(79 days)
Not Found
Not Found
No
The summary does not mention AI, ML, image processing, or any related concepts typically associated with AI/ML medical devices. The intended use is a physical enhancement process.
No.
The intended use describes enhancing porcelain bond and color in dental crowns and bridges, which is an aesthetic or material property enhancement rather than a treatment for a disease or condition.
No.
The intended use is "For Enhancement of Porcelain Bond and Color in Porcelain Fused-to-Metal Dental Crowns and Bridges," which describes a function related to improving the properties of dental restorations rather than diagnosing a medical condition.
Unknown
The provided 510(k) summary lacks a device description, making it impossible to determine if the device is software-only or includes hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "For Enhancement of Porcelain Bond and Color in Porcelain Fused-to-Metal Dental Crowns and Bridges." This describes a process applied to a dental restoration outside of the body, not a test performed on a biological sample to diagnose a condition.
- Lack of Biological Sample Testing: IVDs are designed to test biological samples (like blood, urine, tissue) to provide information about a person's health. There is no mention of any biological sample being used or tested by this device.
- Anatomical Site: The anatomical site is "Dental Crowns and Bridges," which are prosthetic devices, not a part of the human body being tested for a medical condition.
Therefore, this device appears to be a dental laboratory or clinical device used in the fabrication or modification of dental restorations, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
For Enhancement of Porcelain Bond and Color in Porcelain-Fused-to-Metal Dental Crowns and Bridges.
Product codes
EJT
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
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)
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
§ 872.3060 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
Image /page/0/Picture/2 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized emblem featuring three abstract human profiles facing to the right, stacked on top of each other. The emblem is designed to convey a sense of unity and collaboration.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV 2 6 1997
Mr. Kenneth A. Putney rir. Remicen in Facily
Vice President, General Manager Official Correspondent Metalor Dental USA Corporation 255 John L. Dietsch Boulevard North Attleborough, Massachusetts 02761
K973372 Re: Aurofilm 2000 Trade Name: Regulatory Class: II Product Code: EJT September 2, 1997 Dated: Received: September 8, 1997
Dear Mr. Putney:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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, Druq, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act 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 (Premarket Approval), 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 895. ਜੋ substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Requlation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531
1
Page 2 - Mr. Putney
through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or requlations.
This letter will allow you to begin marketing your device as described in your 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 requlation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4618. Additionally, for questions on the promotion and advertising of your device; please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.ffaa.gov/cdrh/dsmamain.html".
Sincerely yours,
O. Alltrust
Timothy A. Ulatowski Directbr Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
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510(k) Number (if known):_____________________________________________________________________________________________________________________________________________________
Device Name: _________________________________________________________________________________________________________________________________________________________________
Indications For Use:
For Enhancement of Porcelain Bond and Color in PorcelainFor Carol Transdate Motal Dental Crowns and Bridges. ancement of Porcelain Bond and Containc Commission of Crowns and Bridges.
Fused-to-Metal Dental Crowns and Bridges.
| (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF | ||||
|---|---|---|---|---|
| NEEDED) | ||||
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Concurrence of CDRH, Office of Device Evaluation (ODE)
| (Division Sign-Off) | |
|---|---|
| Division of Dental, Infection Control, and General Hospital Devices | |
| 510(k) Number | K973372 |
| Prescription use (Per 21 CFR 801.109) | OR | Over-The-Counter Use (Optional Format 1-2-96) |
|---|---|---|
| --------------------------------------- | ------------------------------------------ | ----------------------------------------------- |