(74 days)
Not Found
No
The summary describes a pit and fissure sealant, a traditional dental material, and contains no mention of AI, ML, image processing, or performance studies typically associated with AI/ML devices.
No
The device is described as a sealant and conditioner for teeth, which is preventive or restorative, not therapeutic in the sense of treating a disease or condition.
No
The intended use describes the device as a sealant and conditioner for teeth, which is a treatment or preventive measure, not a diagnostic one.
No
The intended use describes a physical substance (sealant and conditioner) applied to teeth, which is a hardware component, 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 "Pit and fissure sealant and conditioner for use in sealing pit and fissure depression of teeth." This describes a device used directly on the patient's teeth for a preventative or restorative purpose.
- Lack of Diagnostic Information: There is no mention of the device being used to test samples (like blood, urine, tissue, etc.) or to provide diagnostic information about a patient's health condition. IVDs are specifically designed for these purposes.
The description points to a dental device used for a procedure, not for in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
Pit and fissure sealant and conditioner for use in sealing pit and fissure depression of teeth.
Product codes
EBC
Device Description
Not Found
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
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
Not Found
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 872.3765 Pit and fissure sealant and conditioner.
(a)
Identification. A pit and fissure sealant and conditioner is a device composed of resin, such as polymethylmethacrylate, intended for use primarily in young children to seal pit and fissure depressions (faults in the enamel) in the biting surfaces of teeth to prevent cavities.(b)
Classification. Class II.
0
Image /page/0/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is a stylized image of an eagle with its wings spread.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 1 4 1999
Ms. Samantha J. Cheetham Official Correspondent Southern Dental Industries, Incorporated 246 First Street, Suite 204 San Francisco, California 94105
K990650 Re : Conseal F Trade Name: Regulatory Class: II Product Code: EBC Dated: April 22 1999 Received: April 30, 1999
Dear Ms. Cheetham:
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 aqainst 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 Requlations, 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 Druq 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 Please note: this response to your the Federal Register. 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.
1
Page 2 - Ms. Cheetham
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) 594-4692. 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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Page 1 of 1
Device Name:
Conseal F
Indications For Use:
510(k) Number (if known):
Pit and fissure sealant and conditioner for use in sealing pit and fissure depression of teeth.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Susan Runor
(Division Sign City Division of Denvil. Infection Control, and General Housial Devices
51 Number: K990652
Prescription Use: V (Per 21 CFR 801.109)
OR
Over-The-Counter Use: ________________________________________________________________________________________________________________________________________________________
(Optional Format 1-2-96)
Image /page/2/Picture/16 description: The image shows a black circle with a small drip extending from the bottom. The circle is solid black and appears to be a simple graphic or icon. The drip is also black and suggests a liquid or viscous substance.