(80 days)
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No
The summary describes a dental acrylic resin with no mention of software, algorithms, or any technology that would suggest AI/ML.
No
The device is an acrylic resin used for dental applications like repairs and construction, not for treating diseases or health conditions.
No
The device is an acrylic resin used for dental applications like repairs and construction, not for diagnosing medical conditions.
No
The device is described as an acrylic resin, which is a physical material, not software.
Based on the provided information, GC Unifast Trad is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use describes the material being used for dental applications like repairing dentures, constructing temporary crowns, impression trays, bite registration, and orthodontic plates/splints. These are all applications that involve working with or on the patient's body or dental structures, not testing samples taken from the body.
- Device Description: It's described as an acrylic resin, which is a material used in dental fabrication and repair.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in samples
- Providing information for diagnosis, monitoring, or screening of diseases or conditions.
Therefore, GC Unifast Trad falls under the category of a dental material used for fabrication and repair, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
GC Unifast Trad is an acrylic resin used in a variety of dental applications such as repair of full or partial acrylic dentures. Construction of temporary crowns. Impression trays for individual teeth. Check bit registration. Construction and repair of orthodontic plates and splints.
Product codes
EBI/EBG
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
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Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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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 words "Public Health Service" in bold, black font. The words are stacked on top of each other, with "Public Health" on the top line and "Service" on the bottom line. The text appears to be extracted from a document or sign.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB 2 5 1999
Ms. Terry L. Joritz Director-Regulatory Affairs & Quality Control Official Correspondent GC AMERICA INCORPORATED 3737 West 127th Street Alsip, Illinois 60803
K984365 Re: GC Unifast Trad Trade Name: Requlatory Class: II EBI/EBG Product Code: February 15, 1999 Dated: February 19, 1999 Received:
Dear Ms. Joritz:
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 requlations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A 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. Joritz
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 debering of substantial equivalence of your device to a legally marketed predicate device results in a classification for your markets and thus, permits 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 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 gener Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance obtained from choner (800) 638-204) 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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Attachment A
INDICATIONS FOR USE
Device Name:
GC Unifast Trad
Indications for Use
- GC Unifast Trad is an acrylic resin used in a variety of dental applications such as repair of ・・・ー full or partial acrylic dentures. Construction of temporary crowns. Impression trays for individual teeth. Check bit registration. Construction and repair of orthodontic plates and splints.
!
Susan Russn
(Division Sign-Off)
(Division of Dental, Infection Control, and General Hospital, In 510(k) Number .
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Prescription Use -------------------------------------------------------------------------------------------------------------------------------------------------------------Prescription Oso 109)
(Per 21 CFR 801.109)