(8 days)
Not Found
Not Found
No
The summary describes a dental amalgam, a material used for filling cavities, with no mention of AI or ML capabilities.
Yes.
The device is used to fill tooth cavities, which is a therapeutic intervention.
No
Explanation: The device, Silverfil amalgam, is described as being used by dental professionals to fill tooth cavities. This is a therapeutic or restorative function, not a diagnostic one. Diagnostic devices are used to identify or detect a disease or condition.
No
The device is a dental amalgam, which is a physical material used to fill cavities, not a software product.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "fill tooth cavities" by dental professionals. This is a direct treatment or restoration of a physical structure (a tooth), not a diagnostic test performed on a sample taken from the body.
- Device Description: While the description is "Not Found," the intended use clearly places it as a dental restorative material.
- 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
In summary, Silverfil amalgam is a dental material used for filling cavities, which is a therapeutic procedure, not a diagnostic one.
N/A
Intended Use / Indications 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.
Product codes
EJJ
Device Description
Not Found
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
dental professionals
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
Image /page/0/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal features a stylized eagle with its wings spread, facing left. The eagle is composed of three curved lines, giving it a modern and abstract appearance. Encircling the eagle is the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA", arranged in a circular fashion around the top half of the seal.
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.
1
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 (240) 276-0115. 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/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
2
| 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 |
|---|---|
| ---------------- | --------- |
. ▼・・・
・・・==
Page E – 1