(71 days)
PERMAFIX is intended to permanently reline a denture surface that contacts tissue.
The product is self-curing and is intended for chairside use in dental practices and for dental laboratories. It is not intended for over-the-counter (OTC) use.
Applications
To avoid and to relieve pressure areas in the upper and lower denture
Post-damming of the A-line
Elastic cover for dentures in the upper jaw
Cushioning of overdentures that contact implants during the process of healing in the field of implantology
PERMAFIX - Chairside Soft Denture Relining Device. The reliner remains permanently soft. Material: A-Silicone.
I am sorry, but the provided text does not contain information about the acceptance criteria or a study proving that a device meets those criteria. The document is an FDA 510(k) clearance letter for a dental relining material called "Permafix" and lists its intended use and physical characteristics. It does not include details about device performance metrics, sample sizes for testing, ground truth establishment, or any comparative effectiveness studies. Therefore, I cannot fulfill your request based on the given input.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread, rendered in a simple, graphic style.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR 3 0 1998
Ms. Dagmar S. Maeser ·Regulatory Affairs Business Support International Amstel 320- I 1017 AP Amsterdam THE NETHERLANDS
Re : K980616 Permafix Chairside Soft Denture Relininq Trade Name: (7010) (7011-13) Regulatory Class: II Product Code: EBI Dated: April 16, 1998 April 22, 1998 Received:
Dear Ms. Maeser:
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 The general controls provisions of the Act 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. ਉ 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 - Ms. Maeser
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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KOHLER Medizintechnik GmbH & Co. KG
| 510(k) Number: | K 980616 |
|---|---|
| ---------------- | ---------- |
PERMAFIX - Chairside Soft Denture Relining Device Name:
Classification: Resin, Denture, Relining
76 EBI Class II 21 CFR 872.3760 Product Code:
INDICATIONS FOR USE:
PERMAFIX is intended to permanently reline a denture surface that contacts tissue.
The product is self-curing and is intended for chairside use in dental practices and for dental laboratories. It is not intended for over-thecounter (OTC) use.
Applications
To avoid and to relieve pressure areas in the upper and lower denture
Post-damming of the A-line
Elastic cover for dentures in the upper jaw
Cushioning of overdentures that contact implants during the process of healing in the field of implantology
Physical Characteristics:
The reliner remains permanently soft.
Material:
A-Silicone
(PLEASE DO NOT WRITE BELOW-THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Su. 21, 1976
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off) Division of Dental, Infection Control. and General Hospital Devices 510(k) Number
Prescription Use (Per 21 CFR 801.109) Intend.use
OR
Over-The-Counter Use
V
(Optional Format 1-2-96)
§ 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.