(45 days)
Acron MC is a powder/liquid microwave curing denture base resin.
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This document (K991774) is a 510(k) premarket notification letter from the FDA regarding the Acron™ MC dental device. It does not contain any information about acceptance criteria for a device, a study proving the device meets acceptance criteria, or any of the detailed information requested in your prompt (sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth, training set details).
This letter primarily states that the FDA has reviewed the submission and determined that the Acron™ MC modification is substantially equivalent to legally marketed predicate devices, allowing it to be marketed. It also outlines general regulatory information for the manufacturer.
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL - 9 1999
Ms. Terry L. Joritz Director Brootbry Affairs & Quality Assurance/Quality Control Official Correspondent GC® America, Incorporated 3737 West 127th Street Alsip, Illinois 60803
K991774 Re : Acron™ MC Modification Trade Name: Regulatory Class: II Product Code: EBI Dated: May 19, 1999 Received: May 25, 1999
Dear Ms. Joritz:
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 of the Act. The general controls provisions 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 regulations 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 regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register.
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Page 2 - Ms. Joritz
this response to your premarket notification Please note: 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 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
premarket notification" (21 CFR 807.97). 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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8 K991774
INDICATIONS FOR USE
Device Name:
Acron MC
Indications for Use:
Acron MC is a powder/liquid microwave curing denture base resin.
Susan Runny
(Division Sign-Off)
on Asion Sign-Off)
Division of Dental, Infection Control, and General Hospital, Infection Of 510(k) Number
Prescription Use
(Per 21 CFR 801.109)
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§ 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.