(240 days)
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No
The summary provides no indication of AI/ML technology being used. The device is described as a material, not a software or system that would typically incorporate AI/ML.
No
The device is used for temporary restorations, which is a dental procedure. While it addresses a medical need, it doesn't fit the typical definition of a therapeutic device designed to cure, treat, or prevent disease in a broader medical sense, but rather a functional restoration.
No
The device is described as a "High Viscosity Composite Temporary (Provisional) Material" used for "temporary restorations," which indicates it is a therapeutic or restorative material, not a diagnostic device.
No
The device description clearly states it is a "High Viscosity Composite Temporary (Provisional) Material," which is a physical material, 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 "Used for temporary restorations." This describes a material used directly on a patient for a dental procedure, not a test performed on a sample taken from the body to diagnose a condition.
- Device Description: "High Viscosity Composite Temporary (Provisional) Material" further reinforces that this is a material for dental restoration, not a diagnostic test.
- Lack of IVD Characteristics: The description lacks any mention of analyzing biological samples (blood, urine, tissue, etc.), detecting analytes, or providing diagnostic information.
IVDs are devices used to examine specimens derived from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. This device does not fit that description.
N/A
Intended Use / Indications for Use
Used for temporary restorations.
Product codes
EBG
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
Not Found
§ 872.3770 Temporary crown and bridge resin.
(a)
Identification. A temporary crown and bridge resin is a device composed of a material, such as polymethylmethacrylate, intended to make a temporary prosthesis, such as a crown or bridge, for use until a permanent restoration is fabricated.(b)
Classification. Class II.
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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 stylized eagle with three lines forming its body and wings. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circular pattern around the eagle.
OCT 2 8 1998
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Michael O'Malley President Cosmedent®, Incorporated 5419 North Sheridan Road Chicago, Illinois 60640
Re : K980799 High Viscosity Composite Temporary Trade Name: (Provisional) Material Regulatory Class: II Product Code: EBG August 10, 1998 Dated: August 12, 1998 Received:
Dear Mr. O'Malley:
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. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) requlation (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 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 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
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Page 2 - Mr. O'Malley
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 diaqnostic 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" (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,
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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Cosmedent, Inc.
INDICATIONS FOR USE STATEMENT
510K Number (if known):_______________________________________________________________________________________________________________________________________________________
Device Name: ___ Higlı viscosity composite temporary (provisional) material
Indications for Use:
Used for temporary restorations.
(Please Do Not Write Below This Line)
Concurrence of CDRH, Office of Device Evaluation (ODE) Susan Lupper (Division Sign-Off) Division of Dental, Infection Control, and General Hospital Devices Kaso ng 510(k) Number Over the Counter Use__________________________________________________________________________________________________________________________________________________________ Prescription Use Y Or (Per CFR 801.109)