APEX93, APEX87, APEX84, APEX85, APEX77, E-SARANG 88 AND E-SARANG 82 by WE DONG MYUNG DENTAL INDUSTRIAL CO., LTD.

Apex 93, Apex87, Apex85, Apex77, e-Sarang 88 and e-Sarang 82 are dental gold alloys for the fabrication of Porcelain-Fused-to-Metal Crowns, Bridges, and implant-supported prosthesis substructures.

AI/ML Overview

The provided text describes a 510(k) submission for dental gold alloys (Apex93, Apex87, Apex84, Apex85, Apex77, e-Sarang 88, e-Sarang 82) and aims to demonstrate their substantial equivalence to a predicate device, Bioherador SG, Herador S.

However, the provided text does not contain information about acceptance criteria or a study designed to prove the device meets specific performance criteria through empirical measurements or AI model evaluations. Instead, it focuses on the regulatory submission process for a medical device.

The document states:

"Apex93, Apex87, Apex84, Apex85, Apex77, e-Sarang 88, e-Sarang 82 have the same device characteristics as the predicate device. Material, design and use concept is similar."
"Apex93, Apex87, Apex84, Apex77, e-Sarang 88, e-Sarang 82 have been subjected to extensive safety, performance, and product validations prior to release. Safety tests have been performed to ensure the devices comply to applicable industry and US regulations."
"An extensive review of literature pertaining to the safety and biocompatibility of dental gold alloy has been conducted."

These statements indicate that the submission relies on the established safety and performance of the predicate device, general industry standards, and a literature review, rather than a specific, new study with defined acceptance criteria and performance metrics for the submitted devices. The "validations prior to release" are mentioned but no specifics about these validations, their acceptance criteria, or their results are provided in the text.

Therefore, many of the requested items related to a study proving acceptance criteria cannot be extracted from this document.

Here's a breakdown of what can and cannot be answered based on the provided text:

1. A table of acceptance criteria and the reported device performance

Cannot be provided. The document does not define specific acceptance criteria (e.g., tensile strength, biocompatibility thresholds) with numerical targets, nor does it present a table of measured performance data for the submitted devices against such criteria. It generally states that the devices have "the same device characteristics as the predicate device" and have passed "safety tests."

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Cannot be provided. The document does not detail any specific "test set" in the context of a performance study with a sample size. The safety and performance assessments are described broadly as "extensive safety, performance, and product validations" and "safety tests" without specifying sample sizes or data provenance.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable / Cannot be provided. This question is relevant to studies involving expert review for establishing ground truth, typically for AI/imaging devices. As this is a materials submission for dental alloys, such a concept of "experts establishing ground truth for a test set" is not detailed or relevant in the provided text.

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

Not applicable / Cannot be provided. Similar to point 3, this is relevant to expert review processes, which are not described in the context of a performance study for these dental alloys.

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

Not applicable / Cannot be provided. MRMC studies are specifically for evaluating diagnostic performance, often with AI assistance for human readers. This submission is for dental materials, not a diagnostic or AI-powered device, so an MRMC study is not relevant and not mentioned.

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

Not applicable / Cannot be provided. This refers to standalone AI algorithm performance, which is not relevant to a dental alloy submission.

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

Not applicable / Cannot be provided. Ground truth is a concept for evaluating the accuracy of a diagnostic or predictive system. For dental alloys, the "truth" would be adherence to material specifications and biocompatibility standards, and these are stated as having been met through "validations" and "safety tests," but specific methodologies for defining "truth" for evaluation are not detailed.

8. The sample size for the training set

Not applicable / Cannot be provided. A "training set" is used for machine learning algorithms. This submission is for dental materials, not an AI device.

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

Not applicable / Cannot be provided. As above, this is relevant to AI/machine learning, not dental materials.

In summary, the provided document is a regulatory submission for dental alloys, demonstrating substantial equivalence to a predicate device based on similar characteristics, broad safety/performance validations, and a literature review. It does not include the details of a specific study with acceptance criteria and performance data as requested.

Summary

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This summary of 510(k) safety and effectiveness information is being submitted in accordance with requirements of 21 CFR Part 807.92.

Date: 2023.08.28

1. Company and Correspondent making the submission: Name – We Dong Myung Industral Co.,Ltd. Telephone - 770-565-6166 Fax - 770-565-9762 Contact - Mr. Ronald D. Arkin Internet - http://www.dmdental.co.kr
1. Device :

Proprietary Name - Apex93, Apex84, Apex85, Apex77, e-Sarang 88, e-Sarang 82, Common Name - Porcelain fused to metal (PFM) Classification Name - Gold-based alloys for clinical use

1. Predicate Device :
  Bioherador SG, Herador S - Jelenko Co. K003603
1. Classifications Names & Citations :
  21CFR 872.3060, EJT, Gold-based alloys and precious metal alloys for clinical use, Class2 Guidance document for the preparation of premarket notifications [510(k)'s] for dental alloys
1. Description :
  Apex 93, Apex87, Apex85, Apex77, e-Sarang 88 and e-Sarang 82 are dental gold alloys for the fabrication of Porcelain-Fused-to-Metal Crowns, Bridges, and implantsupported prosthesis substructures.
1. Indication for use :
  Reconstruction of porcelain-to-metal dental restorations.
1. Contra-indications :
  Potential complications associated with the use of Apex93, Apex87, Apex85,

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Apex77, e-Sarang 88, e-Sarang 82 may include, but not limited to:

Allergies to metals ●
1. Review :

Apex93. Apex87. Apex84. Apex85, Apex77, e-Sarang 88, e-Sarang 82 have the same device characteristics as the predicate device. Material, design and use concept is similar.

Apex93, Apex87, Apex84, Apex77, e-Sarang 88, e-Sarang 82 have been subjected to extensive safety, performance, and product validations prior to release. Safety tests have been performed to ensure the devices comply to applicable industry and US regulations.

An extensive review of literature pertaining to the safety and biocompatibility of dental gold alloy has been conducted. Appropriate safequards have been incorporated in the design of Apex93, Apex87, Apex84, Apex85, Apex77, e-Sarang 88, e-Sarang 82.

1. Conclusions :
  In accordance with the Federal Food, Drug and Cosmetic Act, 21 CFR Part 807, FDA's "Guidance document for the preparation of premarket notifications [510(k)'s] for dental alloys" and based on the information provided in this premarket notification We Dong Myung Dental Industrial Co.,Ltd. concludes that Apex93, Apex84, Apex85, Apex77, e-Sarang 88, e-Sarang 82 are safe and effective and substantially equivalent to predicate devices as described herein.
1. We Dong Myung Dental Industrial Co.,Ltd. will update and include in this summary any other information deemed seasonably necessary by the FDA.
  END

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird-like figure, composed of three curved lines that suggest the head and body. The logo is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular fashion around the emblem.

Public Health Service

NOV 1 3 2003

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

We Dong Myung Dental Industrial Company, Limited C/O Mr. Marc M. Mouser Responsible Third Party Official Underwriters Laboratories, Incorporated Laboratory & Testing 2600 N.W. Lake Road Camas, Washington 98607-8542

Re: K033446

Trade/Device Name: APEX93, APEX87, APEX84, APEX85, APEX77, e-Sarang 88, e-Sarang 82 Regulation Number: 872.3060 Regulation Name: Gold-Based Alloys and Precious Metal Alloys for Clinical Use Regulatory Class: II Product Code: EJT Dated: October 1, 2003 Received: October 29, 2003

Dear Mr. Mouser:

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 Mav 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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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. Mouser

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); 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.

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (301) 594-4613. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Chiu Lin, Ph.D.

Director Division of Anesthesiology, General Hospital. Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Submission - PFM

1633446 510(k) Number K __

Device Name: APEX93, APEX87, APEX84, APEX85, APEX77, e-Sarang 88, e-Sarang 82

Indication for use: Reconstruction of porcelain-to-metal dental restorations.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use \checkmark OR Over-The-Counter Use __
(Per 21CFR801.109)

Susan Runor

(Division Sign-O) Division of Anesthesiology. General Ho Infection Control, Dental d

510(k) Number: KC23444

Regulation Number and Section

§ 872.3060 Noble metal alloy.

(a)
Identification. A noble metal alloy is a device composed primarily of noble metals, such as gold, palladium, platinum, or silver, that is intended for use in the fabrication of cast or porcelain-fused-to-metal crown and bridge restorations.(b)
Classification. Class II (special controls). The special control for these devices is FDA's “Class II Special Controls Guidance Document: Dental Noble Metal Alloys.” The devices are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 872.9. See § 872.1(e) for availability of guidance information.