(44 days)
The denture materials manufactured by Keystone Industries are intended to be used to form new dentures or to repair fractured dentures. They are to be used only by professional dental practitioners who make or repair dentures for patients.
Not Found
I am sorry, but the provided text is a 510(k) clearance letter for a dental device (denture acrylic material) and does not contain information about acceptance criteria, device performance studies, or ground truth establishment. The document confirms that the device is substantially equivalent to a predicate device and can be marketed, but it does not detail the technical studies typically performed for AI/ML-based medical devices as per your request.
{0}------------------------------------------------
DEPARTMENT OF HEALTH & HUMAN SERVICES
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 depiction of a human figure, with three overlapping profiles facing to the right. The profiles are connected by flowing lines that resemble ribbons or waves. Encircling the figure is the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" in a circular arrangement.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR 2 0 2001
Mr. Larry W. Steffier Director and Vice President Keystone Industries 616 Hollywood Avenue Cherry Hill, New Jersey 08002
K983876 Re: Millenium, sledgehammer, Formula 99 Trade/Device Name: & Naturalyke H.C., High Impact Denture Acrylic Regulation Number: 872.3760 II Regulatory Class: Product Code: EBI Dated: October 28, 2001 Received: November 2, 2001
Dear Mr. Steffier:
This letter corrects our substantially equivalent letter December 16, 1998 regarding the trade name.
We have reviewed your Section 510(k) notification of intent to we have reviewed your referenced above and we have determined the market is substantially equivalent [(for the indications for device is subbeancrary Squily marketed predicate devices marketed in interstate commerce prior to May 28, 1976, acvice marked and fothe Medical Device Amendments or to the enactment acco on reclassified in accordance with the acvices that have 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. concrois of the Act include requirements for annual provisions of the nee instaures, 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 bubles or affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent detcrmination assumes compliance with the Good Manufacturing Practice requirements, as set forth in
{1}------------------------------------------------
Page 2 - Mr. Steffier
the Quality System Regulation (QS) for Medical Devices: General (QS) regulation (21 CFR Part 820) and that, through periodic OS inspections, FDA will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, the Food and Drug Administration (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 the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or requlations.
This letter will allow you to continue 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 yitro 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. Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at their toll free number (800) 638-2041 or at (301) 443-6597 or at its internet address
"http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Jusar unes
Timothy A. Ulatowski
Director
Division of Dental, Infection Control
and General Hospital Devices
Office of Device Evaluation
Center for Devices and
Radiological Health
{2}------------------------------------------------
Indications for Use
The denture materials manufactured by Keystone Industries are intended to be used to form new dentures or to repair fractured They are to be used only by professional dental dentures. practitioners who make or repair dentures for patients.
Prescription Use /
Susan Runner
(Division Sign-Off)
(Division Sign-Off)
Division of Dental, Infection Control,
The Courcel Hospital Devices Division of Dental, Inspital Devices
and General Hospital Devices 0 38 510(k) Number
§ 872.3760 Denture relining, repairing, or rebasing resin.
(a)
Identification. A denture relining, repairing, or rebasing resin is a device composed of materials such as methylmethacrylate, intended to reline a denture surface that contacts tissue, to repair a fractured denture, or to form a new denture base. This device is not available for over-the-counter (OTC) use.(b)
Classification. Class II.