(90 days)
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No
The summary describes a resin material for dental procedures and contains no mention of AI or ML technology.
No
The device is used for repairing or relining dentures, which are prosthetics, not for treating a disease or condition in a living organism.
No.
The device is a resin used for repairing, relining, or rebasing dentures, which indicates it is a therapeutic or restorative material rather than a diagnostic tool.
No
The 510(k) summary describes a resin material used for dental procedures, which is a physical substance, not software.
Based on the provided information, ProTech's Denture Relining, Repairing/Rebasing Resin is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use describes a material used directly on a denture (a medical device) for repair, relining, or creating a base. This is a restorative or prosthetic material, not a test performed on a sample taken from the human body to provide information about a physiological state or disease.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in those samples
- Providing diagnostic information about a patient's health
Therefore, this device falls under the category of a dental material or device used for the fabrication or repair of dentures, not an in vitro diagnostic test.
N/A
Intended Use / Indications for Use
ProTech's Denture Relining, Repairing/Rebasing Resin is indicated for relining a denture surface that contacts tissue, to repair a fracture denture, or to form a new denture base.
Product codes
EBI
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
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies
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Key Metrics
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Predicate Device(s)
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Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 872.3760 Denture relining, repairing, or rebasing resin.
(a)
Identification. A denture relining, repairing, or rebasing resin is a device composed of materials such as methylmethacrylate, intended to reline a denture surface that contacts tissue, to repair a fractured denture, or to form a new denture base. This device is not available for over-the-counter (OTC) use.(b)
Classification. Class II.
0
Image /page/0/Picture/2 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States of America. The seal features a stylized eagle with three lines forming its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.
7 1999 JAN
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Barry Bloch Vice President ProTech, Incorporated 6421 Congress Avenue, #102 Boca Raton, Florida 33487
Re : K983547 ProTech Plus Trade Name: Regulatory Class: II Product Code: EBI October 8, 1998 Dated: Received: October 9, 1998
Dear Mr. Bloch:
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 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). 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 (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 requirements, 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 In addition, FDA may publish further announcements action. 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. Bloch
through 542 of the Act for devices under the Electronic emoduct 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 debting 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) 594-4692. 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" (21CFR 807.97). Other qeneral 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.gov/cdrh/dsma/dsmamain.html".
Sincerely yours,
Timothy A. Ulatowski
Directk Division of Dental, Infection Control, and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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STATEMENT OF INDICATIONS FOR USE
ProTech's Denture Relining, Repairing/Rebasing Resin is indicated for relining a denture surface that contacts tissue, to repair a fracture denture, or to form a new denture base.
Prescription Use . Prescription Ose =============================================================================================================================================================
Susan Lanser
(Division Sign-Off) (Division of Dental, Infection Control, and General Hospital, Intercent 510(k) Number _ 19835