(151 days)
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No
The summary describes a dental resin material and its intended use in fabricating dental prostheses using injection molding or pressing. There is no mention of AI, ML, image processing, or any other technology typically associated with AI/ML in medical devices.
No
The device is a dental resin material used to fabricate dental prostheses like dentures and splints, which are not considered therapeutic devices. They replace missing body parts or aid in their function rather than treating a disease or condition.
No
Explanation: The device is a dental resin used to fabricate dentures, splints, and night guards. It is a material used for fabrication, not for diagnosis. Its intended use is for creating dental prostheses.
No
The device description clearly states it is a thermoplastic resin material used to fabricate dental prostheses, which is a physical material, not software.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health.
- Device Function: The Foundation Dental Resin is a material used to fabricate dental prostheses (dentures, splints, night guards). It is a physical material that is placed in the oral cavity.
- Intended Use: The intended use is to create physical dental devices for patients, not to analyze biological samples for diagnostic purposes.
- Lack of IVD Characteristics: The description does not mention any analysis of biological specimens, diagnostic claims, or any of the typical components or processes associated with IVD devices (e.g., reagents, analyzers, diagnostic markers).
Therefore, the Foundation Dental Resin falls under the category of a medical device, specifically a dental material and a fabricated dental prosthesis, but not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
This provides a highly safe, molded article for fabricating molded articles for Intended Use dental use having a definite shape to be used in the oral cavity and resin materials. Foundation Dental Resin is used to fabricate teeth and gums that are intended for use as removable full and partial dentures as well as occlusal splints and night guards.
Foundation Dental Resin is intended for use by a qualified/trained dentists or dental laboratory technicians on dental plates for dentures (false teeth), temporary crowns, artificial teeth and orthodontic devices.
Product codes (comma separated list FDA assigned to the subject device)
EBI
Device Description
Foundation Dental Resin material is a thermoplastic resin that is used to fabricate dental prosthesis. The resin is used in an injection molding or pressing device to fabricate the prostheses.
Foundation Dental Resin, which is characterized by the fact that the principal component is a copolymer polypropylene.
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
oral cavity
Indicated Patient Age Range
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Intended User / Care Setting
dental professionals including dentists and dental technicians.
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)
Safety Testing - Testing on genotoxity, irritation, toxity, cytotoxicity have been performed on this product to demonstrate compliance with following EN ISO standards. Based on the testing results, we conclude that this product is safe for the intended use.
Effectiveness Extensive testing has been performed on this product to demonstrate its effectiveness and characteristics appropriate for the intended use.
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.
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 for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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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.
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NOV 1 8 2011
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Image /page/0/Picture/2 description: The image shows the logo for UNIX-JAPAN CO., LTD. The logo consists of a stylized emblem on the left and the company name on the right. The emblem is a series of horizontal lines that form a shield-like shape. The text is in a bold, sans-serif font, with "CO., LTD." in a smaller font size.
5. 510(k) Summary
Trade/Proprietary name: Foundation Dental Resin
| Common/usual name: | Moldable Resin for dental use |
|---|---|
| Classification name: | Resin, denture, relining, repairing, or rebasing resin |
| 21 CFR 872.3760 | |
| Product Code EBI |
Summary (Equivalent Marketed Device)
This product is similar in function and intent of use to the Cosmetic Dental Materials, Inc.'s DuraFlex (K063626).
This provides a highly safe, molded article for fabricating molded articles for Intended Use dental use having a definite shape to be used in the oral cavity and resin materials. Foundation Dental Resin is used to fabricate teeth and gums that are intended for use as removable full and partial dentures as well as occlusal splints and night guards.
This dental resin material is used by dental professionals including dentists and dental technicians. They can be used to make various sizes, shapes, and color shades for anterior and posterior preformed plastic teeth.
We are applying an approval as dental resin material as well as preformed product using this material.
Description of the Device Foundation Dental Resin material is a thermoplastic resin that is used to fabricate dental prosthesis. The resin is used in an injection molding or pressing device to fabricate the prostheses.
Foundation Dental Resin, which is characterized by the fact that the principal component is a copolymer polypropylene. Please see further details in COMPOSITION on page 19.
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Image /page/1/Picture/0 description: The image shows the logo for UNIX-JAPAN CO., LTD. The logo consists of a stylized graphic to the left of the company name. The graphic is a series of stacked, curved lines that form a shield-like shape. The text "UNIX-JAPAN CO., LTD." is written in a bold, sans-serif font.
Safety and Effectiveness, comparison to predicate device:
The result of testing indicates that Foundation Dental Resin is as safe and effective as the predicate device.
a) Safety Testing - Testing on genotoxity, irritation, toxity, cytotoxicity have been performed on this product to demonstrate compliance with following EN ISO standards. Based on the testing results, we conclude that this product is safe for the intended use. Please see attached for animal testing results.
This product is thermoplastic and does not use bisphenol A (BPA) which is used to make polycarbonate based dental resin. As this product does not contain BPA, it does not elude BPA.
Acrylic Resin generally contains PMMA (polymethylmetacrylate) and it is made of polymer (powder) monomer (liguid) by mixing in heat. After polymerization, residual monomer becomes a factor that elutes in the human body in the factor for causing an allergic reaction. On the other hand, based on anecdotal study for Foundation Dental Resin, there have not been any cases of allergic reactions.
- b) Effectiveness Extensive testing has been performed on this product to demonstrate its effectiveness and characteristics appropriate for the intended use. Please see attached for Performance Data Document for intended use.
Technological Characteristics and Substantial Equivalence:
Foundations Dental Resin and predicate device are similar in design. material characteristics, physical properties, handling characteristics, intended use and functionality.
Performance and Safety testing:
Extensive testing has been performed on the Foundation Dental Resin to demonstrate compliance with the following EN ISO standards.
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Please see Section 15. Biocompatibility on page. 21 and also attached actual test results on page. 26-65 for details.
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Unix-Japan Company, Limited C/O Ms. Toshiko Boyd Managing Director Eureka Global Solutions LLC 10920 Wilshire Boulevard, Suite 150 Los Angeles, California 90024
HOV. 11 8. 2011
Re: K111709
Trade/Device Name: Foundation Dental Resin Regulation Number: 21 CFR 872.3760 Regulation Name: Denture Relining Repairing or Rebasing Resin Regulatory Class: II Product Code: EBI Dated: October 24, 2011 Received: November 2, 2011
Dear Ms. Boyd:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and 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) that do not require approval of a premarket approval application (PMA). 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations. Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
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Page 2- Ms. Boyd
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801). please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices /ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807,97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
hr for
Anthony D. Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
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4. Indication for Use Statement
... .
Foundation Dental Resin is intended for use by a qualified/trained dentists or dental laboratory technicians on dental plates for dentures (false teeth), temporary crowns, artificial teeth and orthodontic devices.
| Identification of the Device | |
|---|---|
| Common name: | Common name – Moldable Resin for dental use |
| Resin, denture, relining, repairing | |
| Proprietary Trade Name: | Foundation Dental Resin |
| Classification Name: | Denture relining, repairing or rebasing resin. |
| 21 CFR 872.3760 | |
| Class | Class II |
| Product Code | EBI |
Nill Mally, Ca. Ausa Ruyer 11/7/11
(Division Sion-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: K11 1709