SILVERFIL

K053114 · Dunia Perwira Manufacturing Sdn. Bhd. · EJJ · Nov 15, 2005 · Dental

Device Facts

• Record ID: K053114
• Device Name: SILVERFIL
• Applicant: Dunia Perwira Manufacturing Sdn. Bhd.
• Product Code: EJJ · Dental
• Decision Date: Nov 15, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3070
• Device Class: Class 2
• Attributes: Therapeutic, 3rd-Party Reviewed

Intended Use

Silverfil amalgam is used by dental professionals to fill tooth cavities. It is used in the same way as other amalgams used in the world today. Its usage and handling techniques are the same as other amalgams.

Device Story

Silverfil amalgam is a dental restorative material used by dental professionals to fill tooth cavities. The device is prepared and handled using standard clinical techniques consistent with conventional dental amalgams. It is applied directly to the prepared tooth cavity to restore form and function. The device is intended for use in a clinical dental setting by licensed practitioners. It provides a durable filling material for the treatment of dental caries, benefiting the patient by restoring tooth structure.

Clinical Evidence

No clinical data provided; substantial equivalence is based on the device's intended use and established handling techniques consistent with existing dental amalgams.

Technological Characteristics

Amalgam alloy restorative material. Class II device (21 CFR 872.3050). Product code EJJ.

Indications for Use

Indicated for dental professionals to fill tooth cavities in patients requiring restorative dental treatment.

Regulatory Classification

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.

Special Controls

*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.

Submission Summary (Full Text)

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NOV 1 5 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

TÜV America, Incorporated C/O Mr. Stefan Preiss Responsible Third Party Official Dunia Perwira Manufacturing SDN. BHD. 1775 Old Highway 8 New Brighton, Minnesota 55112-1891

Re: K053114 Trade/Device Name: AMALGAM ALLOY - SILVERFIL Regulation Number: 872.3050 Regulation Name: Amalgam Alloy Regulatory Class: II Product Code: EJJ Dated: October 7, 2005 Received: November 7, 2005

Dear Mr. Preiss:

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. Preiss

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 [phone]. 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 [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Snitte Y. Michael Oms.

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

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| | Dunia Perwira Manufacturing Sdn Bhd |
|--|-------------------------------------|
|--|-------------------------------------|

| SUBJECT: | 510(k) Application |
|----------|--------------------|
|----------|--------------------|

| Doc. No: | DPM-510k-001 |
|-------------|---------------------|
| Date / Rev. | July 19th 2005 / 03 |

Section E - Statement of Indication for Use

DEVICE NAME: AMALGAM ALLOY - SILVERFIL

INDICATION FOR USE:

Silverfil amalgam is used by dental professionals to fill tooth cavities. It is used in the
same way as other amalgams used in the world today. Its usage and handling
techniques are the same as other amalgams.

| Prescription Use | YES | AND/OR | Over-The-Counter Use |
|-----------------------------|-----|--------|------------------------|
| (Part 21 CFR 801 Subpart D) | | | (21 CFR 807 Subpart C) |

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Susan Runne

(Division Sign-Off)

Division of Anesthesiology, General Hospital,
Infection Control, Dental Devices

| 510(k) Number: | K053114 |
|----------------|---------|
|----------------|---------|

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