Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The device description and performance studies focus on the material properties and mechanical performance of the milling blanks, with no mention of AI or ML technology.

Therapeutic

No
This device is a material (fiber disks and blocks) used to manufacture dental appliances, not a therapeutic device itself.

Diagnostic

No

The device is described as "milling blanks composed of a multi-directional interlacing of fiberglass and resin" used for making dental appliances like copings, substructures, or frameworks, not for diagnosing a condition.

SaMD (Software as a Medical Device)

No

The device description clearly states it is a "fiber machining disk block" made of "layers of glass fibers kept together by epoxy resin," indicating it is a physical material, not software. The performance studies also focus on material properties and biocompatibility, further confirming it is a hardware device.

IVD (In Vitro Diagnostic)

No, this device is not an IVD (In Vitro Diagnostic).

Here's why:

IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
Device Function: The description clearly states that TRINIA is a material used to manufacture dental appliances (copings, substructures, dentures, frameworks). It is a milling blank that is shaped and used to create physical dental restorations.
Intended Use: The intended use is for making dental prosthetics that are placed in the mouth, not for analyzing biological samples.
Testing Performed: The performance testing focuses on the material properties (strength, hardness, etc.) and biocompatibility, which are relevant for a dental material, not for diagnostic accuracy.

The device is a dental material used for fabrication, not for diagnostic testing of biological samples.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

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).
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).

Product codes (comma separated list FDA assigned to the subject device)

EBF, EBG, EBI

Device Description

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.

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

Dental technicians and dentists

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)

The testing of the performance aspects was performed to recognized standards, such as ASTM or ISO.
Physical Property Testing:
Flexural strength: 393 MPa (N/mm²) (ISO 14125)
Flexural modulus of elasticity: 18.8 Gpa (ISO 14125)
Tensile strength: 169 MPa (N/mm²) (ASTM D3039)
Tensile modulus of elasticity: 18.8 Gpa (ASTM D3039)
Compression strength: 347 MPa (N/mm²) (ASTM D6641)
Charpy impact: 26 KJ/m² (ISO 179)
Rockwell hardness (R scale): 125 (ISO 2039-2)
Barcol hardness: 63 (ASTM D2583)
Shore hardness: 92.5 (ASTM D2240)
Density / Specific gravity: 1.68 g/cm³ (ISO 1183)
Water absorption: 0.03% (ASTM D570)
Short beam shear: 49 N/mm² (ASTM D2344)

Biocompatibility Testing:
Genotoxicity: Non-mutagenic (ISO 10993-3)
Cytotoxicity: Non-cytotoxic (ISO 10993-5)
Irritation or Intracutaneous Reactivity: Non-irritant (ISO 10993-10)
Acute Systemic Toxicity: Non-toxic (ISO 10993-11)

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.

K121735

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

Regulation Number and Section

§ 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.

Summary

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
Name | Common Name | Device | Classification | Class | Product
Code |
|---------------|----------------------------|-------------------------------|-----------------|-------|-----------------|
| TRINIA | Dental CAD/CAM
Material | Tooth Shade
Resin Material | 21 CFR 872.3690 | II | EBF |

Predicate Devices [21 CFR 807.92 (a)(3)]

| Annual program annual possible and
CARDER PARTIC PARTY CONTRACT CARD

Device 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.)

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)
Intended Use –
including the
indications for use		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).	Fiber Disks and Blocks 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 only 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.
Composition of
Materials – the
chemical composition
of the device		Glass fiber
Modified epoxy resin	Glass fiber
Modified epoxy resin
Physical Properties

e.g., compressive
strength, flexural
strength, particle size
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
Parallel to laminate | $347 MPa (N/mm^2)$ | Compression strength
Parallel to laminate | -- |
| | | Compression strength
Perpendicular to laminate | $339 MPa (N/mm^2)$ | Compression strength
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
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
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. 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.

7

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