CEREC BLOCS C IN

K123952 · Sirona Dental Systems GmbH · EIH · Mar 20, 2013 · Dental

Device Facts

• Record ID: K123952
• Device Name: CEREC BLOCS C IN
• Applicant: Sirona Dental Systems GmbH
• Product Code: EIH · Dental
• Decision Date: Mar 20, 2013
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.6660
• Device Class: Class 2

Indications for Use

Fabrication of Dental restorations using Sirona Dental CAD/CAM System.

Device Story

CEREC Blocs C In are industrially manufactured silicate glass ceramic blocks featuring a highly-chromatic dentine core and translucent enamel layer. Used in dental clinics, the blocks are mounted to a metal carrier, inserted into a Sirona CAD/CAM grinding machine, and milled into custom dental restorations (crowns/veneers). Final color appearance is achieved via stain and glaze firing. The device enables dentists to produce patient-specific restorations chairside, potentially reducing wait times for dental prosthetics.

Clinical Evidence

No clinical data. Bench testing only, specifically bending strength tests performed per ISO 6872:2008.

Technological Characteristics

Silicate glass ceramic block; composition includes SiO2 (55-65%), Al2O3 (17-24%), Na2O (5-9%), K2O (7-11%), B2O3 (0-2%). Mounted on metal carrier for grinding. Biocompatible per ISO 10993-1:2009. Bending strength 123 ± 18 MPa. CTE (20–500 °C) (9.3 ± 0.3)10^-6 K^-1. Density 2.36 g/cm³. Transformation range 620 ± 20 °C.

Indications for Use

Indicated for fabrication of veneers and crowns in anterior teeth and premolars (non-endodontically treated) using Sirona CAD/CAM system.

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

• Vita's Vitablocs® (K090644)
• Wieland Dental + Technik's Press X Zr (K070772)

Submission Summary (Full Text)

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

K123952

## 510(k) Summary

for

MAR 20 2013

# Sirona Dental Systems

# CEREC Blocs C In

1 Sponsor Sirona Dental Systems GmbH Fabrikstrasse 31

D-64625 Bensheim

Germany

Contact Person: Fritz Kolle

Telephone: [phone]

Date Prepared: December 20, 2012

#### 2 Device Name

Proprietary Name: CEREC Blocs C In

Common/Usual Name: Powder, Porcelain

Classification Name: Porcelain powder for clinical use

#### 3 Device Classification

21 CFR 872.6660, Product Code EIH

#### Predicate Devices 4

Vita's Vitablocs® (K090644) and Wieland Dental + Technik's Press X Zr (K070772)

Sirona Dental 510(k) Summary

December 20, 2012

Page 1 of 4

CEREC Blocs C In

APPENDIX G

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

#### 5 Intended Use

Fabrication of Dental restorations using Sirona Dental CAD/CAM System.

#### Indications for Use б

CEREC Blocs C In are indicated for the production of crowns and veneers using Sirona CAD/CAM system.

#### 7 Device Description

CEREC Blocs C In is an industrially manufactured, silicate glass ceramic block used to produce crowns and veneer. The block consists of an inlying, highly-chromatic dentine core and an overlying translucent enamel layer. It is grinded to custom made dental restorations using Sirona CAD/CAM systems. The block is initially manufactured in a sintered state; then, is individually processed to specification. 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.

CEREC Blocs C In are available in several colors and additional bleach color. The dental restorations obtain their individual color appearance by stain and glaze firing.

#### 8 Scientific Concept

The underlying scientific concept is

- · Processing dental restorations by Sirona Dental CAD/CAM System
- · Restorations are grinded from an CEREC C In by a Sirona CAM machine

#### Physical and Performance Characteristics 9

#### 9.1 Design

The design of the CEREC Blocs C In is described in section 7, Device Description.

#### 9.2 Material Used

CEREC C In ceramics constitute blocks comprised of silicate glass ceramic. One end plane of a block is mounted to a metal carrier that is inserted in the spindle's

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

clamping chuck of the grinding machine. The material is biocompatible according to ISO 10993-1: 2009, "Biological evaluation of medical devices -- Part 1: Evaluation and testing within a risk management process".

#### 9.3 Physical Properties

Final technical data of CEREC C In:

| Properties | Value |
|-------------------------------------------------------|-----------------------------|
| Coefficient of thermal expansion CTE<br>(20 – 500 °C) | $(9.3 \pm 0.3)10^{-6}$ K -1 |
| Density | 2.36 g/cm³ |
| Bending strength (ISO 6872) | 123 ± 18 MPa |
| Transformation range | 620 ± 20 °C |

#### Chemical Properties 9.4

| Component | % of Total Weight |
|-----------|-------------------|
| SiO2 | 55 - 65 |
| Al2O3 | 17 - 24 |
| Na2O | 5 - 9 |
| K2O | 7 - 11 |
| B2O3 | 0-2 |

Oxides, contained in very low concentrations and used e.g. for coloring, are not specified here.

Sirona Dental 510(k) Summary

CEREC Blocs C In

APPENDIX G

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

### 10 Summary of the technological characteristics

Sirona CEREC C In and Wieland Dental + Technik's Press X Zr are made of silicate glass ceramic. Chemical properties are similar. Sirona CEREC C In and Vita's Vitablocs® are block shaped. All devices meet the ISO 6872: 2008, "Dentistry --Ceramic materials". Physical properties are similar for all devices.

### 11 Nonclinical Testing

Bending strength tests have been performed.

### 12 Clinical Testing

Clinical tests have not been performed.

### 13 Conclusion

Based on the overall comparison of indications for use, contra-indications, material properties and processing/fabrication, Sirona Dental Systems believes that the CEREC blocs C In are substantially equivalent to Vita`s Vitablocs® (K090644) and Wieland Dental + Technik's Press X Zr (K070772).

Sirona Dental 510(k) Summary

December 20, 2012

CEREC Blocs C In

APPENDIX G

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

Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES · USA" arranged around the perimeter. Inside the circle is a stylized symbol that resembles an eagle or bird in flight, with three curved lines representing its wings or feathers.

Public Health Service

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

March 20, 2013

Mr. Fritz Kolle Sirona Dental Systems GmbH Fabrikstrasse 31 Bensheim, Germany D-64625

Re: K123952

Trade/Device Name: CEREC Blocs C In Regulation Number: 21 CFR 872.6660 Regulation Name: Porcelain Powder for Clinical Use Regulatory Class: II Product Code: EIH Dated: December 20, 2012 Received: December 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.

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

Page 2 - Mr. Kolle

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,

Image /page/5/Picture/7 description: The image shows the name "Kwame O. Ulmer" with the letters "KO" in a stylized font. The word "for" is written in a smaller, simpler font to the right of the name. The name is likely associated with a campaign or organization, given the presence of the word "for."

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

{6}------------------------------------------------

123952 510(k) Number (if known):

Device Name: _ CEREC Blocs C In

Indications for Use:

CEREC blocs C In are indicated for the fabrication of veneers and of crowns in anterior teeth and in premolars that have not been endodontically treated, using the Sirona CAD/CAM system.

Prescription Use X (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)

Mary, S. Runner -S 013:03.19 005 PM ( E 3:53:46 -04'00'

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

510(k) Number:

Sirona Dental Systems 510(k) CEREC C In

December 20, 2012

Page v