Dentium Implantium® / SuperLine® Prosthetics are intended for use as an aid in prosthetic rehabilitation. They consist of Dual Milling Abutment, Dual Abutment, Angled Abutment, Temporary Abutment, Direct-Casting Abutment and Metal Casting Abutment.

They are supplied non-sterile and sterilized by the recommended sterilization method in user's manual.

The materials of the Implantium & SuperLine Prosthetics are as follows; Pure Titanium Grade 4: Dual Milling Abutment, Dual Abutment, Angled Abutment and Temporary Abutment.

Co-Cr-Mo alloy (conform to ASTM F799) and Polyacetal (POM): Metal Casting Abutment,

Gold Alloy and Polyacetal (POM): Direct Casting Abutment.

AI/ML Overview

This document is a 510(k) premarket notification for a dental prosthetic device, not an AI software. Therefore, the requested information about acceptance criteria, study design referencing AI/ML performance, and related ground truth establishment methods is not present in the provided text.

Specifically, the document focuses on demonstrating substantial equivalence of the Dentium Implantium® & SuperLine® Prosthetics to legally marketed predicate devices based on:

Indications for Use: The devices are intended as an aid in prosthetic rehabilitation, matching the predicate devices.
Design and Materials: Similarities in materials (Pure Titanium Grade 4, Co-Cr-Mo alloy, Gold Alloy, Polyacetal) and general shapes are emphasized. Minor differences in dimensions (total length, diameter, hex height) are noted but deemed not to affect application.
Performance Bench Testing: Biocompatibility testing (ISO 10993-1) and mechanical performance testing (ISO Static compressive, ISO Fatigue, Corrosion Testing, Adaptation Accuracy) are reported.
Non-clinical Testing: This includes "Reliability Calculation and Testing," "Fatigue Strength Testing," and "Static Load Failure Testing" in accordance with FDA guidance for dental implants/abutments.

The provided text does not contain:

Any mention of acceptance criteria or performance metrics related to an AI/ML algorithm (e.g., sensitivity, specificity, AUC).
Details on a test set's sample size for an AI/ML model, its provenance, or how ground truth was established by experts.
Information on Multi-Reader Multi-Case (MRMC) studies or human-in-the-loop performance with AI assistance.
Details about training sets for an AI/ML model.

Therefore, I cannot provide the requested table or study details specific to AI/ML device performance. The information in the document pertains to the physical and material characteristics and safety/performance of a traditional medical device (dental prosthetics).

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 is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is an abstract image of an eagle with three human profiles embedded within its wings.

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

September 15, 2016

Dentium Co., Ltd. Sangpil Yoon Regulatory 150. Eondong-ro. Giheung-gu Gyeonggi-do 443-270 KOREA

Re: K160828

Trade/Device Name: Dentium Implantium® & SuperLine® Prosthetics Regulation Number: 21 CFR 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: Class II Product Code: NHA Dated: August 5, 2016 Received: August 9, 2016

Dear Sangpil Yoon:

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 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/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 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.

Sincerelv.

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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Dentium Co. Ltd. Implantium® & SuperLine® Prosthetics Abbreviated 510(k)

Indications for Use

K160828 510(k) Number:

Device Name: Dentium Implantium® & SuperLine® Prostehtics

Indications for Use:

Dentium Implantium® & SuperLine® Prosthetics are intended for use as an aid in prosthetic rehabilitation.

Prescription Use 区 (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use □ (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

COMPANY CONFIDENTIAL Indications for Use Statement Section 4 - Page 2

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Dentium Co. Ltd. Implantium® / SuperLine® Prosthetics Abbreviated 510(k)

510(k) Summary

1. Company

	Submitter
Name	Dentium Co., Ltd.
Address	150, Eondong-ro, Giheung-gu, Youngin-si, Gyeonggi-do, 446-914, Korea
Phone / Fax	+82 31 207 2200 / +82 31 207 3883
Contact person	Sangpil Yoonspyoon@dentium.com

2. Device Name

Trade / Proprietary name:	Dentum Implantium® / SuperLine®Prosthetics
Common name:	Prosthetic Device
Classification name:	Abutment, Implant, Dental, Endosseous
Regulation number:	872.3630
Class:	II
Panel:	Dental
Product code:	NHA

3. Predicate Device

K052957 - Implantium Prosthetics K112045 - SimpleLine II Abutment System

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4. Description

They are supplied non-sterile and sterilized by the recommended sterilization method in user's manual.

The materials of the Implantium & SuperLine Prosthetics are as follows; Pure Titanium Grade 4: Dual Milling Abutment, Dual Abutment, Angled Abutment and Temporary Abutment.

Co-Cr-Mo alloy (conform to ASTM F799) and Polyacetal (POM): Metal Casting Abutment,

Gold Alloy and Polyacetal (POM): Direct Casting Abutment.

5. Indication for Use

Dentium Implantium® / SuperLine® Prosthetics are intended for use as an aid in prosthetic rehabilitation.

6. Substantial Equivalence

Dual Milling Abutment, Dual Abutment, Angled Abutment, Temporary Abutment
. Angled abutments are only available at 15 degree and 25 degree angles.
. All other abutments are cast straight. (0 degrees)

	Implantium® / SuperLine®Prosthetics(Subject Device)	Implantium Prosthetics(Primary Predicate)	Similarities /Differencesof Devices
CompanyName	Dentium Co., Ltd.	Dentium Co., Ltd.	Same
510(k)Number	New Device	K052957	-
Classificationand ProductCode	Class II; 872.3630; NHA	Class II; 872.3630; NHA	Same

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Dentium® / SuperLine® Prosthetics® Prostheticss

Implantium® / SuperLine® Prostheticss
Abbreviated 510(k) Abbreviated 510(k)

Indicationsfor use	Dentium Implantium®/SuperLine® Prosthetics is	Implantium® SuperLine®Prosthetics is intended for	Same
intended for use as an aidin prosthetic rehabilitation	use as an aid in prostheticrehabilitation

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Dentium Co. Ltd. lmplantium® / SuperLine® Prosthetics Abbreviated 510(k)

Image: Dual Milling AbutmentDual Milling AbutmentPure Titanium Grade4Non-coatedTotal Length: 14.7mmDiameter: 4.0~6.5mmHex Height: 1.15mm	Image: Dual Milling AbutmentDual Milling AbutmentPure Titanium Grade4Partially TiN coated TotalLength: 12.7~~14.7mmDiameter: 4.0~~6.5mmHex Height: 0.93mm	New devicesare designed toadd variousHex Heightoptions.Detailed SEdiscussionsmentioned asbelows.
Image: Dual AbutmentDual AbutmentPure Titanium Grade4Non-coatedTotal Length: 9.2~~13.7mmDiameter: 4.5~~6.5mm HexHeight: 1.15mm	Image: Dual AbutmentDual AbutmentPure Titanium Grade4Partially TiN coated TotalLength: 9.2~~13.7mmDiameter: 4.5~~6.5mmHex Height: 0.93mm	New devicesare designed toadd variousHex Heightoptions.Detailed SEdiscussionsmentioned asbelows.
Image: Angled AbutmentAngled AbutmentPure Titanium Grade4Non-coatedTotal Length: 15.31mmDiameter: 4.5~5.5mmHex Height: 1.15mm	Image: Angled AbutmentAngled AbutmentPure Titanium Grade4Partially TiN coatedTotal Length: 13.3mmDiameter: 4.5~5.5mmHex Height: 0.93mm	New devicesare designed toadd variousTotal Length &Hex Heightoptions.Detailed SEdiscussionsmentioned asbelows.
Image: Temporary AbutmentTemporary AbutmentPure Titanium Grade4Non-coatedTotal Length: 13.7mmDiameter: 4.5mmHex Height: 1.15mm	Image: Temporary AbutmentTemporary AbutmentPure Titanium Grade4Non-coatedTotal Length: 13.7mmDiameter: 4.5mmHex Height: 0.93mm	New devicesare designed toadd variousHex Heightoptions.Detailed SEdiscussionsmentioned asbelows.

- Metal Casting Abutment, Direct Casting Abutment

	Implantium® / SuperLine®Prosthetics(Subject Device)	SimpleLine II AbutmentSystem(Primary Predicate)	Similarities /Differencesof Devices
CompanyName	Dentium Co., Ltd.	Dentium Co., Ltd.	Same
510(k)Number	New Device	K112045	-

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Dentium Co. Ltd. Implantium® / SuperLine® Prosthetics Abbreviated 510(k)

Classificationand ProductCode	Class II; 872.3630; NHA	Class II; 872.3630; NHA	Same
Indicationsfor use	Dentium Implantium®/SuperLine® Prosthetics isintended for use as an aidin prosthetic rehabilitation	SimpleLine II Abutmentsystem is intended for useas an aid in prostheticrehabilitation.	Same
ShapeMaterialCoatingDimension	Metal Casting AbutmentImage: Metal Casting AbutmentCo-Cr-MoNon-coatedTotal Length:18.7mmDiameter: 4.30mmHex Height: 1.15mmDirect Casting AbutmentImage: Direct Casting AbutmentGold alloyNon-coatedTotal Length:19.2Diameter: 4.50Hex Height: 1.15mm	Metal Casting AbutmentImage: Metal Casting AbutmentCo-Cr-MoNon-coatedTotal Length:19.2Diameter: 4.50Hex Height: 0.93mmDirect Casting AbutmentImage: Direct Casting AbutmentGold alloyNon-coatedTotal Length:18.95 to 19.1Diameter: 4.50Hex Height: 0.93mm	New devicesare designed toadd variousTotal Length &Diameter &Hex Heightoptions.Detailed SEdiscussionsmentioned asbelows.

Raw material, mechanical and physical properties, shape, and intended use are similar to the predicated devices. The differences between the Implantium® / SuperLine® Prosthetics and predicate devices are the slight mechanical and physical characteristics. However, the slight differences do not affect the application of the device. Therefore, we state that Implantium® / SuperLine® Prosthetics are substantial equivalent with the predicate devices.

7. Identification of the Risk

Risk analysis was performed according to Guidance for Industry and FDA staff - Class II Special Controls Guidance Document:Root-form Endosseous Dental Implants and Endosseous Dental Abutments issued on May 12, 2004 and ISO 14971:2007, "Medical devices - Application of risk management to medical devices". All risks identified have been mitigated based on performance testing results and any residual risk is within acceptable levels.

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Dentium Co. Ltd. Implantium® / SuperLine® Prosthetics Abbreviated 510(k)

8. Device Characteristics

Dentium Implantium® / SuperLine® Prosthetics are supplied in many different shapes and sizes to meet the patient specific needs of our customers. All abutments are made with Dentium's universal conical connection so that they securely mate with any Dentium Implantium® / SuperLine® Fixture(cleared under 510(k) # 041368).

9. Performance Testing

Biocompatibility testing on the proposed Dentium Implantium® / SuperLine® Prosthetics has been completed. Requirements for biological evaluation of the purposed device were based on ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process." The biocompatibility test results show that the materials used in the design and manufacture of the components of the proposed device are nontoxic and non-sensitizing to biological tissues consistent with its intended use. The following biocompatibility tests were completed:

-ISO Cytotoxicity	-ISO Systemic toxicity
-ISO Pyrogenicity	-ISO Sensitization
-ISO Intracutaneous reactivity

The proposed Dentium Implantium® / SuperLine® Prosthetics were evaluated using the following performance bench testing to confirm the performance characteristics:

-ISO Static compressive	-ISO Fatigue
-Corrosion Testing	-Adaptation Accuracy

Static Compressive mean and Fatique Limit were evaluated according to ISO 14801. Fracture or cracks or severe distortion of any parts were not detected at the fatigue limit and passed 5,000,000 cycles.

10. Non-clinical Testing

Non-clinical test data was used to evaluate the proposed device's safety and effectiveness, and determine substantial equivalence with predicate devices. Clinical testing was not necessary to establish substantial equivalency of the device.

COMPANY CONFIDENTIAL

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Non-clinical testing was performed in accordance with FDA Guidance "Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Implant Abutments" and it consisted of testing finished assembled implant/abutment systems of the worst case scenario, through Reliability Calculation and Testing, as well as Fatigue Strength Testing and Static Load Failure Testing.

In addition, sterilization validation information and recommended sterilization method based on ISO 17665-1 is provided in the Information for Use.

The testing performed demonstrated implant to abutment compatibility and has established substantial equivalency of the proposed device with predicate devices.

11. Review

All test results demonstrate that the materials chosen, the manufacturing process, and the design utilized for the Dentium Implantium® / SuperLine® Prosthetics met the established specifications necessary for consistent performance according to its intended use.

Dentium Implantium® / SuperLine® Prosthetics have been subjected to safety, performance, and product validations prior to release. Safety tests including biocompatibility have been performed to ensure the devices complying with the applicable International and US regulations.

12. Conclusions

All of the data, consistent with the recommendations in the FDA guidance document Root-Form Endosseous Dental Implants and Endosseous Dental Implant Abutments, demonstrate that Dentium Implantium & SuperLine Prosthetics are substantially equivalent to the predicate device.

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.)