Dentium Implantium and SuperLine Abutments are intended for use an aid in prosthetic rehabilitation. The abutments were originally cleared under 510(k) K041358. The modified designs proposed in this submission consist of the Angled Screw Abutment, Cover Screw, and Screw Abutment Cylinders. Abutments are supplied non-sterile and autoclaved by the end user.

AI/ML Overview

This document describes the Dentium Implantium® and SuperLine® Abutments, which are dental abutments. The information provided focuses on the device's technical specifications and performance testing, rather than a study on an AI/ML-driven device with acceptance criteria typically associated with diagnostic algorithms.

Therefore, the requested information on acceptance criteria, reported device performance, sample sizes for test and training sets, expert involvement, adjudication methods, MRMC studies, standalone performance, and ground truth types are not applicable in the context of an AI/ML evaluation study.

The document discusses performance testing in a general device context, not related to an AI/ML algorithm's diagnostic accuracy. It uses "acceptance criteria" in the sense of the device meeting established specifications through bench testing and biocompatibility assessments, rather than diagnostic performance metrics like sensitivity or specificity.

Here's a breakdown of the available information, noting where the requested AI/ML specific details are not present:

1. Table of Acceptance Criteria and Reported Device Performance

As this is a traditional medical device (dental abutments), the "acceptance criteria" are related to mechanical and biological performance, not diagnostic accuracy.

Acceptance Criteria (Bench Testing)	Reported Device Performance
Biocompatibility:
- ISO Cytotoxicity	- Passed (nontoxic)
- ISO Systemic toxicity	- Passed
- ISO Pyrogenicity	- Passed
- ISO Sensitization	- Passed (non-sensitizing)
- ISO Intracutaneous reactivity	- Passed
Mechanical Performance:
- ISO Static compressive (per ISO 14801)	- Mean evaluated
- ISO Fatigue (per ISO 14801)	- Passed 5,000,000 cycles (no fracture/cracks/severe distortion at fatigue limit)
- Corrosion Testing	- Completed
- Adaptation Accuracy	- Completed
- Modified Surface	- Completed

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

Test Set Sample Size: Not specified in terms of number of cases/patients. The "test set" here refers to physical abutment samples used for bench testing.
Data Provenance: Not applicable in the context of patient data. The testing was conducted on device samples.

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

Number of Experts: Not applicable. Ground truth for dental abutment performance (e.g., fatigue failure) is established through standardized engineering tests, not expert interpretation of cases.
Qualifications of Experts: Not applicable.

4. Adjudication method for the test set

Adjudication Method: Not applicable. Bench tests have objective Pass/Fail criteria based on physical and material properties.

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

MRMC Study: No. This is not an AI/ML device.

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

Standalone Performance Study: No. This is not an AI/ML device.

7. The type of ground truth used

Type of Ground Truth: For biocompatibility, it's based on biological response to material samples (e.g., cell viability, immune reaction). For mechanical performance, it's based on physical failure thresholds and material integrity standards (e.g., absence of fracture after specified cycles, material composition specified by ASTM standards).

8. The sample size for the training set

Training Set Sample Size: Not applicable. This is not an AI/ML device that requires training data.

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

Ground Truth for Training Set: Not applicable. This is not an AI/ML device.

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 a stylized depiction of a human figure in profile, with three overlapping faces suggesting community and support. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the figure.

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

November 12,2014

Dentium Company Limited C/O Ms. Sheryl Higgins US Agent 6761 Katella Avenue Cypress, CA 90630

Re: K141457

Trade/Device Name: Dentium Implantium® and SuperLine® Abutments Regulation Number: 21 CFR 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: II Product Code: NHA Dated: October 14, 2014 Received: October 15, 2014

Dear Ms. Higgins:

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 - Ms. Higgins

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,

Susan Runno, DDS, mA

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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Indications for Use

510(k) Number: K141457

Dentium Implantium® / SuperLine® Abutments Device Name:

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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510(k) Summary

1. Company

	Submitter
Name	Dentium Co., Ltd.
Address	440, Changnyong-daero, lui-dong, Yeongtong-gu, Suwon-si,Gyeonggi-do, Korea, 443-270
Phone / Fax	+82 31 207 2200 / +82 31 207 3883
Contact person	Sheryl Higgins / US Agent714-226-0229 x107shiggins@dentiumusa.com

2. Device Name

Proprietary name:	Dentium Implantium® / SuperLine® Abutments
Common name:	Abutment, Prosthetic Device
Classification name:	Abutment, Implant, Dental, EndosseousNHA, 21 CFR 872.3630

3. Predicated Device

K041368 - Dentium Co. Ltd., Implantium K052823 - Implantium Abutments K052957 - Implantium Prosthetics K112045 - SimpleLine II Abutment System

4. Description

COMPANY CONFIDENTIAL

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Angled Screw Abutment, Cover Screw, and Screw Abutment Cylinders. Abutments are supplied non-sterile and autoclaved by the end user.

Name	Class	Material	Dia(mm)	G/H(mm)	Connection	Angle	Figure	Model Number
AngledScrewAbutment	II	Pure Ti-G4(ASTM F67)TiN Coated	4.5to5.5	1.0to1.5	Hex andNon-hex	15°to30°	Image: Angled screw abutment	ASA45151018HASA45151018NASA45301018HASA45301018NASA55151518HASA55151518NASA55301518HASA55301518N
Screw	II	Ti-6Al-4V ELIalloy(ASTM F136)	1.8to2.3	n/a	n/a	n/a	Image: Screw	ASASC2023SRS18T
CoverScrew	II	Ti-6Al-4V ELIalloy(ASTM F136)Annozided	3.6	n/a	n/a	n/a	Image: Cover screw	CS36
Cylinder -Titanium	II	Pure Titanium,Grade 2(ASTM F67-00)	4.5to5.5	n/a	Hex andNon-hex	n/a	Image: Titanium cylinder	STC45SGSTC45BGSTC55SGSTC55BG
Cylinder -Gold	II	Gold Alloy	4.5to5.5	n/a	Hex andNon-hex	n/a	Image: Gold cylinder	SGC45SLSGC45BLSGC55SLSGC55BL
Cylinder -Metal	II	Cobalt-28Chromium-6MolybdenumAlloy (ASTMF799)	4.5to5.5	n/a	Hex andNon-hex	n/a	Image: Metal cylinder	SGC45CSLSGC45CBLSGC55CSLSGC55CBL

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5. Indication for Use

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

6. Identification of the Risk

Risk analysis was performed according to ISO 14971:2007, "Medical devices - Application of risk management to medical devices". All risks identified have been mitigated and any residual risk is within acceptable levels.

7. Device Characteristics

Dentium Implantium / SuperLine Abutments are supplied in many different shapes and sizes to meet the patient specific needs of our customers. All abutment are made with Dentium's universal conical connection so that thev securely mate with any Dentium Implantium / SuperLine Fixture.

8. Performance Testing

Biocompatibility testing on the proposed Implantium & SuperLine Abutments have been completed. Requirements for biological evaluation of the purposed device were based on the 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 Implantium & SuperLine Abutments were evaluated using the following performance bench testing to confirm the performance characteristics:

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

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 fatigue limit and passed 5,000,000 cycles.

COMPANY CONFIDENTIAL

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9. Reliance on Standards

All testing was performed in compliance with Guidance for Industry and FDA Staff - Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Implant Abutments.

10. Review

All test results demonstrate that the materials chosen, the manufacturing process, and the design utilized for the Implantium & SuperLine Abutments meet the established specifications necessary for consistent performance according to its intended use.

Implantium & SuperLine Abutments have 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.

11. 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 Implantium & SuperLine Abutments 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.)