(87 days)
The product is a denture relining resin material for use in relining the tissue contact sur ace cf dentures (21 CFR 872.3760). For use as a denture reliner.
The product is a denture relining resin material for use in relining the tissue contact sur ace cf dentures (21 CFR 872.3760)
The provided text is related to a 510(k) submission for a denture relining resin material, Tokuyama SOFRELINER TOUGH. It primarily focuses on the regulatory approval process, stating that the device is substantially equivalent to existing predicate devices.
The document does NOT contain information regarding:
- Specific acceptance criteria for device performance (e.g., tensile strength, tear resistance, bonding strength, hardness, water absorption).
- Details of any study that proves the device meets specific acceptance criteria.
- Sample sizes used for test sets or training sets.
- Data provenance.
- Number or qualifications of experts.
- Adjudication methods.
- Multi-reader multi-case (MRMC) comparative effectiveness studies.
- Standalone algorithm performance.
- Type of ground truth used.
- How ground truth for the training set was established.
Therefore, I cannot fulfill your request to describe acceptance criteria and study details with the provided input.
The document states: "It contains materials that are common in dental use and pose no health hazard when used according to directions. It is substantially equivalent to various marketed denture relining products..." This implies that the device's performance characteristics are expected to be similar to legally marketed predicate devices, but the text does not present the specific data or studies to demonstrate this.
To answer your request, you would need a different document, likely a performance testing report or a clinical trial summary, which is not present in the provided 510(k) summary and FDA letter.
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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: 202-261-1000 202-887-0336 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 (301) 594-4613. 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 (800) 638-2041 or (301) 443-6597 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
§ 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.