(109 days)
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 dentists 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 or uncemented restorations (e.g. telescopic restorations).
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.
Here's an analysis of the provided text regarding the acceptance criteria and study for the TRINIA dental device:
1. Table of Acceptance Criteria and Reported Device Performance:
The document establishes acceptance criteria by demonstrating that TRINIA's physical properties and biocompatibility are comparable to or exceed those of the predicate device. For some tests, direct comparison to the predicate is available, while for others, the "acceptance criteria" can be inferred to be the reported result itself, as these values demonstrate the device's inherent mechanical and biological characteristics, which are deemed acceptable.
| Test Name | Acceptance Criteria (Predicate or Implicit) | Reported Device Performance (TRINIA) | Units |
|---|---|---|---|
| Flexural strength | ≥ 302 MPa (Predicate) | 393 | MPa (N/mm²) |
| Flexural strain at max stress | < 5.5% (Predicate - lower is better) | 2.7 | % |
| Flexural modulus of elasticity | ≥ 12.6 GPa (Predicate) | 18.8 | GPa |
| Tensile strength | Not Specified (Implicit: acceptable value) | 169 | MPa (N/mm²) |
| Tensile modulus of elasticity | Not Specified (Implicit: acceptable value) | 18.8 | GPa |
| Compression strength | Not Specified (Implicit: acceptable value) | 347 | MPa (N/mm²) |
| Charpy impact | Not Specified (Implicit: acceptable value) | 26 | KJ/m² |
| Rockwell hardness (R scale) | Not Specified (Implicit: acceptable value) | 125 | |
| Barcol hardness | Not Specified (Implicit: acceptable value) | 63 | |
| Shore hardness | Not Specified (Implicit: acceptable value) | 92.5 | |
| Density / Specific gravity | Not Specified (Implicit: acceptable value) | 1.68 | g/cm³ |
| Water absorption | Not Specified (Implicit: acceptable value) | 0.03 | % |
| Short beam shear | Not Specified (Implicit: acceptable value) | 49 | N/mm² |
| Biocompatibility | |||
| Genotoxicity | Non-mutagenic (Standard) | Non-mutagenic | |
| Cytotoxicity | Non-cytotoxic (Standard) | Non-cytotoxic | |
| Irritation/Reactivity | Non-irritant (Standard) | Non-irritant | |
| Acute Systemic Toxicity | Non-toxic (Standard) | Non-toxic |
2. Sample Size Used for the Test Set and Data Provenance:
The document does not explicitly state the sample sizes used for each physical property test. It mentions that "Testing has been performed to the standards listed in the 'Description of the performance aspects' section." These standards (e.g., ISO 14125, ASTM D3039) typically prescribe specific sample sizes for their respective tests. Without direct access to the full test reports, the exact sample sizes are not known from this summary.
The data provenance is not explicitly stated in terms of country of origin but is implied to be from internal testing conducted by Bicon, LLC (USA-based company). The testing is retrospective, presenting results of already completed tests.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
This information is not applicable to this type of device and study. The "ground truth" for material properties is established by the standardized testing methods themselves, which produce objective, measurable results, not by expert consensus or interpretation in the same way clinical diagnostic studies do.
4. Adjudication Method for the Test Set:
This is not applicable. As the testing involves objective measurement of physical and chemical properties according to established standards, there is no need for an adjudication method by experts.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic imaging or interpretation tasks where human readers' performance is being evaluated and compared, often with and without AI assistance. This device is a dental material, not a diagnostic tool requiring human interpretation.
6. Standalone (Algorithm Only) Performance:
No, a standalone (algorithm only) performance study was not done. This concept is also not applicable to a physical dental material. The "performance" here refers to the material's physical and biological properties, not an algorithm's output.
7. Type of Ground Truth Used:
The "ground truth" for this device's evaluation is primarily based on objective, quantitative measurements obtained via recognized international and national standards (ISO, ASTM) for physical properties and biocompatibility testing criteria (ISO 10993 series). The values obtained from these tests serve as the "ground truth" against which the device's performance is assessed.
8. Sample Size for the Training Set:
This information is not applicable. This is a physical material, not an AI/ML algorithm that requires a "training set" in the conventional sense. The "development" or "design" of the material might involve experimentation and iteration, but this is distinct from an algorithm training process.
9. How the Ground Truth for the Training Set Was Established:
This information is not applicable for the same reasons as point 8.
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MAR 1 4 2014
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:
| TradeName | Common Name | Device | Classification | Class | ProductCode |
|---|---|---|---|---|---|
| TRINIA | Dental CAD/CAMMaterial | Tooth ShadeResin Material | 21 CFR 872.3690 | II | EBF |
Predicate Devices [21 CFR 807.92 (a)(3)]
| Annual program annual possible andCARDER PARTIC PARTY CONTRACT CARDDevice Name | Manufacturer 510(k) # Date Cleared = | |
|---|---|---|
| ' Fiber Disk and Block Permanent | Bioloren S.r.l.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.)
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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 –including theindications for use | Fiber Disks and Blocks (TRINIA) are milling blanks composed of amulti-directional interlacing of fiberglass and resin in several layers.They are intended to be used solely by dental technicians and dentistsfor making copings, substructures, removable dentures, orframeworks for permanent and transitional anterior or posteriorcrowns, bridgework, and substructures that can be for eithercemented or uncemented restorations (e.g. telescopic restorations). | Fiber Disks and Blocks are milling blanks composed of a multi-directional interlacing of fiberglass and resin in several layers. Theyare intended to be used solely by dental technicians and dentists formaking only copings, substructures, or frameworks for permanentand transitional anterior or posterior crowns, bridgework, andsubstructures that can be for either cemented or uncementedrestorations e.g., telescopic restorations. | |||
| Composition ofMaterials – thechemical compositionof the device | Glass fiberModified epoxy resin | Glass fiberModified epoxy resin | |||
| Physical Properties- e.g., compressivestrength, flexuralstrength, particle sizerange, 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 strengthParallel to laminate | $347 MPa (N/mm^2)$ | Compression strengthParallel to laminate | -- | ||
| Compression strengthPerpendicular to laminate | $339 MPa (N/mm^2)$ | Compression strengthPerpendicular 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-RecognizedStandards | 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 symptomsafter injection | ISO 10993-11 | -- |
RESEARCH METHODOLOGY
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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
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| 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)
(Premarket Notification [510(k)] Number
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DEPARTMENT OF HEALTH & HUMAN SERVICES
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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.
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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
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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. Runner -S - - 05.04 2014.03.14 15:02:04 -04'00' Form Approved: OMB No. 0910-0120 Expiration Date: December 31, 2013 See PRA Statement on last page.
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§ 872.3690 Tooth shade resin material.
(a)
Identification. Tooth shade resin material is a device composed of materials such as bisphenol-A glycidyl methacrylate (Bis-GMA) intended to restore carious lesions or structural defects in teeth.(b)
Classification. Class II.