(77 days)
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No
The summary describes acrylic materials for denture fabrication, which are physical materials and do not typically incorporate AI/ML. There are no mentions of AI, ML, image processing, or data sets.
No
The device is described as materials (microwave heat curing acrylic and auto-curing acrylic) used for the fabrication of dentures, not for treating a disease or condition.
No
The device, HI-Wave and Pour-Plus, is described as materials used for the "fabrication of complete or partial removable dentures," which is a manufacturing or restorative process, not a diagnostic one. No mention of diagnosis is made in the intended use.
No
The intended use describes acrylic materials for fabricating dentures, 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 is for the "fabrication of complete or partial removable dentures." This is a process performed outside of the body to create a medical device (dentures).
- IVD Definition: In Vitro Diagnostics are tests performed on samples taken from the human body (like blood, urine, or tissue) to provide information about a person's health.
The description clearly indicates the device is used in a laboratory or clinical setting to create a physical product (dentures), not to analyze biological samples for diagnostic purposes.
N/A
Intended Use / Indications for Use
HI-Wave is a 3 minutes microwave heat curing acrylic and Pour-Plus is a color stable auto-curing acrylic for use in the fabrication of complete or partial removable dentures.
Product codes
EBI
Device Description
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Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies
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Key Metrics
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Predicate Device(s)
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Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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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.
0
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is often associated with healthcare. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the caduceus. The logo is in black and white.
AUG 2 3 2001
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Shuojia Donq Vice President Denplus Incorporated 1221 Labadie, Suite 205 Lonqueuil, Quebec CANADA
Re : K011762 Trade/Device Name: Hi-Wave; Pour-Plus Regulation Number: 872.3760 Regulatory Class: II Product Code: EBI Dated: June 4, 2001 Received: June 7, 2001
Dear Ms. 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 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, 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. ਹੈ 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 requlation (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 action. In addition, FDA may publish further announcements
1
Page 2 - Ms. Dong
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 the Act for devices under the Electronic emoduct Siz or can Control provisions, or other Federal laws or requlations.
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA described in your sie in privalence of your device to a legally marketed predicate device results in a classification for your marketed predicato amits your device 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 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 ene promotion and (301) 594-4639. Also, please note "Misbranding by reference to the requlation entitled, premarket notification" (21CFR 807.97). Other qeneral information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers International and Consumer 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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Page _ 1_ of 1
Koll762 510 (k) NUMBER (IF KNOWN):
DEVICE NAME: HI-Wave and Pour-Plus denture base acrylics
INDICATIONS FOR USE:
HI-Wave is a 3 minutes microwave heat curing acrylic and Pour-Plus is a color stable auto-curing acrylic for use in the fabrication of complete or partial 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 V (Per 21 CFR 801.109) OR
Over-The-Counter-Use (Optional Format 1)
Hessolw shhnded boa MSR
(Division Sign-Off) Division of Dental, Infection Control, and General Hospital Devices 510(k) Number_I