(71 days)
Not Found
Not Found
No
The summary describes a material (A-Silicone) for relining dentures and does not mention any computational or analytical capabilities that would suggest AI/ML. The "Mentions AI, DNN, or ML" and "Mentions image processing" fields are explicitly marked as "Not Found".
No
The device is described as a material for relining dentures to improve fit and relieve pressure, which serves a supportive or corrective function rather than directly treating a disease or condition.
No
The device description and intended use indicate that PERMAFIX is a material for permanently relining denture surfaces to address pressure points, provide cushioning, and similar therapeutic/reparative functions. It is not described as detecting, identifying, or monitoring any medical condition or anatomical state.
No
The device description explicitly states it is a "Chairside Soft Denture Relining Device" made of "A-Silicone," indicating it is a physical material, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use of PERMAFIX is to permanently reline a denture surface that contacts tissue. This is a physical modification of a medical device (a denture) and is used directly on the patient's tissue surface.
- Device Description: The device is described as a "Chairside Soft Denture Relining Device" made of A-Silicone. This is a material used for physical relining.
- Lack of Diagnostic Function: There is no mention of the device being used to diagnose a condition, analyze a sample from the human body, or provide information about a physiological state.
IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. PERMAFIX does not perform any of these functions.
N/A
Intended Use / 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-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
Product codes
EBI
Device Description
PERMAFIX - Chairside Soft Denture Relining Device; Classification: Resin, Denture, Relining; Physical Characteristics: The reliner remains permanently soft. Material: A-Silicone
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Denture surface that contacts tissue (upper and lower denture, A-line, upper jaw, overdentures that contact implants)
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Dental practices and dental laboratories. Not intended for over-the-counter (OTC) use.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
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
1
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
2
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)