TRINIA

{0}------------------------------------------------ # MAR 1 4 2014 K133608 # 510(k) Summary [As Required By 21 CFR 807.92] ### General Information [21 CFR 807.92 (a)(1)] Submitter Name/Address: . Bicon, LLC 501 Arborway Boston, MA 02130 USA Main Phone: 1-800-882-4266 Fax: 1-800-282-4266 December 18, 2013 Date: Contact Person: Richard Wu Quality Assurance and Regulatory Affairs Manager Phone: 617-524-4443 x251 Fax: 617-390-0047 Email: rwu@bicon.com #### Device Name [2] CFR Part 807.92 (a)(2)] The device falls within the scope of the Guidance Document "Dental Composite Resin Devices -Premarket Notification [510(k)] Submissions'' issued on October 26, 2005 fitting in the following: | Trade<br>Name | Common Name | Device | Classification | Class | Product<br>Code | |---------------|----------------------------|-------------------------------|-----------------|-------|-----------------| | TRINIA | Dental CAD/CAM<br>Material | Tooth Shade<br>Resin Material | 21 CFR 872.3690 | II | EBF | #### Predicate Devices [21 CFR 807.92 (a)(3)] | Annual program annual possible and<br>CARDER PARTIC PARTY CONTRACT CARD<br>Device Name | | Manufacturer 510(k) # Date Cleared = | |----------------------------------------------------------------------------------------|------------------------------------------------------------------------|----------------------------------------| | ' Fiber Disk and Block Permanent | Bioloren S.r.l.<br>на про дости пода полития полности в с можно и всем | K121735 February 21, 2013 | #### Description of the device [21 CFR 807.92 (a)(4)] TRINIA is a fiber machining disk block. It is made of layers of glass fibers kept together by epoxy resin. TRINIA products are designed for the manufacturing of non-metallic dental appliances. The dental appliance is machined either by a CAD/CAM machine or by using the copying technique. TRINIA already possesses the mechanical characteristics needed for producing these dental appliances; no curing is necessary at the dental lab to make the product function properly. #### Intended use [21 CFR 807.92 (a)(5)] Fiber Disks and Blocks (TRINIA) are intended to be used for making copings, substructures, removable dentures, or frameworks for permanent and transitional anterior or posterior crowns, bridgework, and substructures that can be for either cemented restorations (e.g. telescopic restorations). (The Summary of technological characteristics is formatted in landscape orientation for ease of reading.) {1}------------------------------------------------ 510(k) Summary Summary of technological characteristics (2) CFR 807.22 (2016). All TRINA are substantially equivalent to the The intended use and critical specifications (flexural formanent | Descriptive Info | | Bicon TRINIA (New Device) | Bioloren Fiber Disk and Block Permanent (Predicate) | | | |---------------------------------------------------------------------------------------------------------------------|--|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------|--------------------| | Intended Use –<br>including the<br>indications for use | | Fiber Disks and Blocks (TRINIA) are milling blanks composed of a<br>multi-directional interlacing of fiberglass and resin in several layers.<br>They are intended to be used solely by dental technicians and dentists<br>for making copings, substructures, removable dentures, or<br>frameworks for permanent and transitional anterior or posterior<br>crowns, bridgework, and substructures that can be for either<br>cemented or uncemented restorations (e.g. telescopic restorations). | Fiber Disks and Blocks are milling blanks composed of a multi-<br>directional interlacing of fiberglass and resin in several layers. They<br>are intended to be used solely by dental technicians and dentists for<br>making only copings, substructures, or frameworks for permanent<br>and transitional anterior or posterior crowns, bridgework, and<br>substructures that can be for either cemented or uncemented<br>restorations e.g., telescopic restorations. | | | | Composition of<br>Materials – the<br>chemical composition<br>of the device | | Glass fiber<br>Modified epoxy resin | Glass fiber<br>Modified epoxy resin | | | | Physical Properties<br>- e.g., compressive<br>strength, flexural<br>strength, particle size<br>range, depth of cure | | Flexural strength | $393 MPa (N/mm^2)$ | *Flexural strength | $302 MPa (N/mm^2)$ | | | | Flexural strain at max stress | 2.7% | *Flexural strain at max stress | 5.5% | | | | Flexural modulus of elasticity | 18.8 GPa | *Flexural modulus of elasticity | 12.6 Gpa | | | | Tensile strength | $169 MPa (N/mm^2)$ | Tensile strength | -- | | | | Tensile modulus of elasticity | 18.8 Gpa | Tensile modulus of elasticity | -- | | | | Compression strength<br>Parallel to laminate | $347 MPa (N/mm^2)$ | Compression strength<br>Parallel to laminate | -- | | | | Compression strength<br>Perpendicular to laminate | $339 MPa (N/mm^2)$ | Compression strength<br>Perpendicular to laminate | -- | | | | Charpy impact | $26 KJ/m^2$ | Charpy impact | -- | | | | Rockwell hardness (R scale) | 125 | Rockwell hardness (R scale) | -- | | | | Barcol hardness | 63 | Barcol hardness | -- | | | | Shore hardness | 92.5 | Shore hardness | -- | | | | Density / Specific gravity | $1.68 g/cm^3$ | Density / Specific gravity | -- | | | | Water absorption | 0.03% | Water absorption | -- | | | | Short beam shear | $49 N/mm^2$ | Short beam shear | -- | | FDA-Recognized<br>Standards | | ISO 10993-3 | Non-mutagenic | ISO 10993-3 | -- | | | | ISO 10993-5 | Does not induce cytotoxicity | ISO 10993-5 | -- | | | | ISO 10993-10 | Non-irritant | ISO 10993-10 | -- | | | | ISO 10993-11 | No adverse physical symptoms<br>after injection | ISO 10993-11 | -- | RESEARCH METHODOLOGY {2}------------------------------------------------ #### Identification of the risk analysis method Bicon has conducted a preliminary hazard analysis which identified risks, including risk of mechanical failure. toxicity and adverse tissue reaction, improper use, and incompaibility with other dental devices. The Failure Modes Effect Analysis (FMEA) showed that all risks, when reduced as far as possible, were acceptable. There were no risks that were so severe as to cause severe damage or lead to the death of a patient. The mechanical properties of the device are comparable to predicate The biocompatibility testing of the composite resin device showed that TRINIA is devices. biocompatible. The labeling of the device was designed to alert the user of any residual risks or warnings. #### Discussion of the device characteristics To reduce the risk of mechanical failure, TRINIA was designed to have a high compressive and flexural strength to withstand the chewing forces. In order to achieve this, the materials and the weave of the fabric were essential to the design; a weave that was too tight could result in the device not able to be cut with standard milling tools, while a weave that was too loose might result in a weaker compressive and flexural strength. In addition, the device was designed to be insoluble to water which is of importance in the oral cavity. This characteristic prevents breakdown of the device as well as preventing the device from entering the patient's body in a manner not intended by the manufacturer. A third characteristic that reduces the risk of mechanical failure of TRINIA is that the operator of the device does not need to perform any additional steps to make TRINIA function at the mechanical specifications. There are no curing steps needed; only milling of the dental appliance is required. This prevents improper fabrication due to varying curing or working times. The possibility of varying depth of cure is also avoided. To reduce the risk of toxicity and adverse tissue reaction, TRINIA was tested against biocompatibility standards as specified by ISO 7405:2008, Dentistry - Evaluation of biocompatibility of medical devices used in dentistry. TRINIA is made out of materials that are not deadly in the health hazard rating and cause no cytotoxic effects. To reduce the risk of improper use, TRINIA was designed to have the fewest steps possible for the user. As stated earlier to reduce the risk of mechanical failure, there are no curing steps required. This reduces the possibility of the user performing the curing incorrectly, as there are no curing steps. The working time for TRINIA is therefore extended and the user does not need to rush to finish the dental appliance. #### Description of the performance aspects (21 CFR 807.92 (b)(1)(2)) The testing of the performance aspects was performed to recognized standards, such as ASTM or ISO. The following table lists the test and the test method used to obtain the actual result shown. | Test Name | Standard | Units | Result | |--------------------------------|------------|-------------|--------| | Flexural strength | ISO 14125 | MPa (N/mm²) | 393 | | Flexural modulus of elasticity | ISO 14125 | Gpa | 18.8 | | Tensile strength | ASTM D3039 | MPa (N/mm²) | 169 | | Tensile modulus of elasticity | ASTM D3039 | Gpa | 18.8 | | Compression strength | ASTM D6641 | MPa (N/mm²) | 347 | | Charpy impact | ISO 179 | KJ/m² | 26 | Physical Properties {3}------------------------------------------------ | Test Name | Standard | Units | Result | |-----------------------------|------------|-------|--------| | Rockwell hardness (R scale) | ISO 2039-2 | -- | 125 | | Barcol hardness | ASTM D2583 | -- | 63 | | Shore hardness | ASTM D2240 | -- | 92.5 | | Density / Specific gravity | ISO 1183 | g/cm³ | 1.68 | | Water absorption | ASTM D570 | % | 0.03 | | Short beam shear | ASTM D2344 | N/mm² | 49 | #### Biocompatibility | Test Name | Standard | Criteria | Result | |-----------------------------------------|--------------|---------------|---------------| | Genotoxicity | ISO 10993-3 | Non-mutagenic | Non-mutagenic | | Cytotoxicity | ISO 10993-5 | Non-cytotoxic | Non-cytotoxic | | Irritation or Intracutaneous Reactivity | ISO 10993-10 | Non-irritant | Non-irritant | | Acute Systemic Toxicity | ISO 10993-11 | Non-toxic | Non-toxic | * NS = Not Specified Clinical testing is not required to demonstrate substantial equivalence as the indications for use is similar to legally marketed devices, the design is similar to designs previously cleared under a premarket notification, and the technology used in TRINIA is not a new technology. #### Reliance on standards Testing has been performed to the standards listed in the "Description of the performance aspects" section. A FDA Form 3654 has been completed for each of the standards listed in this 510(k). There were no deviations to the procedure of the standard for the tests performed. #### Conclusion TRINIA is substantially equivalent in safety and effectiveness to the predicate device based on the results of the physical property and biocompatibility testing. There are no substantive differences in the indications for use or technology, including features, materials, and principals of operations, from the predicate device. Tim Schuler (Signature) (Signature) Richard Wu (Typed Name) December 18, 2013 (Date) K133608 (Premarket Notification [510(k)] Number {4}------------------------------------------------ DEPARTMENT OF HEALTH & HUMAN SERVICES Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with its wings spread, symbolizing protection and service. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circular pattern around the eagle. The logo is simple, using only black and white. Food and Drug Administration 10903 New Hamnshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 March 14. 2014 Bicon, LLC Richard Wu 501 Arborway Boston, MA 02130 Re: K133608 Trade/Device Name: TRINIA Regulation Number: 21 CFR 872.3690 Regulation Name: Tooth Shade Resin Material Regulatory Class: II Product Codes: EBF, EBG, EBI Dated: December 18, 2013 Received: December 20, 2013 Dear Mr. Wu: 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. {5}------------------------------------------------ Page 2 - Mr. Wu 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 contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Sincerely vours, ... # Erin I. Keith -S Erin I. Keith, M.S. Acting Division Director Division of Anesthesiology, General Hospital, Respiratory. Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {6}------------------------------------------------ DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration #### Indications for Use 510(k) Number (if known) ## Device Name Fiber Disks and Blocks (TRINIA) #### Indications for Use (Describe) Fiber Disks and Blocks (TRINIA) are milling blanks composed of a multi-directional interlacing of fiberglass and resin in several layers. They are intended to be used solely by dental technicians and denists for making copings, substructures, or frameworks for permanent and transitional anterior or posterior crowns, bridgework, and substructures that can be for either cemented or uncemented restorations (e.g. telescopic restorations). Type of Use (Select one or both, as applicable) 🇿 Prescription Use (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 801 Subpart C) #### PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED. #### FOR FDA USE ONLY Concurrence of Center for Devices and Radiological Health (CDRH) (Signalure) Mary S. 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