TOKUYAMA TISSUECARE

K081554 · Tokuyama Dental Corporation · EBI · Mar 18, 2009 · Dental

Device Facts

• Record ID: K081554
• Device Name: TOKUYAMA TISSUECARE
• Applicant: Tokuyama Dental Corporation
• Product Code: EBI · Dental
• Decision Date: Mar 18, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3760
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The TOKUYAMA TISSUECARE denture relining, repairing, or rebasing resin material kit is a tissue conditioner and temporary liner for removable dentures. It is a prescription device intended for short-term use for conditioning of soft tissue distorted or damaged by the wearing of ill-fitting dentures, and for use as a temporary lining to make existing dentures more comfortable immediately after tooth extraction or oral surgery.

Device Story

TOKUYAMA TISSUECARE is a dental kit for short-term denture conditioning and temporary lining. Kit components include powder (polyalkyl methacrylate, amorphous silica filler), liquid (polyalkyl acrylate plasticizer, ethanol), and adhesive (polyalkyl methacrylate, ethyl acetate). Clinician mixes powder and liquid to form liner; applies adhesive to acrylic denture surfaces to bond liner. Plasticizer ensures continuous malleability and minimal surface roughness. Used in dental clinic settings by dentists to treat soft tissue distorted by ill-fitting dentures or to provide comfort post-extraction/surgery. Benefits include improved patient comfort and tissue healing.

Clinical Evidence

Bench testing only. Efficacy demonstrated via compliance with ISO 10139-1:1991 standards. No clinical data provided.

Technological Characteristics

Kit components: powder (polyalkyl methacrylate, amorphous silica filler), liquid (polyalkyl acrylate plasticizer, ethanol), adhesive (polyalkyl methacrylate, ethyl acetate). Material properties: continuous malleability, low surface roughness. Biocompatible. Non-sterile.

Indications for Use

Indicated for patients requiring short-term soft tissue conditioning due to ill-fitting dentures or temporary lining for comfort following tooth extraction or oral surgery.

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

• Myerson's Permasoft Soft Reline Material (K933468)

Submission Summary (Full Text)

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K081554

MAR 1 8 2009

# 510(k) SUMMARY Tokuyama Dental Corporation TOKUYAMA TISSUECARE Denture Relining, Repairing, Or Rebasing Resin Material Kit

## Name of Device

| Trade or Proprietary Name: | TOKUYAMA TISSUECARE denture relining, repairing, or rebasing resin material kit |
|----------------------------|---------------------------------------------------------------------------------|
| Common Name: | denture relining, repairing, or rebasing resin material |
| Classification Name: | resin, denture, relining, repairing, rebasing |
| Product Code: | EBI |

## Preparation Date

May 8, 2008

### 510(k) Sponsor

Tokuyama Dental Corporation 38-9 Taitou 1-chome, Taitou-ku Tokyo 110-0016 Japan

## 510(k) Sponsor Contact

Keith A. Barritt Fish & Richardson P.C. 1425 K Street, N.W., Suite 1100 Washington, DC 20005 [phone] Phone: Facsimile: [phone]

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### Intended Use

The TOKUYAMA TISSUECARE denture relining, repairing, or rebasing resin material kit is a tissue conditioner and temporary liner for removable dentures. It is a prescription device intended for short-term use for conditioning of soft tissue distorted or damaged by the wearing of ill-fitting dentures, and for use as a temporary lining to make existing dentures more comfortable immediately after tooth extraction or oral surgery.

#### Technological Characteristics and Substantial Equivalence

The main components of the TOKUYAMA TISSUECARE kit are:

- (1) powder (containing polyalkyl methacrylate and amorphous silica filler):
- (2) liquid (containing polvalkyl acrylate plasticizer and ethanol); and
- (3) adhesive (containing polyalkyl methacrylate and ethyl acetate).

The liner is formed by combining the powder and the liquid. The adhesive is used to bond the acrylic surface (it cannot be used to bond nylon, metal, or silicone surfaces). The TOKUYAMA TISSUECARE device utilizes a plasticizer that allows for continuous malleability and almost no surface roughness of the lining material when used in the short term.

The TOKUYAMA TISSUECARE denture relining, repairing, or rebasing resin material kit is substantially equivalent to several predicate devices, including Austenal's "Myerson's Permasoft Soft Reline Material" (K#933468).

Although the TOKUYAMA TISSUECARE denture relining, repairing, or rebasing resin material kit may have slightly different performance characteristics than the predicate devices, these differences do not raise new questions of safety or effectiveness. The efficacy of the device has been shown to be substantially equivalent pursuant to ISO10139-1:1991, and all ingredients used in the TOKUYAMA TISSUECARE denture relining, repairing, or rebasing resin material kit are biocompatible.

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#### DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 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" around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird-like figure.

#### Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Tokuyama Dental Corporation C/o Mr. Keith Barritt Fish and Richardson P.C. 1425 K Street, NW Suite 1100 Washington, DC 20005

MAR 1 8 2009

Re: K081554

Trade/Device Name: TOKUYAMA TISSUECARE Regulation Number: 21 CFR 872.3760 Regulation Name: Denture Relining, Repairing, or Rebasing Resin Regulatory Class: II Product Code: EBI Dated: March 13, 2009 Received: March 16, 2009

Dear Mr. Barritt:

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 vour 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. Barritt

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 (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.

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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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/industry/support/index.html.

Sincerely yours,

Sutie y. Mchane Davis.

Ginette Y. Michaud, M.D. Acting 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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K081554

Indications for Use

510(k) Number (if known): unknown

Device Name: TOKUYAMA TISSUECARE

(

Indications for Use:

The TOKUY AMA TISSUECARE denture relining, repairing, or rebasing resin material kit is a tissue conditioner and temporary liner for removable dentures. It is a prescription device intended for short-term use for conditioning of soft tissue distorted or damaged by the wearing of ill-fitting dentures, and for use as a temporary lining to make existing dentures more comfortable immediately after tooth extraction or oral surgery.

Prescription Use X (21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED

Concurrence of CDRH, Office of Device Evaluation (ODE)

Kein Muly for MSR

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

510(k) Number: K081554