(194 days)
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No
The description focuses solely on the physical process of melting and injecting a resin material using a mechanical system. There is no mention of any computational analysis, algorithms, or learning processes.
No
The device is a material used to produce denture bases in prosthetic partials, which is a structural component and not directly involved in treating or preventing a disease or condition.
No
Explanation: The device, Uni-flex Resin, is a material used to produce denture bases. Its function is to be molded into a prosthetic, not to diagnose a medical condition.
No
The device description clearly describes a physical material (resin) and its use in a manufacturing process involving heating, injection, and cooling, all of which are hardware-dependent processes. There is no mention of software as the primary or sole component of the device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to produce a denture base for prosthetic partials. This is a manufacturing process for a medical device (a dental prosthetic), not a diagnostic test performed on a sample from the human body.
- Device Description: The description details a process of heating and injecting a resin to form a physical object (the denture base). This is a fabrication method, not a method for analyzing biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific analytes, or providing diagnostic information about a patient's health condition.
IVDs are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or screening purposes. This device's function is purely for the creation of a physical prosthetic component.
N/A
Intended Use / Indications for Use
Uni-flex Resin is a flexible material that is used to produce the denture base in prosthetic partials.
Product codes
EBI
Device Description
Uni-flex Resin is a flexible material that is used to produce the denture base in prosthetic partials. This material is packed and sealed in aluminum cartridges which are especially made to fit the Injection Mold System machine. To begin the production of a partial a cartridge is heated to 490'F. This allows the material becomes molten. The process of melting lasts ten minutes. After the material becomes molten the operator turns the handle of the Injection Mold System. This forces the material to inject into a previously prepared dental mold encased in an Injection Mold Flask. After the injection the cool down period lasts three minutes, the operator must remove the flask from the machine during this time. Then a twenty minute bench cool down period follows, only after the twenty minutes mold is removed from the flask. After this elapsed time the denture is now ready for finishing and high shine polish.
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
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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
DEPARTMENT OF HEALTH & HUMAN SERVICES
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 border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling a stylized caduceus or a representation of the human form, composed of three curved lines.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR 1 3 1999
Ms. Caroline M. Zaleski Trans-Atlantic Dental 46 Arctic Parkway Trenton, New Jersey 08638
Re : K983461 Trade Name: Uni-Flex Resin Requlatory Class: II Product Code: EBI January 11, 1999 Dated: Received: January 14, 1999
Dear Ms. Zaleski:
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 Requlations, 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 the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
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Page 2 - Ms. Zaleski
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
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Trans-Atlantic Dental 46 Arctic Parkway Trenton, NJ 08638 Tel/Fax (609) 695-0168 Indications for Use Statement
Device Name: Uni-Flex Resin
Uni-flex Resin is a flexible material that is used to produce the denture base in prosthetic partials.
This material is packed and sealed in aluminum cartridges which are especially made to fit the Injection Mold System machine. To begin the production of a partial a cartridge is heated to 490'F. This allows the material becomes molten. The process of melting lasts ten minutes. After the material becomes molten the operator turns the handle of the Injection Mold System. This forces the material to inject into a previously prepared dental mold encased in an Injection Mold Flask. After the injection the cool down period lasts three minutes, the operator must remove the flask from the machine during this time. Then a twenty minute bench cool down period follows, only after the twenty minutes mold is removed from the flask. After this elapsed time the denture is now ready for finishing and high shine polish.
Susan Purrer
Division Sign-Orf Division of Dental, Infection Cont and General Hospital Devic 510(k) Number
NOT A PRESCRIPTION