(47 days)
Not Found
Not Found
No
The device description and intended use clearly describe a chemical cure composite restorative material, which is a physical substance used for dental fillings. There is no mention of software, algorithms, or any technology that would incorporate AI or ML. The "Mentions AI, DNN, or ML" field is explicitly marked as "Not Found".
No
The device is a restorative material used to fill cavities, which is a structural repair rather than a therapeutic treatment aimed at curing or alleviating a disease or condition.
No
This device is a restorative material used to fill cavities in teeth, not to diagnose conditions.
No
The device description clearly states it is a chemical cure composite restorative material, which is a physical substance, 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 "fill prepared cavities in teeth." This is a direct treatment applied to the patient's body (specifically, their teeth).
- Device Description: The description details a "direct filling dental composite" and its components, which are materials used for physical restoration within the mouth.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or screening.
IVDs are used outside the body to analyze samples and provide diagnostic information. This device is used inside the body for a restorative procedure.
N/A
Intended Use / Indications for Use
Prime Dent chemical cure composite restorative material is a Bis GMA thermosetting resin with inorganic radiopaque barium borosilicate and glass quartz particles ranging from .04-10 micron average. The kit consists of 15gm catalyst paste, 15gm base paste, 3cc enamel bond catalyst, 3cc enamel bond base, and 7.5 ml etchant.
Prime-Dent chemical cure composite restorative material is a direct filling dental composite used by licensed dentists to fill prepared cavities in teeth. Prime-Dent chemical cure composite restorative material is recommended for class III and class V restorations and for limited use in class I restorations in pre-molars and selected class IV restorations where esthetics are of primary importance.
Product codes
EBF, KLE
Device Description
Prime Dent chemical cure composite restorative material is a Bis GMA thermosetting resin with inorganic radiopaque barium borosilicate and glass quartz particles ranging from .04-10 micron average. The kit consists of 15gm catalyst paste, 15gm base paste, 3cc enamel bond catalyst, 3cc enamel bond base, and 7.5 ml etchant.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Teeth
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Licensed dentists
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
Not Found
Key Metrics
Not Found
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 circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with three lines representing its wings and body.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
(JAN 3 1 2000
Mr. Rolando Marasigan V.P. of Manufacturing Prime Dental Manufacturing, Incorporated 3735 West Belmont Avenue Chicago, Illinois 60618
Re : K994224 Prime-Dent Chemical Cure Composite Trade Name: Restorative Material Regulatory Class: II Product Code: EBF/KLE Dated: December 13 1999 Received: December 15, 1999
Dear Mr. Marasigan:
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 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 regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. ਸੈ 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 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
1
Page 2 - Mr. Marasigan
obligation you might have under sections 531 through 542 of obligation you might have ahability of the Electronic Product Radiation the Act for devices ander on Federal laws or regulations.
This letter will allow you to begin marketing your device as first receir wire 510 k) premarket notification. The FDA described in your sie in promote of your device to a legally Linding of subblancial equired in a classification for your marketed predicate device bus device to proceed to the market.
If you desire specific advice for your device on our labeling II you debite opeonial additionally 809.10 for in regulation (stic devices), please contact the Office of Villo draghobere at (301) 594-4692. Additionally, for questions on Compriation and advertising of your device, please contact the Dffice of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to
the regulation entitled, "Misbranding by reference to premation on your responsibilities under the Act may be Information on your respon of Small Manufacturers Assistance obtained from the bryibion or back-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
2
Indications for Use
Prime Dent chemical cure composite restorative material is a Bis GMA thermosetting resin with inorganic radiopaque barium borosilicate and glass quartz particles ranging from .04-10 micron average. The kit consists of 15gm catalyst paste, 15gm base paste, 3cc enamel bond catalyst, 3cc enamel bond base, and 7.5 ml etchant.
Prime-Dent chemical cure composite restorative material is a direct filling dental composite used by licensed dentists to fill prepared cavities in teeth. Prime-Dent chemical cure composite restorative material is recommended for class III and class V restorations and for limited use in class I restorations in pre-molars and selected class IV restorations where esthetics are of primary importance.
escription Deville
Susan Vanre
(Division Sign-Off) Division of Dental, Infection Control, and General Hospital Device 510(k) Number .