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K Number
K033446
Device Name
APEX93, APEX87, APEX84, APEX85, APEX77, E-SARANG 88 AND E-SARANG 82
Manufacturer
WE DONG MYUNG DENTAL INDUSTRIAL CO., LTD.
Date Cleared
2003-11-13

(15 days)

Product Code
EJT
Regulation Number
872.3060
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Reconstruction of porcelain-to-metal dental restorations.
Device 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 implant-supported prosthesis substructures.
More Information

K003603

Not Found

No
The device description and intended use clearly indicate that the device is a dental gold alloy, which is a material, not a software or system that would typically incorporate AI/ML. The "Mentions AI, DNN, or ML" field is also explicitly marked as "Not Found".

No
The device is a dental gold alloy used for fabricating dental restorations, not for treating or preventing disease or affecting the structure/function of the body in a therapeutic way. Its purpose is structural.

No
This device is a dental gold alloy used for the fabrication of dental restorations (crowns, bridges, and prosthesis substructures), which is a material for reconstruction, not a diagnostic tool for identifying a disease or condition.

No

The device description explicitly states that the devices are "dental gold alloys," which are physical materials, not software.

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

  • Intended Use: The intended use is "Reconstruction of porcelain-to-metal dental restorations." This describes a process performed on a patient's teeth, not a test performed on a sample taken from the body.
  • Device Description: The device is a "dental gold alloy" used for fabricating dental prosthetics. This is a material used in a restorative procedure, not a diagnostic test.
  • Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
    • Analyzing samples (blood, urine, tissue, etc.)
    • Detecting or measuring substances in samples
    • Providing information for diagnosis, monitoring, or screening

The device is clearly a material used in a dental restorative procedure, which falls outside the scope of In Vitro Diagnostics.

N/A

Intended Use / Indications for Use

Reconstruction of porcelain-to-metal dental restorations.

Product codes

EJT

Device 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 implant supported prosthesis substructures.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Not Found

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Not Found

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

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.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s)

K003603

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

§ 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.

0

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,

1

012

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

2

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.

3

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

4

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