(49 days)
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Not Found
No
The summary describes a dental soft liner material and provides no indication of any software, image processing, or AI/ML components.
Yes
The device is described as providing a soft tissue-bearing surface for patient comfort, indicating a direct health benefit and therapeutic purpose.
No
The device is a soft liner for dentures, applied for patient comfort. Its intended use does not involve diagnosing any condition or disease.
No
The device description and intended use clearly describe a physical material (silicone soft liner) applied to dentures, indicating it 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 to provide a soft tissue-bearing surface for dentures for patient comfort. This is a direct interaction with the patient's body (the inside of their mouth) and the denture, not the examination of specimens derived from the human body.
- 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.)
- Providing diagnostic information about a disease or condition
- Using reagents or analytical methods
IVDs are used to perform tests on samples taken from the human body to provide information for diagnosis, monitoring, or screening. This device is a material applied to a medical device (a denture) for patient comfort.
N/A
Intended Use / Indications for Use
Hydro-Cast / Kay-See Dental Silicone Soft Liner is applied to acrylic dentures for the purpose of providing a soft tissue-bearing surface to the denture for patient comfort.
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
Not Found
Predicate Device(s)
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Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three lines forming its body and wings. The eagle is enclosed in a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" surrounding it.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SEP 22 1999
Mr. Clark Smith, D.M.D. Executive Vice President Kay-See Dental Manufacturing Company 124 East Missouri Avenue Kansas City, Missouri 64106-1294
K992609 Re : Hydro-Cast/Kay-See Dental Silicone Soft Trade Name: Liner II Requlatory Class: Product Code: EBI August 2, 1999 Dated: Received: August 4, 1999
Dear Dr. Smith:
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 regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. ਸ substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation 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 through 542 of
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Page 2 - Dr. Smith
the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
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) 594-4690. 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 requlation 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.gov/cdrh/dsmamain.html".
Sincerely yours,
Susan Runne
Timothy A. Ulatowski Director Division of Dental, Infection Control, and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Image /page/2/Picture/0 description: The image shows a sequence of digits and a letter. The sequence starts with the letter 'K', followed by the numbers '992609'. The characters are written in a bold, sans-serif font, and they appear to be hand-drawn or heavily stylized. The image has a high contrast, with the characters in black against a white background.
Statement of Indications for Use
Page
510(k) Number (if known): _ K 9 92
Device Name:
Hydro-Cast / Kay-See Dental Silicone Soft Liner is applied to Indications For Use: acrylic dentures for the purpose of providing a soft tissuebearing surface to the denture for patient comfort.
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109)
OL
Over-the-Counter Use _
(Division Sign-Off) fermela Scart for Susan Runna
Division of Dental, Infection Control,
and General Hospital Devices
510(k) Number K992609
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