(96 days)
Not Found
Not Found
No
The provided 510(k) summary contains no mention of AI, ML, image processing, or any other technology typically associated with AI/ML in medical devices. The intended use and device description (though not found) point towards a material-based sealant.
Yes
The device is used for "prophylactic sealing of pits and fissures" and as a "microrestorative or 'initial layer' of composite restorations," indicating its use in treating and preventing dental conditions.
No
The provided text states the device is for "prophylactic sealing" and "microrestorative" purposes, which are treatment rather than diagnostic functions. There is no mention of the device being used to identify or assess a medical condition.
No
The provided text describes a dental sealant product ("UltraSeal XT plus") used for prophylactic sealing of pits and fissures and as an initial layer for composite restorations. This is a physical material, not a software-only device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use describes a product for "prophylactic sealing of pits and fissures" and "microrestorative or 'initial layer' of composite restorations." These are procedures performed directly on a patient's teeth, not on samples taken from the body for diagnostic purposes.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Providing diagnostic information about a disease or condition
- Using reagents or assays
The description points to a dental material used for preventative and restorative procedures within the mouth.
N/A
Intended Use / Indications for Use
Use UltraSeal XT plus for prophylactic sealing of pits and fissures. It may also be used for microrestorative or "initial layer" of composite restorations.
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
Not Found
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)
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 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" around the perimeter. Inside the circle is an emblem featuring a stylized eagle with three curved lines representing its wings.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB 1 6 2000
Dr. Dan Fisher President Ultradent Products, Incorporated 505 West 10200 South South Jordan, Utah 84095
Re : K993846 UltraSeal XT Plus Trade Name: Regulatory Class: II Product Code: EBC Dated: January 28, 2000 Received: January 31, 2000
Dear Dr. Fisher:
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 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 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 requlation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in
1
Page 2 - Dr. Fisher
the Federal Register. Please note: this response to your the rederal notification submission does not affect any premarker noctricacion baskibility sections 531 through 542 of obligation you might have ahe around Product Radiation the Act for devices ander enderal laws or regulations.
This letter will allow you to begin marketing your device as Inis iceed will arrew your for market notification. The FDA described in your 510 k; premainos newslevice to a legally rinding or bubbeanceal oggresults in a classification for your marketed predicate device rosadesice 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 regulacion (ir devices), please contact the Office of Compliance at (301) 594-4692. Additionally, for questions on compriation and advertising of your device, please contact che promocron and livere at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to
the regulation entitled, "Misbranding by reference to information on your responsibilities under the Act may be Infoimation on your respon of Small Manufacturers Assistance obtained from che Divisa(800) 638-2041 or (301) 443-6597 or at at fes corr free namble (p://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
Page_1 of_1
510(k) Number (if known):
Device Name: _________________________________________________________________________________________________________________________________________________________________ UltraSeal XT plus
Indications For Use:
Use UltraSeal XT plus for prophylactic sealing of pits and fissures. It may also be used for microrestorative or "initial layer" of composite restorations.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109)
OR
Susan Runne
Over-The-Counter Use
(Optional Format 1-2-9«
(Division Sign-Off) Division of Dental, Infection Control, ond General Hospital Devices - U-510(k) Number _