(84 days)
CMP' IMPAK denture relining, repairing/rebasing liquid resin is indicated for relining a denture surface which contains tissue, for repairing a fractured denture, or forming a new denture base.
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This document is a 510(k) clearance letter from the FDA for a dental device. It does not contain information about acceptance criteria, device performance, study designs, sample sizes, expert qualifications, or ground truth establishment. This type of information is typically found in the 510(k) summary or in the actual premarket notification submission, but not in the clearance letter itself.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and 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 a stylized image of three human figures, one behind the other, with their heads tilted slightly forward.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC 1 9 2003
Mr. William Regan CMP Industries LLC 413 North Pearl Street Albany, New York 12207
Re: K033020
Trade/Device Name: Impak Acrylic Repair Resin Liquid Regulation Number: 872.3760 Regulation Name: Denture Relining Repairing or Rebasing Resin Regulatory Class: II Product Code: EBI Dated: September 25, 2003 Received: September 26, 2003
Dear Mr. Regan:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate 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) that do not require approval of a premarket approval application (PMA). 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 (PMA), 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
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Page 2 -Mr. Regan
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
This letter will allow you to begin marketing your device as described in your Section 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), please contact the Office of Compliance at (301) 594-4613. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours.
CluLs
Chiu Lin, Ph.D. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use → 510(k) Number (if known): KO33020 IMPAK MIRYLIC REPAIR LIQUID Device Name: CMP' IMPAK denture relining, repairing/rebasing liquid Indications For Use: resin is indicated for relining a denture surface which contains tissue, for repairing a fractured denture, or forming a new denture base. Over-The-Counter Use AND/OR Prescription Use (21 CFR 807 Subpart C) (P:irt 21 CFR 801 Subpart D) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF N EEDED)
Concurreince of CDRH, Office of Device Evaluation (ODE)
Susan Runore
(Division Sign-Off) Division of Anesthesiology, General Hospital, Infection Control, Dental Devices
033020 510(k) Number:________________________________________________________________________________________________________________________________________________________________
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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.