850-4341 www.osstem.com

510(k) Summary

Date: October 28, 2016

- Submitter's Name:	OSSTEM Implant Co., Ltd.
- Address :	66-16, Bansong-ro 513beon-gil, Haeundae-gu,Busan, Republic of Korea
- Contact:	Mr. Hee Kwon Son
- Phone:	+82 51 850 2575
- Correspondent's Name:	HIOSSEN Inc.
- Address:	85 Ben Fairless Dr. Fairless Hills, PA 19030
- Contact:	DAVID KIM
- Phone:	267 759 7031
Device:
Trade or (Proprietary) Name :	Link Abutment for CEREC
Common or usual name :	Dental Abutment
Classification Name :	Endosseous dental implant abutment21CFR872.3630Class IINHA

3. Predicate Device(s):

Primary Predicate(s)

· ET/SS IMPLANT SYSTEM, OSSTEM IMPLANT CO.,LTD. K120847
Reference Predicate(s)
Straumann® Variobase® for CEREC®, Abutment Models RN, WN, ● RC, NC, Straumann USA, LLC, - K151324
· Sirona Dental Systems GmbH, Sirona Dental CAD/CAM System cleared under K11421;
Sirona Dental Systems GmbH, Sirona Dental CAD/CAM System cleared under K100152;
1. Description:

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Image /page/4/Picture/1 description: The image shows the logo for Osstem Implant. The logo is orange and gray. The word "OSSTEM" is in orange, and the word "IMPLANT" is in gray. The logo is simple and modern.

OSSTEM Implant Co., Ltd.

66-16, Bansong-ro 513beon-gil, Haeundae-gu, Busan, Republic of Korea Tel: +82 51 850-2500 Fax: +82 51 850-4341 www.osstem.com

The Link Abutment for CEREC & superstructure must be sterilized in an autoclave (gravity displacement) at 132°C for 15 minutes before use. After the steam sterilization, the abutments & superstructure should be dried for 15 minutes before use.

Design limitation for Superstructure

(Unit: mm)
Superstructure design limitation
Range(Diameter)	Range(Height)	Range(Wall thickness)	Range(Angle)
4.2~15	6~15	Min. 0.275	0~20°

Item	Content
Link Abutment forCEREC	Material	Titanium Alloy (Ti-6Al-4V)
	Gingivalheights	0.5mm
	type ofconnection	11° Morse taper internal connection
		Mini Connection Hex, Non-Hex
		Regular Connection Hex, Non-Hex
	Diameter	$Ø$ 4.5mm
	Post Height	4.7mm

- Substantial Equivalence Matrix

Part Name	Link Abutment forCEREC	Primary Predicate	Reference predicate
		Transfer Abutment	Straumann Variobasefor CEREC
510K	K160519	K120847	K151324
Material	Titanium Alloy	Titanium Alloy	Titanium-Aluminum-Niobiumalloy (Ti-6Al-7Nb)
Manufacturer	OSSTEM Implant Co.,Ltd.	OSSTEM Implant Co.,Ltd.	Institut Straumann AG

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Image /page/5/Picture/0 description: The image shows the text 'K160519' in a simple, sans-serif font. The text is black and appears to be on a white background. The characters are evenly spaced and clearly legible.

Image /page/5/Picture/1 description: The image shows the logo for Osstem Implant. The logo is orange and gray. The word "OSSTEM" is in orange, and the word "IMPLANT" is in gray. There is a small superscripted "a" in the upper right corner of the logo.

OSSTEM Implant Co., Ltd.

66-16, Bansong-ro 513beon-gil, Haeundae-gu, Busan, Republic of Korea Tel: +82 51 850-2500 Fax: +82 51 850-4341 www.osstem.com

Indication for use	The Link Abutment for CEREC is titanium alloy abutments placed onto HIOSSEN dental implants to provide support for customized prosthetic restorations. Link Abutment for CEREC is indicated for screw-retained single tooth or cement-retained single tooth and bridge restorations. • Link abutment for CEREC All digitally designed copings and/or crowns for use with the Link abutment for CEREC is to be scanned using Sirona CEREC AC or CEREC AF or CEREC AI, designed using Sirona inLab software (Version 3.65) or Sirona CEREC Software (Version 4.2) and manufactured using a Sirona CEREC or inLab MC X or MC XL milling unit. CAD/CAM manufacturing/milling occurs at dental laboratories per the design limitations of the Sirona CEREC.	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.	The Straumann® Variobase® for CEREC® are titanium alloy abutments placed onto Straumann dental implants to provide support for customized prosthetic restorations. Straumann® Variobase® for CEREC® abutments are indicated for screw-retained single tooth or cement-retained single tooth and bridge restorations. All digitally designed copings and/or crowns for use with the Straumann® Variobase® for CEREC® abutments are to be inLab software (Version 3.65 or higher) or Sirona CEREC Software (Version 4.2 or higher) and manufactured using a Sirona CEREC or inLab MC X or MC XL milling unit.
Diameter	4.5mm	4.6 mm. 5.0 mm, 6.0 mm, 7.0 mm	4.5 mm – 7.0 mm
Post Height	4.7mm	4.0 mm , 5.5 mm, 7.0 mm	4.7mm
Implant toabutmentconnection type/ Connectionmode	HIOSSEN dentalimplants;ETIII SA FixtureETIII SA Ultra-WideFixtureETII SA Fixture11° Morse taper internalconnectionMini (Hex, non Hex)Regular (Hex, non Hex)	HIOSSEN dentalimplants;ETIII SA FixtureETIII SA Ultra-WideFixtureETII SA Fixture11° Morse taper internalconnectionMini (Hex, non Hex)Regular (Hex, non Hex)	Straumann dentalimplant platforms: RN(Regular Neck), WN(Wide Neck), RC(Regular CrossFit®),and NC (NarrowrossFit®)
Restorationangulations	20°	0°	20°
Design	Image: HIOSSEN dental implant	Image: HIOSSEN dental implant	Image: Straumann dental implant
mesostructure	Compatible with anymilling blanks clearedfor use with the CERECMC X and MC XLmilling systems (i.e.,containing the pre-machined mountinghole). Currentlyavailable: inCoris ZImeso (K123664)Ivoclar IPS e.max CAD(K132209)Ivoclar Telio CAD(K093708)	-	Compatible with anymilling blanks clearedfor use with the CERECMC X and MC XLmilling systems (i.e.,containing the pre-machined mountinghole). Currentlyavailable: inCoris ZImeso (K123664)Ivoclar IPS e.max CAD(K132209)Ivoclar Telio CAD(K093708)
DesignWorkflow	Per the Sirona CERECInLab, software version3.65	-	Per the Sirona CERECInLab, software version3.6 or later
ManufacturingWorkflow	Per the Sirona CerecMC X and MC XLmilling systems	-	Per the Sirona CerecMC X and MC XLmilling systems
SE	Link Abutment for CEREC is almost same with Straumann Variobase forCEREC except shape, connection structure, and material but connectionstructure and material are exactly same with Transfer Abutment

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Image /page/6/Picture/0 description: The image shows the logo for Osstem Implant. The logo is orange and gray. The word "OSSTEM" is in orange, and the word "IMPLANT" is in gray. There is a small number 6 in the upper right corner of the logo.

OSSTEM Implant Co., Ltd.

66-16, Bansong-ro 513beon-gil, Haeundae-gu, Busan, Republic of Korea Tel: +82 51 850-2500 Fax: +82 51 850-4341 www.osstem.com

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Image /page/7/Picture/1 description: The image shows the logo for Osstem Implant. The logo is orange and gray. The word "OSSTEM" is in orange, and the word "IMPLANT" is in gray. There is a small orange circle with a white "a" in the upper right corner of the logo.

DSSTEM Implant Co., Ltd.

66-16, Bansong-ro 513beon-gil, Haeundae-gu, Busan, Republic of Korea Tel: +82 51 850-2500 Fax: +82 51 850-4341 www.osstem.com

The Link Abutment for CEREC is compatible with the following previously cleared materials:

· inCoris ZI, L size blank (Sirona inCoris ZI meso zirconium dioxide, ZrO2) cleared to market per K062509 and K123664

· IPS e.max CAD Abutment Solutions (Ivoclar IPS e.max CAD lithium disilicate glass-ceramic, LS2) cleared to market per K132209

· Telio CAD (Ivoclar Telio CAD polymethylmethacrylate, PMMA) cleared to market per K093708

The Link Abutment for CEREC abutments are compatible with mesostructure fabricated using Sirona Dental CAD/CAM System

1. Indications for Use Statement
  The Link Abutment for CEREC is titanium alloy abutments placed onto HIOSSEN dental implants to provide support for customized prosthetic restorations. Link Abutment for CEREC is indicated for screw-retained single tooth or cement-retained single tooth and bridge restorations.

· Link abutment for CEREC

1. 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. Sterilization was conducted according to ISO 17665-1:2006. Biocompatibility for the Link Abutment Tibase component is demonstrated by the reference to K120847. All non-clinical testing was conducted for the subject device.
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 CO., LTD. concludes that Link Abutment for CEREC is substantially equivalent to the predicate devices as described herein.

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.)