(66 days)
i.flex by TCS is a thermoplastic resin used for the fabrication of partial or full removable dentures, as well as occlusal splints and night guards.
i.flex by TCS is an injection moldable, flexible, thermoplastic resin provided with trace amounts of colorant added to produce shades of pink. The dental resin is packaged in individual use cartridges or in bulk. i.flex by TCS is used for fabricating removable dental prosthetic appliances such as full and partial dentures, occlusal splints and night guards.
The provided text describes a 510(k) summary for the i.flex by TCS dental resin, which is a thermoplastic resin used for fabricating removable dental prosthetic appliances. The document focuses on demonstrating the substantial equivalence of the i.flex by TCS device to a predicate device (DuraFlex K063626) by comparing their intended use, technology, and performance specifications.
Here's an analysis of the acceptance criteria and study information:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Test/Standard | Acceptance Criteria | Reported Device Performance |
|---|---|---|---|
| Biocompatibility | Cytotoxicity (Agar overlay) | Non-cytotoxic | Confirmed non-cytotoxic |
| Cytotoxicity (MEM elution) | Non-cytotoxic | Confirmed non-cytotoxic | |
| Delayed-type hypersensitivity (sensitization) | Non-sensitizing | Confirmed non-sensitizing | |
| Irritation (Intracutaneous Toxicity) | Non-irritating | Confirmed non-irritating | |
| Genotoxicity (Ames Test) | Non-mutagenic | Confirmed non-mutagenic | |
| Performance to Recognized Standards | ANSI/ADA Spec. No. 12:2002/ISO 1567:1999 (Denture Base Polymers) | Meets criteria specified in standard or for predicate device | Meets performance criteria |
| ANSI/ADA Spec. No. 80:2001/ISO 7491:2000 (Dental Materials - Determination of Color Stability) | Meets criteria specified in standard or for predicate device | Meets performance criteria |
2. Sample Sizes and Data Provenance
The document does not specify sample sizes used for the test set or the data provenance (country of origin, retrospective/prospective) for the biocompatibility or performance testing. It generally states that "testing of the i.flex by TCS material was conducted" and "The i.flex by TCS device was tested."
3. Number of Experts and Qualifications for Ground Truth
This information is not provided in the document. The studies conducted are laboratory-based tests comparing material properties to recognized standards, rather than clinical studies requiring expert interpretation of results for ground truth.
4. Adjudication Method
This information is not applicable for the type of testing described (biocompatibility and performance to standards). No human interpretation or adjudication of an "image" or "case" is mentioned.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No, an MRMC comparative effectiveness study was not conducted. This type of study is typically for evaluating the diagnostic performance of AI algorithms in conjunction with human readers, which is not relevant to the material property testing presented here.
6. Standalone (Algorithm Only) Performance Study
No, a standalone performance study in the context of an algorithm's performance was not conducted. The performance testing refers to the physical and chemical properties of the dental resin itself, not a computational algorithm.
7. Type of Ground Truth Used
The ground truth used for performance testing was based on:
- Recognized consensus standards: Specifically, ANSI/ADA Specification No. 12:2002/ISO 1567:1999 for Denture Base Polymers and ANSI/ADA Specification No. 80:2001/ISO 7491:2000 for Dental Materials - Determination of Color Stability.
- Predicate device performance: The i.flex by TCS was shown to meet the performance criteria established by these standards or to be comparable to the predicate device, DuraFlex (K063626).
- ISO standards for biocompatibility: ISO 10993-5:2009 for Cytotoxicity, ISO 10993-10:2010 for Hypersensitivity and Irritation, and ISO 10993-3:2009 for Genotoxicity.
8. Sample Size for the Training Set
This information is not applicable as the document describes material property testing, not an AI algorithm requiring a training set.
9. How Ground Truth for the Training Set Was Established
This information is not applicable for the same reason as point 8.
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Section 5.0: 510(k) Summary
JAN 1 0 2013
This 510(k) summary of safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.
Manufacturer
Address
Telephone Fax Number Contact at TCS Thermoplastic Comfort Systems, Inc. 2619 Lime Avenue Signal Hill, CA 90755 562-426-2970 562-426-5154 Marilin Posca President marilin@tcsdentalinc.com
Device Name and Classification
Trade name/Product Name Common/Üsual Name Classification Name
Classification Panel Product Code Regulation Number Class
i.flex by TCS Dental resin Resin, Denture, Relining, Repairing, Rebasing
Dental EBI 21 CFR 872.3760 =
Predicate Device
Manufacturer
Device Name 510(k) Number Cosmetic Dental Materials, Inc. (The Myerson Company, Ltd.) DuraFlex K063626
Device Description
i.flex by TCS is an injection moldable, flexible, thermoplastic resin provided with trace amounts of colorant added to produce shades of pink. The dental resin is packaged in individual use cartridges or in bulk.
i.flex by TCS is used for fabricating removable dental prosthetic appliances such as full and partial dentures, occlusal splints and night guards.
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Indications for Use
i.flex by TCS is a thermoplastic resin used for the fabrication of partial or full removable dentures, as well as occlusal splints and night quards.
Substantial Equivalence
The i.flex by TCS device is substantially equivalent to the DuraFlex dental resin (K063626).
The claim of substantial equivalence for the i.flex by TCS is based on intended use. technology and performance specifications. Both the i.flex by TCS and the predicate device are composed of a thermoplastic, ethylene propylene copolymer identified by its CAS registration number 9010-79-1. Both devices are supplied in a natural or clear state as well as in shades of pink. Both materials are supplied in cartridges which are heated to allow for the injection molding of the resin for the fabrication of dental prostheses.
Biocompatibility
Biocompatibility testing of the i.flex by TCS material was conducted in accordance with ISO standards to demonstrate the safety of the device.
The following biocompatibility tests were conducted:
-
- Cytotoxicity: Agar overlay per ISO 10993-5:2009
-
- Cytotoxicity: MEM elution per ISO 10993-5:2009
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- Delayed-type hypersensitivity (sensitization): Magnusson-Klingman Method per ISO 10993-10:2010
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- Irritation: Intracutaneous Toxicity (ISO) per ISO 10993-10:2010
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- Genotoxicity: Ames Test per ISO 10993-3:2009
The test results confirm that the i.flex by TCS device is non-cytotoxic, non-sensitizing, nonirritating and non-mutagenic.
Performance Testing to Recognized Standards
The i.flex by TCS device was tested to the applicable clauses of the recognized consensus standards for dental materials listed below.
-
- ANSI/ADA Specification No. 12:2002/ISO 1567:1999 Denture Base Polymers
-
- ANSI/ADA Specification No. 80:2001/ISO 7491:2000 Dental Materials -Determination of Color Stability
The study results demonstrate that the i.flex by TCS meets the performance criteria specified in the recognized standards cited or for the performance of the predicate device, DuraFlex, confirming the substantial equivalence of the i.flex by TCS to the predicate device.
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Summary of Performance Testing – Conclusion
The results of all testing demonstrate that the i.flex by TCS device does not raise any new significant issues of safety, effectiveness or performance of the device when compared to the existing predicate device.
Thermoplastic Comfort Systems 510(k) for i.flex by TCS
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with its wings spread, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular pattern around the eagle. The eagle is depicted in a simple, black and white design. The text is also in black and white and is written in all capital letters.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002
January 10, 2013
Ms. Marilin Posca President Thermoplastic Comfort Systems, Incorporated 2619 Lime Avenue SIGNAL HILL CA 90755
Re: K123396
Trade/Device Name: I.Flex by TCS Regulation Number: 21 CFR 872.3760 Regulation Name: Denture Relining, Repairing, or Rebasing Resin Regulatory Class: II Product Codes: EBI, MQC Dated: November 2, 2012 Received: November 5, 2012
Dear Ms. Posca:
We have reviewed vour 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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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 devicerelated 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/ReportalProblem/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.goy/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Kwame O. Ulmer
Anthony D. Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Image /page/5/Picture/0 description: The image shows the logo for TCS, which is a company that provides IT services, consulting, and business solutions. The logo is black and white and features the letters "tcs" in a sans-serif font. To the right of the letters is a stylized graphic that resembles a brush stroke or a burst of energy. The logo is simple and modern, and it is easily recognizable.
510(k) Number (if known):
Device Name:
i.flex by TCS
K-123396
Indications For Use:
i.flex by TCS is a thermoplastic resin used for the fabrication of partial or full removable dentures, as well as occlusal splints and night guards.
Prescription Use × (Part 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)
2013.01.09 Susan Runner DDS, MA 14:27:21 - 05'00'
(Division Sign-Off) (Division of Anesthesloiogy, General Hospital Infection Control, Dental Devices
K123396 510(k) Number;
Thermoplastic Comfort Systems 510(k) for i.flex by TCS
CONFIDENTIAL
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§ 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.