Burn-out Cylinder is a component of a dental implant abutment used in the process of fabricating the dental abutment and the prosthetic restoration. The Burn-out Cylinders are modified by the dental lab and incorporated into the wax framework pattern which is cast into a final gold alloy form. Burn-out Cylinder is made with PMMA (Poly(Methyl Methacrylate)) and is available in three cylinder diameters (4.5mm, 5.5mm and 6.5mm) with two connection designs (Hex and Non-Hex).

Angled Screw Abutment is a dental abutment intended for multi-unit loaded restorations and combined with the burn-out cylinder for increasing the post height to be 4mm at minimum when used for single-unit loading. Angled Screw Abutment is fabricated from Grade 4 pure titanium and partially TiN coated. Angled Screw Abutments in this submission are available in three connection designs (Hex, Long Hex and Non-Hex), two diameters (4.5mm and 5.5mm) and two angulations (15° and 30°). The Dentium angled screw abutments were originally cleared under 510(k) K141457. All subject device abutments are compatible with Implantium dental implants of Dentium Co., Ltd. Abutments are supplied non-sterile and autoclaved by the end user.

AI/ML Overview

This document is a 510(k) summary for a medical device called "Burn-out Cylinder and Angled Screw Abutments." It details the device's characteristics, indications for use, and a comparison to predicate devices to establish substantial equivalence.

Based on the provided text, the device in question is a dental implant component, a class II device under regulation 21 CFR 872.3630. The acceptance criteria and the study proving it meets these criteria are primarily based on performance testing to demonstrate substantial equivalence to predicate devices, rather than a clinical study with human readers or a standalone AI algorithm.

Here's an breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are implicitly defined by the relevant FDA guidance and ISO standards for dental implants, specifically demonstrating mechanical performance equivalent to or better than predicate devices.

Acceptance Criteria (Implied)	Reported Device Performance
Mechanical Performance (Fatigue Strength)	ISO Fatigue (ISO 14801:2007): Fracture, cracks, or severe distortion of any parts were not detected at the fatigue limit and passed 5,000,000 cycles. (This implies maintaining structural integrity under specified cyclic loading conditions.)
Mechanical Performance (Static Load Failure)	Static Compressive mean was evaluated per ISO 14801. (Performance is not explicitly stated in numerical terms but is linked to the absence of failure under fatigue, implying satisfactory static strength).
Biocompatibility	Demonstrated by testing included in the previously cleared primary predicate K141457. (This means the material is safe for use in the human body, as established by prior regulatory clearance for the same or similar materials.)
Sterility (for end-user treatment)	Demonstrated by testing included in the previously cleared primary predicate K141457. The device is supplied non-sterile and to be autoclaved by the end user, implying it can withstand sterilization and is clean upon delivery.
Substantial Equivalence to Predicate Devices	Raw material, mechanical and physical properties, shape, and intended use are similar to the predicate devices. Slight differences in length, diameter, and gingiva height do not affect the application of the device. The test results support this claim.
Risk Mitigation	All identified risks were mitigated based on performance testing results, and any residual risk is within acceptable levels according to ISO 14971:2007.

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

The document does not specify the precise number of devices or components used for each individual mechanical test (e.g., how many abutments were subjected to fatigue testing). It refers to "testing finished assembled implant/abutment systems of the worst case scenario," implying a selection of configurations that would be most challenging.

Sample Size: Not explicitly stated as a number of units. The testing is described qualitatively ("worst case scenario") rather than quantitatively with specific sample sizes per test type.
Data Provenance: The tests are "Non-clinical testing performed in accordance with FDA Guidance" and ISO standards. This indicates laboratory testing, likely conducted by the manufacturer or a contracted testing facility. There is no mention of country of origin for mechanical testing data, but the manufacturer is based in Korea. This is not retrospective or prospective data in the clinical sense, but rather bench testing data.

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

This information is not applicable to this type of device submission. The "ground truth" for this device's performance is established by objective physical measurements and engineering standards (e.g., whether a device fractures under a certain load, or passes a specified number of fatigue cycles). Expert review in the context of imaging or diagnostic accuracy is not relevant here.

4. Adjudication Method

This information is not applicable. Adjudication methods are typically used in clinical trials involving human interpretation of data, such as medical images, where there might be disagreement among experts. For mechanical testing, the failure or success is objectively determined by the test apparatus and criteria.

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

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is specifically for evaluating the effectiveness of a diagnostic device or AI algorithm, often in the context of human interpretation of medical data, which is not relevant for a dental implant abutment.

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

No, a standalone performance study (referring to an algorithm's performance) was not done. This device is a physical medical component, not an AI algorithm.

7. The Type of Ground Truth Used

The "ground truth" for this device's performance is based on:

Objective Engineering Standards: Adherence to ISO 14801:2007 (for fatigue and static load failure).
Absence of Failure: The primary ground truth is the absence of fracture, cracks, or severe distortion under specified mechanical loading conditions, and the ability to withstand 5,000,000 cycles without failure at the fatigue limit.
Predicate Device Equivalence: The ultimate ground truth for regulatory purposes is demonstrating substantial equivalence to legally marketed predicate devices, meaning it performs as safely and effectively as existing devices.

8. The Sample Size for the Training Set

This information is not applicable. There is no "training set" in the context of mechanical testing for this type of medical device. Training sets are relevant for machine learning algorithms.

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

This information is not applicable as there is no training set mentioned or implied for this device's evaluation.

Summary

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

August 5, 2016

Dentium Co., Ltd % Younjung Yuk US Agent Dentium USA 6761 Katella Ave Cypress. California 90630

Re: K160483

Trade/Device Name: Burn-out Cylinder and Angled Screw Abutments Regulation Number: 21 CFR 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: II Product Code: NHA Dated: July 6, 2016 Received: July 7, 2016

Dear Younjung Yuk:

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 - Younjung Yuk

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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) 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,

Tina
Kiang -S

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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Indications for Use

510(k) Number: K160483

Device Name: Burn-out Cylinder and Angled screw Abutments

Indications for Use:

Dentium 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)

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K160483

510(k) Summary

Date: August 5, 2016

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: Burn-out Cylinder and Angled Screw Abutments

Common name:	Abutment, Prosthetic Device, ProstheticAccessories to Dental Implant
Classification name:	Endosseous dental implant abutment
Regulation number:	21 CFR 872.3630
Class:	II
Panel:	Dental
Product code:	NHA

3. Predicate Device

Primary Predicate for Angled Screw Abutment K141457 - Dentium Implantium® and SuperLine® Abutments
Reference Device for Burn-out Cylinder K990342 - Staumann SynOcta Prosthetics®

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4. Description

5. Indication for Use

Dentium Prosthetics are intended for use as an aid in prosthetic rehabilitation.

6. Substantial Equivalence

	Angled Screw Abutment(Subject Device)	Dentium Implantium® /SuperLine® Abutments(Primary Predicate)	Similarities/Differencesof Devices
CompanyName	Dentium Co., Ltd.	Dentium Co., Ltd.	Same
510(k)Number	New Device	K141457	-
Indicationsfor use	Dentium Prosthetics areintended for use as an aid inprosthetic rehabilitation.	Dentium Prosthetics areintended for use as an aid inprosthetic rehabilitation.	Same
Materials	Pure Ti-G4 (ASTM F67)	Pure Ti-G4 (ASTM F67)	Same
Shape	Image: Angled Screw Abutment	Image: Dentium Implantium® / SuperLine® Abutments	Same

- Angled Screw Abutment

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Angle	15° to 30°	15° to 30°	Same
Length	7.4 to 9.4mm	6.4 to 7.87mm	Slight differenceLength
Diameter	4.5 to 5.5mm	4.5 to 5.5mm	Same
GingivaHeight(G/H)	2.0 to 3.0mm	1.0 to 1.5mm	Slight differenceGingiva Height
Coating	TiN coated	TiN coated	Same
Use	Prescription	Prescription	Same

- Burn-out Cylinder
	Burn-out Cylinder(Subject Device)	SynOcta Prosthetics®	Similarities /Differences of Devices
Company Name	Dentium Co., Ltd.	Staumann	-
510(k) Number	New Device	K990342	-
Indications for use	Burn-out Cylinders areintended for use as an aid inprosthetic rehabilitation.	The prosthetic accessories todental implants are usedeither in the process offabricating the prostheticrestoration for the implant oras part of the prostheticrestoration.	Same
Materials	PMMA	PMMA	Same
Shape	Image: Burn-out Cylinder	Image: SynOcta Prosthetics	Slight differenceShape
Length	12mm	10mm	Slight differenceLength
Diameter	4.5~6.5mm	4.8~6.5mm	Slight differenceDiameter
Use	Prescription	Prescription	Same

Raw material, mechanical and physical properties, shape, and intended use are similar to the predicated devices. The differences between Dentium Angled screw abutments and Burn-out cylinder (subject device) and predicate devices are different from the slight mechanical and physical characteristics. However, the slight differences do not affect the application

510k Summary

COMPANY CONFIDENTIAL

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of the device. Therefore, we state that Burn-out Cylinder and Angled Screw Abutment 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.

8. Device Characteristics

Burn-out Cylinder is fabricated from PMMA (Poly(Methyl Methacrylate)) and is available in three cylinder diameters (4.5mm, 5.5mm and 6.5mm) with two connection designs (Hex and Non-Hex).

Angled Screw Abutment is fabricated from Grade 4 pure titanium and partially TiN coated. Angled Screw Abutments in this submission are available in three connection designs (Hex, Long Hex and Non-Hex), two diameters (4.5mm and 5.5mm) and two angulations (15° and 30°). All abutments are made with Dentium's universal conical connection so that they securely mate with any Dentium Implantium® Fixtures.

9. Performance Testing

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.

The proposed combination of the Angled Screw Abutment and Burn-out Cylinder was evaluated using the following performance bench testing to confirm the performance characteristics:

-ISO Fatigue: ISO 14801:2007

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

Biocompatibility and sterility of the subject device is demonstrated by testing included in the previously cleared primary predicate K141457.

10. Conclusions

All of the data consistent with the recommendations in the FDA guidance document Root-Form Endosseous Dental Implants and Endosseous Dental Implant Abutments demonstrated that the Dentium Angled Screw abutment and Burn-out Cylinder 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.)