(44 days)
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Not Found
No
The summary describes a dental restorative material and contains no mention of AI or ML.
No
The device is described as a "tooth colored posterior restorative material," which is used to restore the form and function of a tooth rather than treat a disease or condition.
No
The device is described as a "tooth colored posterior restorative material," indicating it is used for treatment (restoration) rather than diagnosis.
No
The 510(k) summary describes a "tooth colored posterior restorative material," which is a physical substance used to fill cavities. This is a hardware device, 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 "Tooth colored posterior restorative material" for use in situations applicable to amalgam restorations. This describes a material used directly on the patient's tooth for restoration.
- Anatomical Site: The anatomical site is "Tooth". This further reinforces that the device is used within the patient's body.
- Lack of IVD Characteristics: IVDs are devices intended for use in vitro (outside the body) to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. The description of this device does not involve any of these activities.
Therefore, this device is a medical device used for direct patient treatment, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
Tooth colored posterior restorative material. For usage in a similar situation that would be applicable to an amalgam restoration.
Product codes
EBF
Device Description
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Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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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
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Key Metrics
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Predicate Device(s)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 872.3690 Tooth shade resin material.
(a)
Identification. Tooth shade resin material is a device composed of materials such as bisphenol-A glycidyl methacrylate (Bis-GMA) intended to restore carious lesions or structural defects in teeth.(b)
Classification. Class II.
0
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus, which is a symbol often associated with medicine and healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the caduceus.
DEC 17 1997
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Murray Gamberg Quality Systems Director Jeneric®/Pentron®, Incorporated 53 North Plains Industrial Road Wallinford, Connecticut 06492-0724
K974131 Re : Alert Trade Name: Requlatory Class: II Product Code: EBF October 30, 1997 Dated: Received: November 3, 1997
Dear Mr. Gamberg:
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, Drug, 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 requlations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (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. Gamberg
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 regulation (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.fda.qov/cdrh/dsmamain.html".
Sincerely yours,
Timothy A. Ulatowski
ula Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radioloqical Health
Enclosure
2
510(k) Number (if known): K974131
Device Name: ALERT
Indications For Use:
Tooth colored posterior restorative material
For usage in a similar situation that would be applicable to an amalgam restoration.
(PLEASE DO NOT WRITE BELOW THIS LINE--- CONTINUE ON ANOTHER PAGE IF NEEDED)
Sutten
Concurrence of CDRH, Office of Device Evaluation (ODE) OR Over-the-Counter Use
(Per 21 CFR 801.109) · · · · · · · · · ·
Over-the-Counter Use
(Optional Format 1-2-96)