BESTALOY by WE DONG MYUNG DENTAL INDUSTRIAL CO., LTD.

The provided text describes a 510(k) premarket notification for a dental amalgam called "Bestaloy." It states that Bestaloy has undergone safety, performance, and product validations and that it has the same device characteristics as its predicate device (LUXALLOY™, DEGUSSA AG K902249). However, it does not provide specific details about acceptance criteria or a study proving that the device meets those criteria with quantitative performance metrics.

Therefore, I cannot extract the detailed information requested in your prompt regarding acceptance criteria, reported performance, sample sizes, ground truth establishment, expert qualifications, or MRMC studies. The submission focuses on demonstrating substantial equivalence to a predicate device rather than presenting a performance study with detailed quantitative results.

Here's what can be inferred from the provided text, but it falls short of your specific requirements:

Table of Acceptance Criteria and Reported Device Performance: Not available in the provided text. The submission states, "Bestaloy has 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 requiations." However, it does not list specific criteria or quantitative performance results.
Sample Size Used for the Test Set and Data Provenance: Not mentioned in the provided text.
Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications: Not mentioned in the provided text.
Adjudication Method for the Test Set: Not mentioned in the provided text.
If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and the effect size: Not mentioned in the provided text. This type of study is generally not typical for a dental amalgam 510(k) submission, which focuses on material equivalence.
If a Standalone (algorithm only without human-in-the-loop performance) was done: Not applicable, as this is a dental material, not an algorithm.
The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.): Not mentioned in the provided text. The submission relies on "device characteristics" being the same as the predicate.
The Sample Size for the Training Set: Not mentioned in the provided text. (Training sets are typically for AI/ML models, which this device is not).
How the Ground Truth for the Training Set was Established: Not applicable as this is a dental material.

Summary of what is available from the text:

Device Name: Bestaloy
Predicate Device: LUXALLOY™, DEGUSSA AG K902249 (K902249)
Basis for Equivalence: "Bestaloy has the same device characteristics as the predicate device. Material, design and use concept is similar."
Testing Conducted: "extensive safety, performance, and product validations" and "Safety tests have been performed to ensure the devices comply to applicable industry and US requiations."
Conclusion: The manufacturer concludes that Bestaloy is "safe and effective and substantially equivalent to predicate devices."

The document is a 510(k) clearance letter, which confirms that the FDA found the device substantially equivalent to a predicate. It does not contain the detailed performance study results that would be part of a submission to demonstrate performance against specific acceptance criteria.

Summary

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We Dong-Myung Dental Industrial Co. Ltd

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

NOV 1 2 2003

ャンプ

Date: August 28, 2003 ________________________________________________________________________________________________________________________________________________________

Company and Correspondent making the submission:

	Company	Correspondent
Name	We Dong Myung Industrial Co.,Ltd.	Arkin Consulting Group, LLC
Address	156-2, Duk Wu-Ri, Bong Dam-Eup, Hwa	1733 Canton Lane,
Address	Sung-Gun, Kyung Ki-Do,	Marietta, GA,
Address	Korea	USA
Phone	+82 2 891-2809	770-565-6166
Fax	+82 2 891-2846	770-565-9762
Contact	Ju Woong Jang	Ronald D. Arkin
Internet	orienta@dreamwiz.com	ronarkin@arkinconsulting.com

2. Device :

Proprietary Name - Bestaloy Common Name – Amalgam Alloy Classification Name -- Dental Materials - Alloys for dental amalgam

3. Predicate Device :

LUXALLOY™, DEGUSSA AG K902249

4. Classifications Names & Citations :

21CFR 872.3050, EJJ, Dental materials - Alloys for dental amalgam. Class2

Guidance document for the preparation of premarket notifications [510(k)'s] for dental amalgams

1. Description :
  Bestaloy is used as a filling material for restoring function to teeth that have lost portions to caries.

156-2, duk Wu-ri, bong-dam-eub, hwa sung, kyung ki, Korea 445

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1. Indication for use :
  This is a dental amalgam for the filling of tooth cavities of Black's Classes I and II .
1. Contra-indications :
  Potential complications associated with the use of Bestaloy may include, but not limited

to:

Allergies to metals
1. Review :

Bestaloy has the same device characteristics as the predicate device. Material, design and use concept is similar.

Bestaloy has 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 requiations.

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 amalgams" and based on the information provided in this premarket notification We Dong Myung Dental Industrial Co.,Ltd. concludes that Bestaloy is safe and effective and substantially equivalent to predicate devices as described herein.
We Dong Myung Dental Industrial Co.,Ltd. will update and include in this summary any 10. other information deemed seasonably necessary by the FDA.
END

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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features a stylized eagle with three lines forming its body and head, symbolizing health, services, and people. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the eagle.

NOV 1 2 2003

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

We Dong Myung Dental Industrial Co., Ltd. C/O Mr. Marc M Mouser Office Coordinator Underwriters Laboratories, Inc. 2600 N.W. Lake Road Camas, WA 98607-8542

Re: K033434

Trade/Device Name: Bestaloy Regulation Number: 872.3050 Regulation Name: Amalgam Alloy Regulatory Class: II Product Code: EJJ Dated: October 01, 2003 Received: October 28, 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 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.

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.

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.

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Page 2 - Mr. Mouser

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 (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.

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) Number K (3334) 34

Device Name: Bestaloy

Indication for use: This is a dental amalgam for the filling of tooth cavities of Black's Classes I and II.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use OR (Per 21CFR801.109)

Over-The-Counter Use

Susa Penny
(Division Sig. or Agent)

Division Sign-Off) Division of Anesthesion gy, General Hospital Infection Control, D

510(k) Number: K033434

Regulation Number and Section

§ 872.3070 Dental amalgam, mercury, and amalgam alloy.

(a)
Identification. Dental amalgam is a device that consists of a combination of elemental mercury, supplied as a liquid in bulk, sachet, or predosed capsule form, and amalgam alloy composed primarily of silver, tin, and copper, supplied as a powder in bulk, tablet, or predosed capsule form, for the direct filling of carious lesions or structural defects in teeth. This device also includes the individual component devices, mercury and amalgam alloy, when intended to be combined with each other to form dental amalgam.(b)
Classification. Class II (special controls). The special control for this device is FDA's “Class II Special Controls Guidance Document: Dental Amalgam, Mercury, and Amalgam Alloy.”See § 872.1(e) for the availability of this guidance document.