(69 days)
Not Found
Not Found
No
The summary describes a dental relining material and contains no mention of AI or ML.
No
The device is described as an acrylic resin used for permanent hard relining of dentures, which is a restorative or prosthetic function, not a therapeutic one. It does not treat or cure a disease or condition.
No
The device is described as an acrylic resin for permanent hard relining of dentures, which is a therapeutic or restorative purpose, not a diagnostic one. It does not mention any function for identifying or assessing diseases or conditions.
No
The device description and intended use clearly indicate a physical material (acrylic resin) used for relining dentures, which is a hardware component, not software.
Based on the provided information, this device is NOT an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "an acrylic resin used as a permanent hard relining for complete and partial dentures." This describes a material used on a medical device (dentures) within the patient's mouth, not a test performed on a sample taken from the body to diagnose or monitor a condition.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Providing diagnostic information
- Measuring analytes or biomarkers
- Being used in a laboratory setting
The device is a material used in the fabrication or modification of a medical device (dentures), which falls under a different regulatory category than IVDs.
N/A
Intended Use / Indications for Use
Ufi Gel hard is an acrylic resin used as a permanent hard relining for complete and partial dentures.
Product codes
EBI
Device Description
Not Found
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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 is a black and white logo for the U.S. Department of Health & Human Services. The logo features the department's name in a circular arrangement around a symbol. The symbol consists of three stylized human profiles facing to the right, with flowing lines connecting them. The overall design is simple and conveys a sense of unity and connection.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN 20 2000
Shuojia Donq, Ph.D. DenPlus, Incorporated 4235 Beaconsfield Montreal, Quebec, Canada H4A 2H4
Re : K993827 Ufi Gel Hard Trade Name: Regulatory Class: II Product Code: EBI Dated: January 11, 2000 Received: January 12, 2000
Dear Dr. Donq:
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 Regulations, Title 21, Parts 800 to 895. ದ 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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Page 2 - Dr. Dong
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,
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
K 9
Page 1 of _1
510 (k) NUMBER (IF KNOWN) :
DEVICE NAME : Ufi Gel hard
INDICATIONS FOR USE :
Ufi Gel hard is an acrylic resin used as a permanent hard relining for complete and partial dentures.
(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) | ||
| (Division Sign-Off) | ||
| Division of Dental, Infection Control. | ||
| and General Hospital Devices |
510(k) Number _