(57 days)
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No
The summary describes a chemically activated sealant and does not mention any AI or ML components or functionalities.
No
The device is a sealant used to prevent dental caries, which is a preventive measure rather than a treatment for an existing condition or disease.
No
Explanation: The device is described as a chemically activated sealant used to seal pits and fissures in teeth. Its purpose is to physically seal and protect, not to diagnose a condition or disease.
No
The device is described as a "chemically activated sealant" and "Pit and Fissure Sealant," which are physical materials, 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 "seal the pit and fissures found in primary and secondary dentition." This is a direct treatment or preventative measure applied to the patient's teeth.
- Device Description: It's described as a "Pit and Fissure Sealant," which aligns with a material applied to the tooth surface.
- Lack of Diagnostic Activity: 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.
IVD devices are specifically designed to perform tests on samples taken from the body, not to be applied to the body for treatment or prevention. This device falls under the category of a dental restorative or preventative material.
N/A
Intended Use / Indications for Use
This is a chemically activated sealant that is used to seal the pit ad fissures found in primary and secondary dentition in combination with the acid etching technique. This sealant assures complete cure in deep fissures.
Product codes
EBC
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
Pit and fissures found in primary and secondary dentition
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
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§ 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 logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, representing medicine and health. The symbol is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" in a circular arrangement. The text is in all caps and is evenly spaced around the circle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG - 7 2001
Mr. Cesar E. Veliz Official Correspondent Rite-Dent Manufacturing Corporation 1056 East 33rd Street Hialeah, Florida 33013-3526
Re : K011822 Pit and Fissure Chemical Curing Trade/Device Name: Sealant K872.3765 Requlation Number: Requlatory Class: II Product Code: EBC Dated: June 7, 2001 Received: June 11, 2001
Dear Mr. Veliz:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the market the action ially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate use beated in the chiriterstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to ene emat 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 The general controls controls provisions of the Act. provisions of the Act include requirements for annual provisions 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 requlations 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 Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, 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.
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Page 2 - Mr. Veliz
concerning your device in the Eederal Register. Please note: concerning your device in executive submission submission does this response co your premains of the have under sections 531 not arrect any obrigation for may and retres under the Electronic through 542 of the Act 101 actions or other Federal laws or regulations.
This letter will allow you to begin marketing your device as Ints recei (x) premarket notification. The FDA described in your 510(x) premaince of your device to a legally marketed predicate device results in a classification for your marketed predicate device robated to proceed to the market.
If you desire specific advice for your device on our labeling II you desire specific additionally 809.10 for in regulation (21 ork razes), please contact the Office of Villo dragnoscic devices/// For questionally, for questions on Compliance at (3017-394-1032 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" (21CFR 807.97). J Other general premarket nocification - (arch soies under the Act may be obtained from the Division of Small Manufacturers obtained from the Bivibron assistance at its toll-free number International and combaments - 115577 or at its internet address ('000')