(68 days)
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Not Found
No
The summary describes a chemically activated sealant and does not mention any AI or ML components.
No.
This device is a sealant used to prevent dental issues rather than to treat an existing disease or condition.
No
The device is described as a sealant for pit and fissures, which is a treatment rather than a diagnostic tool. Its purpose is to physically seal and protect teeth, not to identify or analyze a condition.
No
The device is described as a "chemically activated sealant," which is a physical substance, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVDs are used to examine specimens from the human body. The intended use of this device is to seal pits and fissures in young teeth, which is a direct application to the patient's body, not an examination of a specimen taken from the body.
- The description focuses on a sealant for direct application. The device description and intended use clearly indicate a material applied to the tooth surface for sealing purposes.
Therefore, this device falls under the category of a medical device used for treatment or prevention, not an in vitro diagnostic device used for diagnosis or monitoring by examining specimens.
N/A
Intended Use / Indications for Use
This is a chemically activated sealant that is used to seal the pit and fissures found in young teeth. This sealant assures complete cure in deep fissures.
Product codes
EBC
Device Description
Chemically Activated Pit and Fissure Sealant
Mentions image processing
Not Found
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
young teeth
Intended User / Care Setting
Not Found
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Not Found
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 is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three curved lines representing its wings and tail feathers. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV 25 1997
Ms. Debbie Gillaspy Official Correspondent Medental International 1246 Clear Creek Road Evergreen, Colorado 80439
Re : K973541 Medental Chemical Cure Pit & Fissure Sealant Trade Name: Regulatory Class: II Product Code: EBC September 15, 1997 Dated: Received: September 18, 1997
Dear Ms. Gillaspy:
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 Requlations, Title 21, Parts 800 to 895. ಕ್ಕೆ substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical General regulation (21 CFR Part 820) and that, Devices: 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 - Ms. Gillaspy
through 542 of the Act for devices under the Electronic Product 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 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) 594-4618. 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,
Kathy A. Ulatowski
thu A. Ulatow Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
.Enclosure
2
MEDENTAL INTERNATIONAL 1246 Clear Creek Road Evergreen, CO 80439 Establishment # 1723973
510(k) Number: K973541
Device Name:
Chemically Activated Pit and Fissure Sealant
Indications for Use:
This is a chemically activated sealant that is used to seal the pit and fissures found in young teeth. This sealant assures complete cure in deep fissures.
Susan Rumer
(Division Sign Off) Infection Control, Division ப Divisial Huspail Devices 167354)
510(k) Number _
Prescription Use
(Per 21 CFR 801.109)