(66 days)
Not Found
No
The summary describes a thermoplastic resin for fabricating dental prosthetics and splints. There is no mention of AI, ML, image processing, or any computational analysis of data. The performance studies focus on material properties and biocompatibility.
No
The device is a thermoplastic resin used to fabricate dental prosthetics, which are considered mechanical devices for restoring dental function rather than therapeutic devices for treating or preventing disease.
No
The device is a thermoplastic resin used for fabricating dental prosthetic appliances, not for diagnosing medical conditions. Its intended use is for "fabrication of partial or full removable dentures, as well as occlusal splints and night guards," which are treatment devices.
No
The device is a thermoplastic resin, which is a physical material used for fabrication, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for fabricating removable dental prosthetic appliances (dentures, splints, night guards). This is a structural and mechanical application within the mouth.
- Device Description: The device is a thermoplastic resin used for molding these dental appliances.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or treatment.
IVD devices are used outside the body to analyze biological samples. This device is used to create a physical structure that goes inside the body.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
EBI, MQC
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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
- Delayed-type hypersensitivity (sensitization): Magnusson-Klingman Method per ISO 10993-10:2010
- Irritation: Intracutaneous Toxicity (ISO) per ISO 10993-10:2010
- Genotoxicity: Ames Test per ISO 10993-3:2009
The test results confirm that the i.flex by TCS device is non-cytotoxic, non-sensitizing, non-irritating and non-mutagenic.
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.
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
0
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.
· ={",{",
1
Image /page/1/Picture/0 description: The image shows the logo for TCS, which stands for Tata Consultancy Services. The logo consists of the letters "tcs" in a bold, sans-serif font, followed by a stylized graphic element. The graphic element appears to be a curved line with a textured or dotted pattern, possibly representing a brushstroke or abstract design.
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
-
- Delayed-type hypersensitivity (sensitization): Magnusson-Klingman Method per ISO 10993-10:2010
-
- Irritation: Intracutaneous Toxicity (ISO) per ISO 10993-10:2010
-
- 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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2
Image /page/2/Picture/5 description: The image shows the logo for TCS, which stands for Tata Consultancy Services. The logo consists of the lowercase letters "tcs" in a bold, sans-serif font. To the right of the letters, there is a stylized graphic element that resembles a curved line or brushstroke, with a textured or dotted pattern at its end. The overall design is simple and modern.
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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3
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.
4
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
5
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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