INCORIS TZI

K123545 · Sirona Dental Systems GmbH · EIH · Feb 1, 2013 · Dental

Device Facts

• Record ID: K123545
• Device Name: INCORIS TZI
• Applicant: Sirona Dental Systems GmbH
• Product Code: EIH · Dental
• Decision Date: Feb 1, 2013
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.6660
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Classic and Speed Sintering: Fully anatomic crowns and bridges in the posterior and anterior tooth region. Bridges with max. two pontics. Super Speed Sintering: Fully anatomic crowns.

Device Story

inCoris TZI consists of partially sintered zirconia ceramic (ZrO2) blocks used to fabricate dental restorations. Blocks are mounted to a metal carrier and processed via Sirona CAD/CAM grinding systems. Restorations are colored by dipping in liquid prior to final dense sintering. Used in dental clinics/labs by dental professionals. Final restorations provide high-strength, biocompatible dental prosthetics for patients. Benefits include customized fit and material durability.

Clinical Evidence

No clinical data. Bench testing only, including sintering tests to verify mechanical properties (density, fracture toughness, thermal expansion, bending strength) and material composition analysis.

Technological Characteristics

Material: Yttria-stabilized tetragonal zirconia (Y-TZP) (ZrO2 ≥ 99.9%, Y2O3 5.4%). Form factor: Block. Standards: ISO 6872:2008, ISO 13356:2008, ISO 10993-11:2009. Mechanical properties: Density 6.08 g/cm3, Fracture toughness 6.4 MPa m1/2, Bending strength > 900 MPa. Processing: CAD/CAM grinding and sintering.

Indications for Use

Indicated for patients requiring fully anatomic crowns and bridges in the posterior and anterior tooth region, including bridges with a maximum of two pontics, using classic or speed sintering, or fully anatomic crowns using super speed sintering.

Regulatory Classification

Identification

Porcelain powder for clinical use is a device consisting of a mixture of kaolin, felspar, quartz, or other substances intended for use in the production of artificial teeth in fixed or removable dentures, of jacket crowns, facings, and veneers. The device is used in prosthetic dentistry by heating the powder mixture to a high temperature in an oven to produce a hard prosthesis with a glass-like finish.

Predicate Devices

• Glidewell's Prismatik™ Clinical Zirconia (Prismatik™ CZ) (K060104)

Submission Summary (Full Text)

{0}------------------------------------------------

K123545

# FEB 0.1 2013

## 510(k) Summary for Sirona Dental Systems inCoris TZI

#### Sponsor 1.

Sirona Dental Systems GmbH Fabrikstrasse 31 D-64625 Bensheim Germany Contact Person: Fritz Kolle Telephone: [phone] Date Prepared: November 16, 2012

#### 2. Device Name

Proprietary Name: inCoris TZI

Common/Usual Name: Powder, Porcelain

Classification Name: Porcelain powder for clinical use

#### 3. Predicate Devices

Glidewell's Prismatik™ Clinical Zirconia (Prismatik™ CZ) (K060104)

#### 4. Intended Use

### Classic and Speed Sintering:

Fully anatomic crowns and bridges in the posterior and anterior tooth region. Bridges with max. two pontics.

### Super Speed Sintering:

Fully anatomic crowns.

Sirona Dental Systems 510(k) inCoris TZI

APPENDIX F

Page I

{1}------------------------------------------------

#### 5. Device Description and Function

The inCoris TZI are blocks of various sizes from which custom made dental restorations are grinded using Sirona CAD/CAM system. inCoris TZI ceramics constitute blocks comprised of zirconia ceramics (Zr)2). The blocks are initially manufactured in a partially sintered state; then, they are individually processed to specification, and finally, densely sintered. One end plane of a block is mounted to a metal carrier that is inserted in the spindle's clamping chuck of the grinding machine. Grinded restorations are colored by dipping the restoration in color liquid prior final sintering.

#### 6. Scientific Concept

The underlying scientific concept is

- . Processing dental restorations by Sirona Dental CAD/CAM System
- . Restorations are grinded from an inCoris TZI block by a Sirona CAM machine
- . Different sintering time to gain appropriate material properties

#### 7. Physical and Performance Characteristics

### 7.1. Design

The design of the inCoris TZI is described in section 5, Device Description and Function.

### 7.2. Material Used

inCoris TZI ceramics constitute blocks comprised of zirconia ceramics (ZrO2). One end plane of a block is mounted to a metal carrier that is inserted in the spindle's clamping chuck of the grinding machine. The material is biocompatible according to ISO 10993-11: 2009, "Biological evaluation of medical devices -- Part 1: Evaluation and testing within a risk management process".

### 7.3. Physical Properties

Final technical data of densely sintered inCoris TZI.

| Density: | 6.08 g cm-3 |
|-------------------------------------------------|-----------------|
| Fracture toughness KIC | 6.4 MPa m1/2 |
| Thermal expansion coefficient<br>(20 - 500 °C): | 10.4 x 10-6 K-1 |
| Bending strength: | > 900 MPa |

Sirona Dental Systems 510(k) inCoris TZI

APPENDIX F

{2}------------------------------------------------

### 7.4. Chemical Properties

| Component | inCoris TZI1) |
|----------------|---------------|
| ZrO2+HfO2+Y2O3 | ≥ 99.9% |
| Y2O3 | 5.4% |
| Al2O3 | ≤ 0.35% |
| Fe2O3 | ≤0.01% |
| Other oxides | ≤ 0.2% |

3/Values of colored restorations.

#### 8. Summary of the technological characteristics

Sirona inCoris TZI and Glidewell's Prismatik™ Clinical Zirconia (Prismatik™ CZ) are made of zirconia ceramics' (ZrO2). inCoris TZI is block shaped whereas Glidewell's Prismatik™ Clinical Zirconia is disk shaped.

Both devices meet ISO 6872: 2008, "Dentistry -- Ceramic materials" and ISO 13356: 2008, "Implants for surgery, Ceramic materials based on yttria-stabilized tetragonal zirconia (Y-TZP)". Physical and chemical properties are similar.

#### 9. Nonclinical Testing

Sintering tests have been performed which show that the mechanical properties are appropriate for the indications for use.

### 10. Clinical Testing

Clinical tests have not been performed.

#### 11. Conclusion

Based on the comparison of intended use, indications, contra-indications, material properties and processing/fabrication, Sirona Dental Systems believes that the InCoris TZI blocks are substantially equivalent to Glidewell's Prismatik™M Clinical Zirconia (Prismatik™ CZ) (K060104).

Sirona Dental Systems 510(k) inCoris TZI

· APPENDIX F

Page 3

{3}------------------------------------------------

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird-like figure, composed of three curved lines that suggest wings or feathers. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the bird symbol.

### Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002

### February 1, 2013

Mr. Fritz Kolle Quality Management/Regulatory Affairs Sirona Dental Systems, GmbH Fabrikstrasse 31 Bensheim Germany D-64625

Re: K123545

Trade/Device Name: inCoris TZI Regulation Number: 21 CFR 872.6660 Regulation Name: Porcelain Powder for Clinical Use Regulatory Class: II Product Codes: EIH Dated: November 16, 2012 Received: November 21, 2012

### Dear Mr. Kolle:

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.

{4}------------------------------------------------

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 devicerelated 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/CentersOffices/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,

Anthom Dr. m

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

{5}------------------------------------------------

510(k) Number (if known):

11/23545

Device Name: ____________inCoris TZI

Indications for Use:

Classic and Speed Sintering: Fully and Spece Shirermise
Fully anatomic crowns and bridges in the posterior and anterior tooth region. Bridges with max. two pontics.

Super Speed Sintering: Fully anatomic crowns.

Prescription Use _____________________________________________________________________________________________________________________________________________________________ (Part 21 CFR 801 Subpart D) OR

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

(Please do not write below this line - continue on another page if necessary)

| Concurrence of CDRH, Office of Device Evaluation (ODE) | |
|--------------------------------------------------------|------------------------------|
| | Andrew I. Steen |
| | 2013.02.01 08:55:20 -05'00' |
| | Sirona Dental Systems 510(k) |
| | November 16, 2012 |
| (Division Sign-Off) | |
| Division of Anesthesiology, General Hospital | inCoris TZI |
| Infection Control, Dental Devices | |
| 510(k) Number: | K123.545 |
| | Page v |