TIZIAN BLANK, TIZIAN ZIRCONIUM REINFORCED COMPOSITE BLANK, TIZIAN COLOR BLANK, TIZIAN BLANK OCCLUSAL, TIZIAN BLANK TRANS

K133268 · Schutz-Dental GmbH · EBG · Feb 12, 2015 · Dental

Device Facts

• Record ID: K133268
• Device Name: TIZIAN BLANK, TIZIAN ZIRCONIUM REINFORCED COMPOSITE BLANK, TIZIAN COLOR BLANK, TIZIAN BLANK OCCLUSAL, TIZIAN BLANK TRANS
• Applicant: Schutz-Dental GmbH
• Product Code: EBG · Dental
• Decision Date: Feb 12, 2015
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3770
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Tizian Blank Zirconia Reinforced Composite is made of a composite material reinforced with zirconium dioxide. The blanks can be processed with CAD/CAM technology. Optionally, the blanks can be veneered with a composite or with a monolithic material. Applications are: 1) long-term temporaries (for up to 2 years) - up to 16-unit anterior and posterior crowns and bridges, fully anatomic or reduced - only up to 2 bridge units in the posterior sector - free-end bridges with no more than one attachment 2) small permanent restorations (those must be veneered with an incisal material) - individual crowns - inlays - onlays - veneers - bridges with a maximum of 3 units.

Device Story

Tizian Blank Zirconia Reinforced Composite consists of composite material reinforced with zirconium dioxide; supplied as blanks for CAD/CAM processing. Used by dental professionals to fabricate long-term temporary restorations (up to 2 years) or small permanent restorations (veneered with incisal material). CAD/CAM technology transforms blanks into anatomical shapes; final restorations placed in patient mouth to restore function/aesthetics. Benefits include durability of zirconia-reinforced composite for extended temporary use or specific permanent applications.

Clinical Evidence

Bench testing only.

Technological Characteristics

Composite material reinforced with zirconium dioxide. Form factor: CAD/CAM blanks. Intended for milling/processing via CAD/CAM systems. Class II device per 21 CFR 872.3770.

Indications for Use

Indicated for patients requiring long-term temporary (up to 2 years) anterior/posterior crowns and bridges (up to 16 units) or small permanent restorations (individual crowns, inlays, onlays, veneers, or bridges up to 3 units).

Regulatory Classification

Identification

A temporary crown and bridge resin is a device composed of a material, such as polymethylmethacrylate, intended to make a temporary prosthesis, such as a crown or bridge, for use until a permanent restoration is fabricated.

Submission Summary (Full Text)

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

February 12, 2015

Schuetz Dental GmbH Mrs. Anke Puent Secretary Dieselstr. 5-6 61191 Rosbach GERMANY

Re: K133268

Trade/Device Name: Tizian Blank Zirconia Reinforced Composite Regulation Number: 21 CFR 872.3770 Regulation Name: Temporary Crown and Bridge Resin Regulatory Class: II Product Codes: EBG Dated: November 13, 2014 Received: November 17, 2014

Dear Ms. Puent:

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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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 [phone] or [phone] 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/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/ResourcesforYou/Industry/default.htm.

Sincerely yours.

Tina Kiang
-s

for Erin I. Keith, M.S. 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): K133268

## Device Name: Tizian Blank Zirconia Reinforced Composite Indications for Use:

Tizian Blank Zirconia Reinforced Composite is made of a composite material reinforced with zirconium dioxide. The blanks can be processed with CAD/CAM technology. Optionally, the blanks can be veneered with a composite or with a monolithic material. Applications are:

- 1) long-term temporaries (for up to 2 years)
- up to 16-unit anterior and posterior crowns and bridges, fully anatomic or reduced o
- only up to 2 bridge units in the posterior sector o
- free-end bridges with no more than one attachment O
- 2) small permanent restorations (those must be veneered with an incisal material)
- individual crowns o
- o inlavs
- onlays O
- veneers o
- bridges with a maximum of 3 units. O

Prescription Use X (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)

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