TOKUYAMA SOFRELINER TOUGH

K030663 · Tokuyama Dental Corporation · EBI · May 29, 2003 · Dental

Device Facts

• Record ID: K030663
• Device Name: TOKUYAMA SOFRELINER TOUGH
• Applicant: Tokuyama Dental Corporation
• Product Code: EBI · Dental
• Decision Date: May 29, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3760
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

For use as a denture reliner

Device Story

Tokuyama SOFRELINER TOUGH is a denture relining resin material used by dental practitioners to reline the tissue-contact surface of dentures. The device is applied chairside to improve the fit and comfort of dentures for patients. It is a silicone-based material. The practitioner applies the material to the denture base, which then cures to provide a resilient interface between the denture and the oral mucosa. This process helps alleviate discomfort caused by ill-fitting dentures and improves patient satisfaction. The device is intended for professional use only.

Technological Characteristics

Silicone-based denture relining resin. Material composition consists of components common in dental use. Formulated for professional dental application as a relining material.

Indications for Use

Indicated for use as a denture reliner for patients requiring denture tissue contact surface adjustment. Contraindicated for patients sensitive to silicone-based products. For professional dental use only; not for OTC use.

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

• Tokuyama Softrelininer (K982537)
• Tokuyama Soft Relining (K953589)
• GC Reline (K990736)
• Coe Soft (K940566)

Submission Summary (Full Text)

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K030663

EXHIBIT D

## 510(k) Summary

Daniel J. Manelli Suk mitted by: Manelli, Denison & Selter, P.L.L.C. 2000 Street, NW (Suite 700) Washington, DC 20036 Telephone: [phone] Facsimile:

> On behalf of Tokuvama America, Inc. 510(k) Submission: Tokuyama SOFRELINING TOUGH February 28, 2003

The product is a denture relining resin material for use in relining the tissue contact sur ace cf dentures (21 CFR 872.3760)

The product is for luse only by dental practitioners; it is not intended for over-thecounter (OTC) use. It contains materials that are common in dental use and pose no nealth hazard when used according to directions. It is substantially equivalent to var ous marketed denture relining products, including the following:

Tokuyama Softrelininer (K982537) Tokuyama Soft Relining (K953589) GC Reline (K990736) Coe Soft (K940566)

The Use of the product is contra-indicated for patients who are sensitive to silicone based products.

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Image /page/1/Picture/11 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with three human profiles incorporated into its design. The image is in black and white.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

## MAY 2 9 2003

Tokuyama Dental Corporation C/O Mr. Daniel J. Manelli Manelli, Denison & Selter, P.L.L.C. 2000 M Street, NW, 7th Floor Washington, D.C. 20036-3307

Re: K030663

Trade/Device Name: Tokuyama SOFRELINER TOUGH Regulation Number: 872.3760 Regulation Name: Denture Relining, Repairing or Rebasing Resin Regulatory Class: II Product Code: EBI Dated: February 28, 2003 Received: March 3, 2003

Dear Mr. Manelli:

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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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Page 2 - Mr. Manelli

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); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

This letter will allow you to begin marketing your device as described in your Section 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 regulation (21 CFR Part 801), please contact the Office of Compliance at [phone]. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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/cdrh/dsma/dsmamain.html

Sincerely yours.

Susan Runser

Susan Runner, DDS, MA Interim Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Exhibit C

Page __ 1__ of __ 1__

510(k) Number (if known): K030663

Device Name: _________________________________________________________________________________________________________________________________________________________________ Tokuyama SOFRELINER TOUGH

Indications For Use:

For use as a denture reliner

(Please Do Not Write Below This Line - Continue On Another Page If Needed)

Concurrence of CDRH, Office of Device evaluation (ODE)

Prescription Use (Per 21 CFR 801.109) OR

Over-The-Counter Use

Robert Sbetz DDS for Dr. K. Mulvey.

(Division Sign-Off)
Division of Anesthesiology. General Hospital,
Infection Control, Dental Devices

510(k) Number: K030663