FOUNDATION DENTAL RESIN

K111709 · Unix-Japan Co., Ltd. · EBI · Nov 18, 2011 · Dental

Device Facts

• Record ID: K111709
• Device Name: FOUNDATION DENTAL RESIN
• Applicant: Unix-Japan Co., Ltd.
• Product Code: EBI · Dental
• Decision Date: Nov 18, 2011
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3760
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

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.

Device Story

Foundation Dental Resin is a thermoplastic copolymer polypropylene material used by dental professionals to fabricate dental prostheses. The resin is processed via injection molding or pressing to create custom-shaped dental articles, including dentures, crowns, and orthodontic appliances. Unlike traditional acrylic resins that require mixing powder and liquid monomers, this thermoplastic material avoids residual monomer elution and bisphenol A (BPA) content. The device is used in dental clinics or laboratories to produce durable, biocompatible dental components for patients requiring restorative or corrective oral appliances.

Clinical Evidence

Bench testing only. Biocompatibility testing (genotoxicity, irritation, toxicity, cytotoxicity) performed in compliance with EN ISO standards. No clinical data provided; anecdotal evidence cited regarding lack of allergic reactions compared to traditional acrylic resins.

Technological Characteristics

Thermoplastic copolymer polypropylene resin. Form factor: moldable material for injection molding or pressing. Non-BPA formulation. Biocompatibility tested per EN ISO standards. No software or electronic components.

Indications for Use

Indicated for use by dental professionals (dentists, dental technicians) to fabricate removable full and partial dentures, occlusal splints, night guards, temporary crowns, and orthodontic devices.

Regulatory Classification

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.

Predicate Devices

• DuraFlex (K063626)

Submission Summary (Full Text)

{0}------------------------------------------------

K111709

NOV 1 8 2011

.

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.

{1}------------------------------------------------

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.

{2}------------------------------------------------

Image /page/2/Picture/0 description: The image shows the logo for UNIX-JAPAN Co., LTD. The logo consists of a stylized graphic on the left and the company name on the right. The graphic is a series of horizontal lines that form a U-shape. The text is in a bold, sans-serif font.

Please see Section 15. Biocompatibility on page. 21 and also attached actual test results on page. 26-65 for details.

{3}------------------------------------------------

Image /page/3/Picture/1 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal features a stylized eagle with three lines forming its body and wing. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.

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.

{4}------------------------------------------------

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 [phone] or [phone] 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

{5}------------------------------------------------

K111709

Image /page/5/Picture/1 description: The image shows the logo for UNIX-JAPAN CO., LTD. The logo consists of the text "UNIX-JAPAN" in bold, followed by "CO., LTD." in a smaller font. To the left of the text is a stylized graphic consisting of a series of horizontal lines that form a curved shape.

# 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<br>Resin, denture, relining, repairing |
| Proprietary Trade Name: | Foundation Dental Resin |
| Classification Name: | Denture relining, repairing or rebasing resin.<br>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