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 Description

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.

AI/ML Overview

This submission, K081554, is for a denture relining, repairing, or rebasing resin material kit (TOKUYAMA TISSUECARE). As a 510(k) premarket notification, it focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than providing detailed clinical study data with acceptance criteria and performance metrics for a novel AI or diagnostic device.

Therefore, much of the requested information regarding acceptance criteria, study methodologies for AI/diagnostic performance, sample sizes, expert ground truth, adjudication methods, MRMC studies, or standalone algorithm performance is not applicable to this type of medical device submission.

Here's a breakdown of what can be extracted and what is not applicable:

1. A table of acceptance criteria and the reported device performance

Not Applicable in the traditional sense. This submission is for a material, not a diagnostic or AI device with performance metrics like sensitivity, specificity, etc., that would be compared to acceptance criteria.
What is mentioned: "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." This indicates that the "acceptance criteria" were related to established standards for dental materials (ISO10139-1:1991 for efficacy and general biocompatibility requirements). The "reported device performance" is that it met these standards and was found substantially equivalent.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Not Applicable. No test set in the context of diagnostic or AI performance is described. The "test" for this device involved demonstrating conformance to the ISO standard and biocompatibility.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not Applicable. Ground truth in the context of diagnostic/AI performance is not relevant for this material submission. Expertise in verifying compliance with ISO standards and biocompatibility would have been internal or through a notified body.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not Applicable. No such adjudication method is described or required for this type of submission.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not Applicable. This is a material, not an AI-assisted diagnostic device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not Applicable. This is a material, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

Not Applicable in the diagnostic sense. The "ground truth" for this device refers to its compliance with material standards (ISO10139-1:1991) and biocompatibility requirements.

8. The sample size for the training set

Not Applicable. No training set is involved as this is not an AI/machine learning device.

9. How the ground truth for the training set was established

Not Applicable. No training set is involved.

Summary based on the provided text:

This 510(k) summary for the TOKUYAMA TISSUECARE denture relining, repairing, or rebasing resin material kit demonstrates substantial equivalence to predicate devices based on:

Technological Characteristics: Main components are powder (polyalkyl methacrylate, amorphous silica), liquid (polyalkyl acrylate plasticizer, ethanol), and adhesive (polyalkyl methacrylate, ethyl acetate).
Performance: "The efficacy of the device has been shown to be substantially equivalent pursuant to ISO10139-1:1991." It also notes that "all ingredients used... are biocompatible."
Predicate Device: Austenal's "Myerson's Permasoft Soft Reline Material" (K#933468).

The submission argues that "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." This implies that the performance characteristics, as measured by ISO10139-1:1991 and biocompatibility, were within an acceptable range to be considered substantially equivalent to the predicate.

Summary

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

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 (202) 783-5070 Phone: Facsimile: (202) 783-2331

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

Intended Use

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.

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

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.

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

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 (240) 276-0115. 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 (800) 638-2041 or (240) 276-3150 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

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

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

Page 1 of 1

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

510(k) Number: K081554

Regulation Number and Section

§ 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.