Trilor Disks, Blocks and Arches

K173643 · Bioloren S.R.L. · EBF · Feb 24, 2018 · Dental

Device Facts

• Record ID: K173643
• Device Name: Trilor Disks, Blocks and Arches
• Applicant: Bioloren S.R.L.
• Product Code: EBF · Dental
• Decision Date: Feb 24, 2018
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 872.3690
• Device Class: Class 2

Intended Use

Trilor Fiber Disks, Blocks and Arches are milling blanks composed of a multi-directional interlacing of fiberglass and resin in several layers. They are intended to be used 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.

Device Story

Trilor Fiber Disks, Blocks and Arches are dental milling blanks consisting of multi-directional interlaced fiberglass and resin layers. Used by dental technicians and dentists in clinical or laboratory settings to fabricate copings, substructures, or frameworks for permanent and transitional anterior or posterior crowns and bridgework. The blanks are processed via CAD/CAM milling systems to create custom dental restorations. These restorations are then used for cemented or uncemented (e.g., telescopic) applications. The device provides a structural framework for dental prosthetics, benefiting patients by enabling the creation of durable, custom-fitted dental restorations.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Milling blanks composed of multi-directional interlaced fiberglass and resin layers. Form factor: disks, blocks, and arches. Intended for CAD/CAM dental milling processes. Class II device under 21 CFR 872.3690.

Indications for Use

Indicated for use by dental technicians and dentists to fabricate copings, substructures, or frameworks for permanent and transitional anterior or posterior crowns and bridgework, including cemented or uncemented (e.g., telescopic) restorations.

Regulatory Classification

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.

Submission Summary (Full Text)

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Bioloren S.R.L.

February 24,2018

Ratti Umberto CEO via Alessandro Volta 59 Saronno, VA 21047 Italy

Re: K173643

Trade/Device Name: Trilor Disks, Blocks and Arches Regulation Number: 21 CFR 872.3690 Regulation Name: Tooth Shade Resin Material Regulatory Class: Class II Product Code: EBF Dated: January 19, 2018 Received: January 26, 2018

Dear Ratti Umberto:

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.

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 of medical device-related adverse events) (21 CFR 803); good

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manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

# Sincerely. Mary S. Runner -S

Tina Kiang, Ph.D. Acting 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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# Indications for Use

510(k) Number (if known) K173643

Device Name Trilor Fiber Disks, Blocks and Arches

#### Indications for Use (Describe)

Trilor Fiber Disks, Blocks and Arches are milling blanks composed of a multi-directional interlacing of fiberglass and resin in several layers. They are intended to be used 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.

| Type of Use (Select one or both, as applicable) | |
|-------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------|
| <div> <span> <span style="text-decoration: overline;">X</span> Prescription Use (Part 21 CFR 801 Subpart D) </span> </div> | <div> <span> Over-The-Counter Use (21 CFR 801 Subpart C) </span> </div> |

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