(143 days)
Soft Reline is a visible light cure soft reline material for removable dentures. It is intended for short-term use of at least 30 days.
Soft Reline is a visible light cure soft reline material for removable dentures.
The provided document is an FDA 510(k) clearance letter for a medical device called "Liner II: Soft Reline Liquid." This document does not describe any acceptance criteria or a study proving the device meets those criteria. Instead, it is a regulatory approval letter stating that the device is substantially equivalent to legally marketed predicate devices.
Therefore, I cannot provide the requested information. The document focuses on regulatory approval based on substantial equivalence, not on performance criteria or a study demonstrating achievement of those criteria.
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
7 1999 OCT
Daniel L. Menis, Ph.D. Manager Research and Corporate Development Harry J. Bosworth Company 7227 North Hamlin Avenue Skokie, Illinois 60076-3999
Re: K991687 Soft Reline Liquid Trade Name: Liner II: Requlatory Class: II Product Code: EBI Dated: September 24, 1999 Received: September 28, 1999
Dear Dr. Menis:
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 reqistration, 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 Regulations, Title 21, Parts 800 to 895. ਬ 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
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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,
cerely 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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510(k) Number: K991687
Device Name: LINER II: SOFT RELINE LIQUID
INDICATIONS FOR USE:
Soft Reline is a visible light cure soft reline material for removable dentures. It is intended for short-term use of at least 30 days.
(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 Runne
(Division Sign-Off) Division of Dental, Infection Control. and General Hospital De 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.