FIBER DISK AND BLOCK PERMANENT, TRINIA

K121735 · Bioloren S.R.L. · EBF · Feb 21, 2013 · Dental

Device Facts

• Record ID: K121735
• Device Name: FIBER DISK AND BLOCK PERMANENT, TRINIA
• Applicant: Bioloren S.R.L.
• Product Code: EBF · Dental
• Decision Date: Feb 21, 2013
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3690
• Device Class: Class 2

Intended Use

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.

Device Story

TRINIA Fiber Disks and Blocks are milling blanks consisting of multi-directional interlaced fiberglass and resin layers. Used by dental technicians and dentists in a dental laboratory or clinical setting to fabricate dental frameworks, copings, and substructures for crowns and bridges. The blanks are processed via CAD/CAM milling systems to create custom-fit dental restorations. These restorations serve as the structural foundation for permanent or transitional anterior and posterior teeth. The device provides a metal-free alternative for dental prosthetics, potentially improving patient comfort and aesthetics.

Clinical Evidence

Bench testing only.

Technological Characteristics

Milling blanks composed of multi-directional interlaced fiberglass and resin layers. Form factor: disks and blocks. Intended for CAD/CAM dental milling processes.

Indications for Use

Indicated for 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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## DEPARTMENT OF HEALTH & HUMAN SERVICES

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## Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

February 21, 2013

Mr. Andrea Ratti General Manager Bioloren Srl Via Alessandro Volta 59 Saronno. VA Italy 21047

Re: K121735

Trade/Device Name: Fiber Disk And Block Permanent, Trinia Regulation Number: 21 CFR 872.3690 Regulation Name: Tooth Shade Resin Material Regulatory Class: II Product Code: EBF Dated: January 11, 2013 Received: February 6, 2013

Dear Mr. Ratti:

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. Ratti

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 go to http://www.fda.gov/AboutFDA/Centers0ffices/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/ReportaProblem/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 [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Susan Runner, DDSMA

Mary S. Runner -

S
2013.02.27
15:05:45-05'00'

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

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## Indications for Use

510(k) Number (if known): K121735

Device Name: Fiber Disks and Blocks (TRINIA) Indications for Use:

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.

× Prescription Use (21 CFR Part 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR Part 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Mary S. Runner
Susan Runner, DDS, MA 2013.02.21 08:12:38
Division Sign-Off
-05'00'

(Division Sign-Off) Division of Anesthestology, General Hospital Infection Control, Dental Devices

510(k) Number: K121735

8, General Mes 1. 24/2020

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