(86 days)
Not Found
Not Found
No
The summary describes heat-cure and auto-cure acrylics for denture fabrication and repair, with no mention of AI or ML technology.
No.
The devices are heat-cure and auto-cure acrylics used for denture fabrication and repair, which are materials for prosthetic devices, not therapeutic devices.
No
The "Intended Use / Indications for Use" section states that the devices are "heat-cure acrylics for complete and partial denture fabrication" and "auto-cure acrylic for complete and partial denture fabrication" and "auto-cure acrylic for denture repair." These are materials used for manufacturing or repairing dentures, not for diagnosing medical conditions.
No
The intended use describes heat-cure and auto-cure acrylics, which are physical materials, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that these are acrylics for the fabrication and repair of dentures. This is a material used in the creation of a medical device (dentures), not a test performed on a biological sample to diagnose 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
- Using reagents or assays
Therefore, based solely on the provided text, these acrylics are considered materials used in the manufacturing of a medical device, not an IVD.
N/A
Intended Use / Indications for Use
IMPACT-PLUS, IMPACT-20, DP97, DP97-20 are heat-cure acrylics for complete and partial denture fabrication. DP-POUR is auto-cure acrylic for complete and partial denture fabrication. DP-REPAIR is auto-cure acrylic for denture repair.
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
Not Found
Key Metrics
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 Department of Health & Human Services - USA. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized symbol that resembles a bird in flight, composed of three curved lines.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SEP 8 1999
Shoujia Dong, Ph.D. Vice President DenPlus, Incorporated 4235 Beaconsfield Montreal, Quebec, Canada H4A 2H4
K991996 Re : Impact Plus, Impact-20, DP97, DP97-20, DP-Pour Trade Name: and DP-Repair II Regulatory Class: Product Code: EBI Dated: August 12, 1999 Received: August 20, 1999
Dear Dr. Dong:
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. ಗ substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) requlation (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 requlation 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 – Dr. Dong
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
Page 1 of _1
510 (k) NUMBER (IF KNOWN) : K991996
IMPACT-PLUS, IMPACT-20, DP97, DP97-20, DP-POUR DEVICE NAME : and DP-REPAIR
INDICATIONS FOR USE :
IMPACT-PLUS, IMPACT-20, DP97, DP97-20_ are heat-cure acrylics for complete and partial denture fabrication. DP-POUR is auto-cure acrylic for complete and partial denture fabrication. DP-REPAIR is auto-cure acrylic for denture repair.
(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) |
| ------------------------------------------ | --------------------------------------------------- | ---- | --------------------------------------------- |
|---|
Susan Rusan
(Division Sign-Off)
(Division Sign-Off) Division of Dental, Infection Control, and General Hospital Devic 510(k) Number _