(174 days)
Silicone Soft Reline is usesd as a soft reline material for removable dentures.
Not Found
This appears to be an FDA 510(k) clearance letter for a medical device called "Silicone Soft Reline." This type of document is a regulatory approval, not a scientific study report describing acceptance criteria and performance data. Therefore, the requested information about acceptance criteria, study details, sample sizes, expert qualifications, and ground truth cannot be extracted from this document.
The document states:
- Device Name: Silicone Soft Reline
- Intended Use: "Silicone Soft Reline is used as a soft reline material for removable dentures."
- Regulatory Determination: The device is deemed "substantially equivalent" to legally marketed predicate devices. This means its safety and effectiveness are considered comparable to devices already on the market, rather than requiring new clinical trials to establish its efficacy against specific performance metrics.
To answer your questions, one would need access to the full 510(k) submission (K981691), which may contain performance data and a comparison to a predicate device. However, this specific letter does not provide that level of detail.
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
3 1998 NOV
Mildred M. Goldstein President Harry J. Bosworth Company 7227 North Hamlin Avenue Skokie, Illinois 60076
Re : K981691 Trade Name: Silicone Soft Reline Regulatory Class: II Product Code: EBI Dated: August 17, 1998 August 17, 1998 Received:
Dear Ms. Goldstein:
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 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). 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, qood 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. ਚੋ substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory In addition, FDA may publish further announcements action. concerning your device in the Federal Reqister. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531
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Page 2 - Ms. Goldstein
through 542 of the Act for devices under the Electronic chrough 342 or eno notrol provisions, or other Federal laws or requlations.
This letter will allow you to begin marketing your device as fills feeter wir asio(k) premarket notification. The FDA described in your siet. Ppivalence of your device to a legally Finding of bubbeanslazion a classification for your marketed predicate device robated 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 reguladiagnostic 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" (CFR 807.97). Other general premation 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/dsma/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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510(k) Number (if known): K981691
Device Name: SILICONE SOFT RELINE
INDICATIONS FOR USE:
Silicone Soft Reline is usesd as a soft reline material for removable dentures.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use _ ﺳﺎ_ (Per 21 CFR 801.109)
OR
Over-the-Counter Use
. TOptional Format 1-2-96)
Shunner
(Division Sign-Off) Division of Dental, Infection Control, and General Hospital Devices JCGG 169 510(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.