(223 days)
HurriSeal® is a desensitizer with fluoride and benzalkonium chloride to be applied prior to restorative procedures by the dental professional.
Not Found
The provided document is a 510(k) clearance letter from the FDA for a product named "Hurriseal® Dentin Desensitizer." This letter confirms that the device is substantially equivalent to legally marketed predicate devices.
However, this type of document (a 510(k) clearance letter) typically does not contain the detailed information required to answer your questions about acceptance criteria and a study proving those criteria were met.
A 510(k) submission generally involves demonstrating substantial equivalence rather than conducting large-scale clinical trials with acceptance criteria for device performance in the way you've described for AI/diagnostic devices. For devices like a dentin desensitizer, the evidence for substantial equivalence often relies on:
- Comparison to a predicate device: Showing similar technological characteristics, materials, and intended use.
- Bench testing: In vitro studies to confirm material properties, strength, or specific desensitizing mechanisms.
- Limited clinical data (if necessary): Small studies might be conducted if there are novel aspects, but typically not a full-blown comparative effectiveness study with AI-like metrics.
Therefore, I cannot provide the requested information based on the text provided. To answer your questions, one would need access to the full 510(k) submission document or a separate clinical study report for the Hurriseal® Dentin Desensitizer, which is not part of this letter.
{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
{1}------------------------------------------------
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
{2}------------------------------------------------
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__________________________________________________________________________________________________________________________________________________________
§ 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.