(65 days)
The SOFRELINER TOUGH S denture relining, repairing, or rebasing resin device is for use as a denture reliner.
The SOFRELINER TOUGH S denture relining, repairing, or rebasing resin device is a prescription addition-cured silicone chairside soft lining material for removable dentures. It is indicated for use as a denture reliner.
The main components of the SOFRELINER TOUGH S device are:
-
- A paste consisting of a base and catalyst;
- A primer packaged separate used for bonding to the acrylic surfaces; and 2)
- Various accessories, namely a spatula, brush, drip-cap, drip-cup, mixing 3) tip, coarse point, finish wheel, and washer
Nearly all ingredients used in the SOFRELINER TOUGH S denture relining, repairing, or rebasing device are either commonly used in similar dental devices or have been subjected to extensive biocompatibility testing. However, the paste of the SOFRELINER TOUGH S does contain one new ingredient and thus toxicity testing was performed, namely cytotoxicity, sensitization, irritation, subchronic systemic toxicity, and genotoxicity.
The SOFRELINER TOUGH S denture relining, repairing, or rebasing resin device does not come sterilized and is not intended to be sterilized prior to use.
The provided text describes the 510(k) summary for the Tokuyama Dental Corporation's SOFRELINER TOUGH S Denture Relining, Repairing, or Rebasing Resin Device. Below is an analysis of its acceptance criteria and the supporting study, structured according to your request.
1. Table of Acceptance Criteria and Reported Device Performance
The documentation does not explicitly define "acceptance criteria" with specific numerical targets. Instead, it states that the device was tested for various physical properties and compared to predicate devices for substantial equivalence. The "performance" reported is that the device meets the properties of the standards and is considered as safe and effective as the predicates.
| Acceptance Criteria (Implied from standards) | Reported Device Performance |
|---|---|
| Depth of Penetration | Conducted in accordance with ISO 10139-1: 1991 and ISO 10139-2: 1999 |
| Difference between mean depth of penetration at 24 hours and 28 days | Conducted in accordance with ISO 10139-1: 1991 and ISO 10139-2: 1999 |
| Depth of Penetration Ratio "R" | Conducted in accordance with ISO 10139-1: 1991 and ISO 10139-2: 1999 |
| Consistency | Conducted in accordance with ISO 10139-1: 1991 and ISO 10139-2: 1999 |
| 2-hour Penetration | Conducted in accordance with ISO 10139-1: 1991 and ISO 10139-2: 1999 |
| 7-day Penetration | Conducted in accordance with ISO 10139-1: 1991 and ISO 10139-2: 1999 |
| Penetration Ratio | Conducted in accordance with ISO 10139-1: 1991 and ISO 10139-2: 1999 |
| Appearance | Testing conducted (specific results not detailed, but implied to be acceptable for substantial equivalence) |
| Working Time | Testing conducted (specific results not detailed, but implied to be acceptable for substantial equivalence) |
| Setting Time | Testing conducted (specific results not detailed, but implied to be acceptable for substantial equivalence) |
| Biocompatibility (cytotoxicity, sensitization, irritation, subchronic systemic toxicity, genotoxicity for new ingredient) | Toxicity testing performed and results deemed acceptable (implied sufficient for substantial equivalence) |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify the exact sample sizes used for the non-clinical physical properties testing or the biocompatibility testing. It only states that these tests "were conducted in accordance with ISO 10139-1: 1991 and ISO 10139-2: 1999" and that toxicity testing "was performed."
The data provenance is from Japan, as the submitter, Tokuyama Dental Corporation, is based in Tokyo, Japan. The study appears to be retrospective as it involves non-clinical testing of a developed product to demonstrate its properties.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not provided in the document. The tests described are primarily physical and chemical property assessments according to international standards (ISO). These types of tests typically rely on standardized methods and laboratory technicians rather than clinical experts establishing "ground truth" in the same way it would be for diagnostic devices.
4. Adjudication Method for the Test Set
This information is not applicable/not provided. The assessment involves laboratory testing against established standards, not interpretation by multiple experts that would require an adjudication method.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was Done
No, a Multi Reader Multi Case (MRMC) comparative effectiveness study was not done. The submission explicitly states: "There were no clinical tests performed for the SOFRELINER TOUGH S device." Therefore, there is no effect size of how much human readers improve with AI vs without AI assistance to report.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done
No, a standalone study was not done. This device is a material for dental use, not a diagnostic algorithm or AI system.
7. The Type of Ground Truth Used
The "ground truth" for the physical properties and biocompatibility testing was based on:
- Adherence to International Standards: ISO 10139-1: 1991 and ISO 10139-2: 1999 for physical properties.
- Established Biocompatibility Testing Protocols: As implied by the common practice for cytotoxicity, sensitization, irritation, subchronic systemic toxicity, and genotoxicity tests.
- Comparison to Predicate Devices: The overall performance and safety were assessed in comparison to legally marketed predicate devices. This implies that the performance of the predicate devices served as a de facto "ground truth" for what constitutes acceptable performance for this type of device.
8. The Sample Size for the Training Set
This information is not applicable/not provided. The device is a material, not an AI or machine learning model that requires a training set.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable/not provided for the same reason as above.
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12112445
510(k) Summary Tokuyama Dental Corporation SOFRELINER TOUGH S Denture Relining, Repairing, Or Rebasing Resin Device
The following information is provided pursuant to 21 CFR 807.92.
807.92(a)(1)
(i) 510(k) Submitter
Tokuyama Dental Corporation 38-9 Taitou 1-chome, Taitou-ku Tokyo 110-0016 Japan Phone: 011-81-3-3835-2261
(ii) 510(k) Submitter Contact
Keith A. Barritt Fish & Richardson P.C. 1425 K Street, N.W., Suite 1100 Washington, DC 20005 Phone: (202) 783-5070 Facsimile: (202) 783-2331 Email: barritt(@fr.com
(iii) Preparation Date
August 3, 2011
807.92(a)(2)
| Trade or Proprietary Name: | SOFRELINER TOUGH S |
|---|---|
| Common Name: | denture relining, repairing, or rebasing resin material |
| Classification Name: | resin, denture, relining, repairing, rebasing |
| Product Code: | EBI |
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807.92(a)(3)
The SOFRELINER TOUGH S device is substantially equivalent for purposes of FDA medical device regulations to multiple predicate devices, namely Tokuyama's own TOKUYAMA SOFRELINER (K#982537), TOKUYAMA SOFRELINER TOUGH (K#030663), and GC America's GC RELINE ULTRA SOFT (K#990736).
807.92(a)(4)
The SOFRELINER TOUGH S denture relining, repairing, or rebasing resin device is a prescription addition-cured silicone chairside soft lining material for removable dentures. It is indicated for use as a denture reliner.
The main components of the SOFRELINER TOUGH S device are:
-
- A paste consisting of a base and catalyst;
- A primer packaged separate used for bonding to the acrylic surfaces; and 2)
- Various accessories, namely a spatula, brush, drip-cap, drip-cup, mixing 3) tip, coarse point, finish wheel, and washer
Nearly all ingredients used in the SOFRELINER TOUGH S denture relining, repairing, or rebasing device are either commonly used in similar dental devices or have been subjected to extensive biocompatibility testing. However, the paste of the SOFRELINER TOUGH S does contain one new ingredient and thus toxicity testing was performed, namely cytotoxicity, sensitization, irritation, subchronic systemic toxicity, and genotoxicity.
The SOFRELINER TOUGH S denture relining, repairing, or rebasing resin device does not come sterilized and is not intended to be sterilized prior to use.
807.92(a)(5)
The SOFRELINER TOUGH S denture relining, repairing, or rebasing resin device is for use as a denture reliner.
807.92(a)(6)
The SOFRELINER TOUGH S device has the same basic technological characteristics in terms of design, material, and chemical composition as the predicate devices identified above. The SOFRELINER TOUGH S device does not have an energy source.
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Specifically, for purposes of design the device has the same basic design and performance characteristics as Tokuyama's own TOKUYAMA SOFRELINER (K#982537). TOKUYAMA SOFRELINER TOUGH (K#030663), and GC America's GC RELINE ULTRA SOFT (K#990736). For purposes of material composition, the device has the same basic properties as TOKUYAMA SOFRELINER TOUGH.
807.92(b)(1)
Non-clinical testing of the physical properties of the SOFRELINER TOUGH S device, including depth of penetration, difference between mean depth of penetration at 24 hours and 28 days, depth of penetration ratio "R", consistency, 2 hour penetration, 7 day penetration, and penetration ratio were conducted in accordance with ISO 10139-1: 1991 and ISO 10139-2: 1999. Other testing included appearance, working time, and setting time.
807.92(b)(2)
There were no clinical tests performed for the SOFRELINER TOUGH S device.
807.92(b)(3)
Based on the non-clinical testing conducted of the physical properties of the SOFRELINER TOUGH S device and the material composition review in comparison to the predicate devices and biocompatibility testing as described above, it is concluded that the SOFRELINER TOUGH S device is as safe, as effective, and performs as well as or better than the predicate devices.
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Image /page/3/Picture/0 description: The image contains a partial view of a logo on the left and the word "DEPARTMENT" on the right. The logo includes the words "HUMAN SERVICES - USA" arranged in a circular pattern around a stylized graphic. Below the word "DEPARTMENT" is a horizontal line.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
OCT 2 8 2011
Tokuyama Dental Corporation C/O Mr. Keith A. Barritt, Esq. Fish & Richardson P.C. 1425 K Street, N.W., Suite 1100 Washington, DC 20005
Re: K112445
Trade/Device Name: Sofreliner Tough S Regulation Number: 21 CFR 872.3760 Regulation Name: Denture Relining, Repairing, or Rebasing Resin Regulatory Class: II Product Codes: EBI Dated: August 12, 2011 Received: August 24, 2011
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. 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.
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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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.
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 (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely vours.
Nh 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
Enclosure
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Indications for Use
K112445 510(k) Number (if known): uńknown
Device Name: SOFRELINER TOUGH S
Indications for Use:
The SOFRELINER TOUGH S denture relining, repairing, or rebasing resin device is for use as a denture reliner.
Prescription Use X (21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
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PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED
Concurrence of CDRH, Office of Device Evaluation (ODE)
Susan Kumar
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
Page 1 of 1
510(k) Number: K112445
40743046.doc
§ 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.