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K Number
K033435
Device Name
E-SARANG 86, DM78, DM55
Manufacturer
WE DONG MYUNG DENTAL INDUSTRIAL CO., LTD.
Date Cleared
2003-11-12

(15 days)

Product Code
EJT
Regulation Number
872.3060
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Reconstruction of dental restorations. e-Sarang 86: Inlays for non stress-bearing areas. DM-78: full crowns, 3/4 crowns, and short-span fixed partial dentures. DM-55: full crowns, long-span fixed partial dentures, and removable partial dentures
Device Description
e-Sarang 86, DM-78 and DM-55 are dental casting gold alloy for the fabrication of inlay/onlays, crowns, short span bridges, long span bridges and removable partials.
More Information

K003603

K003603

No
The device is a dental casting gold alloy, a material used for fabrication, and the description focuses on its material properties and intended uses, with no mention of software, algorithms, or AI/ML capabilities.

No

The device description indicates that e-Sarang 86, DM-78, and DM-55 are dental casting gold alloys used for the fabrication of various dental restorations, such as inlays, crowns, and bridges. These are materials used to create prosthetic devices, not devices that directly treat or mitigate a disease or condition. Their purpose is restorative rather than therapeutic in the medical sense.

No

Explanation: The device is a dental casting gold alloy used for the fabrication of dental restorations such as inlays, crowns, and bridges. It is not used for diagnosing medical conditions.

No

The device description clearly states that the devices are "dental casting gold alloy" for the fabrication of physical dental restorations, indicating they are hardware 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 for the "Reconstruction of dental restorations" and the fabrication of various dental prosthetics (inlays, crowns, bridges, partial dentures). This is a structural and restorative function, not a diagnostic one.
  • Device Description: The device is described as a "dental casting gold alloy." This is a material used to build dental devices, not a tool for analyzing biological samples.
  • Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or treatment.

IVD devices are specifically designed to perform tests on biological samples to gain diagnostic information. This device is a material used in the creation of dental prosthetics.

N/A

Intended Use / Indications for Use

Reconstruction of dental restorations.
e-Sarang 86: Inlays for non stress-bearing areas.
DM-78: full crowns, 3/4 crowns, and short-span fixed partial dentures.
DM-55: full crowns, long-span fixed partial dentures, and removable partial dentures

Product codes

EJT

Device Description

e-Sarang 86, DM-78 and DM-55 are dental casting gold alloy for the fabrication of inlay/onlays, crowns, short span bridges, long span bridges and removable partials.

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)

e-Sarang 86. DM-78 and DM-55 have the same device characteristics as the predicate device. Material, design and use concept are similar.
e-Sarang 86, DM-78 and DM-55 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 allov has been conducted. Appropriate safeguards have been incorporated in the design of e-Sarang 86, DM-78 and DM-55.

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

NOV 1 2 2003

Image /page/0/Picture/1 description: The image shows a handwritten string of characters, "K033435". The characters are written in black ink on a white background. The handwriting is somewhat stylized, with the numbers being slightly rounded.

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

Date: 2003. 8. 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 - e-Sarang 86, DM-78, DM-55 Common Name - Dental casting alloy Classification Name - Gold-based alloys for clinical use

    1. Predicate Device :
      Bio Maingold SG, Hera GG - Jelenko Co. K003603
    1. Classifications Names & Citations :
      21CFR 872.3060, EJT and EJS, 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 :
      e-Sarang 86, DM-78 and DM-55 are dental casting gold alloy for the fabrication of inlay/onlays, crowns, short span bridges, long span bridges and removable partials.
    1. Indication for use :
      Reconstruction of dental restorations.
    1. Contra-indications :
      Potential complications associated with the use of e-Sarang 86, DM-78 and DM-55 may

1

012

include, but not limited to:

  • Allergies to metals
    1. Review :

e-Sarang 86. DM-78 and DM-55 have the same device characteristics as the predicate device. Material, design and use concept are similar.

e-Sarang 86, DM-78 and DM-55 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 allov has been conducted. Appropriate safeguards have been incorporated in the design of e-Sarang 86, DM-78 and DM-55.

    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 e-Sarang 86, DM-78 and DM-55 are 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

2

Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of three human profiles facing right, stacked on top of each other. The profiles are connected by flowing lines that resemble a ribbon or banner. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the image.

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 Rd. Camas, WA 98607-8542

Re: K033435

Trade/Device Name: e-Sarang 86, DM78, DM55 Regulation Number: 872.3060 Regulation Name: Dental Alloys Regulatory Class: II Product Code: EJT 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.

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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 (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,

Chris Liu, Ph.D.

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) Number KO33UBS

Device Name: e-Sarang 86, DM-78, DM-55

Indication for use: Reconstruction of dental restorations.

e-Sarang 86: Inlays for non stress-bearing areas.

DM-78: full crowns, 3/4 crowns, and short-span fixed partial dentures.

DM-55: full crowns, long-span fixed partial dentures, and removable partial dentures

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

OR

Prescription Use (Per 21CFR801.109)

Over-The-Counter Use

Susa Rumond

(Division Sign-Off) Division of Anesthesiology, General Hospital, Infection Control, Dental Devices

510(k) Number. KC33435