(34 days)
For use as a denture reliner
The product is a denture relining resin material for use in relining the tissue contact surface of dentures. It is not intended for over-the-counter (OTC) use. It contains materials that are common in dental use and pose no health hazard when used according to directions.
I am sorry, but the provided text does not contain information about the acceptance criteria or any study that proves a device meets such criteria. The document is a 510(k) summary for a denture relining resin material (Tokuyama SOFRELINING) and a letter from the FDA determining substantial equivalence to predicate devices. It discusses the device's classification, indications for use, and regulatory compliance but does not detail performance acceptance criteria or specific studies beyond referencing the 510(k) notification.
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AUG 24 1998
EXHIBIT D
510(k) Summary
Submitted by:
Daniel J. Manelli Farkas & Manelli, P.L.L.C. 2000 Street, NW (Suite 700) Washington, DC 20036 Telephone: 202-261-1000 Facsimile: 202-887-0336
On behalf of Tokuyama America, Inc. 510(k) Submission: Tokuyama SOFRELINING July 17, 1998
Device Classification Name:
Denture relining, repairing, or rebasing resin 21 CFR §872.3760
Predicate Devices: Tokuyama Soft Relining; Molloplast-B Soft Denture Liner; Permafix denture reliner; Coe-Soft Resilient Denture Liner.
The product is a denture relining resin material for use in relining the tissue contact surface of dentures. It is not intended for over-the-counter (OTC) use. It contains materials that are common in dental use and pose no health hazard when used according to directions.
The Use of the product is contra-indicated for patients who are sensitive to silicone based products.
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Image /page/1/Picture/1 description: The image shows the seal for the U.S. Department of Health & Human Services. The seal is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is a stylized caduceus symbol, which is a staff with two snakes coiled around it.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 2 4 1998
Tokuyama America, Incorporated C/O Mr. Daniel J. Manelli Farkas & Manelli, P.L.L.C. 2000 Street, NW (Suite 700) Washington, DC 20036
K982537 Re : Trade Name: Tokuyama SoFRELINING Requlatory Class: II Product Code: EBI Dated: July 17, 1998 Received: July 21, 1998
Dear Mr. Manelli:
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 Requlations, 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. 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 - Mr. Manelli
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 regulation (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.qov/cdrh/dsmamain.html".
Sincerely yours,
S. Autman fer
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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EXHIBIT C
Page__________________________________________________________________________________________________________________________________________________________________________
510(k) Number (if known): K982537
Device Name: Tokuyama SOFRELINER
Indications For Use:
For use as a denture reliner
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
(Per 21 CFR 801.109)
OR
Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________
(Optional Format 1-2-96)
Susan Runnes
(Division Sign-Off) Division of Dental, Infection Control, and General Hospital Devices 108253 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.