(223 days)
None
Not Found
No
The 510(k) summary describes a dental desensitizer and contains no mention of AI, ML, image processing, or any other technology typically associated with AI/ML in medical devices.
No
The device is a desensitizer applied prior to restorative procedures, which aims to reduce sensitivity rather than treat a disease or condition. While it may provide comfort, its primary function is preparatory to a dental procedure, not therapeutic in itself.
No
Explanation: The device is described as a "desensitizer with fluoride and benzalkonium chloride to be applied prior to restorative procedures." Its purpose is to treat or prepare for a procedure, not to diagnose a condition.
No
The device description and intended use clearly indicate a chemical substance (desensitizer) for dental application, not a software product.
Based on the provided information, HurriSeal® is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to be applied prior to restorative procedures by a dental professional. This indicates a direct application to the patient's teeth for a therapeutic or preventative purpose (desensitization and fluoride application).
- Lack of IVD Characteristics: IVDs are used to examine specimens from the human body (like blood, urine, tissue) to provide information about a person's health. The description of HurriSeal® does not involve the analysis of any such specimens.
Therefore, HurriSeal® falls under the category of a dental device used directly on the patient, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
HurriSeal® is a desensitizer with fluoride and benzalkonium chloride to be applied prior to restorative procedures by the dental professional.
Product codes
KLE
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
dental professional
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 (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
§ 872.3200 Resin tooth bonding agent.
(a)
Identification. A resin tooth bonding agent is a device material, such as methylmethacrylate, intended to be painted on the interior of a prepared cavity of a tooth to improve retention of a restoration, such as a filling.(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 depiction of an eagle or bird-like figure with three curved lines representing its body and wings. The logo is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR 2 3 1998
Ms. An-Shih Cheng Cheng & Associates, Incorporated 415 West Aldine Avenue, #10-A Chicago, Illinois 60657-3602
K973002 Re : Hurriseal® Dentin Desensitizer Trade Name: Requlatory Class: II Product Code: KLE January 30, 1998 Dated: February 3, 1998 Received:
Dear Ms. An-Shi Cheng:
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 Requlations, Title 21, Parts 800 to 895. ਰੈ 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 obligation you might have under sections 531 through 542 of
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Page 2 - Ms. An-Shih Cheng
the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
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 requlation (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 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
510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
HurriSeal® Dentin Desensitizer Device Name:
Indications For Use:
HurriSeal® is a desensitizer with fluoride and benzalkonium chloride to be applied prior to restorative procedures by the dental professional.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Susan Rumpler
(Division Sign-Off) Division of Damal, Infection Control, and General Hospital Devices 510(k) Number S 300F
Prescription User (Per 21 CFR 801.109) OR
Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________